Shashidar Reddy Abbidi is a Senior Manager in Clinical Data Management with over 8 years of experience spearheading data management activities for global clinical trials. He specializes in managing the complete data lifecycle, ensuring data quality and integrity from protocol review through final analysis. As a leader, he is passionate about building and mentoring teams to excel in a dynamic and highly regulated environment. His strategic approach has been instrumental in the successful delivery of clean, reliable data for numerous clinical programs.

Laura Acosta, VP of Product Management for Anju's eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further. 

Lyn Agostinelli brings over 35 years of experience in the life science industry and clinical practice as a registered nurse. She has extensive experience managing clinical programs in pharmaceutical and device companies. Lyn has proven clinical and project management skills in both industry and academic settings. Her experience extends into clinical quality assurance where she has worked with clients on the development and implementation of quality systems and inspection readiness activities. She has worked with sponsors to virtualize their studies. Lyn’s diverse therapeutic experience includes cardiology, COVID-19, neuromodulation, asthma/allergy, Duchenne muscular dystrophy, hereditary hemophilia, and diabetes. Such a versatile background is sought by early-stage and venture-backed companies to understand what is feasible in the clinic. Lyn has experience as a Clinical Manager at Boston Scientific (BS) where she developed a remote monitoring group, implemented processes to govern the functions, and managed CRAs performing these activities. While at BS, Lyn led a cross-functional team of manager- and director-level staff to align clinical processes with corporate quality master plans. She was also a Clinical Affairs Manager at AAIPharma and oversaw the day-to-day activities of Research Associates and CRAs. She also held interim project management roles ensuring projects were executed on time and within budget. Lyn earned a Bachelor of Science in Nursing (BSN) from the University of New Hampshire.

Ryan Ahern, MD, MPH, is the Chief Medical Officer and co-founder of Truveta with more than a decade of experience in healthcare data and clinical research. At Truveta, Ryan leads the Life Science Partner team which focuses on developing new partnerships and ensuring those partners are successful in their research. He is currently a Clinical Assistant Professor of Medicine at the University of Washington School of Medicine and practices at Harborview Medical Center, Seattle’s large county hospital. Prior to this, he trained in internal medicine at the Massachusetts General Hospital and has served as a Clinical Assistant Professor of Medicine at Weill Cornell Medical Center and New York Presbyterian; attending physician at Massachusetts General Hospital and instructor at Harvard Medical School.

Amreen Ahmed is Director of Product Management at IQVIA Laboratories Digital Technologies, leading the Labmatrix Product team. With over 10 years of experience in clinical research technology, she focuses on delivering innovative technology solutions that streamline trial operations and data integration.

Angel Akinbinu, Director of Trial Equity & Representation at Takeda Pharmaceuticals, is a recognized leader in advancing diversity, equity, and inclusion (DEI) in clinical trials. With extensive experience spanning roles in CROs and large pharmaceutical organizations, she has contributed to multiple therapeutic areas. Over the past several years, Angel has distinguished herself as a driving force behind efforts to improve representation and access for underrepresented patient populations, ensuring more equitable healthcare outcomes through innovative strategies and impactful implementation. Her expertise makes her a vital advocate for inclusive clinical research.

Director, Head of COA and Patient Innovation, Regeneron, Rinol’s professional focus is centered around integrated innovation, design thinking, and clinical operation with 15+ years of experience in startup and pharma industry. Savvy, results-oriented leader with proven success in transforming and building eCOA organizations from the ground up. In his current role, he leads Clinical Outcome Assessment and Patient Innovation team within Regeneron pharmaceutical.

Melody Aldred, is an experienced clinical research operations leader with over ten years of expertise across a range of roles and therapeutic areas within the pharmaceutical industry globally and within country. As Study Director Community Lead of the Outsourced Trials Community in Global Clinical Operations at Novartis, Melody oversees the execution and delivery of complex clinical trials strategically outsourced and/or acquired across the Development portfolio. She has diverse and in-depth expertise in clinical operations and is a driver of continuous improvement in study operations with a talent for simplifying and communicating complex scientific and medical concepts, elevating collaboration and innovation among study leaders and cross-functional teams. She has led successful initiatives to refine trial team models directly impacting operational efficiency and knowledge sharing. Previously, Melody held various roles of increasing responsibilities and accountabilities, where she built and mentored high-performing teams, streamlined site start-up processes, and strengthened vendor partnerships. Her career includes pivotal roles in project management, contract negotiations, and clinical trial coordination, with a focus on empowering teams and advancing research outcomes. Melody holds a Ph.D. in Toxicology from Rutgers University and UMDNJ, complemented by industry certifications in clinical research and project management.

Demissie Alemayehu is Vice President of Biostatistics at Pfizer. He has over 25 years of leadership experience in the pharmaceutical industry. He has been influential externally, with decades of research and teaching experience at major institutions. He has held important offices at key professional societies and has served on editorial boards of major journals. Demissie has published extensively in refereed journals and has co-authored or edited three monographs. He is a Fellow of the American Statistical Association and holds a Ph.D. degree in Statistics from the University of California at Berkeley.

Tyler A. Allen, PhD is Program Leader for Clinical Research Representation at the Duke Cancer Institute. In this role, he leads institutional efforts to strengthen enrollment of all patient populations in cancer clinical trials through strategy development, protocol review, community partnerships, and investigator support. Dr. Allen bridges scientific expertise with operational and community engagement approaches to advance more representative and impactful cancer research.

Andrés Álvarez, MD, PhD is Executive Director of the Clinical Trials Division at Baptist MD Anderson Cancer Center, leading research strategy and innovation in partnership with MD Anderson (Houston). With over 20 years in translational medicine, oncology, and neuroscience, he has advanced high-impact clinical trials, secured competitive funding, and built strategic partnerships across pharma, biotech, academia, and health systems. His work focuses on health equity, oncology innovation, bioethics, and integrating AI into clinical research.

With nearly a decade in clinical research, Scott is dedicated to expanding inclusivity and access for all patients in clinical trials. At Science 37, he leads the Strategic Solutioning team, partnering with sponsors to advance clinical research through a Direct-to-Patient site model that enables participation from home, boosting convenience and broadening access for diverse populations.

Katrina Arceta, Associate Director, Category Management for Clinical Conduct Services in R&D Procurement, Astellas Pharma US, Inc.

Dr. Armstrong has 28+ years' experience in the CRO industry leading Project Management and Clinical Operations and is currently SVP and Global Head of the Neuroscience Business Unit at Premier Research. Her therapeutic area expertise, across all phases of development, specializes in psychiatry and neurology indications such as ADHD, Schizophrenia, MDD, Bipolar Mania, SAD, GAD, PTSD, OCD, Autism, Binge Eating Disorder, Substance Use Disorders, Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Stroke, and Pain.

Stacey is an innovative solution provider with over 25 years of global clinical development experience across a broad range of therapeutic areas, clinical phases, and outsourcing models. Beginning his career in Biometrics, Stacey has held numerous leadership positions of increasing responsibility over various functional areas for Advanced Clinical and other contract research organizations (CROs). He enjoys partnering with and leading teams to make a positive difference and adding value. Stacey is passionate about improving lives and providing hope for all those involved in the clinical research and product development ecosystem.

Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform, that helps them maximize the impact of research data on patient lives. Dr. Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.

As the Director of Decentralized Solutions, Kelli brings a strategic approach to trial design and execution, working closely with cross-functional teams to ensure that studies are efficient, effective and consistent with the needs of both sponsors and participants. Kelli is a passionate advocate for patient-centric research and is dedicated to advancing the field of decentralized trial solutions through ongoing innovation and collaboration. With more than 17 years with IQVIA Laboratories with roles in project management, project setup, line management and IT, Kelli's career reflects a passion for process and systems improvement.

Stefan is a Sr. Principal Scientist within J&J Innovative Medicine Research & Development where he has worked since 2017. Stefan's work focuses on digital measurement in clinical trials and his experience spans clinical study design, digital health technology evaluation, statistical data analysis, and sensor algorithm development. Stefan holds a PhD in Computational Biology & Bioinformatics from Yale University.

Munther Baara is the product strategy and innovation lead as well as EDETEK’s major industry partnerships. Munther has 25 years of experience in leading the development of numerous clinical systems and business solutions. He has held roles of increased seniority in biotechnology and in the world’s largest pharmaceutical companies, leading global teams and technology implementations. Munther’s experience has been focusing on innovation, trends and emerging technologies in support of the paradigm shift in the execution of clinical trials. Munther was most recently the head of New Clinical Paradigm at Pfizer where he led and/or contributed to transformative technological breakthroughs. Munther also worked on mClinical patient journey (mobile and sensor), blockchain, returning data to patients, Shared Investigator Platform (SIP), clinical aggregation layers, eSource (Industry-Pioneering EHR Data Transfer) and TransCelerate BioPharma Projects. Also, he was awarded the 2018’s Top 20 Innovators in clinical trial advancements by CenterWatch.

Ian Bailey is the Managing Director of AI & Data Science Analytics at Advarra, where he leads strategy and commercialization for AI and data solutions that enhance study design and clinical operations. He has extensive experience in clinical research technology and more than fifteen years in enterprise data and software, helping organizations bridge the gap between innovation and execution. His work focuses on transforming diverse clinical and operational data sources into actionable intelligence that drives more efficient, inclusive, and scientifically sound trials.

Doug Bain is a seasoned technology executive and product strategist with over 20 years of experience driving digital transformation in clinical research. As Founder of ClinFlo, he partners with biopharma sponsors and technology innovators to design scalable platforms, modernise trial infrastructure, and guide the responsible integration of AI. He previously served as Chief Technology Officer at KCR, where he led clinical platform strategy, cloud migration, and the development of enterprise AI initiatives. Earlier in his career, Doug founded eClinicalHealth and architected Clinpal, one of the first decentralized trial platforms. He has held senior leadership roles at Medidata, IBM, and other global organisations, contributing to industry-defining advances in EDC, CTMS, and standards-based integration. A frequent speaker and session chair at international conferences, including DIA, SCOPE, and the Veeva R&D Summit, Doug is recognised for combining deep domain expertise with a pragmatic approach to innovation, always focused on usability, compliance, and operational value.

Sowmya Ballakur is Vice President of Product for Oracle Life Sciences, where she leads product strategy and management, driving innovation to advance trials, safety, and commercialization solutions for global pharma and biotech customers. She brings more than 15 years of experience driving product leadership across SaaS, healthcare technology, and life sciences, with a proven track record of scaling products, accelerating revenue growth, and building high-performing teams. Prior to Oracle, Sowmya held senior leadership roles at Proscia, Tempus AI, Memorial Sloan Kettering Cancer Center, and Amazon, where she launched and scaled transformative digital health, precision medicine, and patient care solutions. She holds a Ph.D. in Biomedical Engineering from Pennsylvania State University and an MBA from Cornell University.

Valerie Balosso is Director for Infectious Disease for GlaxoSmithKline with 15 years of experience in pharmaceutical industry and specifically in Data Management. She has a large experience in selection, set up and management of collaboration with CRO in the Data Management and ePRO area. Valerie has a specific interest for new technologies including Artificial Intelligence/Machine Learning, Decentralized Clinical Trail and Team engagement.

Innovative IT Professional with experience as a Program Manager, Business Analyst, Project Manager, Solution Architect, Account Manager, Principal Instructor, Systems Engineer, Team Leader, and Manager.

Specialties: Academic Medical Center and Medical School Policy and Management, Clinical Translational Research Policy and Administration, Clinical Research Barriers, Emergency Preparedness, Bioinformatics, Health IT, Healthcare Delivery Systems, Hospital Payment Systems, Health Economics, Healthcare Finance and Economics, Government Relations, Healthcare Quality Improvement, Strategic Communications, Web Devolpment, Health centers, Clinical Quality Measures, Grant and Program management, Financial Analysis, Performance Measures, and Program Management.

As a Clinical Innovation and Digital Solutions Lead at UCB, Shelly leads initiatives that integrate novel digital solutions with forward-thinking study execution models. Her work focuses on reimagining how trials are designed and delivered, bridging operational excellence with innovation to drive measurable impact across patient engagement, data quality, and regulatory alignment. With a cross-functional lens, Shelly champions scalable solutions that not only modernize clinical research but also enable sustainable change across global development programs. Shelly is based in Raleigh, NC, USA.

Eliav Barr is senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories (MRL). He leads all late-stage clinical development for Merck’s Human Health portfolio and pipeline. Prior to his current role, Barr led MRL’s global medical and scientific affairs organization expanding Merck’s scientific engagement and implementation efforts in oncology, vaccines and infectious diseases. Since joining Merck in 1995, Barr has held positions of increasing responsibility including leadership roles in oncology and infectious diseases clinical development. Previously, he served as the therapeutic area head for infectious diseases and managed product development teams across oncology and infectious diseases. Prior to joining Merck, he held a faculty position at the University of Chicago. Barr is a cardiologist by training. He received his undergraduate degree from the Pennsylvania State University and his medical degree from Thomas Jefferson University. He completed his internal medicine residency and cardiology fellowship at Johns Hopkins University and subsequently pursued post-doctoral training at the University of Michigan. In 2019, he was a proud recipient of a Penn State Alumni Fellow award for his dedication to the development of medicines and vaccines that treat and prevent infectious diseases. Recognized as a leader giving voice and visibility to the LGBTQ+ community in science, Barr was named to Endpoints News’ 2023 LGBTQ+ biopharma leaders list. He also currently serves as the executive sponsor of Merck’s 3,400-member Rainbow Alliance employee business resource group.

Professor Dr. Dorothee B. Bartels is a trained epidemiologist (Harvard School of Public Health, PhD and Habilitation Hannover Medical School), senior thought leader in (pharmaco)epidemiology, Real World Data (RWD) strategies, and evidence generation, both, based on established methods and (gen)AI. After several senior global leadership roles in the pharmaceutical industry, she moved into the innovative-digital space, i.e. in the innovation hub of Boehringer Ingelheim as Chief Digital Science Officer, to X, Moonshot (Alphabet) as Clinical and Real World Strategy Lead, and to Aetion (a software company analyzing claims/EHR) as Chief Digital Officer. Dorothee is founder of HeDa (HealthData)-Advisors, providing strategic and execution advice for real world data insights and evidence generation. She holds several board positions and is teaching on a regular basis advanced pharmacoepidemiology in academia.

Clinical operations leader at Sanofi specializing in Oncology and Immunology trials. 20+ years driving operational excellence from data management to global project leadership. MD with strong technical foundation. Passionate about delivering quality clinical programs that advance patient care.

Monica Bartucci, PharmD, PhD, has built her career in drug development, clinical research, and regulatory writing, with extensive experience across both industry and academic settings. Currently serving as Associate Director of Clinical Capabilities at Bristol-Myers Squibb, she leads initiatives in digital data flow, AI automation, and process improvement, driving innovation and operational excellence. Her background includes work in translational research, regulatory and scientific writing, mentoring and educational programs. She has held research roles at the Italian NIH and the Rutgers Cancer Institute of New Jersey, managing teams and working on oncology drug discovery. Her academic credentials include a PhD in Biochemistry and Drug Development, a Master’s in Clinical Pathology, and a PharmD. Monica is recognized for her strategic thinking, collaborative leadership, and dedication to quality, innovation and continuous improvement.

Tuba is a Senior Director at Clinical Center of Excellence (CCoE) team as Clinical Capabilities Lead, serving as Global Process Owner for Clinical Protocol Development Process. Some of the highlights from her work are leading cross-functional teams to success for process improvement activities and contributing to organizational excellence. Prior to her role at CCoE, Tuba was a Senior Clinical Development Scientist at BMS Melanoma Program providing scientific leadership and expertise to execute clinical trial activities. Before joining BMS Tuba served as Lead Clinical Scientist at Merck for the Keytruda Lung Program leading her teams to successful global approvals. She was also the Data Monitoring Committee (DMC) coordinator for the Oncology Lung Program. Before her career at Merck, Tuba served as a Postdoctoral Research Scientist at EMD Serono in Translational and Biomarker Research, and Research Fellow at two different academic institutions, the Albert Einstein College of Medicine Cancer Center and Biomedical Engineering Department at Worcester Polytechnic Institute. Tuba has a Bachelor’s degree in Chemistry and Master’s degree in Environmental Sciences from Bogaziçi University, and earned a PhD in Biomedical Sciences from the University of Massachusetts Medical School based on her work in the laboratory of Nobel Laureate, Craig C. Mello, identifying new components of the Wnt signaling pathway in C. elegans; and her work in Kobertz Lab on glycobiology that provided a new biogenic mechanism for channelopathies. In the course of her academic and pharmaceutical career, Tuba has published extensively over a variety of diverse topics including organic chemistry, intracellular signaling pathways, animal models, hematopoietic stem cell physiology, NSCLC, and melanoma. In her spare time, Tuba enjoys traveling, plenty of outdoor activities (hiking, swimming, playing tennis), gaming (computer and board), learning (clarinet, piano, new concepts/languages), reading Sci-Fi books, and socializing with friends and family. Tuba is a happy puppy mom; and she loves spending time with her pup, “Lucky.”

Benjamin Bayes joined AstraZeneca as Associate Director, Risk-Based Quality Management (RBQM) in January 2022 with 20 years experience in the pharmaceutical industry. He has worked in the contract research organization (CRO) setting as well as sponsor companies in both Clinical Data Management and Centralized Monitoring. His main area of expertise is in oncology, in both early and late phase but he has also overseen studies in infectious, cardiovascular and chronic kidney disease. He brings experience in the development, implementation and monitoring of key risk indicators (KRI’s), critical to quality (CtQ) factors and quality tolerance limits (QTLs).

As Director of Patient Engagement at The Michael J. Fox Foundation (MJFF), Eda focuses on advancing the Foundation's patient-centric mission through patient engagement in research to accelerate progress toward a cure for Parkinson's Disease. She works in a patient engagement team that forges partnerships with patients, research volunteers, industry and academic scientists, and the online smart-match tool Fox Trial Finder to increase the flow of participants into Parkinson's disease clinical trials. Eda started her career as a biophysicist but driven by her interest in creating an impact through science to advance community health, patient advocacy, and education, she switched careers to work in nonprofits and healthcare. She holds a Ph.D. in Physics and an MS in Biotechnology and Physics Education. In her free time, she enjoys hiking, listening to podcasts, reading, and traveling with her husband and daughter.

Amanda Beasley is a Director in the Representation in Clinical Research (RISE) team at Amgen. She has been working in preclinical and clinical research for almost 20 years. She holds a Master's degree in Clinical Research Administration and a Doctorate in Human Services. Amanda's passion to support marginalized and underrepresented individuals paired with her many years of study operations experience help to move the RISE vision and mission forward to drive proportional representation in clinical research and eliminate systemic barriers to participation. She specializes in collaborating cross-functionally to build internal infrastructure to make representative studies a part of Amgen’s everyday work. She also works outside of Amgen’s walls partnering with organizations that work directly in the communities where these people live, work, play, and pray to build sustainable presence and trust.

Liz Beatty is the Co-founder and Chief Strategy at Inato, the global technology company on a mission to bring clinical research to all patients, regardless of where they live. Liz is focused on advancing Inato’s corporate strategy, including efforts to promote diverse patient representation in clinical research as well as developing partnerships and driving growth globally. Previously, Liz headed digital clinical trials at Bristol-Myers Squibb, where she held various roles across clinical operations including site management, protocol management, recruitment and retention, and most recently digital innovation. She began her career as a clinical research coordinator at the Yale Multiple Sclerosis Research Center, bringing a unique site and sponsor perspective.

Jimmy Bechtel is the Society for Clinical Research Sites' (SCRS) Vice President of Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter, and operations manager. On the pharma side where he worked in innovation project management, Jimmy utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Jimmy to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Jimmy is in charge of developing and executing the company's site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. Additionally, Jimmy drives the implementation the Membership department’s site-focused operations as well as design and marketing.

I serve as Senior Advisor for Clinical Research at the National Cancer Institute. In my time at the NCI I have worked with the Office of the NCI Director and with the Center for Biomedical Informatics and Information Technology (CBIIT) on initiatives focused on oncology clinical trial modernisation particularly around the IT support for clinical trials, developing a public-private partnership to support NCI funded trials and on ways to incorporate novel tools for data collection, such as decentralised and pragmatic methods. I have been involved in national initiatives including the Cancer White House Moonshot, CancerX and the Bloomberg International Cancer Coalition.

Passionate Leader dedicated to transforming clinical development through digital innovation. With deep expertise in applying digital technologies across biopharmaceutical R&D and proven track record of delivering impactful results in dynamic environments. Goal is to help shape a future where clinical development is faster, smarter, and more connected—ultimately accelerating the delivery of life-changing medicines to patients.

With 15+ years of experience applying data and AI to complex decision-making, Jef has led the design and scaling of multiple AI-driven products across clinical trial design, feasibility, patient matching, EMR-to-EDC workflows, and performance monitoring—most recently at ConcertAI and Medidata AI before joining Veridix. Prior to life sciences, Jef led predictive modeling and machine learning initiatives at AIG and implemented tech solutions at Deloitte Consulting. He holds an MBA from the MIT Sloan School of Management and a BS from the University of Virginia.

At SCOPE, Jef will share lessons learned, practical insights, and client success stories from deploying a scaled AI solution for clinical study document authoring covering protocols, CSRs, SAPs, manuscripts and operational plans.

Jamie Bendrick-Peart joined AstraZeneca as the Sr. Director Innovation & Strategic Projects in July 2024 with more than 25 years of industry experience. Jamie began her career in 1998 as a bench scientist specializing in pharmacology and bioanalysis. Notably, she co-founded the therapeutic drug monitoring center for the University of Colorado and Children’s Hospital transplantation programs. In 2007, she assumed the role of Chief Operations Officer at Eurofins Medinet, overseeing pivotal laboratory operations. In 2011, she shifted gears to become Vice President of Research and Development at a Colorado antibody company. Jamie’s focus then turned to clinical research in 2013, as she pursued her passion for oncology research, initially as a study coordinator at the University of Colorado Cancer Center. Joining Novartis Oncology in 2014 as a Clinical Research Associate, she led numerous pivotal programs as Lead CRA. From 2018 to 2022, Jamie served as CRA Manager for Novartis, overseeing several COVID trials as Lead CRA Manager. For the past two years, she held the role of Associate Director of Operations in Strategy and Operations, concentrating on innovative approaches to advancing cross-therapeutic clinical trial portfolios. Jamie holds a BS in Zoology/Physiology and an MS in Molecular Biology from the University of Wyoming. She completed her pediatric pharmacology PhD research at Medizinische Hochschule Hannover, Germany. Jamie lives in Denver, Colorado, where she enjoys family time with her husband and two sons, runs half-marathons, and enjoys the arts.

Carrie Ben Said is a visionary leader in global clinical trial operations and currently serves as Clinical Trial Teams (CTT) Center of Excellence (CoE) Head at Novartis Pharma AG. She has driven the formation of the CTT CoE and orchestrated a global transformation of CTT ways of working across more than 300 teams, positively influencing over 5,000 associates. Under her leadership, the initiative strengthened team dynamics and fostered a culture of collaboration and continuous improvement. Carrie also established a cross-functional leadership network spanning 40+ functions and oversaw the launch of a coaching academy for CTTs that accelerated transformation by 30%. Her work exemplifies scalable innovation, strategic collaboration, and a deep commitment to excellence in drug development. Carrie brings a rich blend of clinical, academic, and operational expertise to global drug development. She has led cross-functional CTTs as a Study Leader, overseeing strategic planning and execution of Phase I–IV trials in NSCLC, pNET, NET, and MCL, while effectively managing multiple studies with precision and impact. Her foundation in patient care including four years in neonatal and pediatric intensive care with ECMO certification—and academic research as part of Mt. Sinai’s Cardiothoracic Surgical Trials Network uniquely informs her science-driven, patient-centric approach to clinical excellence. She holds a Master's degree in Public Administration (Global Health Policy & Management) from New York University and earned a Bachelor's of Science in Nursing from the University of Texas.

Brinnae Bent, PhD, is a faculty member in Artificial Intelligence at Duke University, Director of the Duke TRUST Lab, and the Executive Director of Tensor and Trust. She is a leader in bridging the gap between research and industry in machine learning, having led projects and developed algorithms for the largest companies in the world.  More importantly, she has built algorithms that have meaningful impacts— from helping people walk to noninvasively monitoring glucose. Dr. Bent is an accomplished researcher and ML practitioner, with over 35 publications and a breadth of experience building algorithms across domains including health/wellness, sports, privacy, interior design, and energy. Her research on digital biomarkers is world-renowned and her emerging research on trustworthy AI strives to solve important problems in the application of AI to real-world problems.

Clara Bernardes is the Co-Founder and Chief Scientific Officer at Biorce, where she leads scientific strategy and clinical innovation at the forefront of AI-driven healthcare. With over a decade of experience in clinical operations, site activation, and regulatory affairs across organizations like MAPS, Ipsen, Parexel, and Cmed, Clara brings a rare blend of operational depth and visionary thinking to the table.

In 2024, Clara co-founded Biorce to challenge the status quo in clinical trials. The company’s name, born from Biology and Force, reflects their mission to accelerate patient access to treatments through intelligent, cost-effective, and scalable solutions.

Clara holds advanced degrees in Nutrition Sciences and Law, alongside a diploma in Medical Coding and training in pre-medical studies. Her interdisciplinary background, combined with her on-the-ground experience managing contracts, budgets, and global site start-ups, makes her a driving force behind Biorce’s scientific rigor and clinical credibility.

Deena Bernstein has deep expertise in healthcare leadership and the clinical research industry. Her career spans over twenty-four years in clinical research site development, operations, and digital technology for the clinical research industry. Deena is a passionate leader with an entrepreneurial spirit who cares deeply about improving study participants' clinical trial experience and process. Deena is TPS's VP of Site Choice, Account Management, where she offers customized and innovative outsourcing solutions for clinical and site operations that drive productivity across clinical trial operations. Deena’s passion with purpose is focused on reducing site burdens, participant engagement & retention, dynamic embedded site staffing, and advancing the decentralized clinical trial models. Deena previously has held leadership and executive roles at large Healthcare organizations, IQVIA (Fortune 500), IROs, Datacubed Health, and as a trusted consultant for the clinical research industry. She holds positions on the SCRS Leadership Council, leads industry initiatives through her work with DTRA and TransCelerate, is an active Non-Scientific Board Member with Univo IRB, and is a Site Luminary for ClinEco.

Anna is a manager in the EY consulting practice, working in research and development (R&D) at the intersection of the life sciences and health sectors.

She supports life sciences companies and health care provider organizations with critical business challenges related to their R&D strategies, operations, financial processes, compliance programs and technology. Her clients include pharmaceutical companies, biotechnology companies, academic medical centers, health systems, cancer centers and children’s hospitals.

Anna is a leader of the EY Clinical Trial Fast Lane solution, which supports clinical trial sponsors and sites in accelerating clinical trial activation. Her other areas of focus include accelerating clinical trial patient enrollment, improving diversity in clinical trials to advance health equity, complex strategic and operational R&D transformations, alternate clinical trial delivery models, and research regulatory compliance programs.

She has a BS in Public Health from The University of North Carolina at Chapel Hill.

Director of Clinical Innovation & Strategic Partnerships at Pfizer's Global Product Development Operations Center of Excellence. With a Ph.D. in Analytical Chemistry from the University of Vermont and a BA/BS from St. Anslem College, I have been with Pfizer since 1994. In my current role I lead Pfizer's Clinical Trial Concierge as part of the Decentralized Clinical Trials Community of Practice, focusing on innovative ways to improve clinical studies. I have extensive experience in leading clinical study teams and BLA submissions for Global Product Development and Research & Development. I also served as a Clinical Supply Chain Lead for 10 years. My work has been instrumental in driving innovation and change within the biopharmaceutical industry, particularly in drug and clinical development. I am also a key contributor to Pfizer's Care Anywhere initiative, which aims to decrease patient burden and increase retention through the use of wearables, telehealth, at-home labs, home health, mobile clinics, and direct-to-patient drug delivery. Additionally, I lead the development and deployment of Mobile Units, which offer location flexibility and expand the reach of clinical trials to more diverse and underserved populations.

Sanjay is the Executive Director and Global Head of Clinical Technology Strategy & Operations at AbbVie where he leads an organization of technologists who enable AbbVie’s Clinical Trials' Data Collection, Aggregation, and Processing. Prior to AbbVie, Sanjay was the Global Head of Clinical Data Management at Allergan. Over more than 2 decades in the Clinical Operations—Clinical Data and Technologies domain, Sanjay has led global teams at Biogen, Novartis, Merck/MSD, and Schering-Plough. Sanjay is the past chair of the Society for Clinical Data Management (SCDM) board and has authored a number of clinical data-related publications.

Industry Leader, Management Consultant, Scientist, and Entrepreneur in Life Sciences and Healthcare. Significant knowledge of digital health, practice building, clinical trials, medical imaging, collaboration, and innovation. Lifelong learner. Digital Health and Remote Services: Actively involved with Decentralized Clinical Trials (DCT), Digital Health Startups, Home Health Services (HHS), Direct-to-Participant (DxP) services, Novel Site Networks/Alternative Sites, and Digital Biomarkers. Practice Building: Provide vision, strategy, and leadership with global firms to drive business agility and effective change to successfully build practices in Healthcare and Life Sciences (HLS). Clinical Trials: Over three decades: Involved in well over 300 clinical studies, over 25 projects, Of these investigational products (drugs/devices, software) over 15 have been approved by regulatory authorities and have gone to market. Medical Imaging: Partnered with pioneers in centralized image interpretation and had most likely been involved or had a strong working knowledge of key technological advancements and notable contributors in this space over the last few decades. Collaboration: A partner and open thinker who values articulation, clarity, messaging, and delivery as equally vital as content, quality, experience, background, and education/training. Innovation: Believes that the drivers for change and improvement will involve catalysts, disruption, early adopters, risk, flexibility, smart scale-up, and acceleration.

Calvin is a Key Account Executive at Abbott Point of Care Diagnostics and serves as subject matter expert in the clinical research utilization of POC blood testing in trials. Holding a degree in Biochemistry and having worked for various biotech companies previously, his experience spans biotechnology, AI, and clinical research. He currently resides in San Francisco, CA.

Karina Bienfait, PhD, is the Executive Director and Head of Consent, Biospecimen & Imaging Management at Bristol Myers Squibb (BMS). In this role, Karina is responsible for end-to-end management of biological specimens, medical imaging and informed consent for all BMS-sponsored clinical trials. Since joining BMS, she has driven the implementation of a state-of-the-art specimen management system, developed policies and processes to ensure specimen and imaging oversight, and has strategically transformed end-to-end consent operations for specimens for both protocol-related and future-use testing. More recently, Karina has assumed responsibility for full informed consent management for all BMS-sponsored clinical trials as well as leadership of the R&D Data & Specimen Governance Council which oversees secondary use of clinical trial data and specimens. Prior to BMS, Karina was at Merck & Co. for 10 years, where she held positions of increasing responsibility within Clinical Pharmacogenomics and Clinical Specimen Management. Her last role was head of Global Genomic Policy, Process, and Compliance (GPPC), where was responsible for evaluating the impact of global genomic and biospecimen policies and laws/regulations on Merck’s research programs; developing Merck policies, processes, and consent related to genomics and biobanking; and ensuring the compliant use of biospecimens. In this role, Karina also implemented routine genotyping of patients participating in Merck’s clinical trials to identify genetic predictors of drug response. Karina is currently an Advisor to SCOPE for Biomarkers and Biospecimens and co-chair of the Industry Pharmacogenomics Working Group. She has also served as a member of the Genomics Roundtable of the National Academy of Sciences, Engineering, and Medicine. Karina completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers University – Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.

Allison Billups is a senior executive with over 20 years of experience in the clinical research industry, specializing in business development and client resourcing strategies. As the Executive Vice President of Client Solutions at ClinLab Solutions Group, she leverages her extensive background to help customers optimize their resourcing strategies. Allison has held leadership roles with multiple outsourcing organizations and a major pharmaceutical company. Her experience spans both sides of the industry, giving her a unique perspective on client needs and solutions. Allison holds a Bachelor's Degree in Business from Florida State University.

With over two decades in leading pharmaceutical and healthcare research, my work has specifically focused on assessing clinical, economic, and humanistic outcomes associated with pharmaceuticals and healthcare interventions to optimize patient care. I have led teams, departments and organizations across the fields of health services research, health economics and outcomes research (HEOR), real-world evidence (RWE), clinical data, informatics and analytics, clinical development and research operations, as well as developing strategies to utilize these tools to maximize stakeholder value across the healthcare ecosystem.

Jen Blinn is an accomplished clinical research leader with over two decades of experience across global pharmaceutical, site, and cooperative group settings. As Senior Director and Head of Clinical Trial Risk Management at Bristol Myers Squibb, Jen drives enterprise-wide strategy for risk-based monitoring, compliance, and operational excellence across hematology, oncology, and cell therapy portfolios. She is recognized for championing integrated risk management plans, forging cross-functional partnerships, and mentoring high-performing teams to deliver inspection-ready, patient-centric trials. Jen’s expertise includes global process ownership, monitoring excellence, and system implementation, with a proven track record in process optimization, audit readiness, and regulatory compliance.

Dr. Johanna MC Blom, Associate Professor in Psychobiology and Pediatric and Behavioral Neuroscience, University of Modena; Former Associate Director of the Part-time Graduate Program in Developmental Psychology, and Associate Prof. of Psychobiology and Behavioral Brain Sciences, Johns Hopkins University, Baltimore, USA. Coordinator of the long-term follow-up of children with cancer and the use of psychotropic drugs, AIEOP; Member of PANCARE, SIOP, and the International Guideline Harmonization Group (IGHG) for the development of Psychosocial and Neurocognitive surveillance guidelines for survivors of childhood cancer. She is currently Chair of the Ethical Committee for Research of the University of Modena and Co-coordinator of the IMI-JU project FACILITATE. Expert in multidisciplinary behavioral toxicity studies linked to child abuse and severe and chronic diseases in childhood. Experience in longitudinal follow-up studies and innovative data driven network analysis as a tool to detect and predict the driving forces of disability using digital data. Her current interests lie in (digital) assessment tools to detect early signs of cognitive and behavioral problems and designing decision tree algorithms by using network analysis and dynamic mapping to understand the driving factors of the trajectory that moves a patient from being at risk to full blown pathology especially during adolescence and test the effectiveness of treatment by linking them to outcome values dynamically recorded in an ecologically valid way.

Łukasz received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially, he was involved in preclinical development programs at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase. Later on, Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In the study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country, and site levels.

Andy has more than 20 years of experience working in the life sciences industry. His career spans from bench scientist to CEO and he currently serves as a trusted advisor to industry executives on AI and R&D strategies. Andy also leads Deloitte's Life Sciences R&D practice. Prior to Deloitte, Andy served as the CEO and founder of SphynKx Therapeutics, an early stage biotechnology company focused on treating kidney disease. Andy began his career as a cancer biologist with Millennium Pharmaceuticals, where he worked on the development of VELCADE®, a blockbuster therapy for the treatment of multiple myeloma. Andy has an MBA from the Darden School of Business at the University of Virginia, in addition to an M.S. in Pharmaceutical Sciences and a B.S. in Molecular Biology, both from the University of Connecticut.

I am a seasoned professional in the field of clinical operations feasibility with over 12 years of experience. As Director of Strategic Feasibility and Analytics at AstraZeneca, I have been instrumental in driving the success of numerous clinical trials across biopharmaceuticals respiratory, inflammation, and autoimmunity. My expertise lies in feasibility analysis, site selection, and operational strategy, ensuring that trials are conducted efficiently and effectively. Throughout my career, I have demonstrated a deep understanding of the complexities of clinical trial operations, leveraging data-driven insights to optimize site performance and patient recruitment. I have a proven track record of collaborating with cross functional teams, regulatory bodies and key stakeholders to navigate the challenges of clinical research and bring innovative therapies to market. I hold a master's degree in developmental kinesiology from Bowling Green State University, a bachelor's degree in clinical psychology, and a bachelor's degree in kinesiology from Michigan State University. I am excited to share my knowledge and experiences on best practices in clinical trial feasibility and operations and am passionate about advancing clinical research and improving patient outcomes through meticulous planning and execution.

Susan Bornstein, MPH brings over three decades of leadership in clinical data management, analytics, and innovation to her role as Principal at SMB Board Advisory and Consulting. She previously served as Executive Director of Clinical Data Sciences in Global Product Development at Pfizer and has held strategic roles in clinical informatics and analytics. Susan’s career spans driving digital transformation, shaping data strategy, and leading modernization initiatives across the pharmaceutical and biotech industries. At Maxis AI, Susan serves as an Agentic AI Advisor, guiding the strategic evolution of the Agentic AI platform, including autonomous clinical data workflows, adaptive protocol optimization, and real-time insight generation. Her vision ensures that Maxis AI solutions are grounded in industry best practices, compliance-ready, and optimized for success in today’s complex clinical trial environment.

Dr. Ivan M. Borrello is a hematologist oncologist and physician-scientist who serves as Medical Director of the Myeloma, Bone Marrow Transplant (BMT) and Cell Therapies program within the TGH Cancer Institute. He is recognized as a leader in the field of immunotherapy of hematologic malignancies (leukemias, lymphomas, multiple myeloma) as well as bone marrow and stem cell transplants. Dr. Borrello joined TGH Cancer Institute from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, where he was the Medical Director of the Cell Therapy Lab, a member of the Cancer Immunology and Immunotherapy Program, member of the Cellular and Molecular Medicine Graduate Program, and an Associate Professor of Oncology. He built a premier Multiple Myeloma Program and served as its director before joining Tampa General. Dr. Borrello received his MD from the Medical College of Virginia, completed his Internal Medicine residency at the University of Chicago and fellowship in Medical Oncology at the Johns Hopkins Oncology Center at Johns Hopkins University. Dr. Borrello’s clinical research interest is in developing immune-based therapies primarily for the treatment of multiple myeloma—cancer of the plasma cell—but his research also extends into other diseases. His published works include his participation in more than 100 peer-reviewed original research articles including the New England Journal of Medicine, Nature Medicine, and Science Translational Medicine and is credited with numerous inventions, patents and, copyrights in areas of his medical expertise. Dr. Borrello has memberships with the American Association of Cancer Research, the American College of Physicians, the American Society of Clinical Oncology, the American Society of Hematology, and the Society for Biological Therapy.

Jeanine Bortel, MPH, is currently Vice President, Head of AI Portfolio, Development at Pfizer based in New York City. Jeanine is responsible for leading the development AI strategy, partnering with R&D functional leadership and digital. Jeanine coordinates AI investment in clinical trials, medical information, and patient & HCP experience. Jeanine leads a team of AI strategy leaders that lead matrix teams for delivery of cross functional AI projects. Jeanine has been with Pfizer since January 2001 in various clinical operations leadership roles. She has supported a wide range of therapeutic areas including anti-infectives, internal medicine, oncology, inflammation & immunology, rare diseases and vaccines. In her previous roles she has led numerous programs, clinical trials and delivered over 50 major submissions driving revenue growth for Pfizer and accelerating availability of important medicines for patients. In 2004, Jeanine was selected as a Pfizer Global Health fellow in Kampala, Uganda to work for the NGO, Health Volunteers Overseas. She has over 30 years of clinical development experience providing strategic and performance driven leadership to successfully deliver global phase 1-IV clinical trials. She is a successful leader and line manager with a history of building and leading effective teams. Jeanine has expertise is leading large-scale process improvement initiatives and developing innovative solutions to optimize the drug development process. Jeanine serves on the alumni board for the Columbia University Mailman School. Jeanine received her Bachelor of Science in Biology from Boston College in 1994 and her Master’s in Public Health in Sociomedical Sciences from Columbia University in 1997.

Jennifer Boscia is the Chief Financial Officer of BioBridges, where she oversees Finance, HR, IT, and Legal in support of emerging and specialty biopharmaceutical companies across the development lifecycle. Her career in life sciences spans both early-stage and high-growth environments. As one of the first employees at XyloCor Therapeutics, a gene therapy company focused on refractory angina, she oversaw a successful $56M Series A/A-1 financing and guided the company’s financial operations through Phase 2 clinical development. Jennifer began her career in investment banking at JPMorgan Chase and has since built deep experience in strategic execution, capital formation, and operational scaling for innovative healthcare organizations. She also teaches an applied Practicum course each spring at Duke University’s Fuqua School of Business.

Dr. Hayden Bosworth, PhD, is an internationally recognized expert in real-world evidence, implementation science, and health behavior, known for translating complex research into actionable health innovations. He is Vice Chair for Research and Professor in the Department of Population Health Sciences at Duke University, holding joint appointments in Medicine, Psychiatry, and Nursing. He is Co-Founder and Chief Research Officer at Luminate Insights—a scalable clinical research education platform developed with the Duke Clinical Research Institute’s (DCRI) i-Cubed center for clinical research innovation. Dr. Bosworth has led global, multidisciplinary education initiatives, including industry-academic collaborations that enhance RWE literacy and adoption across clinical and regulatory environments.

o Alex Boudreau is the Director of AI at Clario. He leads the company’s innovative Generative AI department and oversees the development of the company’s advanced multi-modal GenAI Platform, which encompasses cutting-edge cloud engineering, AI engineering, and foundational AI research. Alex previously pioneered Deep Learning speech analysis systems for automotive applications, led cloud-based enterprise fraud detection solutions, advanced conversational AI technologies, and groundbreaking projects in medical image analysis. His expertise in leading high-impact initiatives positions him uniquely to drive forward the boundaries of AI technology in the business world.

Dr. Ariel Bourla serves as Senior Director on Johnson & Johnson R&D's Data Science and Digital Health team, where she leads efforts to apply real-world data and other innovative technology solutions to advance and accelerate Oncology clinical programs. Dr. Bourla holds a strong background in Medical Oncology, Immunology, and Data Science. She spent 6 years at Flatiron Health as a Medical Director and Clinical Trials Lead. In this role, she led research teams executing prospective real-world studies, methodologic and observational research projects, and development of new technologies for sites and sponsors participating in clinical trials. Dr. Bourla received her MD/PhD training from the Mount Sinai School of Medicine, with a subsequent internship and residency at New York Presbyterian-Columbia University Medical Center, and a Medical Oncology fellowship at Memorial Sloan Kettering Cancer Center. She earned a BA in English Language and Literature from Yale University.

Rich Bowling is a Principal Quality Lead at Roche/Genentech who translates complex quality data into actionable, data-driven insights. With over 20 years in the pharmaceutical industry, he is an expert in leveraging his strong technical foundation to provide practical guidance and drive cross-functional team success. Prior to Roche/Genentech, Rich led global teams at a clinical research organization and a software development company, where he specialized in validating electronic data capture solutions that significantly improved compliance and accelerated patient-focused innovations.

Patricia has over 25 years of industry experience ranging from Phase I - Phase IV drug development, across multiple platforms such as small molecules, biologics and gene-therapies. She started her career as a clinical program manager at Merck. During the decade that she spent at Merck she assumed increasing responsibilities leading large clinical global programs from early development through regulatory filing and continued into post marketing and safety surveillance studies. Patricia later joined Sanofi within the Cardiovascular/Thrombosis therapeutic area. Post the Sanofi/Genzyme merger Patricia became the director of Feasibility for Rare Disease. In this role, she was accountable for feasibility and operational implications of Phase I-IV Sanofi/Genzyme portfolios within Neurology and Rare Disease. Her key responsibilities included identifying protocol specific nuances and consultations on trial placement strategies. These strategies included utilizing wide sources of data to support protocol development and strategic trial execution. During Patricia's time at Sanofi, she led many innovations and process improvement initiatives including the deployment of electronic health records for protocol optimization and site identification based upon qualified cohorts of patient populations. Patricia joined Novartis in 2024 as the Director of the Rare Disease Community. Here she continues her passion for clinical research and the benefits it can bring to the underserved population of patients.

