Amy Abernethy, M.D., Ph.D., is cofounder of Highlander Health, an investment firm advancing evidence generation and personalized healthcare. An oncologist, entrepreneur, and leader in clinical research and health data science, she works to break down barriers between clinical trials and real-world evidence, treating both as parts of one ecosystem that delivers safer, more effective treatments to patients faster. Previously, Dr. Abernethy served as principal deputy commissioner of the U.S. FDA, where she led efforts to modernize clinical evidence generation and advance personalized healthcare, while also serving as the agency's acting chief information officer. She later served as chief medical officer and president of product development at Verily, Alphabet's precision health business. Prior to that, she was the first chief medical officer and chief scientific officer at Flatiron Health, and held academic roles at Duke University, including professor of medicine, director of the Center for Learning Health Care at the Duke Clinical Research Institute, and director of the Duke Cancer Care Research Program. Trained as a hematologist/oncologist and palliative medicine physician, Dr. Abernethy is the author of more than 500 publications and remains an active scholar, teacher, and advocate for making healthcare work better for all.

Elias Abou Zeid is a seasoned digital health and AI leader with 14+ years of experience at the intersection of healthcare, data, and advanced analytics. He currently leads digital health analytics development at Novo Nordisk, driving the application of data science and AI to support more effective, patient-centered care. Prior to Novo Nordisk, Elias served as Associate Director of Data Science at Sanofi, where he led the digital health analytics organization and advanced the development of innovative digital biomarkers across multiple therapeutic areas. Elias holds a BEng in Computer Engineering from Concordia University, an MEng in Biomedical Engineering from McGill University, and a PhD in Biomedical Engineering from the University of Toronto. He is a recognized author of peer-reviewed publications and patents, and he is frequently invited to speak at international healthcare and AI conferences. Outside of his professional work, Elias enjoys table tennis, hiking, and photography.

Romi Admanit is a Director in the Data Science and Applied Machine Learning organization in Biogen, where she leads a team applying high-end machine learning and agentic AI techniques to solve complex problems and drive measurable improvements. She holds a PhD in Applied Mathematics and Statistics and brings over 20 years of experience in machine learning, from research and applied methods to disease modeling and the delivery of production-grade AI solutions.

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.

Dr. Nadir Ammour began his career as an oral surgeon in public healthcare moving into clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, Connected Hospitals Network (EHRs); wearables trials, and on-line patient recruitment. Nadir is a member of the Institute of Innovation Through Health Data, and various cross pharma leadership boards. He led an EIT Health consortium project, EHR2EDC aiming at connecting healthcare and research and involved in several European IHI/IMI Consortia. Dr. Ammour held various global positions previously at Wyeth, now at Sanofi. He is graduated in medical informatics, health economics and an MBA from Reims Management School, besides his Doctorate in Medical Dentistry

Linda Anderson is the Senior Director of Digital Solutions & Enablement at Alexion, AstraZeneca Rare Disease, where she leads the development and implementation of AI solutions that accelerate clinical trial execution and improve efficiency across clinical development. With more than 20 years of experience in clinical development, she has held leadership roles in clinical operations, digital transformation, and technology integration. She leads a multidisciplinary team of automation experts, data scientists, and transformation change managers who develop and scale AI solutions that enhance decision-making, improve productivity, and enable consistent, high-quality delivery across global clinical programs.

Amelia J. Averitt, MPH, MA, PhD, is Associate Director of Advanced Informatics at Regeneron Pharmaceuticals, where she builds machine learning and probabilistic modeling systems that support a variety of informatics, epidemiological, and biostatistical tasks across the drug development pipeline. Her PhD dissertation at Columbia University, Machine Learning Methods for Causal Inference with Observational Biomedical Data, was recognized with the AMIA Edward H. Shortliffe Doctoral Dissertation Award in 2021. She holds an MPH in Biostatistics and Epidemiology from Columbia's Mailman School of Public Health. She continues to teach as an Adjunct Professor in Columbia's Department of Biomedical Informatics, where her research centers on using machine learning—including causal inference, deep representation learning, and Bayesian estimation—to make epidemiological and biostatistical inference more rigorous and more scalable in real-world clinical data settings.

Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Siva Bala is an accomplished clinical data sciences and operations leader with more than 30 years of experience across the pharmaceutical and consulting industries. His expertise spans clinical data management, electronic data capture, eSource and data acquisition, eCOA, automation, process improvement, data standards, vendor governance, and global program leadership. He has led large cross-functional teams, built scalable operating models, strengthened inspection readiness, and implemented innovative solutions—including risk-based data management, smart data queries, and electronic safety-data integration. His career includes senior leadership roles at Pfizer, Cognizant Technology Solutions, Accenture, and Merck / Schering-Plough, supported by an MBA, a master’s degree in computer applications, and a bachelor’s degree in chemistry.

Sam is a Director of Global Study Start Up at AbbVie, overseeing the studies in the oncology therapeutic area. Prior to this position, he held various roles covering business insights, data insights, and asset strategy at AbbVie. He's passionate about applying data, analytics, machine learning and agentic capabilities in clinical operations with a particular focus on study start up.

Andrea Bartucca is a Director of Trial Awareness and Patient Recruitment at Rapport Therapeutics. She has been working in clinical research and supporting patient recruitment for over 20 years at a CRO, recruitment vendor, and several pharmaceutical and biotech companies. Andrea is passionate about supporting clinical trial teams to meet enrollment goals with a patient first approach. Andrea ensures all clinical trial communications will resonate with the desired audience and represents the patient voice, while increasing study awareness, maximizing patient access to clinical trials, and truly understanding the patient population. She specializes in collaborating cross-functionally to build internal infrastructure to efficiently execute customized recruitment strategies across all of Rapport's programs. She also partners closing with advocacy organizations that work directly in the communities as a way to stay connected to our mission and build presence and trust.

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.”