Danilo Branco is a passionate, optimistic, tech-savvy clinical trials Risk Based Quality Management, Central Monitoring, Project Management, and Clinical Operations professional with 21 years of experience managing complex studies in both big Pharma and CRO settings. He leads employees globally and supports study teams in the mission of improving data quality while bringing efficiencies to Clinical Trials conduct. The last 10 years were dedicated to leading and encouraging process creation, continuous assessment, and enhancements to maximize the positive impact of the RBQM adoption in full alignment with regulatory expectations.

Christina Brennan, MD, has devoted her career to clinical research and currently serves as Northwell Health’s senior vice president of clinical research. Committed to the advancement of science and medicine, Christina has more than 25 years of extensive clinical research experience, including over 21 years in clinical research management roles. Throughout her career she has served many roles on clinical trials from PI to sub-investigator to operational oversight. During the pandemic alone she ran all the COVID-19 trials, where in a few short weeks, 1,200 patients were enrolled in trials at Northwell Health. She also performed Northwell's first fully remote (DCT) trial, in which they held their own IND. During that period, she was interviewed by Scott Pelley on 60 minutes prime time which captured more than 8 million viewers. Christina always keeps the patient as a focus point, currently she has partnered with Press Ganey (leading global company for over 30 years for patient surveys) for a pilot as the first site to focus on patient satisfaction surveys for clinical trial participants. She is on the board of trustees for the Association of Clinical Research Professionals as the immediate past Chair. She is on the steering committee and the liaison to the executive committee of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA. She is on the advisory board for Florence Healthcare. She also sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS). She is also an active member of the Women in Bio and the American College of Healthcare Executives. Christina also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings. She developed a clinical trial budget course for CITI. She is an adjunct professor at Yeshiva University and CUNY York College, teaching graduate students on clinical trials.

Dan is the Founder & CEO of 1nHealth. Prior to starting 1nHealth, Dan learned the clinical trials industry as a management consultant, leading client engagements for pharma, biotech, and nutraceutical clients. Following his consulting experience, Dan was the CEO, Founder, and Investor of several e-commerce companies. In these roles, Dan was involved in launching hundreds of new products and direct marketing to a wide range of consumers and use cases. In 2019, Dan set out to blend his perspective in clinical development and direct-to-consumer marketing to launch 1nHealth. As a passionate alumnus, Dan would like to note he earned his M.B.A. from UCF before their football team was good.

Denise N Bronner, PhD, has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch and storytelling refinement, and identifying business opportunities within pharma. Beyond her professional endeavors, she's passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a bachelor’s degree in Biological Sciences from Wayne State University, a Ph.D. in Microbiology & Immunology from the University of Michigan—Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.

Beth Brooks is Head, Patient Insights and Behavioral Sciences (PIBS), within the Patient-Informed Development and Health Value Translation team at Sanofi. The PIBS team generates insights about patient populations of interest to the R&D organization. Among other things, the team uses this information to establish diversity and inclusion recruitment objectives for studies in the United States. Based on these insights and additional findings, the team uses behavioral science principals to develop tools to address recruitment and retention challenges that some patient populations may present in clinical trials. Beth joined Sanofi in 2007 as a Technical Editor in the Clinical Documentation department and worked her way up to R&D Senior Analyst. In 2017, she became a Patient Engagement Lead, working primarily with rare disease patients to gather insights to inform the design and conduct of Sanofi’s studies. Beth earned a Lean Six Sigma Black Belt in 2019 and has contributed to initiatives such as the implementation of EMA Policy 0070, Sanofi’s Lay Summary project, the development of SanofiStudies.com, and more. Prior to Sanofi, Beth worked elsewhere in the pharmaceutical industry and in a variety of other industries as a technical writer and editor. Her undergraduate degree is in Communications with a Technical Writing concentration from Rensselaer. She completed a Master’s of Public Health in Applied Informatics at Emory University in August 2022

Seasoned Clinical Operations Leader with extensive global drug development experience directing all aspects of clinical programs. Holds the capacity to conceptualize and execute global trials and clinical research initiatives while adhering to regulatory standards and organizational values. Expertise in therapeutic areas, including oncology, obesity, women’s health, depression, sepsis, diabetes, neurology, GI, and lipid lowering. Exceptional business and project management acumen with the ability to work across functional areas and/or a team-based environment. Outstanding oral and written communication skills as well as a strong grasp of technological applications.

Wout is the CEO and founder of Deep 6 AI, which uses NLP and AI on clinical data to accelerate clinical trial recruitment and analysis. Deep 6 originated in arguably the world’s most complex data environment, the US Intelligence space.

Tricia Buchheit has over 25 years of Patient Recruitment, Retention, and Project Management industry experience through her work at agencies, CROs, core labs, and biotechnology companies. This vast experience provides a 360-degree perspective of the challenges key stakeholders encounter with recruitment and retaining patients into clinical trials. Currently, Tricia focuses on the development and implementation of thoughtful recruitment and retention strategies and solutions to bring much needed RNAi therapeutics to market.

Nikki is a digital health strategist with extensive experience in global digital strategy and clinical trial recruitment. She has researched and developed a mastery of different awareness campaigns and consumer landscapes and is passionate about applying her knowledge of digital health to solve for recruitment challenges. Nikki’s passion for ethnographic research has made her an expert in social media user behavior. In her role, she often leads research and drives the development of multiple user profiles representing patients and HCPs in the U.S. and countries across the UK, EU, and LATAM driving innovation and diversity in clinical trial recruitment.

Lee is an experienced senior executive and corporate director with deep commercial expertise in the biotechnology sector. His management experience includes as CEO and VP of public and private biotech companies, as well as providing management and strategic consulting services to public and private bio-pharma companies in Canada, the United States, Middle East, Japan, and Europe. Lee’s deepest expertise is in the cell therapy and regenerative medicine sector having lead several transformative transactions including multinational investment and licensing deals involving companies in North America, Europe, and Asia. Lee has particular experience in Canada, the United States, and Japan. Lee holds a Bachelors of Education and a JD from the University of British Columbia.

Dr. Kevin Bugin is the Head of Global Regulatory Policy and Intelligence at Amgen, Inc. Prior to his current role, Kevin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). From May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government’s HHS and DOD operation formerly known as Operation Warp Speed. Dr. Bugin is adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research and medicines development. Dr. Bugin joined the FDA in 2008 in the Office of Business Process Support, then joined the Division of Gastroenterology and Inborn Errors Products within OND as a Regulatory Health Project Manager in 2010, and as the Chief of Project Management from 2015 to 2017. From 2017 until 2020, he served as the Director of Special Programs and the lead of CDER’s New Drugs Regulatory Program Modernization. Prior to joining the FDA, Dr. Bugin held roles in multiple areas and phases of drug development, including discovery (molecular biology) at the Virginia Bioinformatics Institute, translational research and technology transfer at the National Institute of Health’s Office of Technology Transfer, safety and pharmacovigilance with NIH’s National Cancer Institute’s Cancer Therapy Evaluation Program, and regulatory affairs and quality assurance at Amarex Clinical Research. Kevin received a BS in Biology and Chemistry from Virginia Tech in 2005, a MS in Biotechnology from American University in 2006, and a PhD in translational health science from George Washington University in 2020, with a focus on the Science of Team Science in drug development and regulatory science teams. He is certified in US regulatory affairs (RAC) and participates in numerous policy and regulatory science initiatives to foster drug development and promote innovation in clinical research.

Robert Buka is the Senior Director, Product Management for Medidata’s Intelligent Trials portfolio. He leads the development of innovative SaaS, data and AI solutions to help pharmaceutical sponsors and CROs properly design, plan and execute their clinical trials to efficiently achieve study enrollment goals. Robert has over 12 years of experience leading global data science and product management teams to deliver digital transformation projects. Robert studied Biology and Statistics at the University of Pennsylvania.

Dr. Ramona Burress, PharmD, is a nationally recognized clinical pharmacist, Patient-Focused Drug Development (PFDD) leader, and population health strategist whose work bridges lived patient experience, community-based care, and clinical research inclusion. As a metastatic breast cancer patient and clinical trial participant, she brings a firsthand understanding of treatment burden, safety, and access that informs more responsive, patient-centered research and development models. As a Co-Founder of the Onyx Health Collective, Dr. Burress has built a community-rooted infrastructure spanning prevention, chronic disease management, HIV services, and culturally responsive health education across safety-net settings. Her work integrates population-level data, social determinants of health, and patient experience insights to inform trial feasibility, site selection, and recruitment strategies grounded in real-world community needs. With leadership experience at Takeda, Johnson & Johnson Innovative Medicine, Walgreens, and advisory roles with PCORI, Dr. Burress has led enterprise-level initiatives in PFDD, clinical trial diversity, and community partnership development. She specializes in assessing and activating nontraditional community sites such as pharmacies, community clinics, pop-up screening programs, and faith-based organizations into research-ready environments through structured site readiness frameworks, digital enablement, and capability building. Through this model, Dr. Burress advances sustainable population-health-driven pipelines for diverse trial participation, improved retention, real-world evidence generation, and safer, more equitable access to clinical research.

With over 20+ years in sales, marketing, business ops, and strategic partnerships, Kyle brings a wealth of experience, bringing products and services to market. As VP of Partnerships at VivoSense, he works closely with Pharma Sponsor and CRO partners to push innovation in the digital health technology space.

Philip J. Butera is a seasoned professional in clinical trial site operations, supply chain, and manufacturing, boasting over 34 years of comprehensive management experience within cGMP and GCP environments. Based in Charlotte, North Carolina, Mr. Butera has demonstrated exceptional leadership and strategic vision across the pharmaceutical, biotech, and healthcare industries. His career highlights include leading global organizations through harmonized processes, spearheading strategic business planning, and executing complex restructuring and operational improvements. Currently serving as Regional Associate Vice President of Oncology Clinical Trials at Advocate Health / Atrium Health Wake Forest Baptist Comprehensive Cancer Center in Charlotte, NC, he is recognized for driving innovation and operational excellence across major healthcare networks throughout multiple states. Mr. Butera’s expertise encompasses the development and management of diverse teams, supplier base analysis, technology innovation, and the successful integration and troubleshooting of critical business processes, reflecting a career marked by constant achievement and impactful results.

Jennifer Byrne’s career has been devoted to leading organizations, building teams, and cultivating partnerships centered on advancing the clinical research enterprise to better connect patients and providers to clinical trials. Jennifer founded Javara with a vision to revolutionize the industry by accelerating access to research—for patients, biopharma companies, and healthcare systems alike. Her passion and commitment to transforming the clinical research landscape into an integrated component of healthcare are at the forefront of Javara’s mission. As the former CEO of PMG Research and Founder of Greater Gift (501(c)3), Jennifer’s involvement in the clinical research enterprise has been vast across collaborations with hundreds of pharma, device, Contract Research Organizations (CROs), technology, site organizations, and other research service providers for the direct execution of over 7,500 Phase I-IV industry-sponsored clinical trials. Her stellar track record for consistent and excellent quality in patient, provider, and client experiences associated with research trials is but one of many professional accomplishments. As a clinical research thought leader, Jennifer thrives on building high performing teams and partnerships within the evolving healthcare and biopharmaceutical landscapes, leading to better outcomes for all stakeholders. Jennifer has been recognized as a CenterWatch Top 20 Innovator and was included in the 2021 PharmaVOICE Women of Influence. She has been the recipient of both the NC Biotechnology Entrepreneurial Excellence Award as well as ACRP’s 2018 Innovation in Clinical Research Award. Jennifer co-chairs the Racial Equity Task Force at Wake Forest Baptist Health, and serves as the Board Chair for Greater Gift, an immediate past trustee for The Association of Clinical Research Professionals (ACRP) and Board Director of Nmible. She is also an Advisory Chair for the Masters in Clinical Research Management with Wake Forest University, has an Advisory role with the Wake Forest Institute of Regenerative Medicine and the Chancellor's Advisory Council at Winston-Salem State University, is an Investor and Advisor to the FCA Health Innovations Fund, and is a Board Director for the North Carolina Biotech of the Piedmont Triad. She is a graduate of Texas A&M University.

John is the Head of Decentralized Clinical Trials for Walgreens. In his role, he works with an array of stakeholders including patients and sponsors to build and deliver more accessible and less burdensome trials. Prior to joining Walgreens, he served in positions of increasing responsibility at Casimir, a patient-centric decentralized CRO, with his last position as VP of Operations. His work in decentralized trials includes the operationalization of technology and novel measures in global trials. John started his career in rare disease patient advocacy at the Jett Foundation. He has a BA from Colby College.

Natanya M. Candelario is the Senior Director of Inclusive Research at Bristol Myers Squibb. In this role, Natanya is responsible for developing, refining, and executing the priorities for how BMS will embed inclusive research principles across functions, collaborating across business units and markets in addition to external stakeholders and partners. Natanya continues to work collaboratively to transform access to BMS’ innovative medicines in low-middle income countries. In the same setting, she has supported programs that optimize different learning platforms for healthcare professionals and patients. Natanya is also leading a sub-Saharan Africa capacity building effort on behalf of BMS, has spearheaded unique opportunities for BMS employee volunteerism and successfully launched an effort that may inform and drive better equity and access to earlier diagnosis, timely treatment, and community connectivity. Natanya joined BMS in 2010 as a member of the US Field Medical team supporting HIV and viral hepatitis. In 2016, she joined the US Oncology Field Medical team and worked as an Executive Field Medical Scientist for select solid tumors. In both field medical roles, she built substantive peer-to-peer relationships with local, regional, and national thought leaders as well as other health care professionals. Throughout her tenure at BMS and at other companies, Natanya has remained committed to and passionate about Health Equity. She has worked to identified gaps and unveil solutions in screening, diagnosis, linking patients to treatment and presented/facilitated multiple training sessions in resource limited settings. Natanya graduated from the University of Texas at Arlington, with a Bachelor of Science in Biology degree and also earned a Doctor of Pharmacy degree from Howard University in Washington, DC. She completed a two-year postdoctoral fellowship through Rutgers’ Pharmaceutical Industry Fellowship at Roche. She is also a graduate of the University of Florida Master of Science in Pharmacy program with a focus in Pharmacoeconomics.

Natanya M. Candelario serves as Senior Director of Inclusive Research at Bristol Myers Squibb, where she leads the strategic integration of inclusive research principles across global functions. Natanya’s work bridges business units, markets, and external partners to advance health equity and transform access to innovative medicines through clinical research, including in low- and middle-income countries.

A champion for capacity building, Natanya spearheads initiatives in sub-Saharan Africa, driving sustainable healthcare solutions and empowering local professionals and communities. Natanya has launched pioneering programs that foster employee volunteerism and inform new models for equitable access—enabling earlier diagnosis, timely treatment, and stronger community connectivity.

Since joining Bristol Myers Squibb in 2010, Natanya has built trusted relationships with thought leaders and healthcare professionals, supporting both HIV/viral hepatitis and oncology. Natanya’s commitment to health equity is evident in efforts to identify gaps in care, develop solutions for screening and diagnosis, and deliver impactful training in resource-limited settings.

Natanya holds a Bachelor of Science in Biology from the University of Texas at Arlington, a Doctor of Pharmacy from Howard University, and a Master of Science in Pharmacy (Pharmacoeconomics) from the University of Florida. Natanya completed a two-year postdoctoral fellowship at Roche through Rutgers’ Pharmaceutical Industry Fellowship.

Natanya’s vision is to advance global health equity by fostering collaboration, innovation, and sustainable impact—ensuring that all communities have access to quality healthcare and opportunities for better health outcomes.

Guillaume Carbonneau is an accomplished leader in operational insights, specializing in clinical development business problem-solving and decision-making. With two decades in the pharmaceutical industry, he has spent the last 10 years leveraging technology to enhance patient outcomes and foster innovation. As Vice President of Operational Data Insights at Novo Nordisk, he leads a transformative team focused on data-driven decision-making and developing the StudyHub platform. His team’s expertise optimizes clinical trial design, planning, forecasting and execution, ensuring AI-generated insights have real-world impact. They are fostering a culture where data drives decisions across the portfolio. Before Novo Nordisk, Guillaume was Head of Health Data Insights & Design at Novartis. There, he utilized cross-disciplinary experience to develop data-driven methodologies, incorporating profiling methodologies and design thinking to enhance product desirability. His collaborative approach led to innovative healthcare solutions in partnership with external stakeholders, underlining his commitment to transforming clinical practices. Guillaume’s passion for technology, data and AI, continues to drive innovation in data insights, creating actionable outcomes that deliver tangible results.

Sharlene Carnegie is the Senior Vice President of the Medidata Platform. Since joining Medidata in 2020, she has led the product and engineering functions of the Platform. She seeks to continue to mature and unify Medidata’s software platform, complete with centralized and advanced core capabilities, with a consistent and personalized customer experience across Medidata’s suite of product offerings. Sharlene has over twenty years of experience in software engineering and product strategy, in various transformative leadership roles. Most notably, she was the Chief Technology Officer at Graham Capital Management, an asset management company with $15bn in AUM. There, she was responsible for overhauling the firm’s algorithmic trading and order management platform. She holds a BS in Computer Science and Math from Iona University, along with machine learning Master’s coursework from Columbia University.

Mary Carroll is a dynamic and accomplished clinical research leader with extensive experience at AbbVie. With expertise in strategic study planning, and a proven track record of leading teams to achieve key milestones in global clinical trials, Mary is dedicated to elevating clinical research excellence. As Director of Protocol Optimization, she actively streamlines clinical trial protocols to enhance both patient and site experiences across the AbbVie portfolio. Mary holds a Bachelor of Science in Chemistry from the University of Illinois at Urbana-Champaign and brings comprehensive project management, and CRA experience.

Emily leads the Data Science & Analytics Trial Execution teams in R&D at AbbVie. Her teams’ focus is on enhancing the efficiency and quality of end-to-end trial execution through comprehensive data analysis and insights across RBQM, Feasibility & RWD, Medical & Safety, and Business oversight needs and strategic advancements. Her teams have played a pivotal role in driving the transition from descriptive to predictive and prescriptive analytics and expanded the application of Machine Learning and AI in strategic decision making, trial design and operational execution of AbbVie’s clinical trials.

Elisa Cascade, MBA, FACRP is a strategic executive and recognized thought leader in clinical technology with more than 30 years of experience advancing innovation, growth, and transformation in clinical research. As a multi-time Chief Product Officer, she has led businesses exceeding $100M in revenue and introduced solutions that have reshaped how sites, sponsors, and CROs collaborate to streamline the conduct of clinical trials. Elisa has been honored on the PharmaVOICE 100 and Medicine Maker Power 100 for her contributions to clinical trial technology and process standardization and has been an active leader within the Association of Clinical Research Professionals (ACRP) for over a decade, serving on the Board of Trustees and was named an ACRP Fellow in 2025 in recognition of her experience in the profession.

Lynne Cesario has more than 25 years of experience in clinical research and drug development in the pharmaceutical industry. She is currently an Executive Director in the Data Monitoring and Management department, leading the Global Risk Based Monitoring Program at Pfizer. As the overall business lead point of contact for RBM, Lynne coordinates and aligns all cross-functional project workstreams. Lynne also manages the global Central Monitoring teams, as well as a Data Science team that focuses on AI and automations that can be employed in the biometrics space. Lynne is an active member of Transcelerate and PhUSE where she co-led the RBM Workstream.

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). Previously, Meghana led OND's Advisory Committee Team and Science Strategies program, and worked closely on CDER’s Patient-Focused Drug Development program. Meghana holds a master’s in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

Joan Chambers is a senior consultant advising research projects, the Center’s membership programs, and the PACT Consortium. She brings more than 30 years of senior management experience — across a variety of strategic and operating roles - in the life sciences industry. Joan serves on several boards and committees including US PharmaTimes, Citeline Awards, DIA’s Global Annual Meeting Program Committee (AMPC), DIA’s Student Case Competition, CTTI Project Watchtower Initiative, the Pharmaceutical Business Conference Group, and One Rare. Joan is an active member of the Drug Information Association (DIA), has published extensively in trade journals, and is a frequent speaker at industry conferences.

Rachel is the Associate Director of Digital Science Strategy at AbbVie. She integrates digital health technologies into evidence-generation strategies within AbbVie's pipeline projects. Prior, she was the founding Director of Innovation at the Digital Medicine Society (DiMe) and worked on Pfizer's Digital Medicine team, digital health start-ups, consulted for pharma, and supported various other clinical teams for over a dozen years. She lives in Chicago, USA.

With over 13 years of experience in the healthcare industry leading digital departments across Clinical Development and Operations, Abhishek Chatterjee brings deep expertise in solving complex problems and delivering innovative, high impact solutions. Known for driving organizational transformation through data-driven strategies and human centric design thinking, Abhishek has consistently advanced digital capabilities across global teams. Most recently, as a digital transformation leader, Abhishek has successfully overseen and executed multi million dollar initiatives across Commercial and Drug Development functions. By partnering closely with Business Unit leaders and senior executives, Abhishek has redefined strategic approaches—most notably conceptualizing “Planning as a Product”—and leading the design of digital products focused on portfolio acceleration, site selection, competitive intelligence, patient centric solutions, and emerging GenAI and LLM based use cases within Drug Development.

Senior Director with a demonstrated history of working in academia, hospital, and healthcare industry settings and over 27 years’ experience. Skilled in Pharmacoepidemiology, Oncology, Infectious Diseases, Immunology, Vaccines, Global Public Health, Clinical Trials, and Regulatory disciplines. Strong professional with a Ph.D. in Epidemiology from the University of Alabama at Birmingham (2003). Currently leads Walgreens Boots Alliance Pharmacoepidemiology, Real-World Evidence-Clinical Trials across all therapeutic areas.

Dr. Chelico is a board-certified internal medicine and clinical informatics physician. His expertise is in the use of electronic health record systems for the improvement of clinical care, quality, research and financial strength. He is currently the System Vice President and Chief Medical Information Officer at CommonSpirit Health. Formed in 2019 through the alignment of Catholic Health Initiatives (CHI) and Dignity Health, CommonSpirit is the largest nonprofit health systems in the United States, with more than 1,200 care sites in 24 states, serving 25 million patients across America. Dr. Chelico is also currently an Assistant Professor of Medicine at the Zucker School of Medicine at Hofstra / Northwell and continues his clinical practice as an internal medicine hospitalist where he is a ward attending to house staff and medical students. Additionally, he is an Adjunct Assistant Professor of Population Health Sciences at Weill Cornell Medical School where he teaches a course focused on Clinical Informatics and Healthcare Quality since 2016. Dr. Chelico is a graduate of New York University, where he studied Computer Science at the Courant Institute of Mathematical Sciences. He completed his medical education at the State University of New York Downstate Medical Center, and finished residency training in Internal Medicine at North Shore University Hospital in Long Island, New York. Dr. Chelico went on to complete a National Institutes of Health (NIH) funded Post-Doctoral Fellowship and Masters Degree in Biomedical Informatics at the Columbia University Medical Center. During his fellowship, he became intricately involved with the strategy and re-architecture of the clinical data warehouse for the New York Presbyterian Healthcare System of Columbia University Medical Center and Weill Cornell Medical Center. Following his fellowship, Dr. Chelico joined the New York City Health and Hospitals Corporation as the Assistant Chief Medical Information Officer of Bellevue Hospital Center and the South Manhattan Healthcare Network. In the following years, he assumed the position as both the Director of Clinical Informatics at NYU Langone Medical Center and the Director of Data Warehouse Research at NYU Center for Health Informatics and Bioinformatics. At NYU Langone Medical Center he was a physician lead overseeing the Data Warehouse, Business Intelligence, and Epic Electronic Health Record System implementation across the enterprise. In 2011, he joined Northwell Health as the Chief Medical Information Officer at both cornerstone tertiary medical centers of North Shore University Hospital and Long Island Jewish Medical Center to oversee the electronic health information systems implementation and optimization. Starting in 2016 he took on a new role for Northwell Health, as the Vice President and Chief Information Officer of the Feinstein Institutes for Medical Research, where he is responsible for the Information Technology & Informatics that supports clinical research across the entire health system. In 2018 he was named the Vice President and Chief Informatics and Innovation Officer for the health system and founded the Northwell Health Center for Research Informatics and Innovation. This center concentrated on working with commercial partners looking to bring new technology into the health system and capitalize on the data assets that a large health system can provide to industry. Dr. Chelico is regularly invited to participate as a clinical informatics expert and health information technology consultant for industry and health care systems internationally.

30 year industry experience across CROs & Pharma working in Clinical Operations, Business Development & Procurement. Following a Biology Degree I started my career as CRA working for Icon before moving into Business Development at Covance and subsequently Kendle (now Syneos). I joined Bayer in 2003 heading up a European Clinical Outsourcing function. As the outsourcing function developed and ultimately moved into the Global Procurement function at Bayer I assumed greater responsibility. Responsibilities have included leading regional teams across Europe & Asia for Pharma Development sourcing activities and Global teams responsible for Pharma Development Category strategy. During this time I was also heavily involved in the management of key supplier partnerships. I moved back into Bayer R&D to take a role leading an agile team to identify and manage a portfolio of future solutions supporting new approaches to clinical trial Planning and conduct to deliver faster, better, cheaper trials. Subsequently moving to the Alliance Management function in my current role as Strategic Alliances Lead, leading the Bayer's key strategic projects with external suppliers to enable the organizations ongoing transformation.

Scott Chetham Ph.D. is an experienced healthcare entrepreneur who is currently the CEO and co-founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. This multi-faceted strategic and operational role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and Google[x]. Scott has also served as a Venture Partner at Versant Ventures, CTO and Co-founder of Intersection Medical (sold to ImpediMed), and VP Clinical Affairs (ImpediMed). In these latter two roles he was responsible for clinical research strategy and operations.

Amy Chowansky is an AI Strategy Lead at Pfizer, accountable for the implementation of AI technologies to improve Pfizer’s drug development. Most of her work focuses AI solutions related to clinical trial recruitment. In her 10 years at Pfizer, Amy has also held roles in Participant Recruitment and Global & US Marketing. Before joining Pfizer, Amy worked as a marketing strategy consultant at Rosetta, focusing on pharmaceutical clients and projects involving analytics, segmentation, and brand strategy.

Katie joined AbbVie in May 2021 as a Director of Regulatory Affairs in the Emerging Technology, Combination Products and Devices. In this role, Katie and her team support internally developed Digital Health, including Digital Health Technologies (DHTs) and Software as a Medical Device (SaMDs), projects providing regulatory strategy during development and global approvals and registrations prior to launch. Her team also works closely with their colleagues in Data Science in selecting and performing evaluations on DHTs used in clinical trials and beyond. Katie also leads the medical device regulatory strategy for combination product development including gene therapy and amylin analog delivery devices. Recently Katie was positioned as the Global Head of Digital Health Technology Devices and Specialty Products which includes men’s and women’s health combination products. Prior to joining AbbVie, Katie held a biomedical engineer and lead reviewer position at the US FDA Center for Devices and Radiological Health (CDRH) in the Cardiovascular Device Division (DCD) in the Office of Device Evaluation (ODE) from 2006 until 2015. After completing the Leadership Readiness program in 2015, Katie joined the Office of Orphan Products Development (OOPD) in the Commissioner’s Office where she led review of the Humanitarian Use Device (HUD) designations, supported the Pediatric Device Consortium and Orphan Clinical Trials grants. Her last official role at the Agency took her back to CDRH where she headed the partnership with the Medical Device Innovation Consortium (MDIC) in the External Partnerships sector and supported regulatory science project development across multiple initiatives including Digital Health, In Vitro Diagnostics, Early Feasibility Studies (EFS), Case for Quality and Science of Patient Input. Katie holds her undergraduate degree from the University of Pittsburgh (cum laude) in Biomedical Engineering and her master’s degree from Maquette University and the Medical College of Wisconsin in Healthcare Technology Management. Katie resides in NW Washington, DC with her husband, Atiq, and twin boys, Isaac and Isaiah.

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R. has worked extensively with both sponsors and CROs as a Study Coordinator, CRA, Project Manager, Auditor, and Director of Clinical Operations over the past 20 years and has published articles in both The Monitor and The Journal of Clinical Research Best Practices on Risk Based Monitoring, Operational Advisory Boards, Study Feasibility, and CRO Relationship Management. Nikki has conducted hundreds of study visits and developed and facilitated training in multiple international venues. Nikki is an experienced trainer and has presented and conducted workshops at Association of Clinical Research Professionals (ACRP) Global Conferences, MAGI, Cambridge Healthtech Institute, iBIG, and Outsourcing Clinical Trials (OCT).

Ramya Krishna Chunduru is a Clinical Research Regulatory Supervisor at Baylor Scott & White Health in Dallas, Texas, with over nine years of experience in clinical research regulatory operations and compliance, including six years specializing in oncology trials. She holds a bachelor’s degree in biotechnology, a master’s degree in biotechnology from the University of Houston–Clear Lake, and is currently pursuing a Ph.D. in Biomedical Engineering and Biotechnology at the University of Massachusetts Dartmouth. Ramya is an ACRP-Certified Professional (ACRP-CP) and an active member of the Association of Clinical Research Professionals. Throughout her career, she has worked extensively in advancing oncology clinical trials, ensuring adherence to regulatory standards, and mentoring regulatory specialists. Her professional and academic work focuses on leveraging innovative approaches to strengthen regulatory compliance and accelerate access to life-saving therapies. Beyond her professional endeavors, Ramya is deeply committed to balancing her roles as a researcher, supervisor, and working mother. She aspires to contribute to the national interest by developing advanced technologies and best practices in oncology clinical research and regulatory compliance.

Dr. Ciaccio uses Artificial Intelligence and Machine Learning to help accelerate Pharmaceutical Development at AbbVie Biopharmaceutical company. He is a member of the AbbVie RAIDERS (Rapid A.I. Developers) that are dedicated to the implementation of A.I. throughout the company. Mark specifically focuses on Clinical studies, currently working to simulate clinical trial enrollment, write chatbots to help answer regulatory questions, and design machine learning models to implement wearable devices in the clinic.

Mine Cicek, Ph.D., is a consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota. Dr. Cicek is the David F. and Margaret T Grohne Director of the Biorepository Program. She joined the staff of Mayo Clinic in 2008 and holds the academic rank of Associate Professor of Laboratory Medicine and Pathology. Dr. Cicek earned her Ph.D. in Genetics at Virginia Tech in Blacksburg, Virginia. She subsequently completed a Cancer Biology postdoctoral fellowship at Lerner Research Institute, Cleveland Clinic in Cleveland, Ohio and a Molecular Cancer Genetic Epidemiology fellowship at Mayo Clinic in Rochester, Minnesota. As the Director of the Biorepository Program, Dr. Cicek contributes her expertise in research studies and clinical trials and supports the Mayo Clinic Comprehensive Cancer Center, SPOREs, and the clinical trials networks Alliance across all Mayo sites. She provides guidance in study design, biospecimen collections and processing. She continuously brings knowledge to the program to improve automation, expand storage capacity, and educate investigators on best practices for biospecimen usage. In addition, she collaborates with investigators on grant applications and writing manuscripts. Dr. Cicek is a member of the International Society for Biological and Environmental Repositories (ISBER). She is the Mayo Clinic PI of The Alliance NCTN Biorepository and Biospecimen Resource, PI of the RECOVER Biobank, and PI of the All of Us Research Program (AoURP) Biobank and Nutrition for Precision Health (NPH) Biobank. Dr. Cicek also oversees Mayo Clinic Bioservices, an external business arm of the Biorepository Program which offers variety of preanalytical service options to both academia and industry.

Tony is the General Manager and Senior Vice President of the CVS Health Clinical Trial Services (CTS) business unit. CTS’ mission is to expand access to clinical trials with a relentless focus on health equity while improving research effectiveness and patient outcomes through a unique patient-centric delivery model. Prior to CTS, Tony built and led the CVS Health Enterprise Strategy Team that develops the long-term strategy for the overall business, CVS Pharmacy, CVS Caremark, and Enterprise Transformation. He has played a leading role in new growth opportunities, including the creation of CVS Kidney Care, acquisition of Aetna, and creation of the nationwide COVID-19 testing platform. Before joining CVS Health in 2015, Tony served as Chief of Staff to the CEO of Caesars Entertainment. As part of this role, Tony chaired the Business Roundtable (BRT) Health Care Committee, where he worked with Fortune 500 CHROs on national employer policy priorities. Tony’s additional experience includes serving as a Professional Staff on the Senate Finance Committee where he helped draft the Affordable Care Act (ACA), as part of a portfolio managing value-based care models, provider payments, and insurance markets. Tony also spent five years as a senior healthcare equity analyst at Lehman Brothers and Barclays Capital, after starting his career in the Massachusetts State Senate. Tony graduated Phi Beta Kappa from Boston University. He is currently an Aspen Institute Health Innovation Fellow, sits on the Board of Directors of Parsley Health, and serves on the Rhode Island Health Care Cost Trends Steering Committee and the Health in Rhode Island Committee.

Dr. Rebecca Clark is a Partner at Fylde Coast Clinical Research at Layton Medical Centre, a dedicated commercial trials centre in Blackpool. She is a highly experienced trialist with over 70 Phase II/III clinical trials conducted over the last 13 years, with multiple studies as Chief Investigator in the therapy areas of vaccines, obesity medicine, cardiovascular medicine, asthma and diabetes. She holds a number of senior leadership roles including co-clinical lead for the UK Vaccine Innovation Pathway, a UK clinical trials accelerator. Fylde Coast Clinical Research at Layton Medical Centre recruits amongst the highest number of commercial participants across the NHS in England and was in the top 1% of NHS recruiting sites when compared with all 637 sites across both primary and secondary care in 22/23. Study participant retention rates exceeded 99%. Her site regularly achieves UK FPV and she is renowned for accelerated set up and recruitment timelines, experience she is now bringing to her role in the UK VIP. Fylde Coast Clinical Research currently holds contracts with Eli Lilly, Moderna, Astra Zeneca, Roche, Amgen, Merck, Novo Nordisk and GSK, with whom they are members of the PEER preferred site network. Dr. Clark continues to be recognised nationally for her excellence in clinical trial delivery, being a former recipient of the Gold Award for Clinical Site of the Year at the Pharmatimes International Clinical Researcher of the Year awards.

Michael Clark is an accomplished clinical operations leader with over 30 years of experience in managing global clinical trials and imaging programs across the biotechnology and pharmaceutical sectors. He currently serves as the Chief Operating Officer at Image Analysis Group (IAG), a leading imaging CRO,with focus on global scaling capabilities to deliver complex, global imaging trials. Recognized as a bone health and inflammation expert, Michael has been closely involved in the application of advanced imaging techniques such as DXA to support research in osteoporosis, body composition, obesity, and musculoskeletal and autoimmune diseases, and he continues to drive innovation in imaging-enabled drug development through strategic leadership and operational excellence.

Cal co-founded OpenClinica with colleague Ben Baumann in 2006. OpenClinica provides a comprehensive, best-in-class suite of data management and workflow solutions for clinical trials. Cal co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on an eSource initiative integrating EHR and EDC systems. He has been active in standards development work for many years, including as a member of CDISC’s Operational Data Model V2 feature team, the HL7 Vulcan Advisory Council and Steering Committee and the SCDM eSource Consortium.

Cal has served as Chief Executive Officer of OpenClinica since founding the company with Ben Baumann in 2006. He spearheads OpenClinica’s vision to drive the future of digital clinical trials with innovative technology and more seamless integration with the healthcare system. Cal co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has been active in standards development work for many years, including as a member of CDISC’s Operational Data Model V2 feature team and the HL7 Vulcan Advisory Council and Steering Committee.

Cal is a graduate of Harvard University and his work has been featured in publications such as Clinical Research News, Medhealth Outlook, Bioinformatics, ACM/IEEE, and Clinical Leader. He has keynoted, presented, and/or organized sessions at events including the DIA Annual Meeting, SCDM Annual Conference, Society for Clinical Trials, American Medical Informatics Association’s Annual Symposium, the Open Source Electronic Health Records Alliance (OSEHRA) and the tranSMART Annual Meeting. Cal also sits on the board of Isovera, LLC, a digital agency. When not working, he enjoys sailing, gardening, exercising, and spending time with his twin boys.

Anca Copaescu is the CEO and founder of Strategikon , the company behind Clinical Maestro. With over 20 years in clinical operations and outsourcing, Anca is dedicated to transforming clinical business operations through technology that bridges efficiency gaps. Her vision for Clinical Maestro, VISION and CORE arose from her commitment to solving the complexities and inefficiencies that life sciences organizations face in clinical trial budgeting, sourcing, and vendor management. Known for her expertise and innovative mindset, Anca leads Strategikon in its mission to streamline processes and deliver transparency, driving success in clinical trial management worldwide

As a seasoned clinical operations leader with over 24 years of experience in the biopharmaceutical industry, I have a proven track record of delivering high-quality results and driving operational excellence. My expertise lies in oncology, where I have successfully managed complex clinical trials, ensuring compliance, efficiency, and patient safety. I am passionate about advancing clinical trials and improving patient outcomes through innovative and evidence-based treatments.

Dr. Karen Correa is the Head of US Clinical Development Operations at Boehringer, bringing over 30 years of experience in the pharmaceutical industry. She joined Boehringer in November 2024 and is based in Mickleton, NJ. Her career spans leadership roles at Takeda, Rocket Pharmaceuticals, Adare Pharmaceuticals, Pfizer, Sanofi-Aventis, Charles River Laboratories, Inveresk Research, Carolina Clinical Research, and Ciba-Geigy. Dr. Correa is a health and wellness coach, a published author, and a passionate mentor. She is recognized as a subject matter expert in FDA and EMA inspections, community and patient engagement, health policy and advocacy, and diversity, equity, and inclusion in clinical trials. She also serves as a STEM speaker, youth mentor, and Vice Chair of the CAMCare Health Corporation Board.

As Director and Principal Consultant, George Cortez leads the Clinical Supply Consulting team, providing strategic planning support to customers and partners. With over two decades of clinical supply chain experience, his focus is on patient-centric innovation, fostering collaboration, and driving results. Prior to joining CSC, George held previous leadership positions at Almac Clinical Services, ICON, Janssen Bio, and Merck & Co., where he served as subject matter expert in multiple areas within the global clinical supply chain. George has a proven track record of leading teams & spearheading high-profile programs across diverse therapeutic areas in R&D.

With 20 years of experience and industry roles spanning across small to large CRO and Sponsor organizations, Jodi attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, she transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials. Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams. With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations. She is highly passionate about establishing internal and external cross-functional communication processes, effective issue escalation pathways and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

Jacqueline Cousart is a Central Monitoring Manager at Johnson and Johnson Innovative Medicine supporting several trials within Oncology. She is a graduate of St. Joseph's University and Binghamton University and has been working in clinical trials for 12 years and counting.

Michelle Crouthamel is an “intrapreneur” and a pioneer of mobile technologies in pharmaceutical development. As the Head of Digital Science at AbbVie, Michelle leads a team of digital health strategists and signal processing scientists to modernize outcome assessments and advance drug development programs. Prior to joining AbbVie, Michelle led many successful innovation programs in R&D at Merck and GSK and received numerous awards. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health. Michelle also collaborates broadly with academics, tech, consortia, and health authorities to drive progress and realize the value of digital health.

I help emerging biotech leaders translate breakthrough science into commercial success. As a Market Access Executive and consultant, I partner with CEOs, CMOs, and CCOs to navigate the complex landscape of pricing, access, and value generation. My approach is analytical, data-driven, and forward-looking—grounded in real-world evidence, health economics, and payer perspectives that define launch success. Over the past year, I’ve supported venture-backed and Series A biotechs across oncology, rare disease, and advanced therapies with projects spanning Access, Pricing, and Value Evidence Generation: • Commercial Valuation for a Cell Therapy: Built a risk-adjusted NPV model to guide investor communications and platform strategy, giving leadership clear direction on positioning and valuation. • Market Access Launch Readiness Assessment: Helped an emerging biotech evaluate US payer risks, distribution pathways, and value messaging to prepare for Phase 3 and partnership discussions. • Evidence Generation Planning: Designed RWE and network meta-analysis approaches to strengthen payer narratives, drive differentiation, and support peer-reviewed publications for a rare disease asset. Clients note that I provide innovative insights, strategic foresight on policy trends, and focus for scarce resources. Unlike large consulting groups, I bring the advantage of experience across both the pharmaceutical industry and the healthcare sector, giving me a unique perspective on how products are developed, valued, and adopted in practice. I also offer a lean cost base and flexible engagement. My passion is helping biotech leaders maximize the value of their science—for patients, investors, and society.

Sean Cunningham is a Senior Director on the Study Site Engagement Team with Takeda Pharmaceuticals. In this role, Sean is dedicated to establishing, developing, and leveraging meaningful sponsor relationships to help accelerate the Takeda portfolio and provide sites with a positive clinical trial experience. Sean has over 28 years of experience in clinical operations across Oncology, Infectious Diseases, Metabolism, Gastrointestinal/Inflammatory, Dermatology, Cardiovascular, Neuro/Psych, and Rheumatoid Arthritis. Sean earned his MBA with an emphasis in Healthcare Marketing and Strategy from the Olin School of Business at Washington University in St. Louis and his BA from the University of Colorado - Boulder.

Hugh Dai is the Director of Patient Engagement as part of Clinical Trial Design Capability of Eli Lilly and Company. Hugh is passionate in optimizing clinical trial designs by surfacing relevant data insights, and is partnering cross-functional teams to implement this new capability. Prior to joining Eli Lilly seven years ago, Hugh worked in Healthcare industry for more than 20 years, in both clinical research as well as hospital operations, to focus on improving patient care efficiency. In his spare time, Hugh is inspired daily by his family and always looking for new BBQ recipes. He also likes playing soccer, travel, and photography.

Ashley Daigneau is head of clinical trials at Verana Health, where she oversees the strategy and execution of innovative clinical research solutions leveraging real-world data. Ashley has more than 15 years of experience supporting the development of real-world evidence strategies and overseeing clinical study execution.

Elizabeth Dam, PhD, is a clinical scientist with 17+ years across academia and industry, who currently serves as a Clinical Trial Liaison within AstraZeneca’s Biopharmaceuticals portfolio and formerly served as a Medical Science Liaison in Respiratory. She builds strategic site partnerships, leads proactive scientific exchange with investigators and staff, and educates sites and referring physicians on protocols, study designs, and pipeline assets. Collaborating with clinical operations, she identifies and resolves screening and enrollment barriers, informs feasibility, site identification and selection, facilitates site referrals and patient recruitment, and delivers quarterly portfolio updates to partner research centers, contributing to faster start-up and fewer screen failures. Passionate about rural access, she focuses on operational and scientific strategies that reduce barriers and broaden representation. Previously, she advanced cell therapy collaborations at Miltenyi Biotec and contributed to programs and a patent at Nohla Therapeutics. She holds a PhD in Immunology and a BS in Biomedical Engineering.

Wouter is a Medical Biologist by training. He has over 20 years of experience working in Clinical Development & Operations in both project management and leadership positions. Since Feb 2022 he is working as a clinical trial Patient & Site Engagement Lead for the global organization of Boehringer-Ingelheim. He started his career at Eli Lilly, worked for 10 years at Novo Nordisk and since 2013 for Boehringer Ingelheim. He has a special interest for the cardiometabolic indications like diabetes, obesity, NASH, CKD and Heart Failure. Since 2018 he is actively working on patient and site engagement focusing on optimizing the clinical trial experience for trial participants and clinical trial site staff in Boehringer trials. In 2023 he created the Site Engagement Academy within Boehringer Ingelheim which was rolled out globally in 2024.

Omkar Dasari is an accomplished Information Technology leader at Amgen, bringing nearly 20 years of experience, a Master’s degree in Computer Science, and an MBA. He leads the Clinical Trial Data & Analytics team, spearheading the use of innovative technologies — including Robotic Process Automation (RPA), Artificial Intelligence/Machine Learning (AI/ML), Agentic AI, and Data Science — to accelerate insights, improve efficiency, and enhance decision-making in Clinical research. At Amgen, Omkar blends analytical thinking with creative problem-solving to address complex challenges and deliver transformative, data-driven solutions. His leadership emphasizes innovation, operational excellence, and cross-functional collaboration, ensuring technology investments deliver measurable business and patient impact.

Gus Davidson is a global clinical research and outsourcing executive with over 15 years of experience leading strategic vendor alliances and operational transformation. While at Bristol-Myers Squibb, he oversaw a $4B+ outsourcing portfolio, driving innovation through automation, analytics, and scalable contracting solutions. His leadership has delivered multimillion-dollar savings, accelerated vendor onboarding, and enhanced supplier performance. Gus holds an MBA from Georgetown University and brings a global perspective shaped by international education and cross-sector experience.

Over 20 years experience developing and directing patient and professional educational programs, research symposia and consortia involving diverse stakeholder communities in clinical care and clinical research. Trish serves as the PALADIN Consortium Director and is a Senior Consultant with Tufts CSDD working on a variety of initiatives involving building and sustaining relationships with professionals in government, advocacy, academia and industry. Trish holds a Masters of Public Administration (MPA) from the University of South Carolina.

Ian Davison, PhD, is Subject Matter Expert, RTSM at Medrio, with more than 20 years of experience designing and optimizing randomization and trial supply management solutions for complex global studies. Before joining Medrio, he spent almost two decades in clinical trial technology and operations leadership, focusing on subject management, supply chain management, trial status reporting, and end-to-end RTSM process design. Ian holds a PhD in Neuroscience and combines scientific training with deep operational expertise to help sponsors and CROs run more efficient, reliable trials.

Ashley Davidson is the Vice President of Product Strategy at Advarra. In this role, Ashley leads the development and delivery of Advarra’s study collaboration solutions. Ashley has over 20 years of expertise in site activation, clinical operations, data management and clinical strategy.

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development, clinical research, and consulting and his 20-year engagement with CDISC includes roles as a volunteer, implementer, and board member. Chris is passionate about leading CDISC towards a technology-based standards future and expanding the organization's global impact in clinical research standards.

Years with Takeda: 4 Years in the PR&R Industry: 16 Amanda joined the Takeda Patient Recruitment & Retention team in August 2019. Prior to her tenure with Takeda, she worked for several patient recruitment and retention agencies where she partnered with sponsors, CROs, and sites to design and implement multi-channel PR&R campaigns to meet the specialized needs of individual protocols. Amanda has experience across a broad range of therapeutic areas with a forward-looking approach to maintain a strong pulse on the industry’s latest advancements in delivering patient-centric research. She earned a BA and MA from Villanova University in suburban Philadelphia and resides in Conshohocken, PA.

Brian Deighan is a seasoned clinical research professional with over 17 years of experience in the pharmaceutical and life sciences industry. As Program Director at Teckro, Brian leads strategic initiatives across several key accounts, helping global study teams adopt and optimize Teckro’s innovative platform to enhance site engagement and streamline clinical trial operations. With a background spanning clinical operations, project management, and digital transformation, Brian brings a unique blend of technical expertise and operational insight to his role. He is passionate about modernizing clinical trials and is a strong advocate for leveraging technology to improve communication, compliance, and efficiency at research sites. Prior to joining Teckro, Brian held leadership roles at ICON plc, where he managed complex, multi-phase studies across therapeutic areas. His collaborative approach and deep understanding of site, CRA and sponsor needs have made him a trusted partner in driving trial success. Brian regularly speaks to sponsors on topics such as site-centric innovation, digital enablement in clinical research, and the evolving role of technology in patient-centric trials.

Kari Delahunty, MBA, brings more than 20 years of life sciences leadership experience, with a focus on operations, strategy, and management. She joined AMR Clinical from Shearwater Health, where she served as President, Life Sciences. Prior to that, she served in various roles of increasing responsibility at Syneos Health, culminating as Senior Vice President, Corporate Strategy, with responsibility for strategic planning, development, and execution. She is an active member of Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) and has served as a Blood Cancer United Executive Council Member & Executive Challenger of 2023-2025 RTP Light The Night. She formerly held roles as Healthcare Businesswomen’s Association (HBA) Vice President RTP HBA Chapter, advisory board chair for the College of Biological and Agricultural Engineering North Carolina State University and Board of Directors for North Carolina Association for Biomedical Research. Kari earned a B.S. in Biological Engineering and MBA from North Carolina State University.

Angela DeLuca is the Associate Vice President and Head of Global Study Operations at Amgen. In this role, Angela leads the Site Management and Data Management organizations, ensuring excellence and consistency in clinical trial execution across the portfolio. With 20 years of experience in the biopharmaceutical industry, Angela has extensive expertise in oncology and has lived and worked in both the US and Japan. She is recognized for her ability to drive global clinical development excellence through innovative operational strategies and the early adoption of digital health initiatives, optimizing the R&D landscape to accelerate products to the global market. Before joining Amgen, Angela was the Vice President of Oncology and Cell Therapy Clinical Operations at Takeda. She also held leadership positions at both AbbVie and Abbott, where she transformed clinical development operations and established a center of excellence that became an industry benchmark. As the Head of Strategy and Operations for Portfolio Program Management, Angela partnered with the R&D Leadership team to identify and implement innovative improvements across the organization. In her role as Head of Innovation, she led the Japan Design Lab team, integrating digital technologies, health technologies, big data, and predictive analytics to enhance clinical trial design and support strategic business decisions. Angela holds an MBA in Innovation from the University of North Carolina Chapel Hill, Kenan Flagler Business School, and a Bachelor’s in Chemistry from The Ohio State University. She is also a certified PMP.

Jade is a global clinical development leader with over 20 years of experience across Phase I-IV trials within Pharma/Biotech with a current focus on pioneering patient-focused innovative approaches to optimize clinical research and using data and analytics to drive better & faster decisions to design clinical programs that are relevant patients.

Joe has spent the past 30 years focused on bringing life-saving specialty drugs to market, helping patients with complex diseases to access advanced care, and developing future leaders in the healthcare industry. Joe is a passionate leader with a commitment to mentorship and building strong, diverse teams. Joe was the first male National Board member of the Healthcare Businesswomen’s Association. Joe’s experience includes operations globally for multiple biotech, pharma, distribution, professional services, and technology companies. He is recognized for consistently delivering multi-million-dollar revenue gains in highly competitive marketplaces. His core leadership competencies include leading all aspects of strategy, drug development, investor relations, and commercialization with multiple global launches. Most recently, Joe served as Chief Commercial Officer at Vineti, a venture-based technology start-up focused on industrializing the value chain for personalized therapies. His past roles have also included leadership positions at top pharmaceutical companies, Johnson & Johnson and Lilly. Joe also previously served as the President of Cardinal Health Specialty Solutions, EVP Chief Commercial Officer at Sunesis Pharmaceuticals, EVP Global Commercial Operations at Dendreon, VP Global Commercial Operations at ImClone, and VP at Abraxis Oncology. Joe has been published in multiple publications on cell and gene therapy, including Cell & Gene Therapy Insights and PharmaVoice. Joe was also recognized as one of the top 100 pharmaceutical executives by PharmaVoice in 2017 and 2024. Joe’s academic credentials include a BS in Marketing and an MBA, with an emphasis on Pharmaceutical/Chemical Studies.

Aurélie Dequelson is a strategic leader in RBQM with over 20 years of experience in global drug development. She built her expertise through a solid background in clinical trials operations and trial monitoring, in diverse pharmaceutical companies, before taking on global leadership roles in risk-based quality strategies. As Head of Risk Surveillance at Novartis, she leads the end-to-end RBQM strategy, fostering a proactive risk culture, data-driven oversight, and quality by design across trial portfolio. Passionate about meaningful innovation, she is known for her ability to drive impactful change through clarity, strategic mindset, and a strong focus on continuous improvement.

Multidisciplinary expertise with 20+ years clinical research experience as International Lead, landmark studies. Extensive expertise in international and national clinical study leadership and international/national regulatory requirements. Advanced degrees in Public Health and Clinical Research Administration. Key author of two white papers on increasing minority patients in clinical trials and retention strategies in longterm outcome trials. Specialist in diversity in clinical trials including change mechanisms to ensure sustainability. Strong science background with special interests in precision medicine and pharmacogenomics. External collaboration and partnerships with FDA, PhRMA and TransCelerate Biopharma. Demonstrated expertise in international matrix management, including cultural sensitivity and direct line management. Excellent communication skills and strategic planner. Highly adaptable, well-organized, self-motivated and ongoing process assessment to increase efficiencies, reduce costs and expedite timelines. Works well in a team setting as well as management positions. Therapeutic experience includes cardiovascular, respiratory, metabolic, infectious diseases, pediatric and adult oncology.

As Vice President of Portfolio Management at TransCelerate, Rob's current role includes oversight of a portfolio of projects that include digital transformation, pragmatic trials, and real-world data. He is a member of the Vulcan Advisory Committee. From 2018-2021, Rob was the Deputy Chief Health Officer at IBM Watson Health, where he led external collaborations to implement digital COVID Trial screening tools and leveraged his industry experience to guide software developers working on life sciences offerings. He joined IBM after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions. While at GSK, Rob was the Vice President of Clinical Pharmacology Sciences and Study Operations with a global footprint that included the US, UK, Australia, and China. Rob’s team designed clinical trials aimed at profiling new medicines, establishing proof of concept, and delivering critical data for product labeling. He also led the development of a number of late-phase oncology projects leading to successful product approvals. In 2015, Rob launched a Clinical Innovation and Digital Platforms Team at GSK where he focused on identifying, evaluating, and piloting emerging technical solutions to automate different areas of clinical trial design and implementation. Under his leadership, Rob’s team launched the first industry-sponsored Apple Research Kit Study to assess disease burden in rheumatoid arthritis patients in a real-world setting. He also led the Common Protocol Template and Digital Data Flow work streams sponsored by TransCelerate. He was also one of the team leads for the Clinical Trials Transformation Initiative (CTTI) sponsored Mobile Clinical Trials Novel Endpoints project. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality, and ethics in research.

Sina Djali has over 25 years of experience in drug and clinical development in various companies and academia. Currently he is the head of Integrated Clinical and Operations Analytics at Jansen Pharmaceuticals. In this role Sina is responsible for incorporating Risk Management principles through applied analytics in the day to day R&D clinical operations. This includes managing both data engineering and analytics/data science teams to provide sustainable solutions in support of R&D clinical operations. Prior to this role, Sina was the head of Risk Management – Central Monitoring at Janssen R&D. Previously he has been responsible for Clinical Process and System Department at Tibotec Pharmaceuticals, where he developed and implemented a data driven Quality Risk Management System. He has also held several positions in research, regulatory affairs and R&D Quality Assurance departments at Wyeth and Aventis Pharmaceuticals.

Hana is a Research Analyst at Tufts CSDD where she conducts grant-funded research including global online surveys, interviews, quantitative and qualitative data analysis, and literature reviews.

Marissa Dockendorf, PhD, is the Executive Director and Head of the Digital Clinical Measures group at Merck. She has 18 years of experience in the pharmaceutical industry and has made significant contributions to the research and development of several pharmaceutical products. In her current role, she leads a team of scientists in identifying, developing, and implementing novel digital clinical measures in clinical trials across Merck's portfolio to enable more efficient and patient-centric drug development. She has played critical roles in driving innovation projects focused on modernizing clinical trials and has been instrumental in inclusion of blood micro- and outpatient sampling, digital medication adherence monitoring technologies, and wearable devices in clinical trials. Prior to her current position, Marissa spent 10 years in Merck's Quantitative Pharmacology & Pharmacometrics organization providing pharmacokinetic and pharmacometric expertise and scientific oversight for numerous programs across the drug discovery-development continuum, covering diverse therapeutic areas including cardiovascular, neuroscience, and ophthalmics. Marissa also worked at Johnson & Johnson Vision Care for 3 ½ yrs, where she contributed to the research & development of ocular drug-device combination products. Marissa has co-authored over 30 peer-reviewed manuscripts. She has a PhD in chemical engineering and a master’s degree in biomedical engineering from the University of Florida and an undergraduate degree from the Illinois Institute of Technology.

Kaye Doiron is a healthcare entrepreneur, systems innovator, and nationally recognized thought leader in clinical trial operations. She is the Founder and CEO of Research Works, a multi-site clinical research network spanning Louisiana and Puerto Rico, and the Founder of SAMARAS, an agentic operating system designed to radically scale site capacity, workforce readiness, and patient access in clinical research. With over 17 years of hands-on experience, Kaye has worn every operational hat inside a clinical trial site—from patient intake and regulatory to budgeting, staffing, and execution. That lived experience informs her work today: building AI-enabled systems that eliminate operational bottlenecks, reduce burnout, and allow sites to enroll patients faster without compromising quality or humanity. Kaye is the creator of Patient Negative One, a movement and implementation framework advocating for simulation-based training and sandbox environments across all clinical trial technologies—so no staff member or patient ever becomes the system’s first test subject. Her work challenges the industry to rethink how trials are trained, launched, and scaled. A former touring jazz vocalist and songwriter, Kaye brings a rare blend of operational rigor and creative storytelling to the stage. Her keynotes are known for being candid, data-driven, and deeply human—bridging site reality, technology, and patient experience with clarity and urgency. Kaye is a frequent speaker at global life sciences conferences and an advisor to founders, sponsors, and site networks navigating the future of clinical research.

Kristen Dopf, MHS, PA-C is a board-certified Physician Assistant and Principal Investigator at Suburban Research Associates, part of the Atlas Clinical Network. With over 10 years of clinical experience and a strong background in both medical and psychiatric care, she leads medical and mental health-focused clinical trials aimed at advancing evidence-based treatment options. Kristen has conducted more than 10 clinical trials as a Principal Investigator in the past year alone and has contributed to over 40 psychiatric trials as either a Primary or Sub-Investigator throughout her career. She is passionate about bridging the gap between research and real-world practice and is dedicated to improving outcomes and quality of life through compassionate and science-driven care.

Tom Dougherty is currently the Real-World Data Strategy Lead at Novo Nordisk. He is responsible for identifying the gaps in the evidence generation plans and determining fit-for-purpose data partners in the US. Prior to Novo Nordisk, Tom was the Director of RWE Partnerships & Innovation at Pfizer, where he launched therapeutic area external data partnerships and novel technologies. Tom has over 20 years of experience in healthcare with Merck, GE Healthcare, Boston Scientific, and Premier. He received a Bachelor’s degree in Chemistry, an MBA from Villanova University, and is currently seeking his Doctorate of Health Sciences from Thomas Jefferson University.

Shelley Douros is the Senior Director of Financial Management Strategy at Medidata, a Dassault Systèmes company. With over 20 years of experience in the life sciences, she specializes in transforming business operations through strategic planning, process improvement, and the development of innovative financial products. Shelley champions diversity in clinical trials by working to provide greater financial support and reduce the burden on all patients. As a recognized thought leader, she has authored several articles on clinical trial budgeting, including “Transforming Clinical Trial Budgeting with Precision and Transparency,” “Beyond Numbers: Revolutionizing Clinical Trial Budgeting,” and “Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting.”

Gerald Downey is a distinguished biostatistical leader with over two decades of expertise in gene therapy, oncology, and rare disease clinical programs and post-marketing activities, delivering transformative insights for global biopharma. He excels in leading cross-functional teams, managing vendors, and driving innovative statistical methodologies. With a proven track record and a network of global collaborations, he delivers actionable insights that shape clinical and commercial outcomes.

Daniel R. Drozd, MD, MSc is Chief Medical Officer at PicnicHealth, where he oversees scientific collaborations with industry and academic partners and works closely with product and commercial teams. Previously, he was faculty at the University of Washington's Department of Allergy & Infectious Diseases, leading research on using EHR data for observational studies of chronic HIV burden. Before medical school, he worked as an engineer at technology startups and led development of a large EHR data integration platform at UW's Clinical Informatics Research Group. Dr. Drozd completed medical school, Infectious Disease fellowship, and a Masters in Epidemiology (Clinical Research focus) at the University of Washington School of Medicine, with Internal Medicine residency at UCSF. He is an expert in clinical informatics and digital health with 50+ publications and presentations on novel uses of real-world data.

Ronnie is an Associate Principal at ZS Associates in Los Angeles, bringing over 18 years of experience in clinical development, marketing, technology, and data science applied to accelerating drug development and commercialization. Ronnie’s focus is on biopharmaceutical data strategy and data-driven initiatives where he has helped clients maximize the value of their internal and external data assets to drive meaningful business outcomes. Most recently Ronnie has focused on enabling data-driven clinical development design, planning, and operations. Ronnie has a Bachelors degree in electrical engineering and computer science and a Masters in Business Administration, both from the University of California Los Angeles.

Shannon Duffany serves as the Global Clinical Trials Early Planning Lead for Solid Tumors Oncology at Sanofi. She has over 20 years of clinical research operations experience, from study coordinator positions at various hospitals, to clinical operations roles within multiple companies in the pharmaceutical and medical device industry. Currently, she leads a team that is responsible for building global clinical trial strategies in planning country and site feasibility for Sanofi’s solid tumor portfolio. Additionally, her team designs patient recruitment strategies for these trials.

As Chief Strategy and Growth Officer of KPS Life, Nicole plays a key role in shaping and executing KPS Life’s strategic vision. She leads Marketing, Business Development, and Proposals & Sales Operations—driving growth and strengthening the company’s market presence.

With extensive experience in the Pharmaceutical and Contract Research Organization (CRO) sectors, Nicole has a proven track record of leadership and innovation. Her notable achievements include:

• Johnson & Johnson – As Head of Flex Partnerships, she led the global shift to a single-sourcing FSP model, achieving cost savings and operational consistency.

• ICON (PRA Health Sciences, ReSearch Pharmaceutical Services) – As Senior Vice President, Strategic Solutions, she scaled global FSP operations, managed large teams, and earned industry recognition for partnership excellence and innovation.

Nicole is passionate about collaborating with customers to address complex business needs, building high-performing teams, and championing initiatives that drive organizational excellence. She holds a Bachelor of Science in Nursing from Temple University and began her career as an oncology nurse—giving her a deep understanding of the challenges faced by both clients and the patients they serve.

Edye Edens is a licensed attorney with 17 years of experience in international human rights, health law, and clinical research compliance. She is the Founder and Owner of Edye Edens Life Sciences Law Group, advising sponsors, CROs, AMCs, technology vendors, and research sites on FDA regulatory matters, clinical trial compliance, product promotion, and strategic risk management. Previously, Edye held leadership roles at the Kulkarni Law Firm performing similar tasks, and at First Class Solutions, where she built new compliance service lines across the life sciences sector. She also spent nearly a decade at Indiana University, where she provided compliance oversight for more than 600 oncology trials and led extensive Human Research Protection Program (HRPP) initiatives, including research integrity, IRB operations, and enterprise-wide regulatory compliance. A certified IRB and clinical research professional, she is a frequent national speaker and author who brings a rare blend of legal expertise, operational insight, and regulatory foresight to the evolving clinical research landscape.

Shawn is Executive Director and Chief Operating Officer at CVS Healthspire Life Sciences. In his role he and his team develop products and lead the delivery of studies that support the generation of Real World Evidence on behalf of academic public health researchers, pharmaceutical companies and federal entities. He has more than 26 years of experience in healthcare and has held several strategic leadership roles in the Payor organizations that span from Consumer Business to National Business including roles in Medicare and Pharmacy Benefits Management. Shawn obtained a BS degree in Business Administration from Rider University and an MBA in Finance from Rutgers University.

Part of Bayer AG since 2014, always somewhere around the Procurement process, collaborating with all 3 divisions- Pharma, Consumer Health and Crop Science. Currently focusing on Pharma Clinical Trial Technologies and overlaps with other service categories in the DCT ecosystem.

I'm passionate about using the power of creativity to help get patients the treatments they need sooner by speeding up clinical trial recruitment. I founded Havas Faze as part of Havas Health & You, the worlds largest healthcare communications network, to drive the change patients desperately need. Being a chronic disease patient (Crohns) and having working for some of the worlds most successful consumer and healthcare agencies in the world, winning awards at Cannes Lions, Webby's, One Show, and pretty much everything else, I enjoy bringing creative thinking and patient experience to the numerous challenges in patient recruitment. In my spare time I'm founder of Advertising-health.com, mentor for Princes Trust, Webby awards judge and supporter of Crohns & Collitis UK.

If you’ve ever worked in healthcare, you know how much heart it takes. Cheryle started her career as a critical care nurse — learning to make decisions quickly, comfort families, and find grace in difficult moment. Those experiences taught her that every process and innovation ultimately serves one purpose: people. Today, as President of Advanced Clinical, that lesson still guides Cheryle. The work may look different — global operations, new technologies, teams around the world — but the heart of it hasn’t changed. Cheryle believes the best outcomes come from human connection, from building environments where people feel safe, valued, and inspired to do work that matters. Over the past two decades, she's led global teams across therapeutic areas from cardiovascular to dermatology and women’s and men’s health. Cheryle is a lifelong learner — a published voice on risk-based monitoring and a frequent speaker on how innovation and empathy can coexist in clinical research. Outside of work, her favorite moments are simple ones: family dinners, laughter with friends, and long conversations over great food. Those moments remind her why connection matters — in life, in leadership, and in every trial we run.

Michelle Everill is a pioneer in the field of clinical trial optimization that includes the intersection of data science, technology, innovation, and process simplification and flexibility. She has worked in clinical research since 2000 in a variety of roles at sponsors, CROs, and sites, and has participated in trials as a patient. She strives to drive more effective trials in terms of scientific advancement, patient, site, and operational burden, and the time and cost trade off. Michelle has led feasibility, data science, and business operations organizations at three of the top-ten pharma companies, consulted for and advised many organizations, and recently joined Alnylam as VP, Global Trial Optimization to further strategic approaches to innovative and curative medicines research.

Matthew Failor is the Director and Head of Clinical Operations for MAIA Biotechnology. Currently he is responsible for the delivery and oversite of global Phase II/III multi-national clinical trials. Over his 13-year career, he worked and led key clinical trials that contributed to the FDA approval of several new therapies such as VEKLURY (Remdesivir), KEYTRUDA (Pembrolizumab), and ENTYVIO (Vedolizamab).

I have a strong background and interest in patient engagement, especially in clinical development. Working across many therapeutic areas, I have developed a wide range of knowledge surrounding clinical processes. Special interests include working hands-on with patient and site groups to understand their needs and preferences, LGBTQIA+ access to healthcare and use of artificial intelligence in clinical development.

Michele Falk currently serves as the Senior Manager, Patient Engagement & Recruitment Lead at Bristol Myers Squibb. In this role, Michele is a staunch advocate for the inclusion of diverse engagement and recruitment strategies in clinical trial development. She actively contributes to the creation and execution of indication and protocol-specific diversity plans. Michele collaborates closely with enterprise colleagues to foster and maintain strong relationships with site and patient organizations and advocacy groups. She works with these organizations to enhance awareness of and access to clinical trials and the drug development process. With a 25-year career dedicated to enhancing clinical trial recruitment and patient engagement, Michele continues to drive forward the mission of inclusive and effective clinical research.

Jessica Federer is a recognized leader in the global life sciences industry. She was the first Chief Digital Officer for the Bayer AG group, as well as the first woman to hold that role in the industry. She led Bayer’s digital transformation across the pharmaceutical, consumer care, crop science, material science and animal health businesses during record setting years for both sales and EBITDA. Reporting into the Bayer AG Group Management Board, Federer united the company’s digital strategy and investments across divisions to accelerate growth across the 118,00 employees. During her tenure, the company acquired and integrated Merck’s consumer care business and Monsanto, becoming, respectively, the second largest consumer health and the leading agriculture businesses on the planet, and floated their material science division into Covestro. With a focus on scalable digital enablers to business integrations and success, Federer streamlined investments, modernized capabilities, and upskilled the workforce. Prior to leading digital for the group business, Federer established a track record inside Bayer for delivery across regulatory affairs, market access, product launches, and business turnarounds. This includes the launch team for the record holding biologic EYLEA ®, an overhaul in the animal health business, and establishing the market access function globally. Federer regularly contributes to publications and events for the FT, Reuters Health, Bloomberg, and leading consultancies. Ms. Federer joined BMP as a Venture Affiliate in 2018, and is a Partner for the Opportunity Fund. She is a graduate of George Washington University and received an MPH from the Yale School of Public Health.

Entered the industry nearly 25 years back now. Have led a wide range of technology and business organizations for 2 large pharmas throughout my career. Currently lead a team in AbbVie's Development Business Technology group with software development, data engineering, RPA and AI solutions for Clinical Development, Regulatory, Medical Affairs, Pharmacovigilance and Data Management business functions.

Dr. Mimi Fenton, CEO of Cedar Research and Aspen Insights, is an experienced Life Sciences executive with 20+ years of experience in Global Pharmaceuticals (Sanofi), Pharmaceutical Services (Syneos Health), Retail/Pharmacy (Walmart) and Academia (Columbia University, Rutgers University). Mimi has extensive experience developing innovative evidence generation strategies to unlock powerful drug and device value propositions across clinical and commercial applications. Mimi is a business builder with demonstrated success architecting corporate strategy, building teams & processes, driving revenue & flywheel value, and creating commercial, technological and academic partnerships. She empowers teams to bridge the gap between science, innovation, and go-to-market with the intelligent application of data and technology. Mimi has also led her previous teams’ efforts to drive profitable growth, accelerate drug development, enable access, and improve patient lives. Mimi has a Ph.D. in Epidemiology from Columbia University, an M.P.H. from Brown University, and a B.A. from the University of Pennsylvania. She is a thought leader in her field and sits on the Board of Directors for Arkansas Children’s Hospital and the Board of Advisors for Carna Health and Uncommon Cures.

Kristin M. Ferrigno, MLAS, LATG, is an accomplished clinical operations leader with over 20 years of experience driving innovation in clinical research across diverse therapeutic areas. She currently serves as Director of Clinical Operations at Veda Life Sciences, where she leads national teams, oversees trial logistics, and ensures regulatory excellence. Previously, she held senior leadership roles at Alcanza Clinical Research, Marken LLP, and Care Access, where she spearheaded decentralized trial models, site development, and global patient-centric services. With a strong background in people management, process improvement, and strategic partnerships, Kristin is dedicated to advancing clinical trials that prioritize both scientific rigor and patient accessibility

Amy Fesmire-Baus is the Associate Director, Global Patient Recruitment in Neuroscience, Research & Drug Development, Global Patient Outreach at Bristol Myers Squibb with 17 years of experience in the pharmaceutical industry. She is responsible for designing and executing scalable, patient-informed recruitment strategies across high-priority global clinical trials. Her work focuses on integrating patient insights into recruitment strategies to support data-driven approaches that accelerate enrollment and ensure inclusive research reflective of real-world populations.

For 25 years, Rosalie “Rosie” Filling has developed clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence—transforming R&D operations for pharmaceutical companies. As a member of the global R&D leadership team at Keenova Therapeutics, she oversees the coordination and implementation of the company’s clinical development strategies, including clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness, and business operations. Endo’s active research programs span men’s health, orthopedics, and endocrinology, as well as focused development in the areas of sterile injectables and complex generic products. Rosie’s main focus at all times is on the end users—the patients. Bringing new life-enhancing and, at times, life-saving medications to patients drives Rosie’s sense of purpose. As a breast cancer clinical trial participant herself, she knows firsthand that her work and commitment can make a positive impact and improve patients’ lives. Guided by that tireless dedication, Rosie has earned a reputation as a powerful thought leader and mentor. She has participated as a keynote speaker at industry conferences, sharing her vision of how companies can shape the future of clinical trials; she regularly presents to Johns Hopkins University Ph.D. candidates about potential career paths; and within Keenova Therapeutics, she supports team members both formally and informally, particularly as an executive champion for the company’s employee resource group for women, AWE (Alliance for Women at Endo). In previous roles, Rosie built teams and capabilities at Lupin Pharmaceuticals, Teva, and other respected life sciences companies. She earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

John Finn has over 35 years of experience in clinical development through the various positions he has held within private research, CRO, and large pharmaceutical organizations. Before rejoining Pfizer in 2016 (John previously was Head of Repository Management at Pfizer), he was the Global Head of Clinical Data Management Functional Excellence at Genentech and oversaw the process and training management, service provider management, and systems management groups, whose shared purpose was to ensure Data Management's effective and compliant delivery of decision databases through utilization of nimble processes, right-fit systems, and skilled flexible resources. Prior to that, he served as the Global Head of Data Management at Parexel International. He currently oversees a global CDS team of professionals whose mission is to deliver on-time quality data for decision making in innovative and patient-centric ways across phase 1-IV inflammation and immunology and Internal Medicine clinical studies at Pfizer.

Ashley has over 13 years of industry experience in both large CROs and Sponsor organizations, with a wealth of knowledge spanning from Clinical Operations, Quality Assurance, Project Management and Vendor Oversight. While working in these various areas within the industry she began to realize the importance of bridging the gap between sponsor and vendors and creating a 'One Team' mindset. Through her development of relationships with vendors she has been able to advocate for her employers while also empowering the vendor to bring forth their expertise to allow both teams to succeed. Ashley enjoys advancing the vendor relationships through partnership initiatives, recognition of superior work and open communication.

A partner at Aulis Capital—a venture capital firm with offices in Hong Kong, Shanghai, Menlo Park, and Boston, that specializes in investing in digital health and biotech with other investments in technology. Previous experience was in operational roles at both small and large organizations. Specialties: Digital Health, small company strategy, growth and operations. Notable digital health investments include: Reify Health, Autonomize.AI, Shyld.AI, Twist Bio, Evidation Health, Freenome, WellDoc, Outcomes4me, Carta Health and Pluto Health.

Patrick has 30 years’ experience in new drug development. He joined Regeneron in March 2020. His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up, eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics. Patrick has extensive international experience in drug development. He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. Patrick is a former officer in the U.S. Army and is a veteran of the Gulf War.

Maria Florez is a research consultant affiliated with the Tufts Center for the Study of Drug Development. Her research looks at the impact of digital transformation in clinical research; practices, strategies, and incentives driving improvements in the pharmaceutical R&D process; and the economics of new drug development. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held positions at Cleveland Clinic, New York-Presbyterian Hospital of Columbia, and Cornell Universities. Maria holds a bachelor’s degree in quantitative economics and master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.

Transformational life sciences executive with 20+ years orchestrating over $16B in strategic transactions across cell & gene therapy, oncology, precision medicine, vaccines, and AI/ML platforms. I've built my career identifying breakthrough technologies and architecting innovative deal structures that create lasting value. As the founder of Scout Life Sciences, I develop comprehensive market entry, fundraising, and partnership strategies for innovative companies, securing $200M+ in capital and facilitating $600M+ in exits to date. My approach combines deep pharmaceutical industry expertise with venture-building acumen to position emerging technologies for optimal partnerships and commercial success. Previously, I held progressive business development leadership roles at Takeda and Astellas, where I developed expertise in strategic partnerships, M&A, and global alliance management. These experiences provided invaluable insights into how large pharmaceutical organizations evaluate, structure, and integrate novel technologies. I currently serve as Chief Business Officer for Scailyte while continuing to guide a portfolio of emerging ventures through Scout Life Sciences. My passion lies in helping groundbreaking science receive the attention, partnerships, and funding it deserves.

Ruby Madison Ford is a Research Analyst at the Center, where she conducts grant-funded research involving survey and database design, quantitative and qualitative data analysis, and literature reviews. She earned her BS in Public Health from The University of Alabama and her MPH in Health Management and Policy from Georgia State University.

Michael Forst is a pharmaceutical technology leader with 30 years of experience spanning R&D IT, Commercial IT and Operations. At AstraZeneca, he leads the project management office responsible for validating and integrating global production Electronic Health Record to Electronic Data Capture (EHR2EDC) and eSource capabilities, with 20+ studies delivered across 40+ enabled sites in the past three years. He focuses on building enduring capabilities for AstraZeneca’s Oncology Clinical, Regulatory, and Quality Assurance (QA) functions, leveraging diverse teams and strategic partnerships to optimize and streamline R&D workflows.

Dr. Michael Forstner has 25 years' industry experience in various roles in R&D and drug safety in different pharmaceutical companies and as a consultant and has contributed to several successful marketing authorizations of innovative medicines by developing workable, efficient benefit-risk management measures, mostly in the oncology and CNS therapeutic areas. He is currently driving the utilization of RWE in pharmacovigilance processes, as well as methodologies to develop and maintain favourable benefit-risk frameworks informed by patient preferences., and graphical representations of risks associated with ADRs to enable improved patient decision making. As a member of the Royal Society of Medicine’s Digital Health Council as well as in his role as CSO of a digital health start-up he is also at the forefront of integrating digital health offerings into the healthcare space.

As the Corporate Global Head of Accessibility at Merck & Co., Inc., Dr. Stephen Framil has been an ardent advocate and practitioner of equitable access across the range of human experience: including the built environment, food sustainability, education, performing arts, and the digital landscape. With over 30 years of executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise, Steve continues to lead and champion accessibility in multinational corporations, non-profit education, and the performing arts. Steve resides in the Greater Philadelphia area with his wife Natalia, children Aren and Sasha, cats Mila and Jana, and dogs Benji and Joey. Steve maintains an active music career as the founding Executive & Music Director of Camerata Philadelphia and the Port City Music Festival (Wilmington NC), as well as Director of Orchestra & Strings at Eastern University PA. To make this all happen as a CRC Survivor (2024 NED), Steve energizes through marathons and triathlons, and is a 4X Ironman (2021-2024)—why be bad at one sport, when you can be bad at three!

Doug Fulling has 25 years of executive management and business development experience in the life science industry. He has a proven track record for scaling and growing businesses to meet the evolving needs of global pharmaceutical, biotech, and contract research organizations. He has successfully led organizational growth with integrity and vision, including roles at Precision AQ (part of Precision Medicine Group), Symphony Health (an ICON Plc Company), and other key industry players such as PRA Health Sciences. Doug lives with his wife and three daughters near Philadelphia, PA.

Julia is a Digital Health Senior Product Manager in Genentech’s Computational Sciences Center of Excellence. She leads Digital Cough, a pioneering effort that implemented an AI-powered tool to measure cough objectively and continuously in clinical trials, a first for Genentech/Roche and across the pharma industry. Prior to her work in digital health, Julia drove innovative projects ranging from clinical trial automation to utilizing organoids for individualized response prediction via AI-powered image analysis. She has been with Genentech since 2017, following her role in Clinical Science at a cancer immunotherapy biotech acquired by Amgen. Julia graduated in Translational Medicine from UCSF and UC Berkeley and completed her undergraduate studies in Biotechnology at Universidad de Salamanca in Spain.

Laura has a unique role which blends internal and external components. Laura is Merck’s assigned leadership to the Oversight Committee of TransCelerate BioPharma, Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics, and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

Driven by intellectual curiosity, Victoria is focused on improving healthcare by connecting patient-centricity, digital health, and real-world evidence through innovation and digital transformation to evolve clinical research. In her current role as Global Head of Data Governance & Insights, Victoria is accountable for shaping the data strategy and data governance for Clinical Development and Operations. Victoria enjoys connecting with others who support he use of data to generate insights, especially with innovative applications to advance healthcare.

Drew Garty’s career in pharmaceutical technology spans over 25 years and includes significant expertise in EDC, clinical site monitoring, and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015 and has authored multiple patents. Drew joined Veeva in 2016 to lead the ground-up design of Veeva’s clinical data management solutions. In his current role of Chief Technology Officer for Clinical Data, Drew collaborates with customers, partners, and the industry to set the vision and direction of Veeva's Clinical Data product family.

With nearly a career of 30 years in areas ranging from fundamental research (chemistry to solid-state electronics), university teaching, and for many years now clinical research, I find a theme running through what I do. I love trying to make complex things more simple and easy to understand. As Head of Operational Excellence and Translation Management, I am a catalyst for change. With my team we don't stand still - we analyze, invent, imagine and innovate...together. We work hard to ensure that people have what they need to get their job done: process, training, resources. In working for Sanofi, I have found a place aligned with my values, chasing the miracles of science so that we can deliver medicines to patients is something that I am proud to contribute to. I don't do it alone. I am lucky to lead a diverse and international team, to collaborate with many stakeholders internal and external to the company, and to learn and develop solutions together.

Experienced IT and Life Sciences leader specializing in enabling technology for pharma and biotech companies across R&D, global drug development, and clinical innovation. Known for pragmatic, big-picture thinking and hands-on leadership, I drive transformational change by applying digital solutions to enhance patient and site engagement and optimize clinical operations. Proven excellence at strategic planning, building effective teams, and delivering sustainable, high-value technology roadmaps—all with a strong passion for improving patient and sites outcomes.

Lisamarie is entering her 24th year in the pharmaceutical industry, specializing in Clinical Operations and Clinical Supplies. Throughout her career, she has held a variety of roles with increasing responsibility at BioMérieux, Hospira, ThermoFisher and MacroGenics, where she built a reputation for operational excellence, strategic leadership, and cross-functional collaboration. She is also the founder of GuidedPath Consulting, a firm dedicated to helping organizations strengthen their clinical operations and supply chain strategies through expert guidance, practical solutions, and a forward-looking approach. Renowned for her commitment to mentoring colleagues and developing high-performing teams, Lisamarie blends deep technical expertise with a people-first leadership style. Her ability to build strong, resilient clinical supply functions and empower talent has made her a trusted partner and influential leader across the industry.

Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.

Ellyn Getz is the Director of R&D Patient Partnerships at CSL Behring where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and appreciation. Prior to CSL, Ellyn directed CISCRP’s community outreach programs to increase clinical trial awareness, education, and access. Ellyn holds a Master of Public Health from Harvard University and a Bachelor’s degree from Brandeis University.

Max Ghez is Global Head, Clinical Business Development at Syneos Health where he is responsible for driving the global clinical growth strategy with new and existing customers. With more than 25 years of sales and business development experience, he has a longstanding understanding of the global landscape, customer challenges and the evolution of the clinical research industry. He leads the Clinical Business Development, Sales Enablement and Business and Customer Insights teams. Prior to joining Syneos Health, he held global business development positions of increasing responsibility at multiple global Clinical Research Organizations (CROs). An advocate for voice of the customer and differentiated solutions, he holds Master's degrees in Chemistry and Business Administration, Marketing and Sales from University of Paris V and VI.

Al Gianchetti is the CEO of Nuevocor Therapeutics, a biotech company focused on development of novel gene therapies for cardiovascular disease. Prior to this, he was CEO of XyloCor Therapeutics for 10 years. He has more than 30 years of drug development and commercialization experience, including cardiovascular/metabolic, neuro/psychology, infectious diseases and gene therapies. He has raised over $100 million in his role as CEO in biotech, held executive level roles at GSK, and leadership roles with specialty pharma. Al has extensive experience in both commercial strategy/operations and R&D.

Sarah Gill is Senior Director, RBQM Solutions, at Caidya, located in the UK. With over 20 years of industry experience in training and development, clinical monitoring, central monitoring, risk management, department leadership, and people management, Sarah enjoys sharing her knowledge and experience to empower, support, and develop people and enhance and improve processes.

Seth is a digital pioneer in health advocacy, dedicated to making support accessible and community-focused. Often referred to as "every patient's friend," Seth champions patient-driven health outcomes and is a globally recognized expert in technology that empowers patient advocacy. As a patient and social entrepreneur, he believes in achieving global patient-driven outcomes through collaboration and research. CreakyJoints.org, co-founded by Seth and Louis Tharp in 1999, is an international network fostering informed conversations and contributions for better patient and caregiver outcomes. Under Seth's leadership, the Global Healthy Living Foundation (GHLF) has become a leading organization in health advocacy and patient empowerment. GHLF provides a global and local platform for consumer and peer-reviewed research, delivering the latest evidence-based information on issues critical to chronic disease and immunocompromised patients. Seth regularly engages with the FDA, CDC, and regulatory bodies worldwide, such as the PBAC in Australia. Among his most significant innovations are CreakyJoints, PatientSpot (formerly ArthritisPower, originally funded by PCORI), PainSpot, and the global COVID-19 Patient Support Program for immunocompromised patients and their families. These and other GHLF programs engage more than a million patients per month. Seth hosts forums, events, programs, and campaigns around the world. He recently chaired the J-Forum of patient advocacy groups in Tokyo—a first of its kind—formerly hosted the e-Advocacy Summit in Washington, DC, and headlined the COVID-19 lockdown Elvis-themed digital BINGO game for patients globally—also a first of its kind. In his 25 years of driving these innovative projects, Seth has never solicited donations from patients or charged them fees. All resources for these patient-centered activities have been sourced from life science companies, government contracts, grants, awards, and private foundation funding. This unwavering commitment ensures that patients receive the support they need without any financial burden—especially when so many patients in the U.S. are already overburdened by a healthcare system that, to many, feels like it is working 'against the patient.' Seth leads the charge to fix this!

Sharri is currently a Data Scientist at Pfizer, focused on developing and deploying digital solutions to enhance clinical trial processes. This includes building machine learning models to forecast patient recruitment and diversity, with an emphasis on optimizing clinical trial site selection. In his previous role as a Performance Analyst, Sharri played a key role in reporting performance metrics that supported stakeholders in Clinical Development, contributing to the oversight of clinical and regulatory performance. Sharri also helped develop dashboards that consolidated data across various study functions and designed a range of analytical reports, performance dashboards, and presentations to deliver actionable insights to stakeholders.

With over 30 years in technology and 6 years leading Digital Accessibility at CVS Health, Monica has built and scaled enterprise-wide accessibility programs that impact millions of users. Her accessibility journey began in 2018, when she started with no prior knowledge of the field, and has since grown into a recognized leader driving innovation and inclusion. After CVS, Monica established Unified Accessibility and built the UA Nexus platform, where innovation meets inclusion. At its core, UA Nexus combines AI with human insight to deliver comprehensive accessibility solutions that help organizations design products and services everyone can use seamlessly, regardless of ability. Monica’s passion for accessibility was ignited by stories of people with disabilities who created their own solutions to overcome barriers. Today, as both a professional and a person with a disability, she brings the unique combination of expertise and lived experience to her work, championing accessibility not just as a compliance requirement, but as a driver of equity, innovation, and meaningful digital experiences.

Pending

Mr. Goldberg is an Operating Partner of Arsenal where he focuses on networking and sourcing transactions for the healthcare team. Prior to joining Arsenal in 2014, Mr. Goldberg was a Managing Director, Corporate Development of Endo Pharmaceuticals. Previously, he was a founding Partner of ProQuest Investments and the founding CEO or founder of three biotechnology companies that were acquired or taken public. In addition, he also held executive positions at Becton Dickinson and at GSK. He serves on Dana Farber Cancer Institute Visiting Committee and board of NIH/Cambridge/Oxford Scholars program.

With nearly 15 years in the patient access and site management space and an emphasis on developing innovative solutions to deliver life-changing and life-saving therapies to underrepresented populations. As the Head of Strategic Solutions for Elixia Health, Jeff works with Sponsors and CROs to jointly develop site strategies increasing patient access and enrollment with specific focus on Psychiatry, CNS, Nephrology, Infectious Disease, and Cardiometabolic indications.

Jennifer Sydney Goldman is a seasoned professional with extensive experience in the biotech industry, specializing in Finance and Business Operations. With a career spanning multiple organizations, Jen has developed deep expertise in Financial Planning and Analysis, focusing on both short and long-term budgeting and forecasting of clinical trials. She is also skilled in vendor relationship management, clinical operations, site contracts and budgets, and site payments. Jen began her career at Genetics Institute (now part of Pfizer) and has since contributed to the success of several notable biotech companies, including AVEO, Millennium, FORUM, Karyopharm, and Deciphera. Most recently, she has been providing valuable support to a number of small and startup biotechs, including Day One Biopharmaceuticals, Breathe Biomedical, Verismo Therapeutics, and Vigil Neuroscience. In addition to her professional work, Jen loves to speak about all things finance and clinical business operations, and has presented at several key industry conferences, , including Outsourcing in Clinical Trials New England (Boston 2024), the Association of Biotech Finance Officers (ABFO) National Conference (Boston 2024), ClinBiz (2023), and multiple SCOPE and MAGI conferences. Outside of her work in biotech, Jen is an accomplished musician with recent performances at renowned venues such as Boston’s Symphony and Jordan Halls, as well as the Hatch Memorial Shell on Boston’s Esplanade. A passionate advocate for teamwork, Jen believes that biotech, like music, is a collective effort—there are no soloists. She is always eager to connect with colleagues on topics related to Finance and Business Operations.