Andrea Bastek, PhD, is a systems thinker and bridge-builder shaping the future of clinical research. With a PhD in Biomedical Engineering and over 20 years in clinical research, including 15 years in cardiac medical device trials, Andrea has worked side-by-side with PIs, coordinators, site teams, and participants. Her first-hand experience with the challenges sites and patients face fuels her tireless advocacy for process and technology improvements. Today, she leads collaborative initiatives that unite sites, sponsors, and CROs, turning complexity into actionable frameworks and tools. Known for blending empathy with operational precision, Andrea’s work helps make research more inclusive, efficient, and human.

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.

Sarah is responsible for setting strategy and driving implementation of risk-based monitoring procedures, technologies and systems for the Sunovion and DSP global organizations. Sarah received her B.A. in Neuroscience from Johns Hopkins University and her M.S. in Statistics from The University of Georgia. She has held various roles in clinical operations/monitoring across the worlds of academic research, start-up, mid-large sized pharmaceutical companies. Her educational background across different areas of STEM drives her passion to collaborate cross-functionally and strategize on optimal ways to leverage data.

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.

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.

Mehdi Boukhechba, PhD, is a Senior Principal Scientist in Data Science and AI/ML at Johnson & Johnson, where he leads research and development of digital biomarkers, passive sensing technologies, and artificial intelligence methods for clinical research and patient-centered healthcare. His work focuses on leveraging wearable devices, mobile technologies, and machine learning to objectively measure symptoms, functional status, and quality of life across a range of therapeutic areas. Prior to joining Johnson & Johnson, Dr. Boukhechba was an academic researcher and faculty member whose work centered on ubiquitous computing, digital health, and data science. His research pioneered the use of mobile and sensor technologies to model human behavior, monitor health outcomes, and develop scalable solutions for real-world health assessment. He has authored numerous scientific publications and continues to advance innovative approaches that integrate digital measures into clinical trials, helping transform how patient experiences and treatment effects are captured and quantified.

Danilo Branco is a passionate, optimistic, tech-savvy clinical trials Risk Based Quality Management, Central Monitoring, Project Management, and Clinical Operations professional with 22 years of experience managing complex studies in both big Pharma and CRO settings. He supports study teams and cross-functional leaders in the mission of improving data quality while bringing efficiencies to Clinical Trials conduct. The last 11 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.

Nicholas Brooke is the founder of The Synergist. For more than a decade, he has been the driving force behind its mission to build the conditions for collective action, shaping pioneering initiatives in patient engagement, precision medicine, investor engagement, women’s health, clinical trial data network, and the Patient Engagement Professionals Society. He served as the founding Executive Director of Patient Focused Medicines Development (PFMD) from 2015 to 2025, establishing it as the global reference point for patient engagement. An economist by training, Nicholas brings together strategic insight, digital innovation, and coalition-building, making him a leading architect of multi-stakeholder collaboration in global health. Through The Synergist, he continues to guide a portfolio of high-impact programmes, including the Clinical Trial Distribution Network initiative, an open, non-competitive repository of clinical protocols enriched with additional structure and information for better matching of clinical trials.

Courtney Bryant is a strategic leader focused on advancing enterprise transformation through artificial intelligence, digital innovation, and operational excellence. She leads the development of program scope, organizational design, and governance frameworks that enable disciplined execution, strong oversight, and alignment with business priorities. Through cross-functional leadership and strategic partnership, Courtney drives scalable change initiatives that enhance decision-making, accelerate portfolio delivery, and support improved clinical and business outcomes.

Dawn Buchanan is a seasoned Clinical Operations executive with over 25 years of experience at both small/large pharma and a CRO, and now is the Head of Clinical Development Operations at AffyImmune, a small start-up biotech developing autologous CAR T cell therapy for solid tumors. Dawn started at AffyImmune as the first Clin Ops hire and has built the function and her team from the ground up. She is passionate about cell therapy, with a unique CV having also been on the External Manufacturing side of cell therapy as an Operations Lead for establishing a CDMO in the EU while at Celgene/BMS. Her small biotech experience has allowed her to lean into a leadership role in new ways that she finds fulfilling, including building a high-performing team and working closely with other functions including QA, CMC, Clinical Development as part of senior leadership in establishing strategy for the first clinical program.

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.

Kisha M. Bush, BS, EMBA is the Director of Patient & Site Engagement at Boehringer Ingelheim, where she leads strategic initiatives focused on enhancing patient participation, site collaboration, and representation across clinical research programs. In this role, she oversees cross-functional teams responsible for site engagement, patient recruitment and retention, and patient representation, driving innovative approaches that reduce barriers to clinical trial participation and improve research outcomes. With more than 24 years of experience in clinical research and clinical operations, Kisha has built a distinguished career leading complex clinical development programs, optimizing operational performance, and fostering strategic partnerships across sponsors, sites, CROs, and community organizations. Her expertise spans clinical trial execution, site management, regulatory operations, patient engagement, vendor oversight, and organizational transformation. Kisha holds an Executive MBA from the Howard University School of Business and a Bachelor of Science in Organizational Management. She is passionate about creating meaningful connections between patients, sites, and sponsors to advance more inclusive, accessible, and effective clinical research.

Lam Calderon is a clinical operations leader with more than 15 years of experience managing global clinical trials across therapeutic areas. Currently serving as Lead Clinical Study Manager at Takeda, Lam leads the operational strategy, planning, and execution of complex, multinational clinical development trials. Throughout her career, she has successfully overseen CRO and vendor partnerships, cross-functional study teams, and global trial execution to deliver high-quality clinical research. In recent years, Lam has been particularly focused on advancing patient trial equity through the implementation of innovative recruitment and retention strategies designed to increase participation from minority and underrepresented patient populations. Her commitment to inclusive research helps ensure broader patient representation and more equitable access to clinical trials.

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.