As Global Head of Clinical Operations, Robert oversees the performance of all global clinical trials, ensuring delivery to scope, timeline, budget, and quality standards. With more than 16 years of experience across sites, CROs, and sponsors, he brings deep therapeutic expertise spanning analgesia, gastroenterology, pulmonology, hepatology, cardiovascular disease, dermatology, endocrinology, rare disease, oncology, women’s health, men’s health, infectious disease, and CNS disorders. What sets Robert apart is not only his experience but his refusal to accept the status quo. A self-described disruptor, he is redefining how clinical trials are managed, designed, and delivered, with a sharp focus on operational efficiency and an uncompromising commitment to the patient experience.

Jennifer C. Goldsack co-founded and serves as the CEO of the Digital Medicine Society (DiMe), a global non-profit organization dedicated to advancing digital medicine to optimize human health. Jen’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine and Technology Leader at the World Economic Forum. Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System. Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Jen earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

Melanie has been part of the clinical trial industry for 20+ years focusing on trial enrollment and supplier relationships in a variety of therapeutic areas. Her most recent role is with Immunocore supporting Relationship Management across all Clinical Operations suppliers.

Rob Goodwin is the Chief Operating Officer of Parexel. In this role, he is responsible for leading the core clinical functions, specifically, project management, clinical and data operations, inclusive of early phase clinical units, real world research, and the operational excellence office. Rob has over 30 years of industry experience in clinical operations, safety and regulatory. Most recently, he was Senior Vice President of Clinical Development and Operations at Pfizer, where he was responsible for establishing, maintaining, and overseeing the global clinical development and operational capabilities required to develop Phase I through Phase IV study protocols and plans, execute clinical trials and deliver post marketing studies to support the introduction of new therapies for patients. In 2021, Rob was recognized by PharmaVoice magazine as one of the top 100 most influential leaders in healthcare. Rob earned a Master of Business Administration in Pharmaceutical and Chemical Studies from Fairleigh Dickinson University, a Master of Science in Research, Measurement and Evaluation from Southern Connecticut State University and a Bachelor of Science in Psychology from Eastern Connecticut State University.

Passionate about data science, digital technology applications, and artificial intelligence, with a strong commitment to driving innovation and transformation in the life sciences. Proven track record of leading cross-functional initiatives that modernize global clinical development through scalable, tech-enabled solutions. Experienced in partnering with high-impact functions such as Clinical Oversight & Risk Management, Clinical Data Strategy, Biospecimens & Imaging, and Informed Consent — delivering enterprise platforms and modernizing operational processes with precision and agility to boost efficiency and advance long-term strategic objectives.

Professor Bola Grace has decades of leadership experience across multiple sectors across pharma, biotech, and academia, providing strategic, commercial and technical direction to highly skilled cross-functional teams on complex programmes; and delivering numerous innovative award-winning products. She enjoys collaborative research and development as well as the application of data science across therapeutic areas. She was worked extensively on digital measures, devices and digital endpoints in clinical trials. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.

Matthew Graffeo, Managing Director, Global Digital and Clinical Trial Marketing at GCI Health, is a transformational leader who is redefining what digital strategy means in healthcare communications. Matt harnesses his expertise in international digital work to deliver innovation to GCI Health clients around the world. He has led multiple social media campaigns in a variety of languages and across regions, including Europe, Sub-Saharan Africa, the Middle East and Asia. Matt brings years of experience leading social and digital activations to clinical trials, integrating influencer strategy, paid media, AI-enabled creativity and multicultural digital marketing into novel recruitment approaches and campaigns.

Tameika Graham is a Strategic Site Partnership Lead at Pfizer. Tameika’s career has included CRO and Sponsor roles in Clinical Development & Operations and technical roles in laboratory sciences. She has led or contributed to numerous initiatives to enhance patient centered drug development, improve processes, optimize protocol design, and drive quality in clinical trials. Consistent with her appreciation for Public Heath practice, she finds inspiration in work that increases access to healthcare. Tameika believes inclusive research models that bring oncology clinical trials to patients where they are can improve health outcomes and produce more representative results.

Bianca Green brings a deeply personal and cross-functional perspective to her role as Head of Clinical Program Diversity at UCB Biosciences. Her career began at the benchtop in oncology research and continued through direct patient care as an oncology research nurse. These experiences that shaped her commitment to equity in clinical research. Today, she partners across functions from strategy and planning to site engagement and delivery to embed health equity into clinical development. Bianca is passionate about building inclusive partnerships and ensuring that clinical trials reflect the diversity of the communities they aim to serve.

Christy Greene is a former private practice attorney with 7 years of experience in clinical trial research. Today as Director of Global Site Agreements in Merck's Global Clinical Trial Operations organization, she oversees the team that manages the process for site contracting for Merck's clinical trials globally.

Diane Greenlaw is Director, RTSM at Medrio, where she leads strategy and delivery for randomization and trial supply management solutions that support sponsors and CROs in running efficient, patient-centric clinical trials. She brings more than 20 years of experience spanning clinical trials, product management, and operations leadership, including senior product roles focused on CRM, consulting, and complex enterprise platforms. Diane is recognized for her collaborative, service-oriented leadership style, driving process improvement, supply chain optimization, and high‑performing teams across global studies.

Catherine Gregor is an expert in clinical research operations and e-clinical solutions. With nearly two decades of clinical research experience, she has honed a deep understanding of clinical trial design, conduct, and patient outcomes. As the Chief Clinical Trial Officer for Florence Healthcare, she is at the forefront of designing and implementing technology solutions to support the mission of faster cures for everyone.

Results-oriented leader with broad-based experience in clinical health care, legal, process improvement, compliance risks, CAPA, and potential regulatory issues. Effective in setting priorities, creating organization, and adding value. Recognized for excellent communication skills and collaborative abilities.

Zahiah (Zee Zee) Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market and ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

Lindsay Guentzel is an award-winning journalist, writer, producer, and podcast host whose work has been featured in The New York Times, CBS Radio, NPR, ESPN, and more. After being diagnosed with ADHD in 2021—an experience she calls the best thing to ever happen to her—she spent two years learning how to navigate life with a neurodivergent brain. Then, in 2023, her world shifted again with a diagnosis of Dermatomyositis associated with Anti-Synthetase Syndrome, a collection of rare, incurable diseases that drastically changed her daily life. Leaning into advocacy and storytelling has been essential in her journey of learning to live with chronic illness and dynamic physical disabilities. She is passionate about raising awareness and building community for others facing similar challenges and over the last two years has shared her story with her legislators at Rare Disease Day in Washington, D.C., as well as Rare Disease Awareness Day at the state capitol in Minnesota. Lindsay was also invited by the NIH and the FDA to speak at their Rare Disease Day events in Bethesda, Maryland in 2025. In April 2025, Lindsay underwent a CAR T-cell transplant in Denver as part of a clinical trial looking at the treatment's safety and efficacy for use in treating autoimmune diseases. She lives in Minneapolis, Minnesota with her partner John and their rescue animals Ada and Pippi.

Anthony Gulotta is a healthcare technology leader with over a decade of experience bringing transformative AI solutions to market. As Director of Clinical Solutions at Biorce, he partners with pharmaceutical companies, biotechs, and CROs to accelerate clinical trial design and execution through AI-powered innovation.

Prior to joining Biorce, Anthony served as SVP of Sales at Leal Health, a patient-first digital health company leveraging AI, ML, NLP, and Gen-AI to democratize access to advanced cancer treatments. His leadership helped empower patients to take control of their treatment journeys while enabling life sciences companies to optimize trial recruitment, operational setup, and study design.

Anthony’s earlier career includes scaling AI-enabled solutions in HR tech at ENGAGE, where he played a key role in achieving a record-breaking company valuation prior to its acquisition, as well as strategic roles in talent acquisition and technical recruiting in the healthcare and engineering sectors.

Driven by a passion for innovation and measurable impact, Anthony is committed to bridging the gap between cutting-edge technology and real-world healthcare needs—delivering solutions that improve efficiency, reduce costs, and ultimately, bring better treatments to patients faster.

Dr. Arkady Gusev is the Executive Director of Laboratory Excellence and Operations in Biomarker Development/Translational Medicine at Novartis Institute for Biomedical Research. In his current role, he is responsible for the scientific and operational leadership of clinical biomarkers, assay outsourcing, sample operations, central laboratory setup, and vendor management. Previously, Arkady Gusev led the Business and Technology Operations units in the Department of Pharmacokinetics, Dynamics, and Metabolism in Pfizer Global Research Division. Arkady Gusev received his PhD (1992) in mass spectrometry from the Institute of Space Research, Russian Academy of Sciences. Following his PhD, he joined the Department of Chemistry, University of Pittsburgh as a postdoc and held a Research Assistant Professor position in the Department of Chemistry at Vanderbilt University before joining the industry in 1997. Arkady Gusev is the author and co-author of 60+ peer-reviewed publications in different areas of bioanalytical technologies, bioanalysis, biomarkers, and clinical operations. Arkady Gusev’s recent research interests include patient-centric technologies, bioanalytical and biomarker assay outsourcing, vendor management, clinical operations, and the art of operational excellence and portfolio management.

Jacqueline Habib is a recognized thought leader in data fluency and digital innovation, with over 15 years of experience translating complex business needs into transformative business solutions for the pharmaceutical industry. As Senior Director of Portfolio Management Insights at Bristol Myers Squibb, Jacqueline has trailblazed enterprise-wide initiatives that harmonize data, automate reporting, and elevate operational excellence, most notably as the business owner of Performance Central and the driving force behind the IRIS AI chatbot. Her leadership in cross-functional forums and strategic programs has positioned her as a catalyst for collaboration, transparency, and innovation, positioning the Portfolio Insights & Reporting team as a center of excellence for decision-driving insights in Drug Development. Jacqueline’s expertise spans advanced analytics, user experience design, and the deployment of scalable, pragmatic solutions that empower decision-makers and accelerate portfolio success. With a proven track record of fostering high-performing teams and championing AI-driven transformation, Jacqueline offers a compelling vision for the future of pharma—where technology and human ingenuity converge to deliver measurable impact for patients.

Taryn Haffner, M.S., is an Associate Director and Global Trial Lead at Genmab, where she leads global oncology studies with a focus on operational strategy and quality oversight. With a background in molecular biology and diagnostics, she brings a strong technical foundation to clinical operations. Taryn has worked across both start-up and mid-size biotechs, building and refining processes to improve efficiency, scalability, and collaboration. She is passionate about advancing Risk-Based Quality Management (RBQM) as a cornerstone of sustainable trial operations and believes technology and data analytics play a critical role in achieving smarter, more adaptive oversight. Taryn brings a pragmatic perspective on balancing quality, efficiency, and innovation in today’s evolving clinical trial landscape.

Syed Haider is a business strategy Leader in AI and Data Sciences driving digital innovations at Merck. He leads and supports strategic AI solutions and automation with human-in-the-loop in clinical trials. Syed is responsible for AI strategy, successful adoption, and change management in global operations. He is passionate about sharing his knowledge and experience with the new talent; Syed is an Adjunct Associate Professor at Columbia University where he teaches graduate courses in AI, and mentors graduate students at the Data Science Institute. Syed led AI and Data Science in Life Sciences and Healthcare for over 17 years.

Duncan, CEO of Triumph Research Intelligence (TRI), is a seasoned business leader with over 20 years of experience in the life sciences technology sector. Duncan has helped drive innovation in risk-based monitoring and ICH E6 (R3) compliance. At TRI, he leads the development of OPRA - an advanced cloud-based platform for centralized and risk-based monitoring - and oversees a suite of services designed to support efficient, practical adoption of RBQM across clinical operations.

Dynamic biotechology leader with a proven track record of success in developing and implementing strategic plans to drive organizational goals. A critical thinker who excels at asking probing questions to deliver exceptional results through highly proficient mechanics. A highly respected and influential thought leader and communicator, adept at building strong relationships and garnering project support and consensus.

Seth Halvorson is the General Manager of WCG’s Site Solutions business unit that includes WCG’s study start up teams, site network, CTMS, recruitment and retention services, study acceleration, and site augmentation solutions. Seth started at WCG in 2018 as the General Manager of WCG ThreeWire. Prior to joining WCG he was Vice President and Assistant General Counsel at Syneos Health. Seth worked at Syneos Health for 9 years through the i3/PharmaNet merger that created inVentiv Health and the INC Research Merger that created Syneos Health. During that time, Seth was responsible for leading the clinical division’s global contracting teams and providing legal counsel for the clinical division. Seth was a member of the inVentiv Health Patient Centricity task force. Seth devotes his energy to developing and deploying realistic and effective solutions that connect the keys clinical trial stakeholders of sponsor, site, and participant.

Donna Hanson brings over two decades of global experience in clinical trial planning, feasibility, start-up and patient engagement optimization. She has led enterprise-level initiatives to integrate processes into adaptive feasibility and start-up frameworks that reduce blind spots and improve predictability. Donna has guided sponsors through complex transitions to establish best practices across functions as they move to insourced and hybrid models, building scalable infrastructures that anticipate operational risks before they impact milestones. Her expertise spans across multiple therapeutic areas and study phases.

Tracy Harman is Deputy Director of Strategic Development at the National Institute for Health & Care Research (NIHR) Research Delivery Network Coordinating Centre. Her role involves identifying opportunities for expanding research delivery in the UK, making it more accessible, and ensuring research gets to the right person, in the right place, at the right time. She is also looking at barriers to research delivery, developing solutions and helping to embed research into the NHS and wider care environment. Previously, Tracy worked to develop areas of emerging technology and innovation, including Advanced Therapies, by building on her previous 20 years of experience with the UK Cystic Fibrosis Gene Therapy Consortium (now the Respiratory Gene Therapy Consortium) where she supported the delivery of a pivotal multi-dose non-viral gene therapy study for Cystic Fibrosis, and oversaw the set-up and delivery of cross-UK core facilities to support pre-clinical and early phase respiratory gene therapy studies. In addition from 2008-2017 Tracy managed the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London NIHR Biomedical Research Unit and Clinical Research Facility. Tracy has extensive experience in developing strategies, and the downstream strategic project development, developing national processes, financial management and contracting across numerous stakeholders, setting up and overseeing core facilities, coordinating multi-centre grant submissions, linking NIHR infrastructure nationwide and keeping the patient at the centre of research initiatives.

Suzanne Harris leads SubjectWell’s patient marketing and corporate marketing and communications teams with more than 25 years of marketing experience underpinned by 20 years as a patient advocate. At the helm of SubjectWell’s growth initiatives, she brings both strategic marketing expertise and a deeply personal commitment to patient-centric healthcare solutions.

Suzanne’s professional drive is deeply informed by personal experience: advocating for her children born with eosinophilic esophagitis and later navigating her own Ehlers‑Danlos Syndrome journey. These challenges made her realize the power of patient voice in transforming healthcare—from policy change to clinical trial design.

Karen A. Hartman, MS, is the vice chair, Research Administration for Mayo Clinic and assistant professor of health care administration, Mayo Clinic College of Medicine and Science. She administratively leads all aspects of clinical research for Mayo Clinic, including strategy development and execution. In addition, she leads research administration shared services encompassing research subjects’ protection programs, grants and contracting, compliance, research education, and regulatory and quality programs. Prior to this role, Ms. Hartman served as Mayo Clinic’s research compliance officer and as operations manager for the Office of Research Regulatory Support. Earlier in her career, she served as a nurse and officer in the US Navy, last stationed at Portsmouth Naval Hospital. Ms. Hartman earned her bachelor’s degree in nursing from Winona State University in Winona, Minnesota, and a master’s degree in clinical research management from Duke University in Durham, North Carolina. She is active in many professional organizations, including the Council on Governmental Relations, National Council of University Research Administrators, and Women’s Health Leadership TRUST.

Michelle Hartmann, CCRP, is the Director/Owner of South Broward Research which is located in SE Florida. She started with South Broward Research in 2006. South Broward Research is a community based, independent site. She is dedicated to the pursuit of advancing healthcare by ensuring integrity and quality in the work performed at South Broward Research. She feels fortunate to be a part of an incredible team. She attended The Florida State University where she received both her Bachelor of Science and Master of Science. She continues her education in the field of research by attending research seminars and conferences, participating in panels with sponsors and industry organizations, and becoming a Certified Clinical Research Professional. She enjoys spending time with her family, traveling, and can often be found reading a good book.

Jennifer Hebert is Principal Quality Lead at Roche/Genentech with over 20 years’ experience in healthcare and research. She specializes in risk-based quality strategy, data-driven operations, and cross-functional team leadership. With a strong operational background, Jennifer brings practical insights to her quality work. Before joining Roche/Genentech, she led global teams at leading life sciences organizations, delivering initiatives that improved compliance and advanced patient-focused solutions.

Tina began her career in marketing, communications, and public relations, an early foundation that sharpened her skills in stakeholder engagement, strategic messaging, and cross-functional alignment. Her transition into healthcare and clinical research brought those strengths into highly regulated environments, where she quickly rose through roles in site leadership, clinical operations, and trial management. Now with over 24 years in the life sciences industry, Tina serves as Head of Life Sciences Consulting at Just in Time GCP. She leads strategic consulting services that help pharmaceutical and biotech sponsors optimize trial operations, elevate GCP compliance, and solve complex challenges across people, process, data, and technology. She leads a high-performing consulting team and drives strategic offerings that bridge inspection readiness with operational excellence. Over the years, she has held leadership roles at organizations such as Medidata, AmerisourceBergen, Galderma, and Alcon (Novartis), where she guided global programs, led cross-functional transformations, and delivered practical, sustainable improvements. Whether strengthening clinical governance and oversight, leading enterprise-wide change, or mentoring new talent, Tina is known for translating strategy into execution with clarity and impact. Tina is an ER nurse with advanced certifications in trauma care. She holds undergraduate degrees in Communication and Nursing, along with an MBA in Strategic Leadership and an MS in Business and Human Relations. She is a certified Lean Six Sigma Green Belt and Prosci Certified Change Management Practitioner. Known for her clarity, adaptability, and ability to translate vision into action, Tina brings a multidisciplinary perspective to every engagement, grounded in both business strategy and clinical integrity.

As the Vice President of Research Technology at Mass General Brigham, Chris leads a team of over 60 professionals who provide cutting-edge informatics and analytics solutions to support the research mission of one of the largest and most prestigious healthcare systems in the world. With over 20 years of experience in the hospital and healthcare industry, he has a proven track record of delivering value to stakeholders, partners, and customers through strategic vision, operational excellence, and business development. He has been involved from the start in the development of the Mass General Brigham Research Patient Data Registry (RPDR) as well as i2b2 (Informatics for Integrating Biology and the Bedside), an open-source informatics platform used at over 300 academic institutions worldwide. He is passionate about advancing biomedical research and innovation through the use of data and technology with a goal of empowering researchers to discover new insights, improve patient outcomes, and transform health care.

Veteran Clinical Operations professional with 27 years in industry on both the sponsor and CRO side as well as a sponsor consultant. Currently serving as VP of Clinical Operations for Processa Pharmaceuticals. Experience in IND, NDA, sNDA development and submission, as well as phase 1-4 studies, including pediatric oncology, hematology/oncology, rare disease and CNS trials. Previous time served at Amgen, Biomarin, PPD, and Quintiles. My main interest and goal of clinical research is to understand the challenges that front line providers face, and how as sponsors, we can make the process of clinical trials and drug approvals faster, easier, and less intrusive on patient care.

Jameka Hill is the Senior Director and Global Head, Clinical Trial Health Equity at Moderna where she is at the forefront of establishing and guiding the company's strategy to enhance patient involvement, deepen patient and community health partnerships, and ensure diverse and inclusive clinical trials. For over two decades, Jameka has focused exclusively on increasing awareness and improving access to clinical trials as a care option for women, older adults, racial-ethnic minority groups, patients living with rare diseases, and vulnerable populations including pregnant women and pediatrics. Jameka is an avid health literacy and community engagement advocate who strongly believes in the importance of collaborating with internal stakeholders and external thought leaders to improve heath equity around the world.

Jolene Hill is a results-oriented Business Consultant with over 20 years of experience leading global initiatives in the pharmaceutical industry. She specializes in driving innovation by aligning technological solutions with business objectives, leveraging her expertise in process improvement, change management, and digitalization strategies. As a subject matter expert in Specimen Management, Jolene applies her deep knowledge of content standardization, data modeling, translational medicine sample management, clinical development operations, and drug retention programs to streamline operations and enhance efficiencies. Her diverse skill set, and leadership have been instrumental in advancing digitization and optimizing workflows across the pharmaceutical sector.

Dr. Amber Hill founded Research Grid (R.grid) to automate clinical trials to cut costs, reduce delays, and increase patient engagement and retention. Her expertise is in end-to-end medical research, patient engagement, and smart software systems. Prior to R.grid, her career in biomedical neuroscience, AI, and clinical trials (UCL, Harvard, MIT) spans across 15 years in world-leading research institutions where she has built neurological deficit-scoring tech and previously founded a global non-profit supporting patient involvement in research. Dr. Hill has been an expert feature for top publications like the Wall Street Journal, Tech Crunch, and Essence Magazine. She has also received several honors such as the Royal Academy of Engineering fellowships and listed as one of The Financial Times: 100 Most Influential Women in Engineering. Research Grid has subsequently been backed and recognised by leading institutions from the likes of Google, Amazon, Morgan Stanley, the Royal Academy of Engineering, The London Stock Exchange, Plug and Play Health, and several others in the U.S. and Europe. Dr. Hill continues to drive forward her vision to make clinical trials admin-free for more successful medical treatments for everyone, everywhere.

I am passionate about creating new paradigms that create meaningful change through innovation in healthcare and clinical research through investing, strategy, M&A and partnerships. I have held a variety of roles in my ~17 years in healthcare technology (EHR and clinical trial tech) in leadership roles spanning corporate strategy, product strategy, product management, and partnerships across stages from company start-up to scale. Through that time I launched six technology products, driving M&A strategic evaluation and processes including completing six strategic acquisitions, developing corporate strategy, and developing and launching partner programs. I have been on the sell side of company exits twice, helping develop a strategic thesis for growth that has continued to be the path the company follows. I have a Bachelor’s in Molecular / Cell Biology from Vanderbilt University, am a mentor to start-up entrepreneurs in Madison, active in helping improve healthcare in Africa, and spend my free time negotiating with my young daughter or outdoors hiking or kayaking.

With over 20 years of experience in the clinical research industry, Jesse has held significant site and CRO roles, including 12 years at Syneos Health, a global Contract Research Organization (CRO), and 4 years at Advanced Clinical Research, with 2 sites in Utah and Idaho. Since 2019, Jesse has been the Chief Business Officer at AMR, a prominent clinical research site company with over 30 locations across the United States.

Kesley D. Holmes, DHA, MS, CCRP is a clinical research executive with more than fifteen years of experience in research operations, strategic planning, and workforce development. She currently serves as Director of Clinical Research at United Digestive, where she leads the development of research infrastructure and the expansion of clinical trials across a multi-site healthcare network. Dr. Holmes is deeply committed to advancing research operations through strategic innovation and organizational excellence. She has directed transformative initiatives to improve cost recovery, optimize resource allocation, and strengthen institutional research capacity. Recognized for her leadership in data-driven and technology-enabled research management, she has implemented integrated systems that enhance operational efficiency, ensure regulatory compliance, and elevate clinical trial performance. In addition to her operational leadership, Dr. Holmes is dedicated to cultivating the clinical research workforce. She established the Clinical Research Coordinator Certificate (CRCC) Program, a national training initiative designed to promote diversity, excellence, and sustainability within the clinical research profession. Dr. Holmes holds a Doctorate in Health Administration, a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, and a Bachelor of Science in Health Sciences with a concentration in Health Services Administration. She integrates academic rigor with operational expertise to advance clinical research through innovation, equity, and measurable impact.

Randall Holzberger has experienced a wide ranging Clinical Research career spanning over 17 years across CROs and Pharma. He spent over 10 years within Clinical Operations as a CRA and Study Lead before transitioning to a role in the Risk Based Monitoring space. This exciting area has allowed Randall to further explore his interests in data and push the envelope of how to better, more efficiently monitor a study while maintaining a high level of data quality and oversight of patient safety.

Mei Hong is the Director of Business and Information Architecture in the Clinical Development and Digital Solutions organization at Merck. She brings 25+ years of experience delivering technology transformations that drive meaningful business value across pharmaceutical R&D. She has led cross-functional programs that modernize technology platforms and improve AI and data capabilities to enable faster, more informed decision-making.

Paul Hughes is a longtime RTSM professional currently serving as Director of Randomization and Trial Supply Management at Johnson and Johnson Innovative Medicine. Prior work experiences include RTSM roles at Pfizer and ClinPhone. In total, Paul has focused on RTSM for close to 25 years. Paul’s focus now is to put his years as an RTSM Subject Matter Expert into effective strategy and leadership that improves the RTSM space. Paul hosts RTSM Time, a livestream on LinkedIn Live, in which he interviews guests and discusses topics of interest to the RTSM industry. Paul was the recipient of Informa’s first “IRT Lifetime Achievement Award” in 2024.

Lindsay Hughes is a Principal within IQVIA’s Patient Centered Solutions team with nearly 20 years of experience in behavioral and life sciences, focusing on the role of information and human behavior in health outcomes. She leads a team that supports pharma clients in implementing digital measures in clinical research and healthcare settings.

Ann-Marie started her pharma/biotech career over 20 years ago and has found a love of the unique challenges that biotech and start-ups bring. Ann-Marie serves as the Vice President of Clinical Operations at Alpheus Medical, leading a drug device combination program. She has spent the majority of her career in, and has a passion for, oncology drug development.

Over the past 18 years with CNS Healthcare, I have worked as a Clinical Research Coordinator, Site Administrator, Director of Marketing, Clinical Development Liaison and Director of Contracts & Trial Management. These various roles have given me the opportunity to interact closely with patients, physicians, and study teams, and have allowed me to gain experience in the many aspects of running clinical trials from the perspective of the investigative site. Currently, as the VP of Contracts & Trial Management, I negotiate all of the clinical trial agreements for our sites; work with our Finance Team on projecting and reconciling revenue; work with our Business Development Team to ensure we have a consistent stream of new trial opportunities coming in; strategize with our Marketing Team to make sure we’re recruiting enough patients to meet our enrollment goals; and support our clinical teams in their mission of providing great care to patients while collecting clean and accurate trial data. I’m committed to continuous growth and am constantly on the lookout for opportunities to learn from the people around me.

Jeff Huntsman is the Chief Commercial Officer at EmVenio responsible for the overall commercial strategy and revenue generation. Mr. Huntsman joined EmVenio in 2024 with more than 30 years of experience in the Life Sciences space, where he has led global commercial teams selling pharma services solutions across the clinical development and regulatory lifecycle.

Prior to joining EmVenio, Mr. Huntsman ran a consulting firm providing strategic advice to private equity, venture capital and emerging growth companies. Earlier in his career, he was the Chief Commercial Officer at Sitero, Citeline, ConnectiveRx, and LIQUENT. He has held executive leadership roles at Clarivate, Parexel, Thomson Reuters, and Rogers Communications as well as having served as a Health Care Advisor at Warburg Pincus and Growth Capital Partners.

Mr. Huntsman earned a Bachelor of Science in Marketing and Political Science from Ball State University in Muncie, Indiana.

A globally recognized advocate within the patient community, Stacy champions Parexel’s patients-first culture. She ensures that patients and caregivers have a seat at the table to translate their lived experience and recommendations into improvements in the drug development process at its earliest stages. Stacy champions accessibility to clinical research by expanding the definition of diversity to ensure that people with disabilities have an equitable chance at better treatments, improved outcomes, and cures. Stacy is an award-winning 25-year pharma executive with experience in functional areas such as sales, marketing, training, operations, and physician practice management. She is a frequent conference speaker and industry influencer, always championing patient involvement in clinical research, for example, as a member of the Global Annual Meeting Program Committee for Drug Information Association (DIA). Stacy is also co-chair of the board of the American Cancer Society Northeast Region (Pittsburgh market).  Stacy holds a bachelor’s degree in labor and industrial relations from Penn State University and master’s degrees in health administration and business administration from the University of Pittsburgh.

Brett Huselton serves as the Senior Vice President of Partnership, Innovation, and Strategic Solutions at UBC. He is responsible for expanding UBC’s partnerships and innovations practice, through dedicated focus on strategic growth, novel integrated offerings, and transformative approaches to delivering on UBCs Evidence and Access portfolio. Mr. Huselton joined UBC in 2008 and has more than 25 years of experience in the pharmaceutical services industry, from early development through commercial support, globally. His focus is to direct and inform UBC in making meaningful decisions related to the transformation and advancement of our offering in supporting patient care through investing in new approaches, tools, infrastructure, real-world data, and technologies that can streamline the acquisition of key data, take advantage of advancements in the interoperability between systems being promoted externally across health systems, payers, data providers, and pharma. Mr. Huselton focuses not only UBCs internal core competencies and how the ‘integrated UBC’ can support the life-sciences sector, but also in connecting with external parties and novel solutions that extend the collective strength of the UBC offering. Mr. Huselton has degrees in Neuroscience & Psychology and earned his MBA from the Erivan K. Haub School of Business at St. Joseph’s University in Philadelphia.

Dr. Muhammed Y. Idris is an Assistant Professor in the Department of Medicine at Morehouse School of Medicine (MSM), where he is also an Associate Director leading digital transformation in the Clinical Research Center and serves the Founding Co-Director the Center of Excellence for the Validation of Digital Health Technologies and Clinical Algorithms. Trained as a computational social scientist his work combines machine learning and community-based research to design more accessible and adaptive digital health tools and interventions for use in clinical research. Prior to joining MSM, Dr. Idris held several roles leading interdisciplinary teams building, deploying, and maintaining machine learning solutions in industry as well as startups and venture capital. His work has been presented on various academic, policy, and industry platforms and encompasses a TED talk on AI-driven social service delivery that garnered around 1.8 million views. Dr. Idris graduated from the University of Washington and the Pennsylvania State University.

Bill is the Head of Collaboration and Technology Strategy, in the Clinical Development and Analytics function at Novartis and is currently responsible for developing the Analytics strategy and initiating improvement projects. He has developed and led large-scale technology and business process transformation projects in data and digital across the pharma R&D landscape. He was appointed as lead for the Transcelerate Digital Data Flow initiative in June 2018. Bill has over 25 years of industry experience in R&D spanning subject areas of Cancer Epidemiology, Health Care Cost/Utilization Research; Preclinical Safety, and Clinical Development and Regulatory Affairs, and functional experience in Data Management, Programming, Statistics, Data Standards, Data Governance, Information Technology and Operations. He holds a Master’s Degree in Public Health (Biostatistics) from the University of Michigan and a Bachelor’s degree in Psychology from Providence College.

Joe Im is currently the head of digital health technology operations at Regeneron. He has 15 years of experience within the clinical trial space, where he’s been able to exercise his interest in cutting-edge technologies and his passion for improving the lives of patients. He has held positions on the supplier and sponsor sides within the COA project management function, as well as in innovations and imaging category management. In his current role, he leads a team responsible for deploying and operating digital health technologies such as eCOA, sensor devices, digital apps, medical devices, and eClinical solutions into clinical trials. Joe has successfully led initiatives at Regeneron including the COA operations team development, adoption of eCOA BYOD as a standard modality, and development of a decentralize trial operating strategy. Joe is happy to share his experiences and learn from the industry, ways we can contribute to improving the lives and outcomes of our patients.

Anne Marie Inglis has over 25 years of experience in clinical research, spanning all phases and therapeutic areas, but specializes primarily in Clinical Operations. She spent most of her career at GSK, and up until 2020 represented GSK on TransCelerate Biopharma workstreams, leading both the Site Qualification and Training team as well as the Patient Experience Team. She is passionate about improving the patient experience in clinical research and in particular, increasing the diversity of participants in clinical trials. She left GSK in 2020 to move into smaller biotech and at Mallinckrodt Pharmaceuticals developed a Risk Management framework that ensured compliance to ICH E6(R2). She moved to Affinivax and was responsible for developing the innovative operational strategy for an early-phase vaccine asset. In 2022, Affinivax was acquired by GSK, and Anne Marie is back as a Clinical Operations Asset Lead. She remains committed to employing innovative strategies to ensure clinical trials are available to all patients who could benefit, while improving quality and speeding delivery of new medicines to the marketplace.

Dana is a pharmaceutical industry executive, dedicated to humanizing medicine, seeking all opportunities to improve health and well-being through public, private, and academic partnerships. As Global Head, Clinical Operations Program Management within Novartis, Dana leads a global community of experts who use data and insights to inform clinical trial feasibility, which includes forecasting timelines, selecting geographies and investigator sites, and determining how design influences execution. Her team collaborates with cross-functional teams, including clinical development, medical affairs, business development and licensing, project management, and regulatory affairs, to align feasibility assessments with strategic goals to bring medicines that matter to patients in the areas of Oncology, Immunology, Cardiovascular-Renal-Metabolic, and Neuroscience. She has more than 25 years of experience in all aspects of drug development including portfolio and project management and various disciplines within clinical trial operations as well as proven leadership in large-scale organizational transformations. Dana is known for her strong leadership skills, collaborative approach, and ability to create high-performing teams. Dana is passionate about serving the needs of at-risk youth and serves as an advisor for A Chance in Life, a global non-profit organization. Additionally, she is an ambassador on the National Council for American Enterprise Institute (AEI), a public policy think tank dedicated to building a freer and safer world. Dana holds a Bachelor of Science in Biology from Loyola University Maryland as well as a Masters in Medical Humanities from Drew University.

Venky Iyer is Director of Data Strategy & Automations within Information Management Group at Pfizer. He has over three decades of experience in the pharmaceutical sector delivering key enablers for multiple clients to drive business value. Currently, he is actively involved in several AI/ML strategic initiatives partnering with key stakeholders and driving key concepts for enablement. He holds a master’s degree in Mathematics and has been with Pfizer since 2019.

Jennifer Jackman, PhD, MBA, is the Associate Director of Strategic Programs at the DCRI. Dr. Jackman has over 15 years of research experience, including managing an oncology research team at the site level and leading the DCRI Medical Communications team. In her Strategic Programs role, she oversees various programs that relate to clinical research policy, education, and efficient/innovative study design. Dr. Jackman has a passion for optimizing clinical trial design to align with regulatory and evidence-generation needs in a broad range of therapeutic areas. She strives to understand and align the pursuits of stakeholders across the clinical research ecosystem to advance clinical research and healthcare to improve the lives of patients and their families.

Erica Coles Jacobsen is Senior Director and Qualitative Practice Lead at Konovo (formerly InCrowd), where she leads strategic research initiatives that shape commercialization, market access, and product strategy for life sciences clients. With 20+ years of experience turning insights into growth across Pharma, FinTech, and private equity-backed ventures, Erica brings deep expertise in customer strategy, executive advisory, and high-performing team leadership. A Dartmouth College graduate with an MBA from the University of Virginia’s Darden School, she previously spent 17 years at C Space guiding customer-centric strategy for global brands. Outside of work, Erica serves as Chair of the Town of Newbury Finance Committee and enjoys life in coastal Massachusetts with her husband Todd, their two children, Cole and Annie, and their beloved doodles, Laney and Noodle.

Sid leads the Global Development Data Science team, responsible for enhancing clinical trial operations with industry-leading advance analytics and best-in-class linked datasets. Sid’s team also leads several first-in-industry innovations including registries linking clinical trial data with real-world data (RWD) via tokenization to enable real-world effectiveness studies and long-term follow up (LTFU) and a first-in-industry, hybrid External Control Arm (ECA) in neuroscience resulting in groundbreaking real-world evidence generation prior to licensure. Sid is a champion and strong supporter of harnessing the power of technology to advance and transform healthcare. He is passionate about accelerating clinical research and increasing diversity, equity, and inclusion (DEI) in clinical trials by leveraging artificial intelligence and machine learning (AI/ML) models, advancing patient matching using RWD, and reducing patient burden by enabling decentralized/virtual trials – with the goal of bringing lifesaving and -enhancing therapies to patients faster. A recent example of impact is the award-winning ML-driven model, which predicted COVID-19 hotspots with over 90% accuracy, driving highly targeted site selection and shortening enrollment by 6-8 weeks. Prior to joining Janssen, Sid was VP of products at ConcertAI where he was responsible for building the next generation Real World Evidence (RWE) platform, eurekaHealth, which accelerated use of RWD and data science for a variety of R&D and commercial use cases at several leading biopharma companies. Prior to that, Sid was VP of Product Strategy at NantHealth where he managed and oversaw delivery of a broad portfolio of capabilities, including clinical decision support, combining molecular insights with standard of care treatment guidelines and oncology prior authorization. Sid has 20 years of leadership experience in healthcare, data and technology serving patients, biopharma, payers, and providers. Sid holds a Bachelor of Science with a double major in Computer Science and Management Information Systems. In addition, Sid has completed an Executive Management Program at MIT focused on Management and Leadership.

I am currently the Director of Digital Clinical Operations at BeOne Medicines, where I lead initiatives to enhance clinical trial execution through digital innovation, integrated data platforms, and operational excellence. With over nineteen years of experience in pharmaceutical research and development, I have had the opportunity to build and scale clinical technology solutions, including the Cognizant Shared Investigator Platform, and to lead transformation programs focused on study startup, site engagement, and risk-based monitoring. I am passionate about advancing digital maturity in clinical operations and creating connected ecosystems that accelerate the delivery of medicines to patients.

Don Jennings currently serves as Senior Director in Eli Lilly’s clinical research organization, responsible for driving transformational initiatives that accelerate, scale,and improve the reach of Lilly’s clinical research pipeline through use of innovative technologies. Don also participates in the Transcelerate Digital Data Flow (DDF) workstream as Vendor Engagement sub-team lead where he advocates for USDM adoption to realize the promise of industry-scale data system interoperability. Previously, Don was Senior Architect in Eli Lilly’s technical organization responsible for defining, evolving and driving innovation in Lilly’s clinical trial design and operations capabilities (2023-2025). He also led engineering teams in developing SaMD medical device software (2018-2023), eSource technologies, automated clinical information exchange, PK/PD simulation and genomic analytics (2007-2018). Prior to his roles at Lilly, Don participated in the original sequencing of the human and rat genomes at Celera Genomics (2000-2007) and delivered science ground segments for several NASA and ESA high energy astrophysics missions (1989-2000). Don holds an MBA from Butler University, an M.S. in Physics from Iowa State University, and bachelor’s degrees in Physics and Computer Science from the University of Missouri.

Experienced Relationship Development Professional specializes in representing the voice of the client to internal stakeholders. Ability to navigate complex science, regulatory and organizational landscapes. Brings creative & collaborative solutioning to both clients and the patients. Strong Executive presence and the ability to communicate at all levels. Described by peers as a resilient team player who can connect the dots to bring the right resources together to deliver clinical trials worldwide.

Lauren Johnson is currently leading the recruitment and retention execution team and serving as business process owner at Pfizer, working across study teams to and closely with organizational leaders to maintain quality delivery and processes with continuous improvement. Ms. Johnson as has over 20 years of biopharma experience in operations and patient recruitment and retention at Sanofi, Seagen, ICON an PRA, including over a decade in management and leadership, working across all therapeutic areas and phases of clinical research. Ms. Johnson's strategic focus includes reduced site and patient burden, data-driven decision-making, best practice execution and proactive risk-mitigation.

Kristina Johnson is the Vice President and Global Head of Clinical Development Operations at Noema Pharma, bringing extensive leadership experience across central nervous system disorders, neuromuscular and muscle diseases, oncology, and rare pediatric conditions. Her expertise spans CNS indications such as pain and multiple sclerosis; neuromuscular diseases including ALS, SMA, and DMD; oncology across both solid (NSCLC, RCC, TNBC, GIST) and hematologic tumors (ALL, AMC, MM, CML); and rare, pediatric diseases such as MPS I and Pompe.

Kristina has led multiple Clinical Development Operations organizations and served as the operational and strategic program lead for neuromuscular programs including Spinraza®, as well as key oncology programs from the Sponsor and CRO perspectives. She is an active member of a volunteer Clinical Operations Steering Committee and a strong advocate for integrating patient perspectives into clinical development. Kristina is recognized for her commitment to operational excellence, partnership, and advancing patient-centered innovation in global drug development.

Tom Johnson is a seasoned professional who has devoted the last decade to optimizing the clinical study process for life sciences companies, focusing on reducing technical burdens and enhancing efficiency in study start-up and application access management. Exostar's expansive community includes half of the world’s largest pharmaceutical companies, over 36,000 organizations, 122+ connected applications, and over 860,000+ individuals working in thousands of sponsors, CRO and site locations worldwide. With a Bachelor of Science in Industrial Engineering from The Georgia Institute of Technology, Tom brings a unique blend of academic expertise and practical experience to his role, driving impactful solutions within the life sciences industry.

John Jones, CEO and Founder of Entitech Solutions, specializes in data integration solutions for healthcare and life sciences, partnering with leading pharmaceutical companies and contract research organizations to implement integration architectures that streamline R&D and regulatory systems, reducing cycle times, and boosting productivity.

Zhanna Jumadilova is a physician scientist and pharmaceutical executive with broad experience in Clinical Development, Medical Affairs, and General Management at major pharma and biotech companies. Currently, Zhanna leads Pfizer’s integration of pragmatic clinical trials into medical evidence strategies. Zhanna earned an MD with a fellowship in Clinical Immunology from Kazakh State Medical University and an MBA from the University of Pittsburgh. Zhanna has directed complex clinical programs, developed market access strategies, built new development organizations, and ensured regulatory compliance for both large and small companies. Widely published in medical literature, Zhanna is an active member of TransCelerate BioPharma and participates in other industry organizations and has collaborated with major regulatory bodies to advance innovation in clinical research.

Hassan Kadhim is the Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at BMS. In his current role, Hassan's team owns the technology stack and capabilities within Global Development Operations, and drives change and innovation towards better outcomes for clinical trial stakeholders. Hassan is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Hassan regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Beyond BMS, Hassan actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges. He has a degree in bioinformatics and a graduate degree in pharmaceutical sciences, both from the University of Montreal in Canada.

Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, data-driven patient recruitment, and the use of RWD to support evidence generation & submission to regulatory agencies (e.g., FDA). He has this experience across the spectrum of pharmaceutical/biotech, entrepreneurship, and large CRO businesses.

I have been with Bristol Myers Squibb for over 20 years and hold an MBA, bringing an exceptional depth of expertise in biospecimen and operational management. As the leader overseeing the Specimen Library, Systems, and Logistics teams, I manage the end-to-end lifecycle of clinical trial specimens—from physical sample management for ongoing and closed trials to navigating global logistics, ensuring secure customs clearance and timely delivery of biospecimens. Additionally, I oversee the health and maintenance of Polaris, BMS’s robust sample management system, which handles both internal and external sample inventories. I have a passion for operational excellence, advancing clinical research and committed to driving innovation in biospecimen operations.

Dr. Michalis (Mike) Kantartjis leads applied AI at Clinical ink, building intelligent systems that transform how clinical trial teams interact with data. His work spans AI-powered analytics, enterprise knowledge agents, design-to-code automation, and data architecture—all focused on eliminating silos and making complex information accessible to non-technical users. He holds a PhD in Health Informatics from the University of Iowa, where he studied human–data interaction and decision-support systems during the COVID-19 pandemic. Originally from Cyprus, Mike enjoys spending time at the beach with his family and playing guitar.

Beenu Kapoor, Executive Director, Digital Clinical Operations, BeOne Medicines. She is responsible for the Digital Transformation of Global Clinical Operations team with the goal to increase Global Clinical Operations’ productivity, reduce rising costs of clinical trials, and clinical trial inefficiencies. With over 25 years of experience in the biopharma industry, Beenu brings an exceptional blend of strategic thinking and executional excellence. Her expertise extends across strategic and operational planning, business process transformation, and financial management. She has a proven track record in Clinical Operations strategy, digital transformation, and data analytics. Before joining us, Beenu was at IQVIA, where she led the development of the Digital Trial Management Product Suite, including Site Monitoring, CTMS, and RBQM products. Her leadership was crucial in improving patient outcomes and accelerating time-to-market. She played a significant role in building and adoption of the Shared Investigator Platform (SIP), in partnership with TransCelerate, a first-of-its-kind collaboration platform in the Biotech / Pharma industry. Beenu holds an Executive MBA in Finance and an M.S. in Computer Science.

Isik is a director of Biostatistics in Pfizer Research and Development with the AI/ML, Quantitative and Digital Sciences group. The group is comprised of a team of statisticians and data scientists supporting AI/ML and Digital Health Technologies applications in the clinical development. Isik's work is focused on deploying digital health technologies in clinical trials and developing novel digital endpoints.

Teri Karcher is President, Global Project Leadership and Launch Excellence, for Parexel. In this role, she leads our teams collaborating with internal stakeholders and external customers to bring operational and commercial insights, innovation and optimization to support end-to-end delivery across every clinical trial ─ from study strategy and pre-award to start-up through project leadership and execution ─ enabling more seamless and faster drug development and ultimately driving study success. Most recently, Teri led the transformation of our patient and site strategy, feasibility, study start-up and investigator payments team. She has more than 20 years’ experience in the CRO industry (including what is now Syneos Health) across both operational and commercial roles. Her experience includes leadership of enterprise account partnerships with Parexel’s largest customers and work across project leadership as a Senior Portfolio Director. Prior to Parexel, Teri held research faculty appointments in Psychiatry and Behavioral Sciences at Duke University School of Medicine and the University of Miami School of Medicine. She also provided healthcare services to patients as a Clinical Psychologist. For her leadership and impact across the healthcare industry, Teri was named a 2025 Healthcare Businesswomen's Association (HBA) Luminary. Teri received her Ph.D. in Health Clinical Psychology from the University of Miami and her Master’s in Business Administration from Arizona State University. She also completed her Master of Science in Clinical Psychology and a Bachelor of Arts in Psychology from Marquette University.

Numan Karim is an Associate Director of Data Science & Analytics at AbbVie. He has 8 years of experience in the pharmaceutical industry, with a focus on enabling analytics capabilities across Clinical Development. Numan's current work involves developing fit-for-purpose analytics and data science capabilities for healthcare professionals and scientists in Clinical Operations and Patient Safety. Combining visual analytics, statistics, and modern data engineering tactics, he has deployed multiple data science products at scale. Numan is passionate about data science leadership and the intersection of analytics, technology, and medicine. Numan received a BS in Statistics & Integrative Biology from the University of Illinois at Urbana Champaign in 2016, and received an MS in Applied Data Science from the University of Chicago in 2020.

Nechama Katan, is a Wicked Problems Wizard. She has worked in large Pharma where she held the title of Director of Innovative Analytics. She helps organizations understand technical processes and problems and then works to build trust and innovative solutions. Nechama has been supporting Pfizer’s Risk Based Monitoring team for over 6 years. Nechama has worked in multiple industries and organizations of all sizes, including high and low tech, finance, and pharmaceuticals. Nechama’s education includes an MSc from NYU/Courant Institute in Mathematics and an MA from Columbia University in Statistics.

Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Nareen has over 15 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the advanced analytics strategy that covers both scientific and business operations, across clinical development continuum, geostrategy and study start-up, centralized and risk-based monitoring, site engagement, business performance, precision medicine, patient safety, and R&D. In addition, Nareen is actively engaged in evaluating the opportunities created by the technology trends like big data, automation, machine learning and AI, digital health, etc., and strategically instantiating them at AbbVie to drive organizational transformation. Nareen has an MBA from The University of Chicago Booth School of Business and an MS in electrical engineering from University of Texas at Arlington.

Ariel Katz is the CEO and Co-founder of H1, the leading healthcare platform that connects the world to the right doctors. Named to the Top 25 HealthTech Entrepreneurs of New York for 2025, Ariel leads H1 in delivering access to the largest network of doctors worldwide to accelerate drug development & commercialization, advance clinical research, and connect patients with the right care. Katz co-founded H1 in 2017 after previously launching ResearchConnection to help connect students with research opportunities, which grew to over 40 universities and was acquired by the Jefferson Accelerator Fund, Bill and Melinda Gates Foundation, and the Ewing Kauffman Foundation.

Lindsay Kehoe manages the development and implementation of projects at the Clinical Trials Transformation Initiative (CTTI), driving trial innovation and data quality and understanding emerging trends. Lindsay has 10 years of experience coordinating clinical research. Prior to joining CTTI, she served as a clinical trial lead at Children’s National Medical Center in Washington, DC, coordinating both physician-driven and industry-sponsored trials. She also served on the hospital's Institutional Review Board. Lindsay is a genetic counselor with extensive experience in both pediatric and adult genetic counseling. Early in her career, Lindsay worked in early-phase drug development at Millennium Pharmaceuticals (now Takeda Oncology) and then in post-marketing laboratory surveillance at Sanofi Genzyme. Lindsay is a proud alumnus of the University of Virginia and master’s graduate alumnus of Boston University School of Medicine.

Nicole Keidel is a seasoned healthcare thought leader based in St. Louis, with over a decade of experience at Evernorth Health Services. Since joining the organization in 2014, Nicole has held a variety of strategic roles, evolving into a trusted leader known for her ability to drive innovation, build meaningful partnerships, and deliver measurable impact across the healthcare landscape. In 2020, Nicole transitioned into a sales-focused role focusing mainly on life sciences, where she has excelled in cultivating strategic relationships and expanding Evernorth’s reach in the patient recruitment landscape. Her deep understanding of the healthcare ecosystem, combined with her collaborative approach, has positioned her as a key advisor to clients navigating complex challenges in patient recruitment and other clinical trial challenges. Nicole holds a Bachelor’s degree from Truman State University, where she developed a strong foundation in critical thinking and strategic communication. She is passionate about creating value through partnership, whether with clients, internal stakeholders, or industry collaborators. Her leadership style is grounded in transparency, empathy, and a relentless focus on outcomes. Nicole’s career reflects a commitment to transforming healthcare through strategic insight, operational excellence, and a genuine dedication to improving lives.

With a foundation in hands-on patient care and a deep understanding of emerging technologies, Joanna Kemp bridges clinical insight and technical innovation to drive meaningful change. She began her career as a bedside hematology/oncology and bone marrow transplant nurse before moving into roles in clinical research, hospital leadership, patient advocacy. She entered biopharma in 2022, driving digital health commercialization for the hematology and cell therapy portfolios at BMS. In her current role at GSK, she leads the integration of AI/ML and remote monitoring technologies into oncology development, reshaping dose optimization, safety monitoring, and efficacy measures. She relentlessly challenges the status quo in order to accelerate progress for cancer patients.

Francis Kendall is an accomplished senior leader with extensive experience in the field of biometrics and drug development. With an MBA qualification and a people-focused leadership style, he has successfully led teams and implemented strategic change initiatives in multicultural environments. His notable roles include serving as the Head of Statistical Programming, Data and Data Sciences at Biogen, where he manages a that oversees key initiatives such as Data Stewardship, Data Science, and effective evidence delivery. Prior to that, he held positions at Astra Zeneca, Cytel, Roche, Pfizer, Novartis, Nycomed, Sandoz UK, and Hoechst UK, where he made significant contributions to statistical programming, data analysis, and strategic planning. Francis holds various qualifications, including being a Chartered Manager, Chartered Statistician, and member of professional organizations such as PHUSE and the Chartered Management Institute. He has also published articles in prestigious journals, demonstrating his expertise in artificial intelligence, machine learning, and clinical development.

Javiera Kettlun is the Feasibility Strategy and Analytics Lead at Pfizer, with 18 years of experience in clinical trials and six years specializing in feasibility. She leads the development of robust country and site selection strategies at the indication level, identifying gaps, trends, and opportunities to optimize trial delivery. A trained midwife, Javiera brings a unique clinical and analytical perspective to her role, contributing to innovative solutions in trial planning and execution. At the congress, she will present on unlocking the potential of community sites through geo-clustered referral networks in oncology trials, highlighting data-driven approaches to improve site engagement and patient access.

Dr. Irfan Khan is the founder and CEO of Circuit Clinical. Dr. Khan is a cardiologist who served as a principal investigator on both therapeutic and device clinical trials for more than a decade and is passionate about improving access and equity in clinical trials, community engagement, and patient education and empowerment. Over the last six years, he has overseen Circuit Clinical’s growth to more than 2.5 million patients, involving 30+ partner locations including multi-specialty physician practices, Accountable Care Organizations, and Federally Qualified Health Centers. His work at Circuit Clinical has also included the creation of TrialJourney™, the first-ever ratings and reviews platform for clinical trial participants and people seeking clinical research as a care option. Under Dr. Khan's leadership, Circuit Clinical was awarded a "World Changing Ideas" recognition from Fast Company™, as well as being named an Inc. Magazine™ Best Workplace 2021, and a Fast Company™ Best Workplaces for Innovators 2021.

With over two decades of experience leading the development and deployment of digital solutions in the pharmaceutical industry, I have spearheaded data science initiatives that optimize every stage of the clinical trial lifecycle. My expertise includes leading teams to harness machine learning for improved patient recruitment, integrating novel digital endpoints for deeper insights into drug efficacy, employing ML techniques for risk-based data monitoring, and automating regulatory document authoring using generative AI. At Biogen and through my consultancy, I have integrated digital technologies into clinical trials to streamline processes and enhance outcomes. At Harvard and MIT, I developed open-source Python tools for digital health and fostered industry-academia collaborations. I have published over 60 high-impact papers with over 2,000 citations and hold two patents in digital health technologies. Adept at leading cross-functional teams, I seamlessly merge technology and healthcare to accelerate clinical trials and drive strategic objectives.

Tabby Khan, MD, MPH is a Senior Director, Analytics at Komodo Health. Tabby has over ten years of experience in healthcare and has previously worked as a clinical research coordinator, research fellow, and clinician.

Before Komodo Health, Tabby was a clinical research fellow and general surgery resident at the University of Florida. She completed several clinical research projects within the Division of Vascular Surgery in the Department of Surgery, and has presented her work at national meetings and has been published in top journals such as Annals of Surgery and Journal of Thoracic Surgery.

Tabby graduated with BA in neuroscience and behavior from Columbia University and an MD/MPH dual degree from Emory University, where her thesis work focused on racial disparities in lung transplantation.

Dr. Mark Kiel is the founder and chief scientific officer at Genomenon, where he oversees the company's scientific direction and product development. After spending 15 years preparing for a life of academic research, Mark became convinced that revolutionary change in genomics was more likely to emerge from industry. In 2014, he founded Genomenon, an AI-driven genomics company addressing the challenge of connecting pharma researchers with evidence in the literature to help diagnose and treat patients with rare genetic diseases and cancer.

Garo Kiledjian is the Founder and CEO of SGM Alliance, a 501(c)(3) nonprofit advancing Sexual and Gender Minority (SGM) inclusion in clinical research, life sciences and healthcare ecosystem. He also serves as COO for Trialogic, a site network for the largest global HIV healthcare provider. A personal loss to AIDS inspired Garo’s dedication to addressing healthcare disparities for marginalized communities. His diverse experience in administration, research, pharmacy, and finance strengthens his leadership. Garo served on the Executive GALA Committee for the National LGBTQ Task Force, a historic advocacy group focused on grassroots legislative and policy changes in DC. He holds a Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.

Brett Kleger is a nationally recognized executive leader with deep strengths in sales, marketing, corporate development and product management. He has extensive experience building healthcare technology and services companies and divisions, and bringing new offerings and capabilities to market. He is particularly interested in data-driven digital solutions.

Prior to Inspire, Brett was CEO of Datacubed Health, where he transitioned the company during the pandemic from early stage concepts to a major contender in the eCOA and decentralized clinical trial platform categories. Prior to Datacubed, Kleger was Chief Commercial Officer and Chief Operating Officer at DrugDev, where he led the company’s market success to become the leading provider of site facing technologies, resulting in an acquisition by IQVIA. He remained at IQVIA for several years post acquisition to consolidate and lead the commercialization for all of IQVIA’s clinical trial technologies.

Brett holds a business degree from the University of Maryland and a juris doctorate from the Villanova School of Law. In 2018, he was named to the PharmaVoice 100 in recognition of his considerable career achievements.

Adjunct Professor of Pharmacology and Toxicology Brody School of Medicine, ECU Editor at large Journal of Clinical Therapeutics Expert Medical Monitor, and author of several publications on medical monitoring Principal of MedSurgPI, LLC Former SVP Quintiles/IQVIA. https://www.medsurgpi.com/

Olgica Klindworth is Vice President for R&D of Clinical Data Studio at Medidata, where she focuses on developing Data Quality solutions, including creating AI-driven data surveillance approaches. Before joining Medidata, Olgica dedicated 17 years to PPD, with a decade spent in data management leadership roles. During her tenure, she built Data Management capabilities and supervised the execution of numerous clinical trials spanning various therapeutic areas. Olgica also played a pivotal role in developing Data Analytics and Centralized Monitoring processes and capabilities at PPD. Olgica holds a Bachelor of Science degree in Microbiology from the University of Texas at Austin and a Master of Science degree in Analytics from Texas A&M University.

Francesca Kolitsopoulos is the Real-World Evidence (RWE) Pharmacovigilance and Safety, Oncology Head at Gilead Sciences, Inc. Francesca leads the strategic design, implementation, and interpretation of pharmacovigilance/safety studies and requests for Oncology medicinal products utilizing large external databases and primary data collection to help inform medical decision-making throughout the product’s lifecycle. Her expertise includes accurate disease and product safety characterization to improve the likelihood of success of early phase clinical trials, generating pivotal epidemiologic evidence to support regulatory filings, and assessing diversity needs in populations under study. Francesca has been leading observational studies and clinical trials for over 24 years in the pharmaceutical industry, first at Bristol-Myers Squibb, and in roles of increasing responsibility at Pfizer for 20 years. Francesca’s academic training began in Veterinary Technology, where she holds a Bachelor of Science degree from Quinnipiac University, and Master of Public Health in Epidemiology from Columbia University. Francesca enjoys interior design, cycling, travel, and time spent with her 3 sons, husband, and French bulldog, Eze.

With over 18 years of statistical programming experience across global pharma and CROs, Sanjeev has led teams through regulatory submissions, complex data derivations, and Real-World Evidence pipelines in oncology, gene therapy, and rare diseases. He brings hands-on expertise in clinical data structuring, integrated summary development, and detailed outputs including tables, listings, and figures, positioning him as a technical anchor for scalable workflows across the clinical lifecycle. His approach emphasizes quality, clarity, efficiency, and consistency, shaped by years of bridging sponsor-CRO dynamics, mentoring teams, and developing global macros and standards. Sanjeev shares practical insights on strengthening pharmacovigilance strategies through reproducible workflows, transparent cross-functional collaboration, and scalable programming practices, advancing safety analytics with scientific rigor and meaningful impact.

Kristine Koontz is the Vice President of Global Clinical Operations at Daiichi Sankyo. Prior to joining Daiichi Sankyo, Kristi was the US pharma and vaccines clinical operations head for GSK. Kristi started her career as a CRA and from there held various roles of increasing responsibility in clinical operations, Development and Medical Affairs. Kristi spent 15 years at AstraZeneca and 8.5 years at GSK before joining Daiichi Sankyo in 2022 with the bulk of that time dedicated to oncology. From 2013-2018, she took a departure from clinical operations to spend time in global medical affairs where she developed medical affairs plans for Votrient® across various indications and integrated the brand into Novartis following the GSK/NVS divesture. Kristi holds a BS in Biology from Penn State University, an MBA from LaSalle University, and a PhD in Business Psychology from The Chicago School. Kristi is a board member of the BeProud Foundation, a non-profit that provides learning opportunities for children in the Philadelphia area. In her free time, she enjoys travelling, reading, listening to leadership podcasts, and spending time with her husband, two daughters, and their dog Chloe.

Anna Kosenko currently holds the role of Associate Director, Biospecimen Operations at BioNTech US Inc. Anna joined BioNTech US Inc. in July 2024 and recently transitioned from the iVAC Platform Team to lead the Biospecimen Management Center of Excellence within the Biomarker Operations department. In this role, she is focused on advancing biospecimen lifecycle governance and operational excellence across clinical programs. Anna previously worked at Takeda between 2022 and 2024 as Team Lead, Sample Management and Data Operations, playing a critical role in building a biomarker operations team with clinical sample and data operations capability to support Takeda’s oncology and cell therapy portfolio of Phase I through III global studies. Before joining Takeda, Anna worked in Oncology Biomarker Sample and Data Management role at Seagen (formerly Seattle Genetics). Anna spent 7 years at Parexel International, where she gathered a wealth of experience in clinical operations across therapeutic areas by supporting clinical trials for 20+ pharmaceutical and biotechnology companies. Anna holds an MS in Bioinformatics from Freie University of Berlin (Germany).

Becky Kottschade is an experienced clinical research administrator with more than 20 years of experience in the field. Driven by her commitment to Mayo Clinic's primary value, the needs of the patient come first, Becky takes pride in leading the effort of defining best practice in how to successfully implement decentralized clinical trial capabilities from concept to large scale adoption. In her role as research administrator, she is focused on providing streamlined solutions and associated best practices for both people, process and technology improvements that allow researchers and study teams to provide the best care for patients on trial. In addition to her primary functions as an administrator, Becky has been recognized for her extraordinary commitment to relationship building, solutions-oriented excellence in customer service and leading teams through transformational changes at Mayo Clinic.

Jeff is a serial healthcare entrepreneur with over 20 years of commercial and clinical pharmaceutical experience. Jeff currently serves on the Board of Directors for four rapidly growing companies: Signallamp Health (Series B), ProofPilot (Series B), Lokavant (Series B) and VersaTrial (SEED). He was previously on the Board of Directors for Analytical Wizards (acquired by Definitive Healthcare), iContracts (acquired by RLDatix) and RippleScience. As a full-time operator, Jeff was CEO of TrialScope, a global SaaS leader in clinical trial compliance, data sharing and patient engagement. Jeff went from board member to CEO in 2018, re-positioned the company for rapid growth and led the company’s sale to Informa (LSE: INF) in October 2020. Prior to TrialScope, Jeff was the co-founder/CEO of Verilogue, the global software leader in conversation analysis of physician-patient exam room dialogues. Verilogue was acquired by Publicis (PUB:FP) in Dec 2013. Jeff is an EY Entrepreneur of the Year finalist and is the co-author of a method and system patent for analyzing the effectiveness of marketing strategies.

Nils Krüger received his MD from LMU Munich. Combining his research interests in both cardiovascular disease and causal interference, Nils is developing analytical methods to study the comparative effectiveness and safety of biopharmaceutical products using complex longitudinal healthcare databases. Nils holds a honors degree in Technology Management from the Center of Digital Technology and Management, a joint institution of LMU Munich and TUM.

Mara Kramer is a senior clinical research leader with over 20 years of global experience across feasibility strategy, regulatory affairs, and clinical operations. She currently serves as Feasibility Transversal Projects Lead at Sanofi, where she drives enterprise level, data driven feasibility transformation, integrating digital innovation, analytics platforms, and evidence based design to accelerate study startup and patient recruitment. Mara has led global feasibility organizations, implemented AI enabled enrollment modeling and site intelligence solutions, and partnered closely with digital, data science, and external stakeholders to deliver scalable, efficient clinical trial strategies Known for her strategic mindset, change leadership, and operational rigor, she brings deep expertise in GCP, regulatory compliance, and global process innovation and harmonization.

Roula Krayem is a Senior Research Analyst at the Tufts Center for the Study of Drug Development (Tufts CSDD) with a background in pharmacy and health informatics. She holds a Master of Science in Health Informatics and Analytics from Tufts University, where she specialized in applying machine learning and statistical modeling to healthcare research. She also earned a Bachelor’s degree in Pharmacy from Syria. Roula is proficient in Python, SQL, R, and data visualization, leveraging data-driven insights to enhance clinical research and pharmaceutical decision-making.

Geoff Kremer is the Director of Portfolio Resourcing at Merck & Co., Inc.  In this role, Geoff is responsible for leading the resource forecasting team to ensure the business is appropriately resourced to deliver the portfolio. He collaborates with stakeholders across Global Clinical Trial Operations (GCTO) to develop, validate, and maintain resource algorithms and to ensure global alignment and execution on resourcing and capacity strategies, with a strong focus on advanced analytics and data visualization.  Prior to joining Merck, Geoff was the Director of CMR Informatics supporting Clinical, Medical Affairs, and Regulatory Affairs at Novo Nordisk in Plainsboro, NJ, where he led a team responsible for developing and implementing tools to support decision making for stakeholder strategy and operational effectiveness. Geoff earned a B.S. in Business/Operations Management from Chestnut Hill College, an MBA in Finance and Marketing from La Salle University, and completed various continuing education courses at Harvard University.

Jennifer Krohn, MS, has over 17 years of experience in the pharmaceutical industry across a range of functions, with the last decade dedicated to risk-based quality management (RBQM) and a special focus on centralized monitoring (CM). She has extensive experience in developing and implementing CM tools and processes as well as leading data analyst teams at a large CRO. Recently, Jennifer transitioned to the pharmaceutical side at Gilead, where she serves as a Risk Advisor, helping to build RBQM capabilities and advising study teams on the development of strategic monitoring approaches. She also serves as a PHUSE RBQM Working Group lead for Central Monitoring and as a contributor to the QTL project. Jennifer holds a Master of Science degree in Biochemistry and Physiology. She resides in Wilmington, NC, with her husband of 16 years and their 10-year-old daughter.

Marie is a Registered Nurse with over 25 years of experience in clinical research. She began her career in academic medical centers, where she supported Phase 1–3 clinical trials involving both pediatric and adult oncology patients. Driven by a desire to influence clinical development earlier in the process, she transitioned to the pharmaceutical industry to contribute to drug development process before studies reach patients. Since joining Bristol Myers Squibb, Marie has held a variety of roles across the drug development lifecycle, including Clinical Trial Management, Clinical Operations Strategy, Protocol Development and process improvement. In each role, she has remained focused on enhancing operational efficiency, streamlining processes, and driving innovation. She is also actively involved in leveraging emerging technologies to modernize clinical trial execution and improve ways of working.

Jake Krong serves as the Research Director for the Canyons and Desert Regions at Intermountain Health, where he oversees the development, coordination, and execution of clinical research initiatives across multiple sites. With more than 15 years of experience in research operations, Jake has built a reputation for fostering collaboration between investigators, clinical teams, and community partners to expand access to research opportunities.

Dr. Tobias Kruse is the Managing Director of Europe at SubjectWell. He is the founder and former CEO of Trials24, a company supported biotech and pharmaceutical companies, as well as CROs, in accelerating patient recruitment. Trials24 was acquired by SubjectWell in September 2024.

Before founding Trials24, Tobias co-founded ImevaX, a biotech company focused on vaccine development, where he developed and executed the out-of-site databases patient recruitment strategy.

Tobias earned his PhD in Molecular Biotechnology from the Technical University of Munich, where he developed a vaccine against Helicobacter pylori. He holds numerous patents and has published papers in journals such as Nature and EMBO.

Curt is one of the leaders of the ZS Cell, Gene and Advanced Therapy vertical. Prior to ZS, he received his PhD in Genetics and Cancer Biology which provides a unique and complete perspective on the science of these life-changing therapies. In his role at ZS, Curt has partnered with biotech and large pharma in successfully commercializing cell, gene and other advanced therapies by helping to identify and overcome barriers to patient access. From the original oncology launches to recent launches in benign heme indications as well as upcoming chronic conditions, Curt has focused on finding ways to reach more patients including expanding beyond where advanced therapies are offered today.

Sunny Kumar is a Partner at Informed Ventures, where he primarily invests in early-stage companies deploying emerging technologies to transform healthcare delivery, including lead investments in Medable, Deep 6 AI, and Osso VR. Sunny is a physician as well as a published medical researcher with a focus on applying informatics and artificial intelligence to translational medicine in the fields of neurosurgery and gene therapy. He is a serial entrepreneur and most recently founded a company to reduce readmissions for high-risk patients with chronic diseases using voice-enabled natural language processing technology. Sunny received a BS in Molecular Biology from Yale University, an MD from Stanford University School of Medicine, and an MBA from Stanford University Graduate School of Business.

Research Site Advocate and Consultant, Maria has been in the industry for 20 years. Coming from a primarily CRO background with a short time at a research site as CRC, Maria has been a Site Champion for most of her career. Bringing a research site perspective to community, solutions and conversations, Maria is a voice for improved site engagement in the clinical research industry.

Dr. Mary Jo Lamberti manages multi-sponsored and grant-funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was Director of Market Research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a B.A. from Wellesley College and a Ph.D. in Psychology from Boston University.

Rogier Landman is Associate Director Data Science at Pfizer and is based in Cambridge, MA. He has worked on a wide variety of data science projects. His latest work is on using large language models for facilitate clinical trial documentation, including strategies for evaluation of model output.

Mark Laney has more than 20 years of experience with software in the Life Sciences industry focused on delivering the right solutions for customers. As the Sales Engineering and Product Partnership Leader, he is tasked with solving customer challenges using the breadth of functionality and flexibility of Zelta by Merative’s unified clinical data management solution while facilitating partnerships with complimentary industry leading vendors to offer customers a robust technology solution for their clinical needs.

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal decentralized clinical trial platform. In 2019 Kai co-founded the DEEP initiative to co-create a novel integrated ecosystem for the development, validation and acceptance of digital measures. Kai continues to contribute in an advisory role with DEEP, which is now an independent company. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem. Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.

Derek is the Portfolio Strategy & Transformation Lead at Saama and has over 16 years of experience in clinical research, with strong focus in biometrics, programming, systems implementation & integration, and software development. Prior to joining Saama, Derek spent his career in the CRO, biotech, & software spaces, where he supported Data Management, Clinical Systems, & Biometrics activities in multiple roles. An enthusiastic advocate for change & innovation, he helps drive the adoption of new processes & tools in CDM and CDS.

Manny currently holds the position of Senior Vice President, Clinical Development Operations at Kailera Therapeutics, where he is responsible for clinical strategy, planning and execution. Kailera Therapeutics is a clinical stage biotech company in Waltham, MA, dedicated to developing the next generation of therapies in chronic weight management and diabetes. Manny started his industrial career 32+ years ago with positions of increasing responsibility at small, mid-size bipharma and large pharma. Manny holds a Master’s of Science in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and a Bachelor’s of Science in Biology from the University of Massachusetts at Boston. Before working in the device and biopharmaceutical industry, Manny served in the United States Air Force for 6 years as a Staff Sergeant.

Bertrand Le Bourgeois, Dipl. Ing., MSc., President of PharMarketing GDPR Life Sciences and of the French Medical Professionals Industry Association AMMIS, co-manager of the Data ¨Privacy working group of the French Regulatory Affairs Association AFAR, and past Vice-Chair of the International Association for Clinical Data Management (ACDM). Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He spent his career in Management and IT Consulting, in the healthcare and life science industries at major service providers for Clinical Research and Data Management, and as CIO for a key manufacturer. Now Bertrand runs PharMarketing GDPR Life Sciences, a consulting firm which helps life sciences companies to become compliant with Data Privacy Regulation in Europe (GDPR), in the US and abroad, with Good Data Management and Good Clinical Practices (GCP) and with IT Good Practices (GAMP, ISO 27001). PharMarketing also provides Legal Representation in the EU and UK for Data Privacy and other EU schemes, performs CSV and audits. Bertrand is the happy father of three children and loves bicycling and hiking in nature, cooking and history.

Sheri Lee is the CEO and Principal Consultant at Premier Regulatory Consulting (PRC), a leading boutique firm specializing in providing strategic guidance and expertise to companies worldwide. PRC assists corporations in navigating complex regulatory and quality landscapes to ensure compliance with local and international regulations. Her work at PRC is a culmination of the skills acquired throughout her career. Sheri’s strong background in the pharmaceutical industry was fostered during her time spent at the US Food and Drug Administration (FDA). Sheri spent 10 years at FDA in positions of increasing responsibility with a global scope. At FDA Sheri was the National BIMO Program Expert in the Office of Medical Products and Tobacco Operations. Prior to that she held a position as a National Recall Officer for the Office of Enforcement and Import Operations. During the start of her professional career she worked at non-profits, national and local organizations, hospitals managing clinical trials and developing public health initiatives. After Sheri left the FDA she held various leadership positions in the pharmaceutical industry, at Pfizer, Bayer and Organon to name a few. These roles provided her with invaluable experience managing diverse teams, driving organizational growth, building strategic partnerships, and achieving operational excellence. She brings a deep understanding of the industry's challenges, trends, and regulatory landscape. Her expertise spans a wide range of areas, including recalls, clinical trials, regulatory affairs, pharmacovigilance, and quality. She also has skills in manufacturing quality, ensuring compliance with strict regulations for drugs and devices. Sheri is a native New Yorker, who resides in Atlanta Georgia with her husband Darius and their two children Quinton and Lauren. She also enjoys spending time with family and friends, her two dogs Levi and Milo, practicing yoga and traveling.

Mark Lee is founder and CEO of N-Power Medicine. Most recently, he was SVP and Global Head for Personalized Healthcare, Product Development at Genentech/Roche, spearheading transformation of drug development and care delivery through data-at-scale and technology. Mark was on the founding team for GRAIL, where he built one of the largest clinical research programs for early cancer detection. Mark’s previous roles also include Lead for Oncology Clinical Sciences at Google[x] Life Sciences, Chief Medical Officer at Boreal Genomics, and Vice President of Oncology Development at Genomic Health, where he led the successful development and validation of the Oncotype DX tests for Colon and Prostate. Mark holds a PhD (Biological Chemistry and Molecular Pharmacology) from Harvard University, and his MD from Stanford University, where he completed his internal medicine training and medical oncology fellowship.

Susan M. Leister, MBA, PhD, CQA, CSSB has over 20 years of experience covering the pharmaceutical, medical device, and clinical arena, including extensive working knowledge of GCP, cGMP, GLP, ICH E6 GCP, and HSP. She has led numerous regulatory inspections and built several quality management systems from the ground up. In addition, she has led and supported numerous sponsor and site regulatory agency inspections including FDA, EMA, Health Canada, MHRA, PMDA, and MFDS. She has obtained CE marking for medical devices and achieved both ISO 9001 and ISO 13485 certification for various organizations. She previously served her local ASQ Section 509 as the Section Chair. Dr. Leister has received several Merit Awards from the National Institute of Allergy and Infectious Disease Institute as well as the National Cancer Institute. Dr. Leister is seasoned in mock inspections and overall inspection readiness. She has a Bachelor’s Degree in Biochemistry and Molecular Biology, an MBA, a Doctorate in Organization and Management with a focus in Leadership and holds certifications from ASQ as a Certified Quality Auditor and a Six Sigma Black Belt. Dr. Leister is a seasoned speaker covering global platforms on a variety of topics from quality risk management, quality tools, and inspection readiness.

My passion lies in accelerating patient access to vital treatments, and I believe high-quality clinical data is the key. With a PhD in Biomedical Sciences and nearly a decade immersed in clinical data management, I've dedicated my career to optimizing how we collect, manage, and utilize this critical information. I'm driven by a desire to constantly improve, and I've had the privilege of leading and contributing to several innovative projects focused on streamlining data delivery and boosting efficiency in clinical trials. These projects have allowed me to explore and implement improvements across people, processes, and technology, all with the goal of making a tangible difference in patients' lives. I'm excited to continue pushing the boundaries of what's possible in clinical data management and ultimately contribute to a healthier future.

With over 30 years in Pharma, pharma technology solutions, and the systems integration space, Holly brings vast experience in clinical trial operations and management, concentrated in clinical trial financial management. Considered a champion for the site and patient, Holly has built an industry reputation of challenging the status quo to evolve operational thinking in the Payments and Contract space. As a thought leader, Holly has been featured in the MIT Tech Review and presented webinars, video series and at conferences on a variety of topics. Holly earned a BA in Organizational Management from Immaculata University, an MBA in Business Administration from Eastern University, and a certification from Cornell University for "Women in Leadership".

Carrie Lewis is the Executive Director of Clinical Program Optimization at Keenova Therapeutics, since June 2020. Carrie manages multiple teams of people to implement industry standard processes and practices across the organization to prepare Endo for advancement and expansion in both domestic and global clinical programs. Prior to Endo, Carrie was the Director of Project Delivery at PRA Health Sciences overseeing global clinical studies and operational strategy of new bids. Carrie has over 20 years of industry experience, holding various high level roles in clinical operations across both Branded and Generic programs and has experience working with academia, clinical sites, CROs and Pharmaceutical companies. Carrie has a BA in Psychology from West Virginia University and a MS in Clinical Research Administration from George Washington University.

As Head of Clinical Vendor and Contract Management, Nick is responsible for establishing and implementing an effective process to qualify and oversee external suppliers, including contract management, supplier performance, and issue resolution. With more than 15 years working in Procurement and Clinical Operations roles in several different countries, Nick is on a mission to speed up and standardise the qualification process.

Dr. Greg Licholai is Chief Strategy Officer at Syneos Health. Previously he was Chief Medical & Innovation Officer at ICON plc. He is currently on faculty of Yale School of Management and has been visiting faculty at Harvard Business School. Previously, he was President of rare disease at Moderna Therapeutics, President and Chief Medical Officer at Castle Creek Pharmaceuticals, and partner at McKinsey & Co. He was also a senior executive at Proteostasis, Amicus Therapeutics and Medtronic Neurological as well as venture investor for Domain Associates and co-founder of Immunome Therapeutics. Dr. Licholai attended Harvard Business School, Yale School of Medicine, Columbia University and Boston College. He trained in Neurological Surgery at the Brigham and Women's, Children's, and Massachusetts General Hospitals. He serves on multiple company and non-profit boards. His textbook Introduction to Medical Software: Foundations for Digital Health is published by Cambridge University and he writes for Forbes Healthcare.

Alison Liddy, Senior Vice President at IQVIA for Patient and Site Centric Solutions, thrives on variety and challenge. With a career spanning over 20 years in the healthcare and life sciences industry, she excels in overseeing large global teams, P&L management, revenue growth, and C-Suite Relationship Management. Alison's expertise extends to Digital & Change Transformation projects in the data and patient space within the Life Science industry. Passionate about creating efficient ways of working and utilizing technology to drive outcomes, she has held executive positions at ICON plc. and Accenture contributing significantly to their patient, site, and data strategy implementation that helped aide in accelerating drug delivery.

Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/; www.SCOPEsummit.com; www.SCOPEsummiteurope.com

Shaheen is a seasoned executive in the CRO and pharmaceutical industry, with over 23 years of experience in drug development, clinical operations, innovation and strategy, pharmacovigilance and post trial access solutions. He has worked in large pharma and CROs settings including AstraZeneca, LEO Pharma, Veristat and Topstone Research. Shaheen is a visionary leader who combines scientific expertise, business acumen, and operational excellence to deliver outstanding results for WEP clients and stakeholders. He is passionate about advancing clinical research and improving patient outcomes through innovation, collaboration and patient access.

I am a Health Economics and Outcomes Research (HEOR) leader with more than 20 years of experience in the pharmaceutical/biotech industry. Prior to my current role as the Chief Strategy Officer of Stratevi, I led a 30+ US and International HEOR and Pricing team serving patients primarily in the areas of hematology, immunology, and oncology. In addition to a solid track record in generating a variety of HEOR-related deliverables (economic models, health-related quality of life instruments, conjoint analyses, real-world studies, reimbursement materials for launch, etc...), I also have solid understanding and experience in Pricing and Market Access. I am a proven entity in building and growing teams with high reputation that execute on product strategy. I do this through having a winning, positive attitude and truly enjoying working with and helping people, whether they be work colleagues or the patients we serve.

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.

Mari Livermore is the Site Director and CEO of Pantheon Clinical Research, bringing more than 30 years of experience in the clinical research industry. Throughout her career, Mari has built a distinguished reputation as a meticulous clinical monitor and a highly discerning auditor, known for her unwavering attention to detail and deep regulatory insight. Her extensive background across multiple roles within clinical research has provided her with a comprehensive understanding of the industry’s operational, regulatory, and quality-driven complexities. Under her leadership, Pantheon Clinical Research has grown with a strong foundation rooted in Good Clinical Practice (GCP) compliance, timely and accurate data entry, efficient query resolution, and thorough source documentation. Mari’s leadership is defined by integrity, precision, and a steadfast commitment to excellence. Her vision continues to guide Pantheon Clinical Research in advancing high-quality, compliant, and innovative clinical trials—ensuring that every study is conducted with the highest standards of care, accountability, and scientific rigor.

Accomplished pharmacovigilance professional with more than 16 years of experience. Have successfully led teams both as a vendor and as a sponsor. I have been the lead PV scientist for two gene therapy approvals and have enjoyed communicating with the FDA; also prepared for and supported the first advisory committee for a gene therapy for beta-thalassemia and lead commercial gene therapy programs with ongoing clinical development. I have learnt a lot, achieved professional growth and made friends while working at Ironwood pharmaceuticals, Biogen, bluebird bio and Beam therapeutics where I have held positions in varied capacities and responsibilities. In my cumulative work experience, I have gained expertise in safety monitoring as well as operational activities related to clinical trials, regulatory approvals, labeling, commercial use as well as registry set-up. I feel grateful working as a pharmacovigilance professional and striving to ensure patient safety.

Robert Loll is SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.

Neha Shah Londoño has twenty-four years industry experience within the Sponsor, CRO, and biotech environment. She has extensive knowledge of the clinical trials process through career advancement and has driven industry-wide efforts to increase health equity and develop solutions for diversification of clinical trial participants across the ecosystem. Neha is currently supporting oversight enterprise mission, vision, and strategy for clinical trial diversity, equity, and inclusion at Pfizer, where she leads cross-functional teams and partners with patient organizations to meet the needs of diverse medically underserved communities.

As the co-founder and Chief Executive O?cer of Medable, Dr. Michelle Longmire is mission-driven to accelerate the development of new therapies for disease. A Stanford-trained physician-scientist, Dr. Longmire witnessed firsthand the critical barriers to drug development – including the time and costs associated with clinical trial participation. She founded Medable to pioneer a new category of clinical trial technologies that remove traditional roadblocks to participation and radically accelerate the research process. Medable is now the industry leader in decentralized and direct-to-patient research, with the ability to serve patients in over 120 languages, 60 countries, and across all therapeutic areas. In addition to having raised over $500M in venture capital and driving Medable to an industry-leading position, Dr. Longmire has received recognition as a leading innovator and businesswoman, including being named as one of the 100 most creative people in business by Fast Company.

Rana Lonnen is a healthcare technology investor, entrepreneur, and molecular biologist. At Novartis, she leads strategic investments in technology companies, on a mission to transform the healthcare ecosystem and make positive impact on people’s lives. Previously, Rana was Head of Preclinical Development at a UK biotech, Auspherix; investment consultant to IP Group in London; Founder and CSO of a UK-based Biotech, Axendos therapeutics. Prior to this, she was a Wellcome Trust-backed principal investigator in drug discovery in the field of Infection, Immunity, and Inflammation, author and inventor on high impact peer-reviewed publications and patents; before this, Rana worked at Bristol-Myers Squibb, in sales and marketing. Rana holds a PhD in molecular biology and an MBA from Imperial College London. She personally cares about equitable healthcare, social justice, sustainability, and the future of antimicrobial resistance. In her downtime, Rana likes to make culinary experiments, be in nature, and read. Rana is a board observer at Aktana, Cota Healthcare, H1 Insights, Koneksa, Mekonos, NuvoAir, and Dopavision. She is based out of Basel, Switzerland.

Dr. Yun Lu is the Deputy Division Director at Division of Analytics and Benefit-Risk Assessment (DABRA) in FDA’s Office of Biostatistics and Pharmacovigilance (OBPV) at Center for Biologics Evaluation and Research (CBER). Dr. Lu received her Ph.D. in Biostatistics from the Johns Hopkins Bloomberg School of Public Health. Dr. Lu joined the FDA CBER in 2010 as a Mathematical Statistician, and she has extensive experiences with real-world evidence reviews and post-marketing vaccine safety and effectiveness public health surveillance studies using real-world data.

Jennifer Lum is a Co-Founder and Managing Partner of Biospring Partners, a growth equity firm that invests in Life Sciences Technology. She is an accomplished investor and entrepreneur. She has co-founded several companies and has worked with many others from formation through to M&A. Jennifer serves on the Board of Directors of Labviva and she is a Board Observer at ixlayer. Jennifer also serves on the Board of Directors of WTA Ventures. She is a Venture Capital Advisor at Harvard Business School and an Advisor at MIT’s Martin Trust Center for Entrepreneurship. She is also an Advisory Board member at The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Jennifer co-founded Forge.AI (acquired by FiscalNote) and Adelphic (acquired by Time). She was an early team member at Quattro Wireless (acquired by Apple), m-Qube (acquired by VeriSign), and WebHosting.com (acquired by AT&T). She has also held various roles as a management consultant with financial services and technology companies.

Sean Lynch has been working in clinical research for over 17 years with a heavy emphasis on the role of technology and vendors in the very changing landscape of clinical innovation. He started as a data managed at Quintiles before progressing into project management roles at software companies. CROs and start-ups. He has even dabbled in consulting and business development and has lots of tales to tell. Today he is the Innovation Capability Head for Innovative Trial Operations at Novartis.

I am a Clinical Operations and Risk Management Executive Leader. As a Vice President of Clinical Operations and Risk Based Quality Management, Regional Clinical Operations Director, Lean Six Sigma Black Belt, and many other Clinical Operations roles over the years, I bring an extensive and diversified experience in managing people and project initiatives with focus on quality, on-time delivery, and exceptional customer service. In my VP roles, I have worked predominantly at a high strategic level of the company, driving major projects and digital transformation initiatives across Global Development. My leadership experience includes managing diverse leaders and teams virtually, supporting Clinical Operations personnel and holding leadership positions in European and Global Drug Development. I possess extensive project management skills through trial management and as a Lean Six Sigma Black Belt, and have experience working in a matrix-based, project-centric organization. I am comfortable working with vendors and stakeholders at all organizational levels both internally and externally.

Gillian is dedicated to finding innovative ways to accelerate and modernize clinical development. She thrives on turning complex clinical challenges into shared opportunities for innovation through strategic thinking and inclusive problem-solving approaches specializing in fostering collaborative ecosystems through Technology Deployment. Recent activities include building consensus around Study Simplification Strategies, Open Innovation Hackathon Challenge, Quantitative Clinical Trial Burden Assessments, and Protocol Digitization initiatives. Gillian holds a BSc and MSc in Chemistry and obtained her PhD in Pharmaceutical Sciences from The University of Nottingham. Her interests extend to various scientific disciplines, and she recently completed a course on Health Policy & Economics at the London School of Economics (LSE).

As the leader of WCG Avoca’s integrated consulting and research solutions, Cristin MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has over 15 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from pre-clinical research through late-stage clinical development. Crissy earned a PhD in biomedical engineering from Drexel University and a bachelor’s degree from Lafayette College.

With 20 years of experience in managing clinical trials at large Pharma, Biotech and CRO companies, Andrew Mackinnon, Executive GM at Medable, leverages his broad operational expertise to improve how the deployment of clinical trial technology and decentralised methodologies are utilized. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients

Expertise in scaling high growth companies focused on health care data and SaaS tech across life sciences, payer, provider. Real-world evidence (RWD / RWE), payment models including value-based care / outcomes based contracting with provider networks / pharmaceutical manufacturers / CMS / HTAs (Europe), bundled payments, Medicare, Medicaid and Special Needs Plans (SNP).