Michael N. Cantor, MD, MA is Vice President, Data, Technology, and Innovation in Global Development at Regeneron. His current role focuses on clinical data optimization and using AI and other innovative analytics approaches to design and run clinical trials more effectively. Prior to this role, he led clinical informatics at the Regeneron Genetics Center (RGC), where his work focused on developing and optimizing phenotypes from EHR and cohort data and linking them with genetic data to help discover new drug targets. His group’s phenotyping work at the RGC was crucial to several high-profile discoveries including the roles of INHBE and CIDEB in metabolic disease and the initial results of exome sequencing of 450,000 UK Biobank participants. Prior to Regeneron, he was Director of Clinical Research Informatics at New York University School of Medicine where he led informatics for the CTSI. Dr. Cantor is also an Associate Professor in the Department of Medicine at NYU School of Medicine and currently sees patients weekly at Bellevue’s medicine clinic.

Mary Carroll is a seasoned clinical research leader at AbbVie, specializing in strategic study planning and global trial management. As Director of Protocol Optimization, she streamlines protocols to improve patient and site experiences. Mary holds a BS in Chemistry from the University of Illinois at Urbana Champaign and has strong project & trial management and CRA expertise.

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). She leads the CDER Center for Clinical Trial Innovation (C3TI), which aims to improve the efficiency of drug development through innovative clinical trial approaches. Meghana was also part of the FDA team for Prescription Drug User Fee Act (PDUFA) reauthorization negotiations for premarket activities. Previously, Meghana led OND's Advisory Committee Team and Science Strategies program, and worked closely on CDER’s Patient-Focused Drug Development program, Benefit-Risk Framework, and Rare Disease Cures Accelerator. 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.

Chris Chan is Head of Clinical Finance at Eikon Therapeutics, and has over 30 years industry experience, including 25+ managing clinical trial & R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) & Certified Financial Manager (CFM).

Janice Chemidlin is Director of Biospecimen Management at Bristol Myers Squibb, where she leads global biospecimen management activities supporting complex clinical development programs across multiple therapeutic areas. With more than 20 years of experience spanning discovery research, clinical science, global trial management, and biospecimen operations, she has built a reputation for driving innovation, operational excellence, and cross-functional collaboration throughout the biospecimen lifecycle. Janice is passionate about advancing the science and operational practices that support high-quality biospecimen collection, processing, storage, and utilization in clinical research. She has led initiatives focused on risk-based governance, biospecimen standardization, vendor oversight, sample integrity, and AI-enabled solutions that improve quality, compliance, and efficiency. A strong advocate for talent development and organizational capability building, she frequently collaborates with scientific, operational, and technology partners to develop scalable solutions that enhance clinical trial execution and patient-centered research.

Caitlin is Manager, Biosamples at Alexion, where she leads initiatives focused on biospecimen governance, informed consent data, and maximizing the long-term scientific value of clinical trial samples. Since joining the organization in 2023, she has been instrumental in developing and advancing processes that connect biospecimens with participant consent and associated metadata, enabling compliant sample reuse. With more than eight years of experience in biospecimen management, clinical biobanking, and laboratory operations, Caitlin has supported the implementation and optimization of large-scale biorepository operations, driven improvements in operational processes and consent data integration, and partnered with researchers to enable compliant use of banked biospecimens that support ongoing scientific discovery.

Sky Cheung, Ph.D. is the Director of Genmab’s Clinical Development Data Science and AI Group focused on AI-enabled workflow automation, literature analytics, and practical evaluation of emerging technologies in regulated environments. Previously, Sky was a data scientist supporting clinical trial operations at Janssen Pharmaceuticals. Sky holds a Ph.D. in Computational Physics and an undergraduate degree in Applied Physics and Mathematics, all from Columbia University.

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.

Dr. Mark Ciaccio is a Principal AI Data Scientist responsible for incorporating Artificial Intelligence into application delivery for clinical studies. Specifically, Mark works with agentic RAG and graphical models to bring cures to patients faster.

Dr. JP Clement is the CEO and Founder of the JPCC Associates group. He has worked over the last 35 years in Drug Safety and PV in multiple capacities, including managing worldwide functions, building or improving PV organizations to meet the highest standards, and leading the JPCC Associates consulting group over the last 13 years. Prior to consulting, Dr. Clement worked for several biotech and large companies such as Janssen, Merck KGaA, Abbott, Sanofi, Onyx and Cubist with global international responsibilities. Dr. Clement has a track record of implementing highly efficient PV groups and activities, with high strategic output and compliance levels. He has also guided organizations to successfully manage critical hurdles such as PV inspections, market approval, expansion of global PV footprint and handling of safety crises. He has been part of the Annual DIA Pharmacovigilance and Risk Management Strategies for several years, both as a member and in a chairmanship role. He has been a regular guest speaker for several international PV seminars. With JPCC Associates, he has aided with the establishment of highly compliant and effective PV organizations within multiple pharmaceutical companies, elevating PV contributions to a strategic level, and acting as fractional Head of PV for several companies. Dr. Clement graduated with a degree in Family Medicine from Sorbonne Medical University in Paris, France. He studied Pharmacology at medical universities in Paris and Lyon, France. Dr. Clement worked for 8 years in clinical practice prior to joining the pharmaceutical industry.

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.

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.

Leila Cupersmith is Founder and CEO of Choice ClinOps, where she leads a team of fractional senior female clinical operations executives who rescue failing oncology and rare disease trials and serve as embedded fractional VP-level leaders for global small and mid-size oncology and rare disease clinical trial sponsors. With 24+ years of hands-on Phase I–III clinical trial experience across 30+ countries, she specializes in rapid trial turnarounds, delivering measurable results in 90 days or less without CRO overhead, and ensuring clinical trial operations consistency during mergers and acquisitions. Her team has achieved up to 25% faster global study startup, $2M+ in cost avoidance, and 30% stronger enrollment through patient-centered operations. She speaks globally on clinical operations strategy and shares insights through the Choice ClinOps newsletter The Global ClinOps Brief. Leila's mission: increasing successful global oncology and rare disease clinical trials that are operationally efficient, fiscally disciplined, human-centered, and accessible, equitable care options.