Asif Mahmood, M.D., M.P.H., M.B.A., is working as Vice President & Head of Medical Safety and Pharmacovigilance at AskBio (a subsidiary of Bayer) since May 2023. Prior to that he has worked as Chief Safety Officer/Vice President Global Safety & Pharmacovigilance at Medicago (a subsidiary of Mitsubishi Pharma Japan) since July 2019. Prior to joining Medica1go, Asif Mahmood held several roles of increasing responsibility from Director to Associate Vice President at Pfizer, Sanofi, Genzyme, Sanofi Pasteur and Apotex in the US and Canada from 2004 to 2019. He has experience of working on many diverse therapeutic areas including Gene therapy, vaccines, hepatology, oncology, infectious diseases, rare diseases, biosimilars, 1drug delivery devices, generics, and OTC. Earlier in his career, he has worked as the Deputy Director General, Federal Ministry of Health in Islamabad, Pakistan, and as Medical Director and Joint Executive Director for Pakistan Institute of Medical Sciences and Children's hospital Islamabad. He has also worked on many public health and immunization projects of WHO, UNICEF and Japan International Corporation Agency. He received his M.D, from King Edwards Medical University in Pakistan. He also possesses an M.P.H and M.B.A degree in Health management.

Dr. Malikova is an Assistant Professor of Surgery at Boston University, School of Medicine, and an Executive Director of Research at the Department of Surgery at Boston Medical Center. Dr. Malikova has PhD in Biochemistry with strong background in biomedical sciences. She also holds a Master’s Degree in Clinical Investigation and Master’s of Business Administration in Health Sector Management from Boston University. She has over 18 years of experience in the biomedical product R&D, clinical development, operations and regulatory compliance fields; with the past 11 years on executive level. In her current role as Executive Director, Dr. Malikova macro-manages research programs in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations and compliance, strategic planning and execution oversight of clinical trials; safety and risk management. She is a member of International Society of Pharmacovigilance (ISoP), and currently serves as the Vice-President of NASoP.

Myla Maloney is the Chief Growth Officer for PINC AI™ Applied Sciences, a division of PINC AITM, the technology and services platform of Premier. With 24 years of experience in the healthcare industry, Maloney supports Premier’s mission of transforming healthcare by leading population health improvement collaboration between PINC AI Applied Sciences and life sciences organizations. Maloney has been with Premier for the last seven years and previously served as Premier’s Chief Commercial Officer, PAS and Vice President of Strategic Supplier Engagement, where she partnered with leading biopharmaceutical and IT companies.

Myla received her B.S. in business administration and MBA from East Carolina University.

Adam Mariano joined LexisNexis® Risk Solutions in April 2023 as the President and General Manager of the healthcare business. Adam leads the overall strategic direction and operational execution of the healthcare business and is committed to delivering critical insights that empower healthcare organizations to transform operations and create healthier communities. Adam is responsible for developing and implementing data and analytics solutions for organizations across the healthcare ecosystem including health systems, health plans, pharmacies, life sciences organizations and healthcare IT companies. Adam has more than 20 years of clinical, technical, and legal experience across the provider, payer, retail health, and pharmaceutical industries. Throughout his career, he has made significant strides in helping organizations drive health equity, healthcare interoperability processes, real-world clinical data usage, large-scale analytics and healthcare platform development. Adam is also a licensed nurse and an attorney. He uses his law license to provide pro bono support in underserved communities of color with immigration, civil rights and health equity issues.

Latoya Marshall is the Director of Clinical Research at the Neely Center for Clinical Cancer Research (NCCCR) at Tufts Medical Center. With over 17 years of clinical research experience, she oversees staff and develops key partnerships with industry sponsors, collaborators, and clinical trial networks. She leads the NCCCR in promoting oncology and hematology clinical research, managing a portfolio of more than 60 active trials in compliance with federal and sponsor regulations. Latoya holds an MPH from Boston University and is a Certified Clinical Research Professional. In her free time, she enjoys yoga and spin.

Fred Martin, the CEO of SubjectWell, has a vision for improving global patient access to healthcare.

With a 30-year leadership journey, Fred has guided clinical and commercial startups as well as Fortune 500 companies through strategic growth, brand development, and operational excellence. His expertise lies in creating innovative solutions to address customer challenges, driving innovation, and fostering partnerships that deliver value to stakeholders.
As a member of the LGBTQ+ community, Fred is a passionate LGBTQ+ rights activist and a champion of clinical trial diversity. Known for building high-performing teams defined by chemistry, diversity, and character, he fosters a culture where colleagues are encouraged to bring their real perspectives, expertise, and curiosity to their work.
Fred holds an MBA in Marketing from the University of Michigan, a Master of Industrial and Labor Relations from Cornell University, and a Bachelor of Arts in Communications from the University of Colorado, Boulder.

Bahador Marzban is a leading Senior Digital Health Data Engineer at Johnson & Johnson, specializing in data science, wearable devices, and predictive modeling with digital health data. With a background as a Data Scientist at Daxor, he developed innovative algorithms and predictive models for wearable technologies. Holding a Doctorate in Engineering, his research focused on cell motility modeling. During his postdoctoral fellowship at the University of Michigan's Medical School, he specialized in cardiovascular systems and multiscale predictive models for heart failure patients. Currently at Janssen Pharmaceuticals, Bahador spearheads digital health transformation, converting vast data into valuable insights. He excels in creating disease-specific digital health biomarkers, implementing precise data extraction algorithms, and enhancing data processing solutions in regulated environments. His multifaceted contributions drive advancements in cardiovascular health, neuroscience, immunology, and beyond, establishing him as a leader in digital health research.

Lydia Matombo, BSN, RN, PMP®, ACRP®-CP, is a Clinical Operations and Risk-Based Quality Management (RBQM) leader with more than 24 years of experience in global Phase I–III clinical trials across oncology and multiple therapeutic areas. She most recently served as Director of Clinical Operations at Merck, where she led enterprise-wide RBQM and data integration initiatives aligned with ICH E6(R3), E8(R1), and Quality-by-Design principles. A former trauma ICU nurse, Lydia brings a pragmatic, execution-focused perspective to trial design, site engagement, and risk-based oversight. She is a frequent speaker and session chair at SCOPE, DPHARM, and other global clinical research forums. She currently serves as Co-Founder of Clinavence, where she contributes thought leadership at the intersection of clinical operations, data quality, and modern trial execution.

Mark is in his 30th year of drug development and is an SME in the use of Digital Heath Technologies in clinical research. He holds a BS in Molecular and Cellular Biology and a Master’s in Business and has held positions in research, manufacturing, portfolio management, and business development in large pharma, biotech, CRO, and technology companies.

Dr. Matveeva is the Director of cGMP Cell Production Operations within the Dept of Neurosurgery at the Mass General Hospital/Harvard Medical School. Dr. Matveeva is on charge of all aspects of a cGMP cell manufacturing cleanroom for early-phase clinical trials focused on regenerative cell therapy. Within this role, she created all compliance programs required for safe and efficient cell production within the startup, with a focus on feasibility, compliance, safety, and fiscal efficiency. From logistics to environmental monitoring to documentation and personnel management, Dr. Matveeva has been key in developing an all-encompassing infrastructure for cGMP manufacturing within a hospital setting. Tatyana Matveeva, PhD. holds a doctorate in Cognitive and Brain sciences from the University of Minnesota, maintaining a focus on translational science and public health throughout her graduate and postdoctoral work.

A globally oriented technology executive leading research, biotech, and consumer products organizations through complex changes. I have built organizations for explosive growth, consolidated them in business downturns, and led merger/acquisition/divestiture programs. I have led teams in 20+ countries, led all aspects of IT including major business transformations and culture change across organizations. I am an adept strategic thinker with experience advising several early stage biotech firms, an advisory board member to a software startup, and board chair for large ($100M+) social services agency. I have set technology strategy, implemented global programs, fixed broken operating models, rebuilt teams, negotiated large scale partnerships, and always focused on business success.

Sarah McClure is a Global Data Engagement Lead, Clinical Studies Unit, at Sanofi. Her pharmaceutical career spanning over 20 years has included site monitoring, local and global project management, technology and process solutions and implementation efforts. Sarah current role is leading the relationship with data source vendors and ensuring appropriate aggregation of data sources so that Sanofi can leverage data driven decisions.

Tom has over 20 years of industry experience in various roles within clinical trial supply and execution. Nearly half of this time has focused on the clinical supply chain—including raw materials, investigational supplies, lab kits, and biospecimens. When not concentrating on optimizing global logistics, Tom enjoys spending time with his family, boating, and music.

With over 30 years of experience in pharmaceutical research and development, Rachel is a distinguished leader in clinical program operations. Currently serving as Clinical Development Operations Lead (CDOL) for Mental Health/Cardio-Renal-Metabolic at Boehringer Ingelheim. Rachel oversees the delivery of key clinical development programs across various assets and indications, provides strategic operational insight into Evidence and Execution Plans for early- and late-phase clinical trials. Her expertise lies in navigating complex organizational and regulatory environments to ensure the successful execution of clinical trials. Rachel’s previous role supported CNS programs at Purdue Pharma. Prior to that Rachel worked at Bristol-Myers Squibb and held various operations positions, including site manager, protocol manager, hybrid line manager for site and protocol managers. Rachel's comprehensive background and leadership in pharmaceutical R&D empower her to guide teams with vision, rigor, and a deep commitment to driving results that align with company goals and patient needs.

Emily McInturf, Director of Feasibility at PSI, brings 17 years of experience in clinical research. She leads PSI’s feasibility strategy, aligning study design with top-enrolling investigators globally.

Kelly McKee serves as vice president of Decentralized Clinical Trials (DCTs) in Patient Cloud at Medidata. She is responsible for creating new solutions to engage clinical trial patients pre-trial, in-trial, and post-trial, as well as developing patient and product communications around all Patient Cloud Products for decentralized and hybrid clinical trials. Kelly is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Prior to Medidata, she spent over 20 years within clinical operations and patient recruitment at top-tier pharmaceutical companies including Sanofi, Merck, Eli Lilly and Co., and Vertex Pharmaceuticals. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of Life Sci Voice’s Top Industry Leaders in 2022, PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012.

Mackenzie McKinney is the Executive Director, Site Solutions and Patient Experience at Jumo Health. She leads strategic initiatives that deliver high quality patient and caregiver education at the moment of need and simplify site training and engagement. Prior to Jumo, she was at Moderna where she integrated patient voice with technology and services, including home health, travel concierge, participant payments, and digital patient-facing solutions, to improve the trial journey. She's also led digital implementation teams at PPD and Signant Health, delivering patient technologies and engagement tools across global studies.

Patrick McNamara is a senior life sciences commercial leader with over 20 years of experience helping pharmaceutical, biotechnology, and CROs improve trial execution by reducing operational friction. He serves as Chief Commercial Officer at Yunu, where he leads global commercial strategy and partnerships focused on modernizing clinical trial imaging. Over his career, Patrick has held executive leadership roles across clinical services, imaging, and technology organizations, building and scaling commercial teams and working closely with top-tier sponsors and CROs. His work is driven by a focus on aligning technology with real-world clinical operations to enable faster, more reliable trials and data. He is a strong advocate for site-centric, workflow-driven approaches that enhance transparency, usability, and real-time data access while maintaining the highest scientific rigor and regulatory compliance.

Proven C-level leader with deep experience running global Fortune 500, start-up, and emerging pharmaceutical businesses, possessing the unique ability to blend, build, and strengthen performance from the ground up. Broad understanding of market strategy development within clinically diverse programs that achieve meaningful product differentiation. Significant accomplishments creating profitable business development and investment community partnerships within the C-suite. Strategy/Vision: Deep start-up, transaction and capital raising success through the establishment and guidance of Adiso, Adastra, and Churchill; creation and execution of clinical development and business strategy to lead the companies from formation; with the identification and advancement of multiple first-in-class drug product assets; negotiated and managed lucrative business development partnerships; business development and licensing with Baxalta, transaction to Cothera Bioscience and Sun Pharma FZE. Change Leadership: Adaptable and insightful leader instrumental in the cultural and team transformation of Onconova from a private 16-person medicinal chemistry company into a commercially prepared 67-employee Nasdaq listed company executing a successful Initial Public Offering (IPO). Commercial Innovation: Directly involved in numerous successful product development/co-development programs and commercial launches within oncology and specialty therapeutics. Demonstrated ability to employ unique approaches to value pricing and contracting within competitive markets. Execution/Implementation: Ability to visualize and articulate both long-term and near-term goals while promoting excellence through organization design, leverage of key functional areas, with clear decision making and process application. Global M&A: Marshalled Churchill Pharma through nine-month transaction process and successful sale of assets prior to product approval by FDA, while simultaneously preparing for a Churchill launch. While at Onconova, initiated and negotiated two separate license agreements for Japan/Korea and Europe

Michael works in the Cell and Gene Therapy Group at ZS focusing on designing a seamless C> treatment experience in order to define and shape the future commercialization of products. Working cross-functionally across site operations, supply chain, clinical and commercial operations, Michael leads the process of streamlining C> product delivery to provide a best-in-class customer and patient experience. By facilitating, supporting, and simplifying the end-to-end operations of C> products in a clinical trial setting, Michael prepares customers for commercial planning and launch when bringing transformative cell and gene therapies to market. Michael has spent 10+ years in the cell and gene therapy industry helping C> organizations operationalize products, build global site footprints, develop supply chain strategies, lead patient and customer engagement, and prepare for commercialization and product launch. Working for cell therapy biotech startups as well as global pharmaceutical companies such as Adaptimmune, Immatics and GSK, Michael has unique hands-on experience helping companies shape the clinical trial experience with C> products. With his rare and versatile experience, Michael has pioneered innovative C>-specific roles, such as the Cell Therapy Patient & Site Operations Lead, serving as a cross-functional C> subject matter expert.

Driving change in healthcare through data, analytics, and technology.

I am currently an Associate Director, Protocol Review Committee (PRC) Lead at Bristol Myers Squibb, supporting Hematology, Cell Therapy, Immunology, and Cardiovascular therapeutic areas. I pride myself on my exceptional organizational skills, which allow me to manage complex projects and coordinate cross-functional teams to ensure the efficient and timely delivery of key initiatives. My strong analytical mind enables me to interpret large data sets, identify trends, and make informed decisions that enhance compliance and streamline processes. I have expertise in developing and implementing robust training strategies, designing curricula and role-based learning paths, and optimizing learning technology to improve user experience and drive measurable outcomes. With a proactive approach to problem-solving, I utilize continuous improvement methodologies and collaborate effectively with stakeholders to achieve outstanding results. Born in India and raised in Massachusetts, I now reside in New Jersey with my husband of 15 years and our two boys. Outside of work, I enjoy beach outings, spending quality time with my large extended family, and embracing movement and tradition through adult Bollywood dance classes. I am also an avid audiobook listener and find relaxation in solving puzzles.

Emily Merrell has worked within the Healthcare sector for 25+ years with global development experience spanning Biotech, Pharma, CROs, and the NHS. In addition to roles in drug development, Emily has also worked as a project consultant within The National Healthcare System (NHS) where she led the development and implementation of a virtual COVID hospital that resulted in improved outcomes for COVID-19 patients. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from First In Human trials to Long-Term Follow-Up and Post Marketing surveillances. Prior to joining the Cell and Gene Therapy Catapult as current Director of the ATTC Network, she was Senior Director of Therapeutic Expertise and Head of the Centre for Cell & Gene Therapy at ICON driving the strategic & operational growth of the Centre’s capabilities which has so far supported the delivery of 170+ Cell and Gene Therapy Clinical Trials over the last 5 years across a diverse range of therapeutic areas, development phases and technologies. Emily has a passion for enabling new ways of working by challenging ‘traditional models’ and cultivating more integrative working within and across organizations as the driving force of improving health outcomes for patients worldwide. She is also co-chair for ATMP Engage and sits on the Board of Directors for Genetic Alliance-UK.

Jennifer Merriman is a Senior Manager for R&D Trade Compliance with the Innovative Medicine division of Johnson & Johnson. She is part of a team that leads critical initiatives, and improvement projects sought to standardize and integrate trade practices in global R&D logistics processes focusing on Clinical Supply Chain. Furthermore, she has fifteen years' experience in global supply chain, logistics and trade.

Over 24 years of leadership experience in clinical operations, project management and medical affairs which includes clinical development strategy, protocol design, training and development, vendor management, and stakeholder relationships. Therapeutic experience includes pulmonary, rare disease, central nervous system, dermatology, gastrointestinal, nephrology and oncology.

Kathy Mickel is the Director of Membership & Programs at the Society for Clinical Research Sites (SCRS), where she leads strategic initiatives to advance the clinical research site community globally. She directs key programs including SCRS IncluDE and the SCRS Oncology Program, driving member engagement and organizational growth across SCRS's network of over 12,000 research sites. With extensive clinical operations experience spanning research sites, CROs, and pharmaceutical companies across diverse therapeutic areas, Kathy brings a comprehensive, site-focused perspective to the clinical research ecosystem. Her career has been defined by leading field-based teams in matrix organizations and driving transformational process improvements that optimize capabilities, accelerate growth, and enhance performance. Passionate about personal and professional development, Kathy is dedicated to inspiring the research site workforce and championing the critical role sites play in bringing new therapies to patients.

Dmitri Mikhailov is the Global Head of Biomarker Study Coordination, Translational Medicine at Novartis. Dmitri’s team is responsible for clinical biomarker study setup across multiple therapeutic areas, and for developing new processes and technologies to improve clinical study conduct. As part of his role, Dmitri represents Novartis on the Patient Centric Sampling IQ consortium, developing best practices for new generation clinical trials. Dmitri is also the global lead for Novartis Human Tissue Network, the company wide effort to develop risk-based strategy and efficient processes to enable translational research using human samples. Dmitri joined Novartis in 2003 and had several positions of increasing responsibility in early biology, lead discovery, safety pharmacology and drug repositioning. Dmitri Mikhailov holds a Ph.D. in Biology and M.S. in Physics & Applied Math.

As Vice President of Patient Commercial Strategy at IQVIA, Anthony Mikulaschek manages all commercial aspects of the IQVIA Patient Suite of applications including eCOA, IRT, and eConsent. Previously, he was the VP of eCOA Operations for 6 years. Mikulaschek has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 37 years, including 30 years in the pharmaceutical sector.

Mathias Milici is an experienced clinical operations leader with a strong passion for Risk-Based Quality Management (RBQM). As Head of Central Monitoring at Novartis, he leads the strategic implementation and continuous improvement of centralized monitoring processes across global clinical studies. Previously, Mathias was part of the RBQM Center of Excellence at Roche, where he played a pivotal role in driving the adoption of RBQM surveillance mechanisms across the portfolio. His work focuses on leveraging analytical insights and innovative technologies to modernize clinical trial oversight and operations. Mathias is deeply committed to advancing scalable, patient-centric solutions that enhance quality, efficiency, and regulatory compliance in clinical research.

Dr. Jennifer Miller is Co-Director of the Program for Biomedical Ethics and an Associate Professor of Internal Medicine (primary) and Biomedical Informatics and Data Science (secondary) at Yale School of Medicine. She is also the interim CEO of the Good Pharma Scorecard, an index that ranks pharmaceutical companies on their bioethical performance, and Founder of the nonprofit Bioethics International. Her current research focuses on ethics and governance in drug development, healthcare data sharing, and AI enabled medicine. She specializes in developing and using accountability metrics to enhance patient centricity, responsibility and accessibility in biomedical innovation. Prior to joining Yale’s faculty, she was tenure track faculty in NYU School of Medicine and completed training in physics, regulatory governance, bioethics, and ethics at Fordham University, Duke University, Regina Apostolorum Pontifical University, and Harvard University.

Gus Miller is the director of Clinical Labs Procurement at Regeneron Pharmaceuticals. In his role at Regeneron, Gus is responsible for the development, execution, and continued oversight of supplier strategies designed to enable Central, Specialty Biomarker, and CDx lab testing. Prior to joining Regeneron, Gus was the director of Clinical Functional Partnerships within R&D Global Procurement at Bristol Myers Squibb. During his tenure at BMS, he led categories across clinical development including FSP, CRO, Data Management, and many others. His experience at BMS encapsulated the historic Celgene acquisition as well as many small / medium sized acquisitions that drove changes to the outsourcing strategy.

Cilla Mistry is a seasoned professional in the pharmaceutical industry, with a career spanning over two decades. She is currently a key member of the Central Monitoring and Data Analytics group at GSK, a position that allows her to leverage her extensive experience and deep understanding of the industry. In the past five years, Cilla has honed her expertise in Risk-Based Quality Management (RbQM) for both in-house and outsourced trials. Her work in this area is driven by a passion for revolutionizing the management of complex clinical trials, a testament to her commitment to innovation and excellence in her field. In addition to her work in RbQM, Cilla also brings to the table substantial experience in Data Management across various therapy areas. This diverse skill set makes her a valuable asset in the pharmaceutical industry, as she continues to contribute to advancements in the field.

Denise Moak is a life sciences technology leader who turns complex clinical systems into practical, high-impact solutions. As founder of Alexander-Moak Consulting Services, she helps biopharmaceutical teams streamline TMF, EDC, and trial operations, making data work smarter. Her career spans three decades, including leadership roles at MacroGenics, AstraZeneca, and GlaxoSmithKline, as well as managing large-scale technology programs at Booz Allen Hamilton for NASA and the EPA. Known for clear communication and collaboration, Denise excels at guiding teams through complexity to achieve measurable results. She is a Scaled Agile Framework Practitioner with degrees from Boston University and American University.

Kristie S. Moffett’s career in the healthcare industry spans over 25 years. She began her healthcare career in cancer research at the Cleveland Clinic and spent over 10 years across various leadership positions with cancer and the institutional centralized research oversight office. Within the centralized research oversight office, she implemented an enterprise-wide strategy for satellite clinic and hospital research, managed the research portfolios for the Wellness Institute and Genomic Medicine Institute, and managed institutional projects and strategic research initiatives including the following: research dashboards; process improvement and consultation for the CC Central Biorepository; and the design and implementation of an enterprise-wide new clinical trials management system (CTMS). In 2016, Ms. Moffett moved to Tampa, Florida as a Senior Director at the Moffitt Cancer Center to oversee the Clinical Trials Office. She also designed and implemented a new centralized Non-Therapeutic Research Office called NiTRO that manages a portfolio of over 700 non-treatment studies and the centralized biorepository protocol with greater than 200,000 participants.

Ophelia Mok is the Senior Manager of Business Analytics at the Global Development Office in Takeda Pharmaceuticals. With a background in Epidemiology and Biomedical Engineering, Ophelia has a unique perspective on the intersection of healthcare and technology. Prior to joining Takeda, she worked on Clinical Analytics Strategies at Anthem and a healthcare AI startup, AllazoHealth, based in New York City. Ophelia is passionate about leveraging data and technology to improve patient outcomes.

Lisa leads Medidata’s Strategy Organization, ensuring our customers’ voices drives the value we bring to market. Lisa is a seasoned leader in the intersection of technology and clinical research, with nearly 25 years of experience across pharma, biotech, and medical devices. Her roles include leadership of product, engineering, AI research, and customer engagement organizations within both sponsor and product technology companies – supporting the industry’s ever evolving need for innovative technology to improve clinical development and patient outcomes. Lisa serves on the board of ACRO, and is on the advisory board for the Sexual and Gender Minority Alliance. Lisa holds a BS in Biomedical/Biochemical engineering from the University of Southern California.

April Monge is the Innovation Capability Head of Recruitment (formerly the Novartis Digital Recruiting (NDR) Capability Center) at Novartis Pharma AG based in Basel. The NDR Capability Center was formed in April, 2020 and evolved into the Innovation Capability for Recruitment. Her team leads digital patient recruitment efforts for global development trials. April has been in clinical operations for > 30 years. She has been with Novartis since 2003 covering a variety of roles, responsibilities and therapy areas. For more information: https://www.linkedin.com/in/april-monge-4583a716/.

Michelle Monosmith is an Administrator in the Office of Clinical Trials (OCT) at Mayo Clinic leading all Study Startup activities. Michelle’s 28 years of Mayo Clinic experience include leading Study Startup within the OCT, managing industry and federal teams within the Office of Sponsored Projects Administration, developing and managing the Code and Coverage Analysis Office (CCA), leading research billing processes in Research Finance as well as previous roles in Revenue Cycle and Finance. Michelle holds an M.S. in Management and Organizational Leadership and a B.S. in Accounting.

With over 25 years of experience in the clinical research industry, I have dedicated 19 years as a Site Director at a private research clinic, where I successfully oversaw the completion of more than 150 clinical trials across 50 indications. Currently, I serve as a Site Relationship Manager, where I support both seasoned and novice sites in navigating the complexities of running clinical trials. My role involves close collaboration with site teams and sponsor clinical teams to ensure that the site’s perspective is integrated into every aspect of the trial, fostering smoother and more effective study execution.

Melissa Mooney has over 19 years of experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance testing, eCOA data management, and BD support.

As a seasoned Technology Leader with over two decades of experience, I specialize in driving critical IT programs in the pharmaceutical manufacturing and services sector. My strategic leadership encompasses a comprehensive understanding of the clinical supply chain and its associated technologies, including supply forecasting, MES, inventory control, EDC, IRT, eCOA, CTMS, and ERP systems. Key Achievements: Leadership Excellence: I have successfully directed diverse IT and operational teams, delivering high-performing RTSM systems and services worldwide. My leadership has been instrumental in building robust solutions across various modalities for clients and sponsors globally. Organizational Development: With a focus on team growth and business strategy, I have built and managed dynamic teams, coaching and mentoring members while collaborating with senior leaders to implement successful business strategies. Program Management: I have a proven record in delivering systems within budget and timelines, emphasizing world-class quality to uphold study integrity and participant safety. Innovation in Technology: My leadership in integrating data analytics and machine learning has optimized complex global supply chain operations, marking a significant step towards technological advancement in the industry. Areas of Expertise: Strategic Planning | Executive & Board Reporting | Business Administration | Program Management Global Operations | Business Intelligence | Agile SDLC | Software Project Management | System Integration | AI/ML Applications Enterprise Resource Planning (ERP)

After a 25-year career leading multiple global teams across the CRO industry, including providing account management to pharmaceutical partners, Shawne Moran brings decades of expertise in operational models and outsourcing best practices. Shawne is now the Head, In-Country Study Operation, Clinical Delivery & Patient Centricity at Merck KGaA/EMD Serono. Merck KGaA/EMD Serono provides a comprehensive support and delivery model for their clinical programs, unique in industry, providing specialized site and clinical oversight and engagement teams with a strong focus on site engagement, patient recruitment, retention, and ensuring inclusivity and ethical integrity in research, while maintaining the highest standards of quality and site excellence. Shawne’s cross-provider expertise over her career allows he to bring a unique perspective from the multiple stakeholders involved in clinical programs and driving their success.

Kissondra Morris is the Oncology PRC Lead at Bristol Myers Squibb, where she oversees the scientific rigor and quality of oncology clinical trial documents. With over 10 years of experience in drug development, she has held roles spanning Innovation and Digital Health, Study Optimization, and Trial Digitalization. At BMS, she has partnered across functions and with external collaborators to introduce new approaches in RWD and trial innovation that improve study design, streamline site technology, and strengthen patient experience. Earlier in her career, she held research roles at Moffitt Cancer Center, the University of South Florida, and Intezyne. She holds an MBA, an MS in Biotechnology, a Graduate Certificate in Intellectual Property, and has contributed over 4,000 volunteer hours in healthcare and environmental projects.

Kasia Moscicka, MPharm, heads up the global feasibility department at PSI CRO. With PSI since 2008, she’s developed the feasibility methodology that allows PSI to maintain the stable metric of 90% or higher on-time study delivery in oncology, GI, hematology, neurology, infectious diseases, and other therapeutic areas.

Dr. Murphy is the Chief Research Information Officer at Mass General Brigham, is Professor of Neurology at Harvard Medical School and serves as Executive Director of the Hospital Integrated Research Organization (HIRO). HIRO accelerates clinical trials with AI technology to prepare data and extract insights at hospitals prior to trial initiation. He received his BS in Chemistry from the University of Notre Dame, and his Ph.D. in Pharmacology and Physiology and MD from the University of Chicago. Dr. Murphy’s research interests include the creation of query methods for healthcare data that enable them to be directly used by scientists even when the data is extremely large. Dr. Murphy was an inventor of Informatics for Integrating Biology and the Bedside (i2b2), a high impact and widely accepted open-source project that focuses on the integration of highly diverse phenotypic, imaging, and genomic data such that new discoveries can be visualized and produced from secondary use of routinely collected healthcare data and be applied to new methods of providing clinical decision and clinical trial support in a learning healthcare system.

Laurie began her career in the field of developmental disabilities, where her passion for advocacy and justice was born. Laurie began her career at Merck in 1999 in marketing, then led our company’s global health literacy efforts for a decade, supporting improved patient communications in clinical trials, medication labeling, packaging, and patient education. After leading our company’s global oncology health equity efforts, and several years in sustainability, she is thrilled to return to health literacy, with a strong focus on clinical trial innovation. Laurie has worked to include respondents with low health literacy into patient labeling research, earning a national health literacy award. She has co-chaired two working groups on lay summaries and health literacy in clinical trials, at the MRCT Center (Multi-Regional Clinical Trials Center of Brigham and Women’s and Harvard). She served as an invited member of the EMA lay summaries working group, where she helped to influence guidance to reflect principles of health literacy, numeracy, and readability. She was an invited speaker by the FDA at a 2017 labeling conference, with an international audience of over 2000 people in 42 countries. She has co-authored multiple publications and previously served for many years on the National Academies of Medicine Health Literacy Roundtable. She has won an MM&M Top 40 Healthcare Transformers Award and two INvolve allyship awards. She has a bachelor’s degree from Yale and an MBA from Wharton.

Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving cross-therapeutic area global patient recruitment. In her current role as Program Director for the Decentralized Trials and Research Alliance (DTRA), she has focused on chartering and delivering outputs across the Alliance’s Initiative teams. One of her key contributions has been the design and delivery of the DCT Tubestop, a digital playbook for DCT methods that has been positively received by FDA and other regulatory agencies, pharmaceutical sponsors, and cross-industry consortia. Prior to joining DTRA full time, Jane was VP of Innovation at Curebase from 2021-2023, following her role at LabCorp where she Director, DCT Implementation. Jane worked at Roche/Genentech for 17 years in various roles, ultimately driving global implementation of patient and site facing technology into trials. Additionally she has held positions leading global trials at Lilly, Sanofi, small biotechs, and niche CROs. Jane is a sought-after speaker and thought leader at international conferences and professional meetings, primarily focused on clinical trial innovation.

Radhesh Nair focuses on democratizing access to clinical data and creating analytics-driven pan-R&D insights and solutions.

Richard Nelson, PhD is a Professor in the Department of Internal Medicine and the Co-Director of the Health Economics Core in the Clinical and Translational Science Institute at the University of Utah. He is also a Research Health Scientist and Investigator in the IDEAS Center at the VA Salt Lake City Healthcare System. Dr. Nelson is a health economist who has been conducting research using data from the VA electronic health record for more than 15 years. His research studies have focused on a number of different areas including healthcare-associated infections, diabetes, HIV/AIDS, hepatitis C, multiple sclerosis, cirrhosis, homelessness, rural health, and many others. Dr. Nelson teaches a graduate-level course in cost-effectiveness analysis at the University of Utah.

Barrie Nelson is a passionate advocate for accelerating the clinical development processes through digitalization. With extensive experience in the BioPharma industry, Barrie has expertise in Biostatistics, Clinical Data Management, and Data Standards organizations. He led foundational standards development at CDISC, where he also contributed as a volunteer for many years. As one of the founders of Nurocor, Barrie leverages his knowledge and insights to drive the innovative and groundbreaking Nurocor Clinical Platform solution. Empowering Nurocor's clients to fully harness the benefits of digitalization and bring true acceleration to their clinical development portfolios, is the culmination of a career spent striving to work smarter.

Dr. Damion Nero, PhD, Global Head of Statistics for HEOR/HTA, Daiichi Sankyo, Inc., has more than 15 years of experience in data science, analytics, developing machine learning algorithms, and overseeing IT infrastructure as well as HEOR and RWE research. He has extensive experience working with large scale datasets including administrative claims, EMR, registries, genomics, SDOH and other healthcare databases. I also have experience working with survey data and patient reported outcomes. He is also well versed in the use of statistical software such as SAS and R as well as experience using Python for advanced modeling techniques. He has worked with many leading pharmaceutical, medical device and biotech companies as well as state and government agencies. He has also worked on all aspects of project development from proposal drafting to protocol/analytic plan development and generation of analytic results. In addition to this he has extensive experience building teams and developing operations from the ground up. He specializes in tackling difficult challenges in operations whether it be data ingestion, infrastructure or developing/implementing analytic techniques or algorithms in order to gain insights into data and patient populations. His work has always had a patient centered focus in research and he has dedicated his research efforts to move organizations towards embracing AI and advanced analytics as well as shifting focus to precision medicine.

Dr. Vani Nilakantan is a senior research consultant and founder of SIKARA- a research advisory firm. Previously she was the System Vice President, Research at CommonSpirit Health, one of the largest health systems in United States. A CommonSpirit Health, she was the organizational representative for research and was responsible for oversight of nationwide research in 18 states, over 95 clinics and 700 clinical research studies. Prior to that role, Dr. Nilakantan was VP Research at Allina Health. At Allina Health, she was the head of research for the health system, provides executive level leadership for clinical and basic research within an integrated hospital system environment and was the authorized organizational representative and signatory for system. Dr. Nilakantan Provides visionary perspective on the future of research at a major health care institution. She also sets strategic direction for research and reorganized research structure for Allina Health System. Prior to joining Allina, Dr. Nilakantan was the Director of Investigator Initiated Research and Sponsored Programs Office at Aurora Health Care. At Aurora Health Care, she had oversight of basic science, preclinical, translational and clinical research, innovation in alignment with Aurora Health Care mission and strategic priorities. She also created effective collaborative relationships with senior administrative leadership and clinical system program leaders and medical staff. Her responsibilities included oversight of the grants management for the system.

Brittany Niland is the Senior Director of Clinical Trial Foundations – Community-Based Research at Eli Lilly and Company, where she leads global strategy and implementation for community-based clinical research. With over 15 years of experience in oncology clinical development, she has a strong track record of driving innovation, advancing trial diversity, and delivering high-impact results across late-phase oncology programs. Her career began at Indiana University Simon Cancer Center, where she discovered her passion for clinical research. Since joining Lilly in 2016, she has held key roles in project and program management, clinical trial leadership, and diversity, equity, and inclusion strategy. Recognized for her cross-functional leadership and strategic vision, she has successfully managed global study teams, overseen trial operations across multiple CROs, and played a pivotal role in integrating acquired assets into Lilly’s portfolio. Brittany holds a Bachelor of Science in Medical Imaging Technology and an Associate of Science in Radiography from Indiana University. Outside of work, Brittany enjoys spending time with her 4-year-old daughter, running, and cheering on all the Indy sports teams.

Christer Nilsson is a dynamic entrepreneur and the CEO of Replior, bringing over 30 years of leadership experience in IT, Finance, and Life Sciences. Throughout his career, he has successfully launched and managed several businesses with a strong focus on innovation and customer satisfaction. At Replior, Mr. Nilsson is committed to a transparent and honest approach, ensuring that clients’ needs are at the heart of every decision. He leads the integration of cutting-edge digital endpoints, sensor technology, and gamification strategies into clinical research solutions, aimed at reducing patient dropout and increasing compliance. Under his leadership, Replior is pioneering a more patient-centric and effective model for clinical trials.

Jonathan Norman is the Director, Localization & Scale Management at YPrime, with 9 years of experience localizing paper and electronic COAs. Today, he leads translation and questionnaire licensing strategies, focusing on quality, accuracy, and reducing translation burdens while increasing trial diversity. Jonathan is a trusted SME in localization best practices, maintaining strong industry relationships with eCOA providers, pharma sponsors, and copyright holders.

Over the last decade, Justin has led dozens of software solutions from idea to commercial release with companies including Phillips Healthcare, goBalto, and Oracle. He brings a deep background in data science and clinical research to his role in TriNetX, where he has overseen the development of products for trial design and feasibility.

Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies and supporting internal teams and partners around the implementation of industry, regulatory, and scientific best practices in clinical trials using mobile health technologies. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia and was previously the Industry Vice-Director of the C-Path ePRO Consortium.

Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation, where he worked across the health outcomes, health economics, and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health (now Signant Health), an eCOA provider, where he led their health outcomes team. He has an MSc in Cognitive and Clinical Neuroscience. In addition to his extensive professional experience, Paul has been an active contributor in his field, having served as both speaker and chair at numerous conferences, including but not limited to SCDM, OCT, DIA, and EUCROF.

Stephanie Oestreich is Managing Director of the Myeloma Investment Fund (MIF) and is the chair of the McCloy Alumni Association. She is also on the faculty of MIT, a member of SpringBoard Ventures, an advisor at grIP Venture Studio, to Biognosys (a Bruker company), Invitris, CART company CelineTx and to the drug development and investment company OrangeGrove Bio. Previously she was Chief Business Officer at Galecto, Vice President at cell therapy company Mnemo Therapeutics, a Venture Partner at RA Capital and Executive Vice President at Evotec where she built its North American investment arm and started an incubator with Samsara BioCapital. She also worked as International Business Leader at F. Roche Hoffmann-La Roche Ltd., and for Novartis in Business Development and in Commercial. Stephanie conducted the research for her Ph.D. in biochemistry in the lab of a Nobel Prize winner at Harvard Medical School and obtained an MPA from the Harvard Kennedy School.

Paulius Ojeras is a clinical operations leader with more than 18 years of experience across biotech and CROs. He has led complex global programs in gene and cell therapy, with a strong focus on innovative trial design, outsourcing strategy, and operational execution. With deep expertise in outsourcing strategy, operational innovation, and data-driven execution, Paulius focuses on advancing trial efficacy—accelerating timelines, strengthening vendor partnerships, and integrating emerging technologies such as AI. His perspective combines hands-on operational experience with a forward-looking vision of how biotech can adapt to shifting industry dynamics and deliver transformative therapies faster.

Christine Oman is a Clinical Trial Manager at MindMed, a clinical-stage biopharmaceutical company pioneering novel psychiatric therapies and digital therapeutics to address some of the most common and widely recognized mental health disorders. Since joining MindMed in June 2024, Christine has been managing clinical trials that combine traditional approaches with digital tools to better understand patients and improve study outcomes. She holds a Master of Science in Biotechnology Innovation and Regulatory Science from Purdue University and brings over eight years of experience in the clinical research industry. Her background spans hands-on site-level work as a study coordinator and operational roles within CROs as well as biotech companies. This range of experience helps Christine run clinical trials with a strategic mindset, strong organizational skills, and a focus on the patient's experience and safety. Beyond her professional work, Christine is actively involved with Linking Pharma Women, a community dedicated to empowering and connecting women across the pharmaceutical and life sciences industries.

Carlos Orantes is CEO of Alcanza Clinical Research, and brings >31 of experience in the drug development arena. Carlos also holds other positions in the industry including President of hyperCORE International, a leading collaborative super network of sites, and is a founding Board Member as the Secretary of a newly formed trade association called Association of Multi Research Site Corporations (AMRC). His efforts have been focused on building capable teams and leading them through transformations at several successful small to large companies, privately and publicly held. He is passionate about empowering team members and holding to a high standard of delivering on commitments.

As CEO of Alcanza Clinical Research, Carlos Orantes provides leadership and strategic direction for site network. With nearly 30 years of experience within the life sciences industry, his career has included executive leadership, operational management, LEAN Six Sigma process improvement, as well as systems and technology deployment. Most recently, Carlos served as Executive Director, Site Operations for Accelerated Enrollment Solutions, a business of PPD and ThermoFisher Scientific. There, he led the site operations for the Americas site operations in support of the company’s vast global clinical trial network. Prior to joining PPD, Carlos served as Chief Executive Officer of Amplify Clinical and Accel Research Sites, where he developed the business strategy to effectively compete in Phase II-III clinical research involving multi-therapeutic trials and specialty vaccines. He also led activities related to both companies’ asset purchase by private equity. Earlier career positions included 20 years of operational, quality assurance, process improvement and laboratory management roles of increasing responsibility at Covance, now part of LabCorp. Carlos earned a master’s of business administration degree from Old Dominion University, and a bachelor of science degree in biology from George Washington University. He is a certified Lean Six Sigma Black Belt from Six Sigma Academy.

Rachel has had the privilege of working across various areas of the clinical research industry, including a site network, a CRO, and currently at a sponsor company. In her current role as the Global Head of Feasibility & Planning at Boehringer Ingelheim, she is an integral part of the Clinical Development Operations Leadership team. She leads a dedicated group focused on conducting country and site feasibility and planning, as well as advancing technology within the feasibility space at Boehringer. Her diverse roles have granted her the opportunity to see and appreciate various perspectives within clinical research. This exposure to different experiences and viewpoints fuels her ambition to continuously improve and innovate within the clinical research industry. Rachel is driven by the desire to benefit everyone involved, and most importantly, our patients.

Dr. Javiera Oyarzun earned her undergraduate degree in Biology from the Pontifical Catholic University of Chile before pursuing graduate studies in Psychology at the University of Barcelona, where she completed her Master's degree and subsequently her PhD. During her postdoctoral research at Harvard University, Dr. Oyarzun studied cognition, memory, and anxiety, with particular emphasis on understanding the cognitive mechanisms that influence individual vulnerability to anxiety disorders. Today, Dr. Oyarzun works at Sanofi as a Clinical Lead at the Digital Biomarkers Innovation Lab, where she identifies and develops early digital biomarkers with potential as promising endpoints in clinical trials. Her work bridges fundamental cognitive neuroscience with clinical research, contributing to the advancement of digital health solutions for therapeutic development.

Scott Palmese, Executive Director, Site-Focused Solutions, brings over 15 years of clinical trial experience at both the site level and CRO level to Worldwide Clinical Trials. In his role, he oversees global site partnerships and innovative delivery models with the goal of making it easier for sites to work with Worldwide. Through the efforts of Scott and his team, Worldwide is aiming to facilitate rapid start-up and competitive enrollment for our sponsor partners by leveraging our close relationships with sites around the globe. Scott has dedicated his career to supporting sites and patients across the clinical trial lifecycle with responsibilities in site operations, patient recruitment, feasibility, financial management, and more.

Dharmesh Patel has 15 years of experience in Biospecimen Planning and Operation in the pharmaceutical industry. Currently, he is a director for biospecimen planning for late/full development at Bristol Myers Squibb. Dharmesh's interests lie at the interface of biological science, planning, operation, and data. He is a graduate of Delaware Valley University.

Medha A. Patel is a seasoned leader in clinical development with over 20 years of expertise in data management, Biostatistics and Statistical Programming. As the Director of Strategic Development Design and Analytics at Amgen, she spearheads innovative data strategies that enhance clinical trial efficiency and drive impactful patient outcomes. Recognized as Amgen R&D People Leader, Medha has a proven track record in fostering team excellence, optimizing processes, and leading transformational initiatives. Her expertise spans data lifecycle management, and cutting-edge solutions for data acquisition and integration. Medha’s commitment to diversity and inclusion complements her technical acumen, making her a trailblazer in driving change and advancing the field of clinical development. She holds master’s degrees in Applied Statistics and Biostatistics and is an active member of the Healthcare Businesswomen’s Association. Medha’s passion for innovation and collaboration continues to shape the future of data-driven healthcare solutions.

Krisha Patel is an epidemiologist with over 10 years of experience in real world evidence research, population health consulting, and healthcare analytics. She is responsible for leading the execution of real-world evidence studies at Walgreens Clinical Trials, through internal and external cross-functional collaboration.? Krisha has expertise in building patient registries, designing and evaluating health economics and outcomes research (HEOR) studies, questionnaire development, and applied epidemiologic methods in RWE across a variety of infectious and chronic conditions including HIV, Huntington's Disease, oncology, hemophilia, atopic dermatitis, and others. ?Krisha has a Master of Public Health from Yale University and is an active member of the International Society for Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Meghan Patterson has more than 15 years of professional experience in organizational development, project management, and program development. She has advanced program development and management skills in infectious disease, asthma, diabetes, and obesity. She has expertise in taking large life science organizations through large-scale transformations. She is skilled in working with and leading cross-functional teams and has experience in process improvement, organizational design and development, and change management and training. She has prior experience in the development and implementation of data collection regulations, grant models, and policy development across large health systems to improve clinical outcomes. She also has experience in post-market surveillance studies for medical device organizations.

Meghan has experience leading her own consulting practice supporting organizational change processes, training and facilitation, and creating and conducting evaluation assessment tools focused on aligning organizational needs and strategic goals across several public health organizations.

Meghan earned her Master of Public Health degree in Epidemiology and Biostatistics from Boston University School of Public Health. Before that, she completed a Bachelor of Arts at Tufts University, where she studied Pre-Medicine/Pre-Medical Studies and Spanish, with a minor in Italian Renaissance Art History.

John Pavletic leads Lilly Ventures’ Tech investing strategy globally. This strategy focuses on next generation technologies and business models that can advance drug discovery and development as well as healthcare delivery. Prior to joining the Lilly Ventures team, he led early-stage product strategy for Lilly’s Digital Health group. Prior to Lilly, he held sales, marketing, and finance roles at Abbott across its Animal Health, Molecular Diagnostics, and Health IT business units.

Kira Pavlik, MPH, CCRP, is an award-winning leader and clinical research professional. She is the Associate Director of Clinical Trials Operations and Director of Special Projects, Strategy and Innovation at the Yale Cancer Center Clinical Trials Office (YCC CTO). Kira is an active member of both SOCRA and ACRP. She has spent the last 16 years at Yale University where she has strived to improve clinical research operations, as well as CTO culture, relationships across ancillary groups, and integration with hospital leadership. In her current role, Kira oversees the Clinical Operations and Clinical Research Support Lab units within the Yale Clinical Trials Office, which includes trials of all phases and diseases across 16 Smilow Cancer Hospital locations in both Connecticut and Rhode Island. On a national level, Kira serves on the Research Operations Initiative (ROI) Steering Committee, multiple AACI Task Forces, the Equitable Access to Clinical Trials (EACT) project, and is a member of the SWOG Oncology Research Professionals (ORP) Executive Committee, serving as a co-chair for the SWOG ORP Education Subcommittee. Kira also serves as the Vice Chair of the Biospecimen Management Consortium (BMC), a non-profit organization seeking to improve clinical research sample integrity, data and compliance. She has shared her expertise as a panelist and facilitator for multiple national conferences. Kira is deeply motivated on both a personal and professional level to improve patient outcomes, which stems from our ability to improve clinical research and how it is applied in our everyday practice.

Maggie is currently Vice President and Global Commercial Head for BMS’s hematology cell therapy portfolio, with full P&L accountability for the ex-US business, which is nearing $500 million annually and growing rapidly. She is responsible global strategy and P&L delivery across two inline CAR-T brands — a best in class CD19 asset in lymphoma and a first in class BCMA asset in multiple myeloma—as well as BMS’s next-generation GPRC5D pipeline program slated for US launch in 2027. Maggie’s scope spans lifecycle strategy, global launches, market access, pricing, manufacturing coordination, and commercial-R&D integration across all international markets. She also leads BMS’s industry-level work with the Alliance for Regenerative Medicine to expand CAR-T access and enable community-based delivery. Prior to joining BMS, Maggie worked at 2seventy bio, an oncology cell therapy company, where she was the General Manager for Abecma, the first approved CAR T in multiple myeloma, and Head of Commercial Development. In that role, Maggie oversaw the development of commercial and BD strategy for the company’s CAR T and TCR pipeline, created the new product planning function, and partnered with BMS to maximize the patient and profit opportunity for Abecma. Prior to 2seventy, Maggie held various roles of increasing leadership responsibility in sales, marketing, R&D and corporate affairs at GSK and Pfizer, in Europe and in the US. She started the first chapter of the Healthcare Businesswomen’s Association (HBA) in the UK in 2011 and subsequently held various Board positions within HBA Europe, including Chapter President in 2017. Maggie is a passionate champion for gender equity and was Chair of GSK’s Women’s Leadership Initiative from 2015 – 2021, during which period the group’s membership grew to >10,000 (from 1,000) and was able to influence the company to introduce global standards on shared parental leave and meaningfully increase the number of women in VP positions and above to over 40%.

As the Chief Executive Officer of AutoCruitment, Jill Pellegrino brings over 15 years of leadership experience across patient recruitment, real-world evidence, and clinical research site operations. Prior to joining AutoCruitment, Jill led the Real World Evidence and Patient Recruitment initiatives at CVS Health, where she built and scaled these functions and helped place more than 35,000 patients into clinical trials and research studies, significantly increasing diversity and access to research participation. In her role as CEO, Jill heads AutoCruitment, a leading patient recruitment organization that partners with sponsors, CROs, and research sites to deliver high-quality, protocol-qualified, and diverse patients for their clinical trials. With experience across more than 120 conditions in over 700 studies and having contributed to more than 13,700 randomized patients worldwide, AutoCruitment uses proprietary technology, data-driven targeting, and multi-channel digital strategies to accelerate enrollment timelines, increase randomizations, and improve the patient experience while reducing burden on research sites and sponsors.
See more at www.autocruitment.com

With over 30 years of experience across Sales, Training, Marketing, Market Access, Patient Advocacy, and Corporate Affairs, Josée Pelletier brings deep cross-functional expertise to advancing patient-focused innovation in drug development. She is currently Senior Director, Global Patient Advocacy – Research & Drug Development at Bristol Myers Squibb, where she leads global early engagement strategies to ensure patient perspectives are embedded in clinical trial design and execution. Her therapeutic experience spans oncology and multiple other areas, with a strong track record in leading global patient insight initiatives, developing early engagement frameworks, and driving strategic collaborations that support more inclusive, impactful research. Grounded in a background in science and supported by an Executive MBA, Josée combines analytical rigor with business acumen to align stakeholders around shared goals. Bilingual in English and French and experienced across Canadian, US, and international markets, she brings a global mindset, cultural agility, and a deep commitment to purposeful partnership in elevating the patient voice across the healthcare ecosystem.

Adam Penna has been in clinical research for over a decade. He has a background in finance and corporate law and has previously worked with a US healthcare access non-profit. Adam is presently an Associate Director, Clinical Operations at Merck overseeing a team of Clinical Operations Managers who work with clinical trials sites to negotiate contracts and budgets. Adam is involved in multiple technology, patient access, and Diversity, Equity, and Inclusion initiatives at Merck.

Heidi is a seasoned clinical operations leader with over 20 years of experience in trial execution, strategic planning, and vendor management. As Vendor Program Strategy Director at Novartis, she drives program-level vendor strategies and is a driving force on the company’s outsourcing initiative, with a focus on building early partnerships that accelerate trial startup and delivery. Her career spans diverse roles across clinical development, giving her deep expertise in operational excellence and cross-functional collaboration. Heidi is dedicated to optimizing processes and delivering measurable impact across the clinical research landscape.

Jessica Perry is a clinical research leader focused on advancing patient-centric innovation in clinical trial operations. With more than 20 years of experience, she has led initiatives that improve trial accessibility, efficiency, and participant experience through digital and decentralized approaches. Prior to joining Kymera Therapeutics, Jessica drove strategy for decentralized trials across Moderna’s clinical pipeline, expanding community access through novel initiatives such as the first fully retail-pharmacy–based vaccine trial and mobile health clinics for community pre-screening. As a leader in patient centricity and digital health, she has launched award-winning technologies grounded in patient insight. Her passion is accelerating the delivery of medicines to and for more people.

Stacey Peterson is a Research Manager at the Utah Clinical and Translational Science Institute, where she leads the Rural Connections to Research (RCR) initiative. With more than 15 years of experience in healthcare research and risk management, she focuses on community engagement and expanding access to clinical trials in rural communities. She earned an MBA with advanced training in project leadership and community collaboration, expertise she applies to advancing research partnerships and organizational initiatives. She also holds a Project Management Professional (PMP) certification, highlighting her ability to lead complex projects. Stacey serves on the advisory board of Chhlat Health, supporting global efforts to strengthen healthcare infrastructure.

Stephanie Pfister is a Vice President of Clinical Operations at Biohaven. She has had a long career in the pharmaceutical industry, with primary area of expertise in clinical/operational management of CNS and late phase clinical trials. Stephanie previously worked at Cerevel Therapeutics (acquired by AbbVie in 2024), where she was Vice President of Clinical Operations, overseeing a team of more than 30 clinical operations experts responsible for clinical trials in all phases of development across multiple neuroscience and psychiatry indications. Prior to joining the pharmaceutical industry, she spent 5 years in academic research, focusing in areas such as cocaine/heroin addiction and affective disorders. Stephanie holds a Master of Arts degree in Psychology and a Master of Business Administration.

Alekhya Pochiraju is a senior lead in clinical operations, product development, at Genentech, where she provides clinical oncology operations expertise and advocates for health equity in clinical trials. She believes, with the future of healthcare geared towards personalized medicine, biomarkers are a critical element of cancer drug development and cancer therapeutics. Her recent talk at SCOPE EU, Biomarkers & Precision Medicine USA Congress and Salesforce Women's Summit, focused on health equity disparity among minorities and people of color. Prior to joining Genentech, Alekhya worked in quality technology at Fluidigm and Sanofi-Genzyme. Alekhya holds a master's degree from Northeastern University in biotechnology.

Vera Pomerantseva is Director of Product Management at eClinical Solutions. Vera has over 20 years of pharma industry and business consulting experience in quality and risk-based quality management (RBQM), leading innovations and data analytics. Experienced in driving strategy and leading design and implementation efforts, she has a proven track record of success in leading a variety of R&D projects, including RBQM. Prior to joining eClinical Solutions, Vera was Associate Partner at ZS, after spending 20 years in big pharma including Novartis and Bristol Myers Squibb. She is a published author and member of various industry groups.
Vera holds a Master of Science in Management and Post Graduate Certificate in Risk Management from State University of Management, Moscow, along with a certification in Clinical Trials Management from UC Berkeley.

Jennifer Poon, PharmD, is a Director, Clinical Capabilities Lead in the Clinical Center of Excellence (CCoE) at BMS. She is a licensed Pharmacist with over 15 years of experience in Clinical Research and Development (R&D). Jennifer serves as the Global Process Lead for the Clinical Protocol development process. She leads a variety of cross-functional teams to enhance and streamline the protocol development process, leveraging innovation and emerging technologies, and contributes to enterprise and organizational excellence. Prior to her role in the CCoE, Jennifer was a Clinical Scientist Team Lead in the Hematology organization, leading a team of Clinical Scientists in the research and development of mezigdomide in multiple myeloma. Before BMS, she took on roles of increasing responsibility at Schering Plough/Merck, Novartis, and Celgene within Clinical R&D, leading Phase 1-3 clinical trials in adult and pediatric hematologic malignancies and solid tumor indications within Hematology, Oncology, and Cell Therapy. Jennifer has a PharmD from the University of Michigan and she completed her post-doctoral fellowship in Clinical Research with Rutgers University Ernest Mario School of Pharmacy. Jennifer has published extensively during her career in Clinical R&D. In her spare time, Jennifer enjoys spending time with her family, including her two young daughters, traveling, hiking, and exploring new foods and adventures.

Gian Prakash is the Director of Data and Analytics supporting Global Therapeutics at AbbVie. With a wealth of experience in data and analytics coupled with a deep understanding of the pharmaceutical industry, Gian is instrumental in shaping the vision and strategy for data-driven initiatives within the organization. In his role, Gian leads efforts to integrate data, analytics and technology into AbbVie's global therapeutic endeavors, ensuring that data is leveraged effectively to enhance decision-making and drive successful business outcomes. Under Gian's leadership, the Data and Analytics team at AbbVie thrives on a culture of collaboration and innovation, continually seeking to enhance the impact of their work across the global therapeutic landscape. His dedication to excellence ensures that AbbVie remains at the forefront of leveraging data to deliver tangible benefits to patients and the healthcare community at large.

Megan co-founded the patient recruitment business for the Pregnancy and Parenting division of Everyday Health Group, home to BabyCenter and What to Expect. She currently leads the execution of patient recruitment campaigns for women’s health and pediatric clinical studies. Megan has 17 years of experience in program and partnership management with a focus on maternal and global health. She holds a Masters in Public Administration from Columbia University’s School of International and Public Affairs, and a BA in Anthropology from Skidmore College. A passionate mom, choral singer, cook, and camper, she lives in the Bay Area with her husband, son, and two cats.

Dr. Edward Price is a Principal Scientist in AbbVie's Quantitative, Translational & ADME Sciences department, specializing in computational drug development. Leveraging data analytics and computer modeling, he helps cross-functional teams make data-driven decisions, accelerating medical solutions. Over 6 years at AbbVie, he has enhanced computational drug ADME (absorption, distribution, metabolism, and excretion) capabilities, contributing to safer and more effective drugs. Previously, he designed advanced physiologically-based computer models for a defense contractor, used by the FDA, EPA, and industry to advance drug development. He also founded a startup supported by NSF iCorps and Harvard Business School's Lean Startup programs, focusing on nanotechnology applications for detecting and treating viral agents. Dr. Price earned his Ph.D. in chemistry from the University of Central Florida's Nanoscience Technology Center, where he integrated chemistry, nanoscience, and biology to develop computer models aimed at reducing reliance on animal testing, enhancing drug delivery technologies, and contributing to ethical drug development.

Johann Proeve has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, and the ‘Best presentation on RBQM’ at the 2024 PHUSE Connect conference, Johann is widely regarded as the go-to source for Clinical Data Management and RBQM. In this regard, Johann has been invited to speak to clinical organizations worldwide, including regulatory bodies, sponsors, and CROs, at conferences like DIA, SCDM and SCOPE. Additionally, Johann has published numerous thought leadership articles for media, including ACT, Contemporary Clinical trials, and DIA Journal. Johann holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharmaceutical Medicine program).

Johann Proeve has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, and the ‘Best Presentation on RBQM’ at the 2024 PHUSE Connect Conference, Johann is widely regarded as the go-to source for Clinical Data Management and RBQM. Johann holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharmaceutical Medicine program).

Raviv is the co-founder & CEO of PhaseV, a technological company that developed a causal-ML-based platform for the design and execution of adaptive clinical trials. Raviv has over a decade of experience as a technological leader in the advanced technological defense industry, after which he transitioned into the health-tech industry and joined Immunai as SVP of Operations and Analytics. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion and Ph.D. in computational neuroscience from the Weizmann Institute.

Marisa is the leader of the newly formed Clinical Site Start-up & Engagement group. This group was created as part of our GDO org redesign to support Future Fit in the predictable delivery of accelerated clinical trials. The new group brings together and grows key functions to optimize study start-up and feasibility, clinical trial diversity, patient recruitment and retention, site engagement, site contracting, and oversight of CRAs. Before coming to Takeda, Marisa worked at Vertex for 5 years, where she served as Global Head, Study Start-Up and Site Strategy. Also at Vertex Marisa headed up Site Engagement with responsibility for leading the North American Regional Site Advocate team and creating/maintaining investigator site relationships across the rare disease portfolio. Prior to Vertex, Marisa spent over 16 years at Merck, building her expertise in clinical operations including leading clinical operations teams, and leading Global Trial Optimization responsible for clinical trial feasibility and recruitment strategies for all Merck’s late-stage development projects.

Angela Radcliffe is a clinical research expert and data ethics evangelist with over two decades of experience driving transformation and organizational agility at the intersection of health, tech, and data. Angela’s work has impacted >100 global clinical research efforts across almost every therapeutic area. As an author and speaker, Angela uses her personal journey to demonstrate how inclusive research can impact the root causes of our most challenging social issues such as homelessness, social justice, and climate change. She is committed to delivering on the promise of digital health and decentralized clinical trials in pursuit of health equity, giving data ownership back to humans to promote authentic patient engagement and trust, the promotion of health and data literacy for all, and normalizing clinical research as a care option.

Dr. Mitesh Rao is the Founder and CEO of OMNY, a venture-backed company revolutionizing how healthcare data is shared and valued. A Board-Certified Emergency Medicine Physician, Dr. Rao practices clinically as an Assistant Professor of Emergency Medicine at Stanford. Most recently, he served as the Chief Patient Safety Officer at Stanford Healthcare where he led Patient Safety, Quality, and System Redesign for the Enterprise. Dr. Rao began his career as a Fellow in the Robert Wood Johnson Clinical Scholars Program. As a physician leader and executive, he has helped implement systems-level improvements for quality and safety in institutions across the country and overseas that have had lasting effects on patient care provision. He has also led multiple campaigns and initiatives to improve healthcare quality on a national level. Throughout his career, Dr. Rao has helped implement and scale new technologies within the clinical venue. He also serves as a mentor to multiple startups and accelerator groups across the country in order to help guide the development of innovative solutions that can sustainably impact patient care.

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Chief Products and Innovation Officer at Saama. With over 30 years of experience in information technology and analytics, including more than a decade in healthcare and life sciences, Prasanna brings a wealth of knowledge and expertise to his role. Previously, as Global Head of AI/ML, Clinical Data Sciences at Pfizer Research & Development, Prasanna worked closely with stakeholders, vendors, business SMEs, machine learning developers, and data scientists to foster innovation and advance the adoption of AI in clinical data sciences. His tenure at IBM Watson as a Watson Solution Architect was marked by significant achievements in implementing AI systems for a diverse range of clients. An accomplished speaker, Prasanna regularly presents at major industry conferences, including SCDM, DIA, SCOPE, DPharm, Tufts University CSDD, and Outsourcing Clinical Trials (OCT). He is also the holder of an IBM patent titled "Monitoring Clinical Research Performance," further cementing his status as a leading authority in leveraging technology for clinical development in the pharmaceutical industry.

Prasanna continues to drive transformative advancements in AI and machine learning, delivering groundbreaking solutions to accelerate clinical research and development.

Ratan Ratnesh is a Senior Director and Head of Outsourcing & Vendor Management at Taiho Oncology. Prior to joining Taiho/Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.

Rosemary Rebuli, with over 20 years in the pharmaceutical industry, has held leadership roles in clinical development, pharmacovigilance, marketing, and medical affairs and today leads Global Study and Site Operations at Novartis, overseeing clinical trial teams and portfolio delivery across all of Novartis’ clinical development focus areas and in more than 40 countries. A medical doctor, Rosemary is passionate about transforming science into medicine through collaboration, innovation, and a strong focus on the site and patient experience. Rosemary has had many opportunities to lead major organizational change and is currently excited by the transformative promise of AI in clinical development.

Dr. Bhargava Reddy has over 16 years of experience working in the pharmaceutical industry. He is currently Head of Advanced Insights at Janssen Pharmaceutical supporting clinical operations by providing data science solutions. Prior to this role, he was Associate Director of Advanced Analytics at UCB. In this role, he was responsible for the development and application of machine learning methodologies supporting clinical decision making within Immunology and. He was also leading the analytics work supporting Risk Based Monitoring. Prior to this role, he managed a statistical programming group and was also overseeing a large statistical programming group offshore. Dr. Reddy has published several methodology papers in peer reviewed academic journals in the areas of machine learning and deep learning. He is actively involved as an associate editor for the Frontiers in AI journal and also as a reviewer on several journals. He has a Ph.D. from Oklahoma State University and MS from Northwestern University.

Clinical Research Innovator, Leader, and Mentor with 30+ years of experience in creating new solutions and adding value to clinical programs. Passionate about developing meaningful and authentic relationships with all stakeholders in the clinical trial process. Responsible for corporate strategy, innovation, and study optimization, including site and patient engagement strategies as well as global feasibility in order to deliver predictable timelines and deliverables. Driven to find new and better solutions that create efficiencies and offer opportunities to improve the clinical research process. Expertise in strategic consulting, clinical development planning, global project feasibility, site start-up and management, patient recruitment, innovative technologies, and a full suite of CRO services. Key experiences in study rescue and transition programs, with processes and strategies for both full CRO study management transition as well as functional service provider (FSP) programs. Responsible for developing and managing key strategic relationships across the globe. Current member and Deputy Director of Midwest Mentoring Program for Healthcare Businesswomen's Association (HBA); Co-Lead for Crowdsourcing Evidence Workstream and on Content Council for Decentralized Trials Research Alliance (DTRA); Led Site Budgeting for DCTs workstream for ACRP. Key awards include PharmaVoice 100, HBA Luminary award, President's Club at Inventiv Health, and President's Club 10 years in a row at Advanced Clinical. Advanced Clinical is the premier mid-sized CRO, offering full global contract research organization (CRO) services, dedicated functional teams/services (FSP), and strategic resourcing solutions. We are extremely proud of the success of our privately-held organization and its culture, which includes being voted year after year in the top 100 companies to work for in the Chicago area. Most importantly, from the top down and at all levels, we strive to make a better clinical experience for our clients, partners, vendors, sites, and patients each day.

Sunee Reiner is a strategic healthcare leader with over 20 years of experience spanning medical affairs, clinical operations, and research. As R&D Field Medical Director for Immunology at Sanofi US, she spearheads pipeline clinical trial medical strategy and cross-functional initiatives. Sunee's career trajectory, encompassing roles in preclinical quality, global clinical pharmacology program management, trial operations, and medical affairs, has honed her expertise in change management and process improvement. She is known for developing innovative communication frameworks that bridge traditional silos, accelerate milestones, and enhance outcomes. Her passion for fostering cross-functional collaboration has consistently driven transformative results through the strategic alignment of medical expertise with operational excellence, creating synergies that advance both clinical research efficiency and scientific impact.

Valerie Reynaert serves as the Head of Global Clinical Operations at Immunocore. She joined Immunocore in April 2023. Valerie has more than 20 years in clinical development and operations in a variety of leadership roles in Vaccines and Pharmaceuticals development in both Europe and the US. Valerie has a Masters in Medical and Social Sciences from the Catholic University of Leuven, Belgium. She lives in the Philadelphia area.

Leyla Rich is Senior Director of R&D Portfolio Operations BI&T at BMS, leading enterprise initiatives that enhance visibility, forecasting, and decision-making across the R&D Portfolio. With a background in digital transformation across the Pharma value chain, Leyla is driving the integration of agentic AI and automation into operational workflows enabling R&D Portfolio delivery.

Kevin has made a career of overhauling analytics strategies at organizations across multiple industries including manufacturing, healthcare and now pharmaceuticals. He was brought into AstraZeneca 2 years ago to overhaul the Quality Management System analytics strategy bringing an approach that has led to the successful implementations of inspection readiness, quality and process compliance reporting and solutions. Kevin is passionate about uplifting the capabilities of the industry to deliver safe and effective clinical trials to patients through effective and transformative strategy in the quality space.

Amy Ripston is the Founder & President of the Biospecimen Management Consortium (BMC), a non-profit organization dedicated to driving sample excellence in clinical research. Founded in June 2024, the BMC mission is to raise awareness of the importance and criticality of biospecimen management, develop industry standards and best practices, and advocate for change within the clinical trial ecosystem through standardization, policy, and thought leadership.

As the head of Analytics Innovation and Digital Health, Gaelan and his team are responsible for leading cutting edge real-world data alliances and most importantly creating and developing innovations across R&D. He co-leads the BMS digital initiative for global drug development, which is enabling a spectrum of digital solutions, including several types of decentralized trial capabilities. Gaelan is an industry leader in the development and infusion of digital innovation solutions to enable optimization of pharma drug development. In past roles Gaelan has led and developed strategic partnerships with large academic medical centers and networks. He has also supported trial design and start-up for the BMS oncology and immunology programs. This experience led him to develop industry leading trial design software and processes that create digital protocols and feed downstream systems and processes. He is passionate about not only the ideation and creation, but the development and business change that creates lasting advancement in the industry. Gaelan holds an MBA from Temple University along with MS in human physiology and biophysics from Georgetown. Outside work, Gaelan lives in southeastern Pennsylvania with his wife, enjoys traveling around the globe, cooking, and restoring their historic home.

Kimberly Rivera has three decades of experience in the pharmaceutical industry, at Pfizer and Roche/Genentech, serving in Data Management & Clinical Research roles as a Clinical Study Trial Lead & Global Study Manager. She began her career with summer internships at Pfizer in the early 1990s and has since risen to the position of Senior Director/Sr. Group Lead in Pfizer’s Clinical Data & Information Sciences org. Kimberly is accountable for delivering critical programs in I&I, Digital Health Tech & Rare Diseases yielding successful new medicine approvals. She has led the eSAE Business initiative since 2018, revolutionizing electronic SAE data collection & now serving as co-team lead of a new UDMS Safety Gateway enablement. Kimberly also serves as department expert for Protocol Deviations, due diligence, and database release. She enjoys developing staff and teaching interns to pay it forward.

Jason Rizzo serves as Oracle’s Group Vice President of North America Sales for Life Sciences inclusive of its clinical trial technologies, Research Services and Fusion Applications. Mr. Rizzo brings more than 25 years of industry experience across foundational AI builders, vertical cloud software companies, and contract research organizations.  In his most recent work prior to Oracle, he led field organizations at Aily Labs and InsightRX. He was part of the foundational team establishing Aily as a US entity and bringing its first-generation Decision Intelligence app to Fortune 100 CFOs across industries. At InsightRX he was instrumental in scaling its MIPD (model informed precision dosing) app for enterprise life sciences organizations. Over a 17-year period at Medidata Solutions followed by Veeva System he was a key executive leading growth of Rave and the Vault Platform, respectively. His experience spans drug development, commercial pharma, and general business operations. He holds a BA from Greensboro College and an MBA from the University of Notre Dame.

LaShell Robinson is the Director of Diversity, Equity & Inclusion in Clinical Research at Takeda Pharmaceutical Company, Ltd. Here she leads the company’s strategic vision for increasing the diversity of Takeda’s clinical research programs by fostering partnerships & implementing strategies focused on education, awareness, access, and operational excellence. LaShell brings her experience from Janssen Research & Development, a Johnson & Johnson Pharmaceutical Company where she held the position of Clinical Operations Lead, Diversity & Inclusion in Clinical Trials (DICT). In this role, she supported the vision to ensure that all patients have access to innovative, high-quality care and the best possible health outcome regardless of race or ethnicity. LaShell was responsible for providing D&I strategic and tactical support to trials, including the COVID-19 vaccine and treatments trials. LaShell’s previous roles centered on Patient Recruitment & Retention and Site supporting global clinical trial programs with disease-focused strategy to expedite trial enrollment. Her specializations included training clinical teams, facilitation of site & patient engagement workshops, managing small to large scale investigative site support programs all of which focused on highlighting the patient experience to enable a better clinical trial experience. LaShell is a proud alumna of Tuskegee University where she obtained a Bachelor of Science in both Biology & Physics. Here she saw firsthand the impact history has on the patient’s perception of clinical research. This continues to fuel and influence her passion for educating others about clinical research and the diversity of the patient experience. LaShell has a Master of Science in Biomedical Engineering from the University of South Florida. LaShell and her family currently reside in Maryland.

Chris is a Strategic Partnerships Lead in Pfizer Ignite a new end-to-end developmental and clinical service model for biotech innovators to help advance novel therapies to market. In the past, Chris worked in Strategy and Consulting working across the R&D continuum from idea to launch and has been involved in and led a number of efforts across the drug development value chain from organizational redesign (e.g. creation of a new clinical organization, enabling functions), integration efforts (e.g. Wyeth, Allergan) and unit level strategies (e.g. GTx operations) to productivity analyses (e.g. productivity, metrics analyses, cost per POC), forecasting (e.g. pre-launch milestone forecasting) and competitive analyses linked to overall strategic priorities. Chris’s career is fueled by a relentless curiosity and a passion for forging meaningful connections with the extraordinary individuals he encounters. He is a proud alumnus of Stevens Institute of Technology, where he obtained a bachelor’s degree in Chemical Biology, and Rensselaer Polytechnic Institute, where he earned his MBA. Chris’s personal life is just as fulfilling as his professional one. He resides in Mystic, CT, with his wonderful wife, their spirited son, and two exuberant huskies, who bring joy and a touch of chaos to their home.

Alexandra Rosário is the Clinical Director at Biorce, supporting scientific leadership and clinical innovation at an AI-driven healthcare company focused on advancing modern clinical trials. She brings extensive experience across the healthcare and pharmaceutical industries, having led Medical Affairs teams at companies including Baxter, Eisai, Amarin, and Cogent Biosciences. Her work spans the full product lifecycle, from early clinical development and Phase I–III trials through market access and product launch. Alexandra holds a PhD in Biomedicine and has a background in basic research. Combined with her experience across multiple therapeutic areas, this enables her to navigate today’s clinical trial landscape and drive it forward with patients as the central priority.

Hillary Rose is an accomplished IT leader and Product Manager in Global Clinical Development IT at Bristol Myers Squibb (BMS). With an MBA from Cornell University and prior experience in EHR systems management at Cerner Corporation, Hillary began her BMS journey as a Technology Leadership Development Program associate, gaining cross-functional expertise across Drug Development, Commercialization, Business Development, and Digital Health. She now leads transformative initiatives in the Global Development Operations space, such as leveraging AI to streamline clinical documentation and crafting the technical strategy for clinical protocol authoring. A passionate advocate for talent development, Hillary also now leads the Technology Leadership Development Program at BMS. Her leadership and commitment to innovation continue to shape the future of clinical IT at BMS.

John Rose is Senior Vice President, Healthcare at GlobalData, where he leads global teams delivering data, analytics, and insights that help Sponsors, CROs, and Technology Providers accelerate and de-risk clinical development. With more than two decades of experience across clinical R&D, commercial strategy, and health data science, he works at the intersection of real‑world data, clinical trial intelligence, and forecasting to support evidence-driven decisions from early development through post‑launch.​ He regularly partners with biopharma, medtech, and service providers to shape portfolio and asset strategy, inform indication and trial design choices, and translate complex data into practical actions for clinical, medical, and commercial leaders.​ In addition to his leadership role, John is an active contributor to industry conferences and executive forums on topics such as global trial landscape trends, patient access and unmet need, and the evolving outsourcing and partnership models in clinical R&D

Dr. Rosenberg is a 35-plus-year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical, and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions, and new product/licensing evaluations, he brings tremendous hands-on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society, and also Managing Partner of eP2Consulting, Inc. since 2001.

Steve’s career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. Today, he continues to leverage this deep experience to drive uMotif’s hypergrowth. Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Before that, Steve was at the forefront of advancing the adoption of electronic data capture and was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010. Steve has been named twice to the prestigious PharmaVoice 100 list. He recently served on the Board of Anju Software and currently sits on Prix Galien’s Digital Media and USA Digital Health Advisory boards. He also served a six-year term on CDISC’s Board. Steve and his wife Pam founded the non-profit The One By One Project to meet the urgent needs of people in greater Boston who would otherwise fall through the cracks. In his spare time, Steve enjoys summers on Cape Cod with his family.

Julie Ross is President & CEO of StuffThatWorks, an AI-driven, global patient crowdsourced real-world experience platform company transforming drug development. As a tenured executive leader, she has led the growth, profitability and overall success of multiple companies in the clinical research industry including CROs, Patient Recruitment Companies and Site Networks. She is passionate and focused on innovative methods for reducing the time and cost within clinical trials.

I am a Clinical Operations professional with over 13 years of experience primarily focused on cell and gene therapy in rare pediatric disease. I am currently the Director of Clinical Operations at Taysha Gene Therapies, Inc. with a wonderful group of people working towards bringing an in vivo gene therapy to the market for the Rett Syndrome community.

Emma Rouse is Senior Patient Engagement Lead in Global Partnerships and Trial Optimization at Regeneron, overseeing patient engagement across the Oncology and Genetic Medicines portfolio. With 20+ years in biopharma, she has extensive operational expertise and a proven track record of integrating patient perspectives to improve trial design, recruitment, and retention. Passionate about advancing patient-focused research, Emma takes a strategic and collaborative approach to strengthen the connection between patients and clinical trials, helping ensure that research is both meaningful and accessible.

Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.

Matthieu Ruffin is a seasoned professional with 20 years of experience in clinical operations within large and mid-size pharmaceutical companies. He has strong leadership skills, having led global study leadership and development operations. Matthieu has successfully driven clinical operations strategies and delivered on business goals across key therapeutic areas and various types of clinical trials, from early- to late-phase trials. Currently, Matthieu serves as the Vice President, Head Study Leadership at Novartis, where he leads the global Study Leadership organization to ensure timely and quality execution and delivery of global clinical trials across all Novartis Development programs. He is accountable for the Novartis Clinical Trial Team model, related tools, and operational excellence. Matthieu ensures cross-functional excellence in clinical trial execution and leads the biospecimen scientist organization responsible for the operational execution of clinical biospecimen samples. Previously, Matthieu held the position of Global Head Development Operations, at Advanced Accelerator Applications (AAA), a Novartis company, where he led the Development Operations organization focusing on RadioLigand Therapy (RLT). He was accountable for delivering clinical trials from early to late phases in the AAA portfolio and drove timely and efficient trial execution in collaboration with global medical affairs, legal, research, and regulatory affairs functions. Matthieu holds a Postgraduate Degree in Combinatorial Chemistry and Drug Design, and a Master of Science Degree in Analytical and Organic Chemistry from the University of Orléans in France.

Brandon leads the Integrative Clinical Data group in Digital R&D, a team of computational scientist, engineers, program managers and analysts focused on using ML/AI to integrate clinical and real-world data for several drug development applications, including drug repurposing, proxy endpoint identification, safety prediction, and simulation of novel mechanism of actions on a target cohort. Prior to joining Sanofi, Brandon worked as a Data Scientist building large language models at a healthcare company in Toronto. He was also a lead Data Scientist developing end-to-end software applications which derived cohort insights to inform combination drug treatments at a biotech company.

Krista Russell is eager to utilize her well rounded technical, operational and clinical research expertise to solve complex challenges. She is a Global Portfolio Leader at Evinova focused on developing and implementing new and innovative Software as a Service solutions for customers. Krista’s passion for technology began with her career in the United States Navy. It was through this effort and her own journey to seek treatment as part of service connected injuries that she gained an understanding of the importance of both technology and the experience along the care continuum. She is passionate about improving health outcomes for patients through the adoption of the right technology solutions. Prior to Evinova, Krista spent years developing, validating, and managing business and clinical technology tools for clinical trial sites and Pharmaceutical sponsors. She has worked directly with patients, sites and teams on developing new and better patient care solutions for both Research and Development and Commercial outcomes. Krista is a certified clinical research coordinator and clinical project manager. Her experience in advancing trial delivery includes managing clinical trials and large technical system projects with success.

Stephanie Russell is a seasoned Clinical Development Professional with over 15 years of expertise in the pharmaceutical industry. With a proven track record of success in efficiently delivering Phase I-IV clinical trials, Stephanie is a trusted provider of top-tier solutions tailored to the highest quality standards. As the Sr. Director of RTSM Solution Services at Medidata Solutions, Stephanie leads a dynamic team dedicated to streamlining clinical trial Randomization and Trial Supply processes. She serves as a crucial link between service delivery and product development, ensuring that solutions align with industry trends and cater to each trial's specific needs.

Ralph J. Russo is the Global Head, Clinical Data Collection Strategies at Pfizer. In this role, Ralph is responsible for all modes of Clinical Trial Data collection, including EDC builds, eCOA management, Third Party Data, Medical Technology, and Image management. Ralph has over 39 years’ experience in the pharmaceutical industry. Prior to joining Pfizer, Ralph worked at Merck where he was responsible for various groups including External Data Acquisition and Clinical Database Management. Ralph also has 14 years’ experience at Wyeth where he was responsible for designing clinical trial databases using the Oracle Clinical suite of applications. Prior to this, Ralph worked on various drug development teams in support of Discovery Research as a Research Chemist at Wyeth. Ralph has an MBA with a concentration in Management Information Systems from Temple University’s Fox School of Business, a Master of Science degree in Chemistry from Seton Hall University, and a Bachelor of Arts degree in Chemistry from Rutgers University.

Dr. Said is the Founder and CEO of Outcomes4Me, a health technology company focused on empowering cancer patients with personalized, evidence-based navigation and improving outcomes through better access to innovation. Prior to founding Outcomes4Me, she was Senior Vice President of Global Market Access & Policy at Novartis Pharmaceuticals and Vice President of Strategy & External Innovation at Sanofi. Dr. Said is a strong advocate for life sciences innovation and serves on the Board of Directors of Transgene, Pieris Pharmaceuticals, and Home Biosciences. She was a founding member of the Boston Consulting Group Strategy Institute. Dr. Said trained at the Massachusetts Institute of Technology, earning dual degrees in Biology and Electrical Engineering and Computer Science with a minor in Economics. She also holds a Master of Science in Toxicology, a Master of Engineering in Electrical Engineering, and Computer Science, and a Doctor of Science in Electrical Engineering, Computer Science, and Systems Biology, all from MIT.

David Sall is a marketing and engagement specialist with a focus on the healthcare industry. He was graduated with honors from The George Washington University with a Bachelor of Arts in Communications and a concentration in Business Marketing. David started his career in national broadcasting sales by representing hundreds of the nation’s top radio properties. As the media industry hit the technology revolution, David continued his career by building and managing the New York office of Hiwire, one of the original pioneers in digital streaming technology. With the opportunity to bring this knowledge to the traditional media space, David joined CBS Broadcasting’s management team and handled the flagship terrestrial radio news properties as well as the many digital assets of the Tiffany network. David is now the CEO and President of Patient Enrollment Advisors, which focuses on the recruitment and retention of qualified participants in medical clinical trials. This venture was born out of a clear need for the industry to approach the business of clinical trials with a unique set of eyes. “Our company takes a patient-focused strategy to help the healthcare industry quickly and safely bring products to market for those in need. Patient Enrollment Advisors not only finds qualified patients, but we also listen to them.” This humanistic approach makes the clinical trial process a better experience than ever before - for everyone involved - which ultimately helps pharmaceutical companies meet their research goals. Patient Enrollment Advisors reaches qualified trial candidates, retains them, and ensures they fulfill all requirements to bring a clinical trial to a successful, complete end. David is very excited to be a partner with SCOPE for the Participant Engagement Awards, and especially excited to highlight the innovation of engagement with study participants. He lives and works in New York City with his wife and two children.

Leslie Sam, President of Leslie Sam and Associates, LLC, is a recognized leader in clinical trial research and quality management with over 30 years of experience. A Six Sigma Black Belt and a trusted partner to pharmaceutical companies and global health organizations, Leslie specializes in transforming clinical quality management systems to meet the evolving needs. Her innovative approach focuses on collaboration, change management, and risk-based strategies, ensuring regulatory compliance and operational excellence. Leslie’s industry contributions include co-developing a pioneering clinical quality management and issue management frameworks with TransCelerate and reviewing its global risk management guidelines. These efforts are examples of her commitment to driving industry standards forward. Leslie's expertise has been sought globally, including her leadership in applying Risk-Based Quality Management (RBQM) to a Mass Drug Administration, Decentralized Clinical Trial in Kenya, involving nearly 25,000 participants. As a speaker and consultant, she is highly regarded for her ability to guide organizations in adopting strategic, data-driven approaches to clinical operations.

Brooke J. Samuelian is a Senior Manager, Biomarker Operations at Syndax Pharmaceuticals where she is responsible for the management of biospecimens as well as central and analytical lab activities. Brooke has 12 years' experience in the industry and began her career in the lab at Eurofins. She then spent time at Syneos Health (formerly inVentiv Health) and Bristol Myers Squibb before joining Syndax in March of 2022. Brooke has been involved in a variety of process improvement initiatives and is passionate about exploring innovative solutions to operational challenges. She has been recognized for her efforts and is currently leading a pilot of an electronic sample management platform. Brooke received her B.S. in Forensic and Toxicological Chemistry from West Chester University in 2013.

John is a senior data scientist at Pfizer, based in Cambridge, MA. Being a part of the operational AI group, his work focuses on enhancing operational efficiency and quality across the spectrum of drug development. Prior to joining Pfizer, John earned his PhD in computational medical engineering and medical physics from MIT and Harvard. He is passionate about teaching and mentoring students.

I have 20+ years of experience within the Life Science and Pharma Industry, starting as a Lab Chemist, Data Manager, Business Integrator/System Specialist, and finally, as an associate director for Data and Analytics supporting Clinical Trials.

Rachna Saralkar, MD, is a double board-certified Investigator at Flourish Research, specializing in psychiatry and clinical informatics.

Prior to joining Flourish Research, Dr. Saralkar served as Medical Product Director at Deliberate AI, where she worked on the development of AI-enabled tools for mental healthcare. She also served as an advisor and fractional chief medical officer to early stage startups working on incorporating AI into their care delivery platforms. Her experience spans traditional psychiatric care delivery – including outpatient, emergency, and virtual settings.

Dr. Saralkar completed her psychiatry residency at Johns Hopkins University and holds a Master’s in Clinical Informatics Management from Stanford University School of Medicine. As a practicing psychiatrist licensed in California and Pennsylvania, she is passionate about bridging the gap between innovative healthcare technologies and clinical research, working to advance treatments that can meaningfully improve patients’ lives.

Anamika joined Regeneron Pharma in 2017 and currently the Lead of Intelligent Automation group in Global Development Solutions. Prior to Regeneron she worked at Paragon Solutions (currently CGI) where she was strategy consultant in Clinical and Regulatory Operations spaces for both Biotechs and CROs. Some of her past experience in consulting includes as IT consulting role at Daiichi Sankyo Pharma and Domain Consultant for big pharma companies at Wipro Technologies. She is passionate about bringing right drug to right patient. Anamika is a PhD and MBA (Pharma Industry Management from Rutgers University), who started her scientific career as Computational Biologist, after her PhD, in the same field, from IITD (Indian Institute of Technology Delhi, India). She has worked as scientist both in academia (University of Washington Seattle, Memorial Sloan Kettering Cancer Center, Mt. Sinai School of Medicine) as well as pharma industry (Novartis, Inc.). She had been consulting as a bridge between business, technology, and science since 2012 'til she joined Regeneron in 2017.

Dr. Saul is the worldwide lead for healthcare and life sciences at AWS focused on supporting the work of top investors and their most promising healthcare and life sciences start-ups—bringing Amazon technology, resources, and relationships to bear on the unique challenges and opportunities facing those at the cutting edge of healthcare. Dr. Saul began his career practicing clinical neuroradiology while also pursuing a variety of startup ventures and ultimately left clinical practice to fully pursue entrepreneurial ambitions as a founder, CTO, advisor, and investor. Dr. Saul received his medical doctorate from the University of Medicine and Dentistry of New Jersey where he subsequently completed a residency in radiology. He then completed fellowship training in neuroradiology at the University of Arizona. He lives in New Jersey with his wife and two sons.

Over 30 years of drug and device development experience. Most recently served as the Chief Growth Officer at WCG Clinical, responsible for the company’s enterprise growth and commercialization strategy. Prior to WCG, was Elligo Health Research’s COO where she furthered company’s growth, efficiency and mission of optimizing the intersection of healthcare and research. Dawn was also the Chief Development Officer at Clinipace (now Caidya) where she developed the strategy and grew the organization to be a trusted partner for sponsors. Prior roles included President, Development Innovations at Sarah Cannon and SVP and General Manager Hematology/Oncology at inVentiv Health (now Syneos).

Scott has extensive experience having predominantly worked in senior positions for large multi-national corporations, mostly as an R&D Sourcing professional. His varied industry experience with both sponsors and CROs includes R&D Sourcing & Procurement, Supplier Relationship Management, and Business Development, with sponsor companies Centessa Pharmaceuticals, ADC Therapeutics, Adare Pharmaceuticals, Novartis Pharmaceuticals, Aventis, and CROs Crovelis, Syneos Health, and Covance.

With more than 30 years in the pharmaceutical industry, George drives the operational infrastructure that ensures KPS Life delivers consistent excellence for its clients. global growth. Since joining in 2014, he has expanded the company’s client base and strengthened service delivery, becoming COO in 2018.

Previously, George held senior roles at Teva Pharmaceuticals, Cephalon, and ReSearch Pharmaceutical Services (RPS), leading global procurement, contracting, and outsourcing functions. His experience includes building the first centralized outsourcing unit within Pfizer’s Global R&D.

George’s expertise in strategic outsourcing and relationship management ensures that KPS Life delivers operational excellence, efficiency, and long-term value for its clients.

Drug development executive with over 30 years of experience leading people and projects in a wide variety of positions within drug development including clinical project management, study management, data management, regulatory submission coordination and international clinical trials.