Amy Curley, PhD is a Feasibility & Planning Manager at Boehringer Ingelheim, where she supports global clinical development programs and leads initiatives focused on improving planning efficiency, knowledge management, and decision-making. She is currently leading a strategic collaboration with Microsoft exploring AI-enabled approaches to project tracking and organizational learning in clinical trial planning. Her work sits at the intersection of clinical operations, feasibility, process innovation, and applied artificial intelligence.

Savine DaCosta is the Clinical Trial Diversity Site Lead within Global Clinical Operations at Biogen. Savine's career spans 20+ years in the Pharma/Biotech industry including substantial experience in Sales, Marketing, Patient Engagement, Health Equity, and Clinical Trial Diversity. Savine is a subject matter expert in community collaboration and engagement. Savine’s authentic, heartfelt approach has been impactful with underrepresented communities' understanding of clinical research. She is a natural convener, communicator, and solutions provider. Savine graduated from Boston University with a Bachelor of Science degree in Business Administration. Savine also earned a Master’s in business administration from Eastern University in St. David’s, Pennsylvania. Savine resides in Pennsylvania with her husband and son. She enjoys photography, basketball, and an enjoyable book.

Anbu Damodaran is an Associate Director of Statistical Programming at AstraZeneca with over 25 years of experience in clinical trials, real-world evidence, rare disease, oncology, registries, and global regulatory submissions. His work focuses on AI-enabled clinical trial delivery, RWD/RWE integration, metadata-driven programming, evidence traceability, and responsible AI use across clinical data operations and biometrics.

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.

Ebony Dashiell-Aje, PhD is currently the Executive Director & Head, Patient Centered Outcomes Science, BioMarin . Dr. Dashiell-Aje is a leading expert in patient-centered outcome tool development including clinical outcome assessment (COA) design and implementation, digital health technology tool development and optimization, and related study endpoint issues in regulatory science. As a health outcomes researcher and methodologist, Dr. Dashiell-Aje is driven by her passion for public health and promoting patient-focused medical product development. Dr. Dashiell-Aje has notably contributed her research expertise in academic, consulting, and regulatory environments to arrive at evidence-based solutions, to shape health policy.

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.

20+ years in the industry including positions in central lab supplier, EDC and sponsor roles. Currently, leading a new organization that has grown out of the goal for end to end management of biospecimens from collection to destruction.

Erron Deloney, Director of eSource Capabilities at Eli Lilly, has spent 19+ years advancing clinical trial data management across biotech, pharma, and CRO environments. At Lilly, he serves as CRIO Implementation Lead and eSTL (eSource Trial Lead), directing the rollout of CRIO eSource across multiple concurrent studies and leading the CRIO-to-Veeva EDC integration that carries site-captured data through to the clinical database. Erron owns UAT and CRIO integration functionality efforts, is building the eSource library to keep data collection aligned with Lilly standards across the portfolio, and tracks data-quality metrics through PowerBI dashboards for program-level visibility. He applies automation and AI/ML to drive efficiency across the eSource process. Prior to Lilly, Erron built data management functions and standards governance at Loxo Oncology, Sarepta, Astellas, PPD, and PAREXEL.

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.

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.

Ms. DiFrancesco is Senior Vice President of Clinical Operations at Endeavor BioMedicines. Over her 25 years in the biotech industry she has designed and managed numerous clinical trials from Phase 1 to Phase 3 in therapeutic areas including oncology, pulmonology, musculoskeletal disorders and pain. Ms. DiFrancesco previously served as Vice President of Clinical Operations at Samumed, LLC, and served as a team member at Huya Bioscience, Cypress Bioscience and Chiron Corporation. She earned her Bachelor of Science from Georgetown University.

Ventsislav Dobrev is a seasoned healthcare and life sciences professional with over two decades of experience across pharma, medtech and healthtech. He has held leadership positions at large organizations including IQVIA, Novartis, Ypsomed and Roche. Currently, he leads a global function at Roche which is responsible to integrate digital biomarkers in clinical trials.

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.

David Donohue has spent 28 years at GSK driving quality and regulatory systems transformation across global drug development. Beginning his career at the frontier of electronic regulatory submissions, he has held progressive leadership roles spanning regulatory technology, global systems strategy, and quality analytics. He currently leads the digital and data transformation of R&D Quality as Head of Quality Services & Solutions within GSK's QuRE function, where he focuses on applying AI and automation to make quality predictive and decision-driven. He holds an MBA in Pharmaceutical Business.

Tom Dougherty is currently the Real-World Data Strategy Director 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.

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer by education, he has been working in the Pharma industry since 2000 in roles of increasing accountabilities and leadership in the areas of digital solutions, data analysis and GCP/GVP Quality. Roshan also chairs the IMPALA consortium, a non-profit organization focussed on improving biopharma quality with digital and advanced analytics methodologies to medical solutions to patients faster.

Joe is an innovator sitting at the intersection of life sciences and technology with goals focused on making the whole drug development process faster for pharma and better for patients. Recent world events have brought the reality of how complex clinical trials are into the mainstream news and this pandemic has been a rallying cry for our industry resulting in the rapid acceptance of new ways to conduct clinical trials, designed with the patient experience at the center and technology that works smarter for all stakeholders. For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up a 12-year run with Medidata. He has worked with top Pharmaceutical, Biotech, and CRO organizations on innovation, change management, implementation, product development, sales, and consulting. Joe is a graduate of Roger Williams University Gabelli School of Business with a degree in Computer Information Systems and Political Science. He is a member of the Drug Information Association’s Regional Advisory Council and the Leadership Council for the CNS Summit.

As Head of Quality Analytics & Risk Management at Boehringer Ingelheim, I lead a multidisciplinary team of Data Scientists, Risk Managers, and Data Governance professionals. My passion lies in unlocking the power of data to transform Quality from reactive to proactive, and from prevention to prediction. With a foundation in Epidemiology, I leverage both quantitative and qualitative insights to identify opportunities, assess risks, and drive enterprise-wide growth, innovation, and continuous improvement. Since joining the pharmaceutical industry in 2002, I have held roles spanning Pharmacovigilance, Clinical Operations, GxP Auditing, and Quality Management, building a broad perspective on quality and risk across the product lifecycle. I am committed to advancing data-driven decision-making and fostering a culture where analytics, governance, and risk management enable sustainable quality excellence.

Satish Eraly, MD, PhD, MAS, is Executive Director of Clinical Research at Alnylam Pharmaceuticals, where he oversees multiple early-stage neuromuscular development programs. He received MD, PhD (Neuroscience/Molecular Biology), and Master's degrees in Clinical Research/Biostatistics from the University of California, San Diego and is board-certified in Internal Medicine. Prior to joining industry, Dr. Eraly spent 11 years on the UCSD faculty, leading independently funded multidisciplinary research programs spanning genomics, translational biology, animal models, and clinical investigation. He has over a decade of drug development experience across multiple therapeutic areas and modalities, with involvement spanning pre-IND through Phase 3 development, global regulatory submissions, and post-marketing studies. Most notably, he served as Clinical Lead for the HELIOS-B pivotal trial of vutrisiran, supporting its successful global approvals for ATTR cardiomyopathy. Dr. Eraly has authored over 50 scientific publications and is recognized for combining clinical, scientific, and quantitative expertise to accelerate innovative drug development.

Cole Eshbach is a senior clinical trial manager at Keenova with over a decade of experience across pharmaceutical and contract research organizations. He has supported clinical trials across a range of therapeutic areas, bringing a strong operational and site-focused perspective to trial execution. Cole holds a master’s degree in counseling and previously worked in behavioral therapy, where he focused on improving individual outcomes through practical, human centered approaches. He carries this same philosophy into clinical operations, with a particular emphasis on improving the research site experience, fostering collaboration, and driving sustainable growth within the clinical research industry.

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.

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.

Caroline Feys is Senior Director, Innovative Health at J&J Innovative Medicine, where she leads efforts to accelerate the discovery, development, and deployment of innovative capabilities that transform clinical research. With more than 20 years of experience spanning R&D, Medical Affairs, Clinical Operations, and Innovation, she has built a strong track record of driving complex transformational programs that improve patient experience, enhance site engagement, and advance operational excellence across global clinical development.

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.

Results-driven leader in regulated environments, currently Head of Learning, Processes & Digitalization. Brings over 20 years of experience in global quality management, process optimization, and digital transformation. Held multiple global roles, including Global Process Owner for Learning Management Systems. Proven track record in driving compliance, enhancing learning ecosystems, and delivering scalable process improvements and system developments. Career started in clinical research and advanced through quality, risk management, and compliance leadership roles across different countries. Holds an MSc in Computer Engineering from TU Vienna.

John Finn has over 36 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.

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.

A Product Leader with a demonstrated history of delivering clinical IT transformations for pharma, biotech/CROs with a Wharton Management Development Program, Kellogg Product Strategy and Stanford Advanced Program Management from Stanford University. He is a big believer in product innovation and leads large teams in product development using SAFe Agile methodologies. He is an ex-IQVIA/ex-Medidata with 20+ years in clinical IT. Anand is a tech savvy leader with interests in AI, big data, blockchain and use them to address the challenges faced by the life sciences industry. Anand loves participating in hackathons and social innovation activities in the life sciences/ healthcare space. More recently Anand was a semi- finalist in 'HITLAB Breakthrough One' Challenge featuring EZTrialFinderâ„¢, a Gen AI driven innovative solution enable patients find clinical trials from their mobile phone.

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.

With 16 years in the CRO space and a deep expertise in clinical technology across various platforms, I have specialized in RBQM technology training, adoption, and implementation since 2018. Currently, I’m the Director of Customer Success at CluePoints, where I leverage my extensive background to drive impactful outcomes and enhance client experiences.

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.

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.

With over 25 years of leadership experience in the pharmaceutical industry, Bernhard has consistently advanced in roles with increasing responsibilities in project and people management. From managing smaller-scale projects to leading the global Xarelto initiative with over 500 team members, Bernhards career is marked by significant achievements in operational excellence and innovation. As Vice President of Clinical Operations, he led teams >1000 FTE in 40 countries, has transformed organizational structures, boosting productivity by > 25% through strategic resource allocation and flattening hierarchies. Currently, he is pioneering initiatives to empower decentralized decision-making and enhance customer engagement in Clinical Operations EMEA/LATAM, this strategy contributed propelling Bayer Clinical Operations from the global position 7 to 1 (Top Sponser) in the CenterWatch site relation survey.

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.

Gretchen Goller leads the Patient Recruitment and Retention Solutions group at Seagen with a focus on oncology-specific solutions resulting in a holistic, patient centered approach ensuring that patients and their families have the most positive experience. Ms. Goller has over 20 years’ experience gained in pharma and CRO industries. Prior to Seagen, she was the Global Head of the Patient Recruitment and Retention team at ICON. Previously, Ms. Goller was the Patient Recruitment and Retention leader at sanofi-aventis. Other roles included Clinical Trial Manager, Medical Affairs at Wyeth and Study Manager at Astra Zeneca. She has held positions at the University of Pennsylvania including Study Coordinator and Site Director working on a range of therapeutic areas including vaccines, cardiovascular, cardiology, ophthalmology, women's health, HIV, and endocrinology. Ms. Goller has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania and is located outside of Philadelphia, PA.

Rob is the Senior Vice President and Head of Clinical Development & Operations within Pfizer Research and Development, a discipline focused on accelerating clinical development innovation and execution with an emphasis on quality, speed, and cost. Rob has over 30 years of industry experience in clinical operations, safety, and regulatory. He is an executive Six Sigma Black Belt and has been a past member of PhRMA (Pharmaceutical Research and Manufacturers of America), past board member for CDISC (Clinical Data Interchange Standards Consortium), current member of the SCDM (Society for Clinical Data Management) advisory board and former co-chair for the Vulcan HL7/TransCelerate research accelerator. In 2021, Rob was recognized in PharmaVoice magazine as one of the top 100 most influential leaders in healthcare. Rob holds a B.S. in Psychology from Eastern Connecticut State University, a M.S. in Research, Measurement, and Evaluation from Southern Connecticut State University, and an M.B.A. in Pharmaceutical and Chemical Studies.