Hollie Schmidt is the Vice President of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS, a participatory research network for MS established to perform and support patient-centered research in MS. In this role she works to promote patient engagement throughout the research process and to develop research collaborations on topics of interest to people with MS. She founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at promoting racial and ethnic diversity in MS research studies. Before joining Accelerated Cure Project, Ms. Schmidt's endeavors included co-founding a management consulting firm and two software companies. Ms. Schmidt has an MS in Management, as well as a BS and MS in Materials Science and Engineering, all from the Massachusetts Institute of Technology. She also serves on the Institutional Review Board of Beth Israel Deaconess Medical Center and is Secretary for the Multiple Sclerosis Coalition.

Clinical Data Management professional with over 30 years in leading internal and vendor personnel in clinical trials for Phases I - IV t in biotech, pharmaceutical and non-profit venues. Risk Based Quality Management certification—Black Belt, Study Rescue Specialist, Therapeutic areas include HIV (Pediatric and Perinatal), Oncology (Multiple Myeloma and Leukemia, GIST, Breast, Prostate, Pancreatic, Glioblastoma, and other Solid Tumor) and Devices (Surgical mesh).

Charlie Semenchuk is the Head of Business & Technology Capabilities for Global Clinical Development Operations at Jazz Pharmaceuticals. He currently oversees a number of functions within GCDO covering technology, data innovation, analytics, AI/ML, and various business functions such as TMF Operations and Learning & Development. Charlie has spent over 20 years working in the pharmaceutical development space, specializing in the intersection of science and technology. With experience at sites, technology service providers, industry consortiums such as TransCelerate, and sponsor companies both big and mid-sized; he has a wealth of knowledge and experience from all sides of pharmaceutical development with a passion for the advancement of innovative medicines.

Christine Senn, PhD is the SVP of Site-Sponsor Innovation at Advarra, a global company offering services and technology solutions to safeguard trial participants and enable collaboration across all industry domains. She has worked in clinical research since 2005, starting at the University of Vermont College of Medicine then spent 16 years building the site network that became Centricity Research, where she served in various business roles across strategic growth initiatives, project planning and execution, and continuous process improvement. Senn has a PhD in psychology and master’s degrees in clinical psychology and advertising and public relations. She was the 2023 Chair of the Association of Clinical Research Professionals (ACRP), is an ACRP Fellow (FACRP), and is double certified as a Certified Clinical Research Coordinator (CCRC) and Certified Principal Investigator (CPI).

Craig Serra is a senior leader within the clinical development operations space with his most recent experience at Novartis. Prior, he was Senior Director in Clinical Delivery Transformation at IQVIA and Senior Director in Clinical Sciences and Operations at Pfizer. He was also the recipient of the PharmaVOICE "100 of the Most Inspiring People in Life Science" award in 2017 and 2020, and named to Pharmaceutical Executive's "2020 Emerging Pharma Leaders."

Dr. Sema Sgaier is a serial entrepreneur with nearly 20 years of experience using data and behavioral science to drive innovation in healthcare. As co-founder and CEO of Surgo Health, she has led the development of the world’s most comprehensive and insightful AI-powered data platform that reveals the why behind people’s behaviors and decision-making. She previously founded Surgo Foundation and Surgo Ventures, led large-scale programs at the Gates Foundation, holds a Ph.D. in Neuroscience from New York University, and fellowship from Harvard Medical School.

Ashish Shah currently works at Bristol Myers Squibb in the Clinical Development department within the Neuroscience Therapeutic Area. As a Clinical Science Lead, he is responsible for designing and overseeing clinical trials. With nearly a decade of experience in Clinical Development, Ashish has contributed to both Cardiovascular and Neuroscience research. Prior to his role at BMS, Ashish worked in the Generic Pharmaceutical Industry, where he successfully supported the submission of 15 Abbreviated New Drug Applications (ANDAs), including first-to-file (FTF) and NCE-1 submissions. He holds an undergraduate degree in Pharmacy, a Master of Science in Pharmaceutical Sciences, and a Doctor of Pharmacy from Nova Southeastern University College of Pharmacy in Florida. Additionally, he is a registered Pharmacist in the State of Florida and has experience in Retail and Hospice Pharmacy settings. Ashish is passionate about drug development and is dedicated to creating novel therapies for diseases with high unmet needs. His diverse background and commitment to improving patient outcomes drive his work every day.

I’m a results-driven executive and independent consultant for clinical technology and AI, with 15+ years of global experience leading innovation at the intersection of clinical research, medical devices, and digital health. I specialize in building enterprise strategies and scalable digital solutions that drive growth, transformation, and clinical impact—especially in highly regulated environments. My background includes leading high-performing global teams, delivering AI/ML-enabled platforms, and aligning digital product portfolios with regulatory and business goals. I have a strong track record of driving execution through PMO leadership, strategic portfolio management, and data-driven decision-making. Certified in PMP and trained in Data Science by MIT and Berkeley HAAS, I bring a balanced blend of structure and innovation. I hold a master’s and bachelor’s degree from the University of Illinois Chicago and am a co-inventor on multiple technology patents. Passionate about advancing digital health, I focus on using technology and data to improve healthcare delivery and outcomes. Always open to connecting with others in the healthcare innovation space.

Moulik Shah has been at the forefront of leveraging technology to transform pharmaceutical and life sciences clinical trials for over 20 years. A passionate healthcare technology entrepreneur, Moulik’s dedication to improving clinical outcomes has fueled his vision of an integrated healthcare ecosystem built on the effective use of data and analytics platforms. Under his leadership, Maxis AI has become a leading provider of clinical data and analytics, driving real-world impact in pharmaceutical and life sciences clinical trials.

A seasoned leader and consultant with extensive expertise in SDLC management. Imran oversees clinical supply chain systems, process, and vendor management within clinical drug supply at Biogen. He is also the co-chair of the Clinical Supply Blockchain Working Group.

Kate Shaw is Co-Founder and CEO of Innovative Trials, an internationally renowned clinical trial patient recruitment and retention company. She has more than 20 years’ experience in patient recruitment support for clinical research and has achieved widespread recognition for her work. In 2024, Kate was awarded the ‘Woman in Pharma’ award at the Pharma Industry Awards UK for her commitment to advancing science and inspiring more women into STEM.

Jie Shen, PhD is an innovative leader with a track record of building innovative solutions to address various drug discovery and medicine development problems. He is a Research Fellow and Director of Digital Science at AbbVie, leading the digital health technology development, validation, and digital data analytics. Prior to his current role, Jie has led data science and advanced analytics capability development and execution for precision medicine, clinical trial optimization, digital health, and drug discovery at AbbVie and Eli Lilly and Company. Jie has published 50+ papers with more than 6000 citations.

Deborah Shepard is Director, Group Lead—Biomarkers Data Acquisition in Clinical Data Sciences at Pfizer. She oversees development of biomarker data transfer specifications across the Pfizer portfolio to ensure timely, standardized, and high-quality transfer of data from laboratory partners. She is a subject matter expert for biomarker data standards and is a CDISC volunteer. She joined Pfizer Clinical Data Sciences in 2023 from the Pfizer Oncology Clinical Assay Group, where she had provided scientific and technical oversight of laboratory partners involved in clinical trial biomarker specimen analyses as a Biomarker Clinical Assay Lead. Prior to joining Pfizer, she held positions of increasing responsibility in project management, lab management, and data management at Quintiles. Deborah holds a PhD in biochemistry from the University of Wisconsin at Madison.

Heather Shih is currently Senior Director Biomarker Operations in Global Clinical Devleopment Operations at BioNTech US Inc. Heather joined BioNTech in 2024 to lead a global biomarker operations team to support the company's entire clinical pipeline consisted of Phase I through III global studies. Prior to BioNTech, Heather held a number of leadership positions at Takeda Pharmaceuticals, Bill & Melinda Gates Medical Research Institute, EMD Serono (a US subsidiary of Merck KGaA), and Pfizer. Heather has 22 years of experience in pharmaceutical and biotech industry, with a broad spectrum of experience in drug discovery and development. She was a member of the clinical team at EMD Serono that brought the anti-PD-L1 therapeutic antibody Avelumab (BAVANCIO) to the market. During her scientific career, she authored 22 publications and 2 book chapters. Heather holds a BS in Chemistry from the University of Massachusetts at Lowell, a PhD in Biochemistry from Tufts University School of Medicine, and an MBA from the University of Massachusetts at Lowell.

Michelle Shogren, CEO of Innovate In What You Do! LLC boasts 25+ years in clinical research, beginning as a patient participant. Her journey led her through roles in nursing, monitoring clinical trials, and a pivotal tenure at Bayer Pharmaceuticals. Michelle's innovation-driven career culminated in founding her own innovation company in 2022. She's passionate about revolutionizing clinical trials, promoting user voice, and fostering innovation in healthcare.

Millie Shultz is currently the Global Head of Clinical Operations at Galderma. She has over 25 years of experience leading global clinical operations teams in the oncology and dermatology space. Prior to joining Galderma, she was Head of Americas for Site and Country Operations at Pfizer and the Head of Regional Clinical Trial Operations at Seagen. Other roles include Oncology Indication Lead at Merck and various clinical leadership roles at Millennium/Takeda across the Cambridge and Shanghai sites.

Shuba is an accomplished technology leader with a proven track record in solution engineering and operations, specializing in the pharmaceutical industry. As Senior Director and Head of Engineering & Operations at Bristol Myers Squibb, Shuba oversees the entire product lifecycle for Global Development Operations (GDO), driving innovation and breakthrough business outcomes through high-quality, enterprise technology solutions which resulted in significant cost savings and accelerated clinical trial cycle time. Shuba is recognized for pioneering AI-native solutions, notably implementing Generative AI and Agentic frameworks to optimize operations and accelerate software development lifecycles, resulting in substantial cost and time savings.

Chris Sinclair is a seasoned technology leader with a career spanning 26 years at Abbott and AbbVie, where he has successfully embraced diverse roles in various functions. His journey began with technical product support and then shifted into roles encompassing CMC Drug Product Development, Finance, Global Medical Affairs, Regulatory, R&D Quality, and Patient Safety. In his current role as VP of Global Therapeutic Platforms, Chris is accountable for technology leadership and delivery for the “D” of Pharma R&D. As part of Information Research within Business Technology Solutions, his teams work to unlock information that makes cures possible. Chris Sinclair holds a Ph.D. in Biochemistry and Molecular Biology from Purdue University and an MBA in Strategic Management from Indiana University. He has been certified as a Project Management Professional (PMP), a Master Black Belt in Lean Six Sigma, and is an experienced facilitator in Design Thinking, “WhatIf” Innovation, and Visual Recording.

Ankit Singh is a Sr. AI Scientist at AbbVie, leading pharmaceutical company, dedicated to using AI solutions to improve and facilitate clinical and regulatory development. With a MS degree in Data Science , Ankit's career has been focused on using data to solve complex problems. He joined AbbVie in 2020 and has been instrumental in analyzing data and building end to end AI solutions to help facilitate drug development process. He has worked extensively on Regulatory Correspondence projects helping them design and architect graph infrastructure, AI based clinical drafting, enterprise wide internal AI platform, OCR based projects and multimodal data search platform. Outside of work, Ankit enjoys hiking, playing cricket, and spending time with his family. He is passionate about using his skills to make a positive impact on the world and is grateful for the opportunity to do so through his work in the pharmaceutical industry.

Mark Slette is the Vice President of Global Operations and Strategic Transformation at Labcorp Central Laboratories, bringing nearly 18 years of industry experience, including 16 years with Labcorp. He has held roles across laboratory science, operations, project management, vendor management, and transformation leading large, global teams. Mark has overseen major strategic initiatives and transformation programs designed to modernize central laboratory operations and strengthen partnerships across the clinical research ecosystem. He is deeply focused on connecting the industry and advancing how clinical trials are executed worldwide. Mark holds a B.A. in Biology and Biochemistry from Augustana College and an MBA from Indiana Wesleyan University.

Anne is the Head of the Central Monitoring Team at Regeneron where she is responsible for both central monitors and data analysts, along with leading an RBQM implementation project with-in clinical development. She has been at Regeneron for 5 years. Anne has worked on both the Pharma and CRO side of the industry in RBQM, project management and data management roles in her career, often with a focus on technology implementation of some kind. Anne has a bachelors degree in Nursing from Indiana University.

With over 20 years of buy and sell experience in the industry, I have helped lead teams and companies to attain better KPIs, cost savings, and delivery of study results. In being able to see outside of the standard process(es), I have been able to be creative in my negotiations, assure a specific spend, and avoid downstream delivery issues.

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/Biological Threat Exclusion. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bioterrorism from entering the U.S. Mr. Smith has more than 20 years of public service with CBP, and has worked in a variety of environments, including on the southern land border, maritime, air passenger, and cargo locations. He has also been able to assist in several past domestic and international CBP disaster recovery operations.

Renee Smith has over 25 years of experience in research and healthcare. Renee currently holds the role of Head, Early Development Capabilities and Alliances in the Oncology Therapeutic Area at Johnson & Johnson (J&J) Innovation Medicines. Prior to J&J, Renee served as Associate Vice President of Global Quality and Education at Sarah Cannon. Her experience with clinical trials spans from developing and implementing quality and educational programs for investigative sites and CRO operations to working in a large pharma where she established an oncology investigative site partnership program and leadership support for the ED Oncology Clinical Therapeutic Area. Her unique perspective provides a good understanding of challenges across clinical research stakeholders. Renee serves as a member of the AACI corporate roundtable representing J&J, she has previously served as a Council Member on the American Society of Clinical Oncology (ASCO) Research Community Forum (RCF) as well as participated in several ASCO working groups. She has participated in research focused working groups with the Clinical Trials Transformation Initiative and the National Academies of Sciences, Engineering and Medicine. She has participated on the Society of Clinical Research Sites (SCRS) planning committee for the Oncology SCRS Oncology Summit for several of their annual meetings.

Kevin Smith is the Vice President of US Operations and Scientific Affairs at Eurofins Central Laboratory. With over 25 years of experience in the clinical trial space, Kevin has held leadership roles across Laboratory Operations, Project Management, Data Management, Information Technology and Development. A passionate and forward-thinking leader, Kevin is committed to driving innovation and enhancing sponsor experience. He has spearheaded the development of advanced digital solutions, including web-based laboratory requisition systems and data reporting portal tools, ensuring seamless access to critical trial information, and improving operational efficiency.

BioPharma professional with a strong background in Genomics, Technical Support, Training, and Clinical Biomarker Operations. Currently Director of Oncology Scientific Operations at GSK, 30 years of experience in BioPharma from the Bench to Bioinformatics and Distributed Computing, to Assay and Reagent Commercial Teams and now Clinical Trials and Biobank Strategy.

Megan Sniecinski has served as our Chief Business Officer since December 2021. Prior to joining us, Ms. Sniecinski was at BioCryst Pharmaceuticals, where she served as Chief Business Officer from July 2019 to August 2021. Previously, Ms. Sniecinski held senior leadership roles at PTC Therapeutics, Inc. from September 2014 to June 2019, culminating as senior vice president of business operations and program management. Prior to joining PTC Therapeutics, Inc., Ms. Sniecinski worked at Merck for more than 12 years, serving in a diverse set of operational and strategic roles with increasing responsibility. Ms. Sniecinski received a B.S. in chemical engineering from the University of Virginia and an MBA from the Wharton School of the University of Pennsylvania.

Rachel was trained as a pharmacist in Australia and started her career in the industry at the Novartis Institutes for BioMedical Research where she held roles in clinical operations, clinical sciences, patient engagement and advocacy, and clinical innovation. In light of the pandemic, she was assigned to lead the development and transition of ‘Next-Gen’ trial capabilities – including patient-centric trial models, digital platform solutions, and novel recruiting strategies – from pilot phase to systematic implementation across the early phase portfolio. Rachel was thrilled to join the Janssen Clinical Innovation team in 2022 where she continues to explore non-conventional trial models and recruitment solutions which aim to increase access to clinical trials for both physicians and patients, while also supporting the charge to develop strategic initiatives that encourage Diversity, Equity, and Inclusion in clinical trials at Janssen.

Mr. Soth helped to launch the Society for Clinical Research Sites to unify and amplify the voice of clinical research sites globally. Inspired by SCRS Founder Christine Pierre, Sean works to improve collaboration within the clinical research ecosystem while focusing on site success. With over nearly 2 decades in life sciences, Sean is a regular speaker, panelist and host, leading the SCRS Global Impact Partner program, Sites NOW, and several Site Solution Summit programs.

Nick Spittal serves as Chief Operations Officer at Velocity Clinical Research, the leading global multi-site clinical research organization. In this role, Nick leads operational excellence across project delivery, patient recruitment, and site operations to expand access to diverse clinical trial participants worldwide. With over 25 years of experience in clinical development and business operations, his teams leverage Velocity’s global scale, integrated technologies, and collective clinical expertise to improve trial efficiency and recruitment.

Sam K. Srivastava is the chief executive officer of WCG, a global leader of clintech solutions that improve the quality and efficiency of clinical research conducted in over 130 countries and enables biopharma, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients. He is a transformative leader with a proven track record of driving growth and innovation in healthcare. Prior to WCG, Sam served as chief executive officer of NeueHealth, a tech-enabled, risk bearing care delivery company with over 1M consumers across 17 states through owned clinics, partnered affiliates and high performing value-based networks. Sam was also chief executive officer of Magellan Healthcare, a leading behavioral, specialty and pharmacy management company serving 50M consumers worldwide. During his tenure, the company doubled in size by launching the nation’s first health plan for the seriously mentally ill, developing digital therapeutics and advanced illness programs. Prior to that, he worked at Cigna Healthcare as president of the national employer and Medicare businesses. He also led US strategy and development, that included the acquisition of HealthSpring and the launch of Cigna Ventures. Sam has held executive positions at UnitedHealth Group and HealthNet (Centene). He also served as a management consultant in the US and Europe, developing integrated delivery systems for providers, insurers, and governments. Sam serves as the Yale School of Public Health advisory council chair and Recovery Centers of America board director. He is a frequent national speaker and has testified to Congress regarding the opioid crisis aiding in the passage of the bipartisan Support Act. Sam graduated from Kent State University with Bachelor of Arts in medical science and humanities and completed graduate work at Yale University in health care management.

Srivatsan has over thirty years of experience in growing businesses in the Digital, Data, AI, Analytics, IT, Product and Operations management areas across several industry verticals. Currently he is helping companies unlock exponential growth opportunities to scale their businesses by leveraging the power of AI. Previously as Chief Digital Officer for R&DS Technologies, IQVIA he was responsible for driving growth and leading product development and operations of R&DS Technologies. Prior to that, as Chief Growth Officer for EXL he oversaw the Sales & Marketing, Consulting and Strategy functions helping EXL become a Strategic digital transformation partner to its customers. Before that, as Venture partner, he grew Cognizant’s foray into Digital & Platforms. He identified, incubated and grew innovative digitally enabled ventures across the Healthcare & Life Sciences value chain. Early on, He was responsible for growing Cognizant’s Life Sciences business unit to be a Tier one provider. He has worked with the many of the top 50 global Life Sciences organizations providing them comprehensive end-to-end consulting, analytics, business process and IT solutions. He has provided strategic leadership in helping life sciences organizations leverage technology and the global delivery model to effectively transform their businesses. Srivatsan was recognized as the top 100 most inspiring people in the life sciences industry award by PharmaVOICE publication in 2010 and 2021. Srivatsan holds a bachelor's in electrical engineering from B.I.T.S. in India and a master's degree in electrical engineering & computer science from Northwestern University.

Srivatsan has over thirty years of experience in growing businesses in the Digital, Data, AI, Analytics, IT, Product and Operations management areas across several industry verticals. Currently, Srivatsan serves as the CEO of Endpoint Clinical, a global leader in Randomization and Trial Supply Management (RTSM). He is spearheading the next phase of growth, strengthening Endpoint’s position as a trusted partner in accelerating clinical trials and bringing innovative treatments to patients. Additionally, he advises companies, helping them unlock exponential growth opportunities. Previously as Chief Digital Officer for R&DS Technologies, IQVIA he was responsible for driving growth and leading product development and operations of R&DS Technologies. Prior to that, as Chief Growth Officer for EXL he oversaw the Sales & Marketing, Consulting and Strategy functions helping EXL become a Strategic digital transformation partner to its customers. Before that, as Venture partner, he grew Cognizant’s foray into Digital & Platforms. He identified, incubated and grew innovative digitally enabled ventures across the Healthcare & Life Sciences value chain. In addition, he significantly grew the new markets portfolio for Cognizant by penetrating the Government & Energy & Utilities sector globally. He was a member of the Executive Leadership Team. Early on, He was responsible for growing Cognizant’s Life Sciences business unit to be a Tier one provider. He has worked with the many of the top 50 global Life Sciences organizations providing them comprehensive end-to-end consulting, analytics, business process and IT solutions. He has provided strategic leadership in helping life sciences organizations leverage technology and the global delivery model to effectively transform their businesses. Srivatsan was recognized as the top 100 most inspiring people in the life sciences industry award by PharmaVOICE publication and has been regularly quoted in national and global magazines on digital, Automation, Analytics, AI, healthcare & life sciences related topics. He has been a speaker in various seminars, webcasts and conferences on Healthcare and Life sciences domain, Business Transformation, Business & Technology/Outsourcing, Enterprise Integration and Digital Transformation topics. Srivatsan holds a Bachelors in Electrical Engineering from B.I.T.S. in India and a Masters degree in Electrical Engineering & Computer Science from Northwestern University. He also completed graduate studies in Telecommunications Policy and Management at Northwestern University.

Kristin leads the dynamic RBQM Operations team at Takeda, drawing upon her extensive experience in clinical trials operations and technology. For Kristin, the most rewarding aspect of her role is spearheading significant quality enhancements and fostering cross-functional collaboration through RBQM methodology. Beyond her professional life, Kristin and her family like traveling, kayaking, playing escape games, and pickleball together.

Nicole Stansbury, Senior Vice President, Global Clinical Operations, is responsible for oversight of clinical operations which includes clinical strategy and delivery, study start up, central monitoring, and site management and risk-based monitoring at Premier Research. She leverages an innovative, data-driven approach and more than 25 years of industry experience to help sponsors address the rapidly evolving demands of the clinical development industry. In her role, Stansbury is focused on finding ways to simplify process and improve technology adoption to decrease the time, cost, complexity, and risk of delivering clinical research. Prior to joining Premier Research, Stansbury held various CRO leadership positions where she was instrumental in the strategic implementation of risk-based monitoring, central monitoring and continuous improvement of clinical operations processes. Stansbury has been co-lead for the Association of Clinical Research Organizations Risk-Based Monitoring (ACRO RBM) Working Group working with TransCelerate and the FDA since 2014. She holds a Bachelor of Science from Texas A&M and a Lean Six Sigma – Yellow Belt certification.

Brad Stefanovic is a seasoned Life Sciences professional with a wealth of experience spanning over 17 years in the domains of Clinical Trial management, clinical technology implementation, vendor management, business operations, development, and strategy. Before joining SLP, he held the esteemed position of Head of Clinical Operations (Vice President) at Ocugen, a pioneering biotech company specializing in gene and cell therapies for Ophthalmology, Orthopedics, and Vaccines. He has also previously held the role of Vice President, Clinical Operations at Aura Biosciences, another prominent biotech firm, where he led a team focused on utilizing Virus Like particles for the treatment of Ocular Oncology and Solid Tumor indications. His leadership extends to various biologics areas, including his role as Senior Director of Clinical Operations and program lead of the Clinical Team for the Injectable Biologics, Orthopedic, Pain Management, and Sports Medicine program at TissueTech Inc. (Now Bio-Tissue), a world-leading Regenerative Medicine company. His expertise in Life Sciences is the result of his multifaceted career, which encompasses consulting, academic, non-profit, and commercial ventures, including overseeing outsourced full-service clinical trial management activities for large multinational medical companies. Brad is widely recognized as an outstanding scientific communicator in the life sciences industry, with a proven track record of successfully leading large teams through various phases of the medical product lifecycle. His international experience is noteworthy, having relocated from Australia to the USA 10 years ago and effectively managing multiple international clinical programs. In 2022, he earned the prestigious title of alumni of the year at his former institution, the University of the Sunshine Coast, in recognition of his exceptional foresight, strategic engagement, and innovative leadership in the Biotechnology field.

Gary Steidl’s comprehensive knowledge of early clinical phase research is driven by his depth of experience working in and managing Phase 1 clinics with multiple CROs. Gary is a registered pharmacist in the state of New Jersey and a graduate of the Brooklyn College of Pharmacy at LIU. After leaving retail pharmacy in 1999, Gary began a career in clinical research. He has maintained positions as a staff pharmacist, pharmacy manager, site director, business development, client services, and VP of Clinical Operations. He is currently with Spaulding as Clinical Strategies and Development. Gary has extensive experience in technology upgrades as well as site remodeling and modernization for Phase 1 clinical research sites.

Réne Stephens is a biopharmaceutical research and development industry consultant with over 25 years of business operations, outsourcing, and relationship management experience. He has worked within large and small pharma/biotech, CRO, SMO, medical imaging, and academic CRO companies, fulfilling roles ranging from individual contributor to global functional head. Réne understands the critical path of development and has a wealth of experience in outsourcing/procurement strategies and practices; vendor oversight, governance, and strategic relationship management; budget and contract negotiations (vendor and site level); clinical operations and finance management; process development and improvement; and technology solutions. Réne holds a BA in Corporate & Organizational Communications (WKU), and an MSHS in Clinical Research Administration (GWU). He has been providing outsourcing and relationship management consulting services to various R&D companies since 2018. While at Astellas Pharma Global Development as Executive Director and global head of Contracts & Outsourcing, Réne also served as the Global Procurement Lead for TransCelerate Biopharma, Inc., acting on behalf of and supporting the 20 biopharmaceutical company consortium for vendor selection, negotiation, and governance. He is the standing moderator for the quarterly Linking Leaders Outsourcing Roundtable meeting, where current issues are discussed among development outsourcing heads; and is a regular speaker at conferences and symposia on business operations topics related to drug development, outsourcing, and vendor negotiation, management, and oversight/governance.

Susie Stephens is a strategic technology executive with more than two decades of experience driving digital transformation across biopharma R&D. She currently leads client-facing R&D technology at Amgen, where she partners closely with clinical, scientific, and operational teams to modernize processes, improve data quality, and accelerate decision-making through innovative digital solutions. Prior to Amgen, Susie held senior leadership roles at Novo Nordisk and Pfizer, where she built high-performing global teams and led enterprise-scale transformations focused on data integration, AI/ML, and advanced analytics. Her earlier career in the technology sector at Oracle and Sun Microsystems shaped her expertise in product strategy, emerging technologies, and guiding organizations through complex change. Susie holds a Ph.D. in Physiology, has published extensively, and is an alumnus of Harvard Business School. She is passionate about enabling sustainable, human-centered change through thoughtful technology adoption and stakeholder engagement.

Robert Stevens is a transformative business leader and the founder of RS Consultative, LLC, with over 15 years of experience driving digital and data-driven innovation within the pharmaceutical industry. Previously serving as the Global Head of Digital & Data Insights at Novartis Pharmaceuticals, he now partners with Fortune 500 companies and emerging health-tech startups to implement enterprise-wide technology transformations and go-to-market strategies. An expert in AI strategy and organizational excellence, Stevens holds an MBA in Pharmaceutical Management and is a recognized speaker on the intersection of digital strategy and healthcare evolution.

Dave Stevenson is COO & Managing Director and a founding partner of Merck GHI Fund since inception in 2010. GHI Fund invests venture capital in start-up companies that improve health care as well as those that improve pharmaceutical operations specifically. Dave is responsible for identifying opportunities in clinical trials and also manages the GHI portfolio and operations. Dave brings more than 25 years of healthcare strategy and operations expertise to the GHI team. Dave started his career with Novartis where he built their first clinical trial management system. He holds an MBA from Vanderbilt University and a BA from Washington University.

Jennifer Stewart is the Executive Director of Clinical Data Sciences at Premier Research, responsible for a global team of data experts. She leads corporate initiatives for improving quality, efficiency, and resourcing and serves as the business owner for Premier’s forecasting platform. She plays a key role in clinical technology strategy and vendor governance and continues to drive evolution of clinical data sciences within the organization. Ms. Stewart has spent more than 20 years in the industry in roles that span data management, risk-based quality management (RBQM), and product development. She is a member of the Association of Clinical Research Organizations’ RBQM working group, where she has contributed to multiple publications and podcasts, and has had the opportunity to sit with members of the FDA to discuss practical application of regulations and challenges in the uptake of RBQM across the industry. She is passionate about developing and mentoring the next generation of clinical data scientists, transforming the way things have always been done, and influencing the strategic vision of an organization.

Storm Stillman is the CEO of Curebase. After years operating Curebase’s own CRO, virtual site, and full DCT services, he brings a deep understanding of what patients and sites truly need from technology, which is insight that now drives the vision behind building the company’s AI-native eClinical platform.

An operator at heart, Storm believes software should reduce cognitive load, not add to it, and he continues to question assumptions the industry set aside long ago.

Master of Jurisprudence in Healthcare Pharmaceutical Law & Policy. Patient advocate, educator, and care provider with over 30 years of experience in Pharmaceutical R&D and healthcare. Focused on ensuring bioethical best practices, compliance with ICH, and privacy laws to improve global public health equity and scientific innovation. Facilitating inclusive multi-stakeholder collaboration to accelerate the development of high-quality, safe, and effective treatments to address the unmet health needs of patients by enabling the development of solutions which will provide equal access to relevant health data to help patients and their care partners make informed decisions about their care options, including clinical trials.

Eli A. Stoddard, MS is Senior Director of Clinical Laboratory Sciences at Eli Lilly and Company. With over 25 years of experience in clinical development and laboratory operations, Eli leads a team that delivers high-quality, scalable solutions across all therapeutic areas and phases of drug development. His work focuses on third-party partnerships, optimizing laboratory logistics, sample management, and to ensure timely and cost-effective lab and diagnostic outcomes. He holds degrees in Chemistry and Organic Chemistry from Butler University and Purdue University, respectively, and has held multiple leadership roles at Eli Lilly and Company, including Six Sigma Black Belt. Eli is a founding board member of the Biospecimen Management Consortium.

Entrepreneurial Track Record: Launched a biotech venture and secured $15-20 million funding; Remapped development, regulatory, CMC, and commercial launch strategies to outposition market leading biologics; Negotiated licensing terms and drove strategic partnerships. Recognized Thought Leader: Invited speaker on reimbursement policies at the White House, US Congressional Budget Office, and US Congress; Featured in mainstream media such as Wall Street Journal and Washington Post. 15 + Years of Global Value Strategies Leadership: 8 + years at the Director level shaping value & access for oncology, neuroscience, hematology, and endocrinology portfolios. End-to-End Market Access Expertise: Led payer strategy from pre-POC assets through late-development and in-line products—defining evidence generation strategies, executing key tactics, and securing access. Cross-Functional & Cross-Cultural Team Builder: Founded and scaled three high-performing teams (20+ professionals) across APAC, EMEA, and North America, fostering collaboration among clinical development, commercial, medical, and access. Leadership principles: Authenticity; Empathy; Extreme ownership; Play to win

Margaret (Maggie) Suhanovsky, PhD, is Associate Director, Alliance Lead at Bristol Myers Squibb (BMS). In this role, Maggie is responsible for maintaining effective working relationships and vendor management structure for Central and Specialty lab partners across all phases of development operations. Prior to joining BMS in 2022, Maggie spent 5 years at Eurofins in their Insourcing division, including serving as New England Regional Manager where she managed a portfolio of biotech and biopharma clients for technical on-site laboratory resources. Maggie completed postdoctoral fellowships at Colgate University and Brown University. She holds a doctorate degree in biochemistry from University of Connecticut and a bachelor’s degree from George Washington University.

Aparna Swaminathan, MD, MHS is a pulmonologist and an Assistant Professor of Medicine in the Division of Pulmonary and Critical Care in the Department of Medicine at Duke University. She completed her residency in internal medicine, chief residency, and pulmonary/clinical care at Duke, where she also completed a Masters in Health Sciences degree. A faculty member of the Duke Clinical Research Institute, Dr. Swaminathan currently serves as an Associate Director for iCubed, a center for clinical research innovation. In this role she oversees the development of tools with potential to transform clinical research. Dr. Swaminathan is also the Director of Clinical Data Research Networks (CDRN) at Duke.

Shawntel Swannack is the Director of Central Monitoring and Data Analytics at GSK. Her career has spanned over the last 22 years in clinical research as a coordinator at the site level, CRO Clinical Research Associate (CRA), Sponsor CRA, Data Management, Asset Lead, Central Monitoring Lead, Manager to Director. Her passion has always been driven to help people live their best lives. Whether for the patients’ health through the clinical trials or the careers of her colleagues, seeing people thrive, inspires her desire for success. For the last 12 years, her passion for effective ways of working and day to day efficiencies with pristine focus on data integrity and quality has driven her career to Risk Based Quality Management.

With over 25 years of experience in the clinical research industry, Ginger Switzer currently serves as the Senior Vice President (SVP) of Clinical Operations at AMR Clinical. Throughout her extensive career, Ginger has held various leadership roles, honing her expertise in clinical trial management, operations, and regulatory compliance. As SVP, Ginger is responsible for the strategic oversight and execution of clinical trials across AMR’s expansive network of research sites. She leads a dedicated team, ensuring high-quality trial execution, adherence to Good Clinical Practices (GCP), and the alignment of operations with organizational goals. Her leadership has been integral in optimizing operational efficiency, driving process improvements, and fostering a culture of accountability and excellence within the organization. In addition to her operational responsibilities, Ginger collaborates closely with cross-functional teams and external partners, including investigators and CROs, to ensure seamless trial execution and strong stakeholder relationships. Her strategic thinking, analytical skills, and commitment to continuous improvement have positioned her as a key driver of AMR’s success. Ginger is passionate about mentoring and developing future leaders in clinical research, ensuring that her team is equipped to navigate the evolving landscape of the industry.

Enabling clinical trials and advancing therapies often begins with critical data from human biosamples, which are essential to driving scientific progress and successful drug development. Ensuring the integrity and management of these samples is a complex but vital responsibility. Strong operational processes are key to ensuring confidence in biosample data and enabling clinical trial success by providing needed structure to manage samples effectively. Let’s explore challenges and opportunities in sample management, highlighting how innovation and collaboration can enhance biosamples' role in generating reliable data, adapting to new technologies in an ever changing global human environment, and driving progress in clinical research.

With 15 years of industry experience in various trial management roles, including over a decade-long focus on Centralized Monitoring and Risk-Based Quality Management (RBQM), Gosia brings significant expertise to her current role as Associate Director of RBQM at Gilead Sciences. In this role, she is responsible for providing subject matter guidance and leadership in the implementation of RBQM and centralized monitoring. Previously, Gosia held a pivotal role as a member of the Centralized Monitoring Leadership Team at AstraZeneca, where she oversaw RBQM and Centralized Monitoring activities within Oncology projects and also led the implementation of Centralized Statistical Monitoring. Gosia holds a Doctor of Philosophy (PhD) degree in Cell & Infectious Biology, earned from Hannover Medical School.

Healthcare Executive with a record of accomplishment leading business development and growth at Fortune 500 companies, entrepreneurial success through three acquisitions, including M*Modal by 3M for $1.1B, and academic medical center thought leadership shown through the co-founding of MSK’s Clinical Research Innovation Center. Visionary Innovator motivated by developing strategies and delivering industry-first products that enable clinical efficiencies and improve patient care within the healthcare arena. Product Expert with recognized ability in creating and maintaining partnerships with large tech companies, and healthcare systems across every market. Driven Leader known for developing and empowering high-performing, autonomous teams that consistently exceed objectives and expectations.

Healthcare strategy and market access professional with 6+ years of consulting experience and 4+ years of bioinformatics research. Skilled at translating complex scientific, clinical, and commercial insights into clear, compelling, data-driven stories that influence decision-making. Expertise across oncology and rare diseases, with a strong specialty focus in cell and gene therapies, including evidence generation, access strategy, and stakeholder engagement.

As the Chief Clinical Trials Officer at Walgreens, Ramita Tandon is responsible for leading and driving growth for the Company’s new clinical trials business. In her role, Ramita works across the healthcare and life sciences industries to enable next-generation clinical trials so that breakthrough treatments reach patients faster. Her team is focused on unlocking value and improving access, awareness, and trust by efficiently matching diverse patient populations to sponsor-led trials, reducing trial operational complexities and patient burdens, as well as capitalizing on Walgreens' deep patient insights and leveraging real-world data from owned and partner assets. Ramita brings more than 25 years of leadership and operational experience across a portfolio of industry-leading businesses and services in real-world evidence and patient-centered health outcomes. Prior to joining Walgreens, she served as the Chief Operating Officer at Trio Health, and prior to that she was the Executive Vice President, Commercialization and Outcomes at ICON. As a transformational leader, Ramita is passionate in her belief that a best-in-class operating model employing insights and innovation can deliver gains in operations and forge stronger connections with all stakeholders, including biopharmaceutical companies, healthcare systems, and payers. Ramita has recently been named to Drug Store News’ Top Women in Health, Wellness & Beauty class of 2022 for Business Excellence, Fierce Healthcare’s 2022 Women of Influence, and listed in the 2018 PharmaVOICE 100. Ramita is an internationally recognized speaker and author whose focus is on how to bridge the gap between commercial and clinical development. She is a graduate of the University of Michigan and the Boston University School of Public Health.

Michael Tanen is the senior director of operations for the translational molecular biomarker group at Merck Research Laboratories. Michael leads a group that is responsible for collection, tracking, and storage of clinical biomarker specimens collected in clinical trials. During his 20 years at Merck, he has been involved in the utilization of clinical biomarker specimens from the prospective of discovery research through the usage for diagnostic development. His team has established an industry leading specimen management solution that supports data integration between clinical data and specimens, improving how we make utilization decisions in the complex area of biomarker research.

Michel Tarabocchia, MA, is a pharmaceutical industry leader with 20+ years of experience. As Director of Clinical Laboratory Operations in Precision Medicine at Regeneron, she leads a team overseeing all aspects of clinical laboratory delivery across the REGN portfolio, spanning all therapeutic areas and development phases. Michel drives strategic innovation in laboratory operations, collaborating with stakeholders to execute complex clinical studies and advance Precision Medicine.

Kindra is a results driven executive, working with corporations to leverage external innovation and drive growth. A people-first leader, Kindra's expertise in venture investing, corporate strategy, and market research enables her to deliver results for clients and partners while positively impacting culture. She enjoys partnering with ambitious thinkers who are passionate about the intersection of scale and innovation and its power to change the world.

I am a physician-scientist, adept at steering R&D teams and driving transformative projects in precision medicine, quantitative medicine, and quantitative systems pharmacology (QSP). My multifaceted background also encompasses proficiency as a systems biologist, leveraging my skills in bioinformatics, computational biology, artificial intelligence, and mathematical modeling to forge quantitative frameworks for clinical medicine advancement. My prowess extends to orchestrating precision clinical trials, particularly focused on elucidating biomarkers and the clinical significance of complex molecular big data.

Sylvia Taylor, PhD, MPH, MBA, is an infectious disease epidemiologist and currently Head of Medical and Payer Evidence Strategy for AstraZeneca’s Vaccines and Immune Therapies Unit that was formed in November 2021. She is passionate about vaccines and preventive interventions for infectious diseases and has spent more than 20 years working on related global health initiatives in both the private and public sector. She initially joined AstraZeneca in 2020 as the lead epidemiologist for AstraZeneca’s COVID-19 vaccine program, playing a key role in the distribution of >3 billion vaccine doses worldwide. She was previously also a senior epidemiologist for GlaxoSmithKline Vaccines, leading epidemiology strategy/activities for late and early-stage vaccines, including HIV, Ebola, TB, HPV, RSV, and Streptococcus Pneumoniae, over a period of 8 years. She has additionally worked as a Senior Technical consultant for the United Nations' International Organization for Migration, collaborating with the US Centers for Disease Control on community-based surveillance among Venezuelan migrants in Colombia, and as a research scientist at the Institut Pasteur in Paris, with focus on epidemiology and prevention of HIV, TB, and Hepatitis C. Originally from the United States, she has spent the last 17 years working/living abroad, including in Belgium, Cameroon, Cambodia, Colombia, Egypt, England, France, and Peru. During 2017-2019, while on sabbatical in Cameroon, she completed a TRIUM Global Executive MBA—a joint program with the London School of Economics, HEC Paris, and New York University Stern School of Business—and worked on several business development projects in Cameroon, China, and Europe.

Andrew Taylor, J.D., is an Associate Director of Site Start Up at Takeda specializing in startup and management oversight. With over 15 years of experience in clinical research across various therapeutic areas he brings a realistic approach to process development and risk management during start up.

Kim Tedesco is Director of gene and cell pharmacy operations at Walgreens Gene & Cell Services Pharmacy. She is an inspiring pharmacy leader dedicated to driving the pharmacy industry forward. In her current role, Kim leads the strategic direction of the gene and cell pharmacy at Walgreens to create a best-in-class center of excellence dedicated to gene and cell therapies. She uses innovative ways to overcome obstacles to help ensure these new-to-market therapies reach the intended patients. Kim has previous experience in retail, pharmaceutical sales, operations, and specialty pharmacy. She is a licensed pharmacist in 26 states and attended Duquesne University School of Pharmacy in Pittsburgh, Pennsylvania.

Stacy Tegan is the Program Director at TransCelerate Biopharma, Inc., a not-for-profit organization collaborating to converge clinical research and clinical care. In her current role she oversees efforts to digitize clinical trial protocols, increase the integration of EHRs into clinical research processes, and enable pragmatic trials to be conducted at the point of care. She has 20+ years of experience improving regulatory and clinical processes, and expertise in project management, strategic planning, digitization, and change management. Stacy is passionate about taking improving the community, with a history of volunteerism at the Drug Information Association (DIA), youth organizations, and she currently serves on her local Environmental Advisory Council.

Sheetal Telang is a seasoned clinical research professional and pharmacist with over 20 years of experience across the pharmaceutical and clinical research industries. In her current role as Americas Head of Therapeutic Strategy, she leads global strategic planning across clinical programs, bringing together scientific expertise, operational insight, and data science driven innovation to accelerate drug development. Her career spans leadership and operational roles in diverse functions including project management and clinical operations and therapeutic area strategy. She has lived and worked across the United States, Asia Pacific, and Europe, and has successfully led cross-functional teams across 28+ countries, reflecting her strong global acumen and cultural fluency. Known for her collaborative approach and strategic mindset, Sheetal has worked closely with large pharma, mid-sized and emerging biopharma companies—delivering value through integrated program leadership and tailored solutions. She is particularly passionate about using data science to transform operations, improve trial efficiency, and support innovation across the clinical development lifecycle to enhance patient experience on clinical trials.

Jamuna B. Thimmarayappa is Director of Life Sciences Product Management at Oracle, where she helps shape product strategy and planning while serving as an industry subject matter expert to customers and partners. With over 20 years of leadership experience across pharma, biotech, CRO, and academia, Jamuna has built and led global clinical development operations teams supporting programs from preclinical through late-stage trials. Her expertise spans oncology, immunology, hematology, infectious and rare diseases, with deep experience in global trial execution, patient advocacy, and companion diagnostic development. Throughout her career, she has driven transformations, forged key partnerships, and enabled innovation to accelerate drug development and improve patient outcomes.

Kent Thoelke is the CEO and founder of Paradigm, a healthcare tech company with a mission to create equitable access to the best possible care for any patient anywhere. Mr. Thoelke is a 30-year veteran of the clinical research industry, most recently serving as the Chief Innovation Officer at ICON plc following the acquisition of PRA Health Sciences, where he was Chief Scientific Officer. Throughout his career, he has focused on digital transformation within companies conducting clinical trials, advocating for better use of data to make drug development more e icient and more equitable for patients. His work spans multiple therapeutic areas and many geographic regions, giving him a truly unique perspective on the needs of patients, physicians, and biotech companies within the clinical research industry.