Dr. Goetz Gortner is a Partnership Lead at Boehringer Ingelheim, where he drives strategic partnerships and innovative approaches to creating measurable value in healthcare. His work spans patient-related services, vendor performance, and ROI-based decision-making, helping organizations better understand how investments translate into patient and business outcomes. Alongside this work, Dr. Gortner is leading a pilot initiative focused on enhancing the patient experience through a greater emphasis on patient wellbeing, reflecting his belief that healthcare value extends beyond clinical outcomes alone. By combining scientific rigor, business analytics, and patient-centered thinking, he helps organizations design services that are both impactful and sustainable. Dr. Gortner holds a degree in Molecular Biology from Goethe University Frankfurt and is passionate about translating data into actionable insights that improve healthcare delivery and patient experience.

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.

Amit Gulwadi is a biopharmaceutical R&D leader specializing in data science, digital innovation, and transformation to modernize clinical development, regulatory, and safety organizations. At Alexion, AstraZeneca Rare Disease, he leads Data Science, Digital, and Transformation for Development, Regulatory, and Safety, driving advanced analytics, AI, technology partnerships, and process innovation to accelerate portfolio execution, strengthen risk management, and advance patient-centric clinical development. Following Alexion's acquisition by AstraZeneca, he led the integration of advanced technology, analytics, and clinical capabilities across the organizations. Previously, Amit held leadership roles at Saama, Celgene, and Bristol Myers Squibb, where he advanced clinical innovation, AI-enabled analytics, patient engagement, and operational excellence across global development organizations.

Christine Guo leads the clinical and data science team at Ametris, responsible for the scientific strategy and services supporting Ametris‘s leadership in digital health. Christine has over 15 years of experience in clinical research and a vision for leveraging technology in clinical trials and practice. Prior to Ametris, Christine was Head of Scientific Innovation at Biogen Healthcare Solutions, leading the clinical development and validation of Biogen’s digital medicine products (software as medical device) in multiple sclerosis, neuromuscular, and neurodegenerative diseases. Christine brings unique scientific insights by bridging across clinical and technical disciplines and is passionate about leveraging data and technology to improve people’s health. Christine holds a B.A. in biological sciences from Peking University and PhD in neuroscience from Stanford University.

I work on insights across clinical development digital solutions. With 10 years of experience in life sciences industry, I focus on using data, digital innovation, and AI to support better decision-making across drug development - clinical development plan, protocol optimization, feasibility, execution etc. My work sits at the intersection of clinical development, technology, and strategy, translating complex data and business needs into actionable insights that help advance digital solutions for the pharmaceutical value chain. I bring a multidisciplinary background spanning analytics, technology, AI, product management, consulting, and strategy.

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.

Kim Halbert is a nuclear medicine technologist and imaging scientist with a 12-year career in oncology, spanning clinical practice, academic research, contract research, and the pharmaceutical industry. She is currently focused on theranostics, supporting the development of targeted radiopharmaceutical therapies. Her experience across all phases in the clinical drug development lifecycle provides a broad perspective on imaging operations, and she is passionate about advancing operational excellence, standardization, and best practices through cross-industry collaboration to improve the quality, consistency, and execution of global clinical trials.

Laura Hanson, MS, PMP is a people-centered leader in clinical research operations at Mayo Clinic. As the Director of Research Operations in the Office of Clinical Trials, she guides enterprise clinical trial operations in bringing forward new trials to the organization, aligning strategy, operational excellence, and change management to strengthen research activation. Across prior roles, Laura has led clinical trial and core laboratory operations and applied project and operations management expertise to build new offices, support process improvement, and enhance service delivery. Laura’s work focuses on mentoring and empowering research teams—embedding practical project management, regulatory stewardship, and continuous improvement habits that help early career staff grow into confident, collaborative professionals. Her work centers on coaching teams through complex transformational change to elevate service delivery and accelerate study activation. Committed to lifelong learning, Laura holds an MS from Iowa State University and maintains PMP and Prosci Change Management certifications.

Kasia Harris, MD, is Head of Country and Feasibility at Astellas Pharma, with more than 20 years of experience in clinical drug development. She brings expertise in strategic trial planning, enrollment forecasting, operational risk assessment, and country and site strategy, supported by extensive experience in clinical trial execution and cross-functional leadership. Her current work focuses on how data, technology, and AI can strengthen early trial planning and decision-making while accounting for uncertainty and operational realities. She is the author of From Enrollment Forecasting to Site Selection: Strategic Feasibility in Clinical Trials.

Pharmaceutical systems leader with nearly three decades of experience at the intersection of pharmaceutical science and technology. He earned a B.S. in Biology, with a focus on microbiology, from Drexel University, beginning his career in the lab studying viral protein expression before moving into regulatory operations. Over 27 years in the industry, Boris helped modernize regulatory technology infrastructure, managing global FDA and EMA gateway submissions and advancing through roles including Business System Owner, Technical System Owner, and Business Change Lead. He has managed systems such as Safety Distributions to Sites, Site Profiles, and intake of Externally Sponsored Research Proposals. Notable achievements include supporting six major FDA filings within a single year and designing automation tools that streamlined publishing and submission processes. Boris joined Bristol Myers Squibb in 2021 as Business Capability Lead for Investigator Sponsored Research, and since 2023 has worked as a Product Manager in Clinical Development IT, supporting Site, Medical, and Patient Engagement.

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.

David Hilfiker is currently the Head of Risk Based Quality Management in Daiichi Sankyo R&D, where he is responsible for designing and sustaining a risk based approach for clinical trial design and oversight across all phases of clinical development. He got his career start at the FDA, spending 8 years in various roles in the Center for Drug Evaluation and Research. He has since worked for over 20 years in the industry with 3 different mid to large sized companies, focusing on Regulatory Strategy, Policy and Communications and R&D Quality and Compliance. He is based in New Jersey, USA, and enjoys spending time with family and friends, outdoor activities and cooking.

Jenn Hill is a site contracts and payments expert, with more than 20 years' experience working in pharmaceutical companies and contract research organizations of all sizes. At Vertex Pharmaceuticals, Jenn leads a global team responsible for global clinical site contracts and payments.

Nick brings over 30 years of experience in global clinical development, with a strong track record in driving operational excellence and transformation. Nick’s career includes leadership roles at major pharmaceutical companies such as Johnson & Johnson, GSK, Novartis, Altana Pharma, Chiron Biopharma, and Pfizer, as well as senior positions in the CRO sector. His expertise spans clinical operations, study and project management, data management, vendor oversight, and inspection readiness to MHRA, EMA, and FDA standards. Nick holds a BSc (Hons) in Pharmacology from the University of Edinburgh. He is passionate about advancing clinical development to improve patient outcomes and is active in supporting medical education and community initiatives in the UK. Outside of work, Nick enjoys spending time with his family, traveling, and staying active through sports such as squash. He’s also an avid follower of English rugby and cricket.

Jessica Hotter is Senior Global Portfolio Strategy & Operations Lead within Oncology Clinical Operations at Gilead Sciences. She specializes in portfolio strategy, operational intelligence, and clinical trial execution across global oncology programs. Jessica partners closely with executive and cross-functional stakeholders to advance data-driven decision-making, strengthen governance frameworks, optimize portfolio planning, and enhance trial delivery. Recognized for her ability to translate complexity into clarity, Jessica brings together strategic insight, operational expertise, and cross-functional perspectives to help navigate challenges, drive informed decision-making, and deliver meaningful impact. Known for her collaborative and relationship-centered leadership style, she is deeply passionate about advancing science through clinical research and the opportunity clinical trials provide to extend and improve the lives of patients facing cancer. Her work focuses on innovation, patient-centricity, and the responsible application of artificial intelligence to address evolving challenges in clinical development, accelerate insights, and improve outcomes for patients worldwide.

Xiu Huang, received her PhD from Yale University in 2016, now Director of Statistics at AbbVie, where she serves as a clinical statistician supporting immunology therapeutic areas while leading efforts to build standardized, reproducible analytical capabilities for clinical development. Her work includes developing a validated library of statistical analysis modules and the supporting platform, process, and validation framework needed to bring AI-assisted statistical analysis into a regulated environment. Her current focus is on how infrastructure, context engineering, and rigorous validation can move AI-assisted analytics from demonstration to trusted production capability, always with the goal of empowering rather than replacing statisticians.

Lars Hulstaert leads Data Science teams within Johnson & Johnson R&D focused on applying AI and advanced analytics to improve clinical trial planning and execution. His experience combines machine learning, software engineering, and pharmaceutical development across both commercial and R&D settings. Lars previously worked at Microsoft and holds an MPhil in Machine Learning from the University of Cambridge.

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.

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.

Paul Jacobs is Associate Director of Global Development Innovation at Regeneron. He is part of a function responsible for enabling clinical trials innovation by bringing innovative thinking, tools and techniques to the table through an innovation pipeline process. Before joining Regeneron in 2021, Paul worked in innovation roles at LEO Pharma as Head of Innovation, helping to establish and grow the R&D Data and Analytics function and, before that, as a founding member of the LEO Pharma Innovation Lab. Paul has also held roles in consultancy with Frog (Capgemini Invent) as Head of the UK Life Science Practice and various Medical Editing, Digital Strategy and Client Service roles at Publicis Healthcare, Sonic Boom and Nucleus Group companies. Paul received his Masters Degree in Biomedical Sciences from King’s College, London and his Bachelor’s degree in Biological Sciences from The University of Salford.

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.

Olivia Javornik is an Associate Director in Clinical Operations at Merck with more than a decade of experience supporting global clinical trials across many therapeutic areas. She specializes in specimen lifecycle management, central laboratory operations, supplier governance, and process optimization, with a focus on improving operational efficiency and data quality throughout the clinical trial ecosystem.

Statistician and data scientist with experience in all phases of clinical development, real world evidence, and AI engineering. Currently principal scientist of biostatistics at Merck with 9 years of pharmaceutical experience.

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.

Lindsay Jorgenson is a product leader and developer at Biogen, where she designs and delivers data-intensive applications that help operational teams make faster, more informed decisions. Combining a decade of experience in public health research with expertise in software development and user-centered design, Lindsay specializes in transforming complex data into intuitive, engaging experiences. Lindsay's expertise spans R, R Shiny, React, Node.js, data visualization, application architecture, product design, and user experience strategy. She is recognized for developing interactive analytics platforms that balance sophisticated functionality with elegant design, helping organizations derive greater value from their data and accelerate data-informed decision-making. Before transitioning to the biotechnology industry, Lindsay spent more than ten years working in epidemiological and public health research. She earned master's degrees in Public Health and Social Work from Washington University in St. Louis. Lindsay is passionate about the intersection of design, technology, and data, with a focus on creating products that are accessible, impactful, and genuinely enjoyable to use. Outside of work, Lindsay enjoys sewing, chess, animation, following international soccer, and catching Pokémon with her children.

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.

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.

McKenzie Kays is an IT Product Manager for Patient and Site Engagement within Research & Development at Bristol Myers Squibb. In her role, McKenzie leads the strategy, design, and delivery of digital products that simplify clinical trial participation and reduce operational burden for investigative sites, with a strong focus on scalable, compliant, and user-centered solutions. She has been instrumental in advancing foundational site engagement capabilities by modernizing onboarding, document exchange, and collaboration workflows across the clinical trial ecosystem. A core focus of McKenzie’s work is leveraging emerging technologies, including AI, to improve productivity, decision-making, and operational excellence. She applies agile product management practices, human-centered design, and iterative experimentation to translate complex site and patient needs into scalable digital capabilities, while continuously measuring outcomes through experience and performance metrics. Her work includes leading the development of custom digital applications that reduced document exchange burden by 30%, accelerated site activation, and delivered frictionless experiences for sites and internal teams alike.

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.

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.

Christoph, an experienced medical leader, heads Bayer's Global Development and Clinical Operations, overseeing the entire portfolio's clinical development. With a patient-focused approach, he leads teams from early development to late stages. As the former Chief Medical Officer at Otsuka, Christoph managed diverse development and medical functions globally. His expertise spans roles at Bristol-Meyers Squibb and Novo Nordisk, emphasizing cardiovascular medicine. Christoph, a 1994 graduate of Ruprecht-Karls University, Heidelberg, Germany, holds an MBA from Schiller International University and is board-certified in internal medicine and diabetology. His fusion of medical knowledge, business strategy, and regulatory proficiency drives impactful contributions to global patient access and clinical innovation.

Kerstin is the Head of Global Research & Development Quality at Bristol Myers Squibb and in this role, she is responsible for the development and oversight of the world-wide quality assurance activities in the areas of Product Development Quality, Good Laboratory Practice, Good Clinical Practice and Good Pharmacovigilance Practice. Prior to joining BMS in May 2020, Kerstin spent more than 20 years of her professional career in Quality Leadership positions with various pharmaceutical companies. Her current professional interests are the evolution of quality, e.g.; Quality Risk Management, Quality-by-Design, Quality Culture, Auditing of the future and the role of technology in clinical trials e.g., data analytics, virtual trials. Kerstin is the EFPIA Topic Lead in the ICH E8 (R1) Expert Working Group and has been a project lead for the Clinical Trial Transformation Initiative (CTTI) Quality by Design adoption initiative. “Quality is everyone’s responsibility” W. Edwards Deming.

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.

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).

Lynne Krajkovich is the Global Head of Biomarker and Imaging Operations in Global Development Operations at Novartis. She’s worked at Novartis for 30 years, with the last 20 years in biomarker operations. Lynne’s enjoyed being at the forefront of biomarker operations at Novartis, enabling the evolution from pharmacogenetics to exploratory biomarkers, to clinical studies with biomarkers as primary endpoints and inclusion criteria, and to the development of companion diagnostics.

Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. Prior to ACRP, Jim consulted for a variety of clients such as investigator sites, academic institutions, sponsors, and suppliers. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, Jim spent 24 years with Eli Lilly and Company. From 1999 to 2008, he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. Jim is on the advisory board of CISCRP (a non-profit organization focused on enhancing patient participation in clinical trials) and is a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the FDA. He is a frequent presenter at industry conferences and has written articles and papers that have been published in a wide variety of trade journals.

Sri Krishnamurthy is a technology leader and life sciences expert, specializing in clinical systems and commercial operations. As Director of GD-IT (Delivery & Operations) at Regeneron, he supports GD-IT domains like Biostatistical Data Management, Early Clinical Development, and Clinical Sciences. Sri leads impactful projects such as digitizing clinical trial protocols, implementing advanced human sample tracking systems, developing a Scientific Data Lake, and enhancing analytical platforms with SAS, R, and Databricks. His work advances Regeneron's operational capabilities and scientific endeavors.

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, Jenn transitioned to the pharmaceutical side at Gilead, where she serves as a Risk Advisor, helping to build RBQM capabilities including risk assessments, centralized monitoring, 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.

Darshan Kulkarni, PharmD, JD is a food and drug regulatory attorney, educator, and life sciences advisor who works with pharmaceutical, biotechnology, medical device, clinical research, and healthcare companies on FDA compliance and emerging regulatory issues. He is the Principal Attorney at Kulkarni Law Firm and an adjunct professor teaching FDA regulatory law and related subjects. Darshan brings a practical perspective to the use of artificial intelligence in healthcare and clinical research, with particular focus on how AI can affect clinical trial design, data integrity, patient privacy, informed consent, regulatory compliance, and decision-making. Through his legal practice, teaching, and work with life sciences companies, he helps organizations understand how emerging technologies can create both significant opportunities and significant regulatory risk.

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 as a Site Advocate, Maria is a voice for improved site engagement in the clinical research industry.

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.

Sir Martin Landray is CEO of Protas (protas.co.uk), Professor of Medicine and Epidemiology at Oxford University, and a practising hospital physician. He has over 25 years’ experience of leading large, randomised trials with particular experience in cardiovascular and kidney disease. He is co-lead of the RECOVERY trial of treatments for COVID-19, which discovered 5 effective treatments and saving an estimated 1 million lives globally. His work focuses on the fusion of smart design and intelligent technology to drive gains in speed, quality, and efficiency. He has played leading roles in regulatory improvement initiatives working closely with regulators, government and health organisations (including FDA, EMA, MHRA, ICH, G7, WHO).

Marta León Montagut is Senior Vice President, Site Activation Center of Excellence at Parexel. In this role, she leads and oversees a cross-functional team of highly skilled professionals who work collaboratively on the development and implementation of comprehensive country and site strategies that accelerate study start-up and optimize patient recruitment in clinical trials. Through effective leadership and collaboration within these teams, Marta ensures the seamless integration of key functional areas—including site selection, country strategy, and patient targeting—to support successful study launches and enable Parexel's customers to meet their enrollment objectives. Marta has over 22 years of experience in the healthcare sector and throughout her career she has exhibited exceptional leadership skills and a strong track record of driving successful clinical trial activations for pharmaceutical companies around the globe. She possesses a unique blend of scientific knowledge, commercial acumen, and strategic thinking, making her an invaluable asset in the world of clinical research and drug development. Prior to joining Parexel in May 2020, Marta held various senior leadership positions with clinical research organizations and pharma companies, where she led cross-functional teams and fostered strong relationships with key stakeholders, including regulatory authorities, healthcare providers, and site networks. Marta's commitment to innovation and continuous improvement is evident in her dedication to staying at the forefront of industry trends and best practices in site activation and study start-up. She actively collaborates with thought leaders, and consistently seeks opportunities to enhance the effectiveness and efficiency of country and site strategies.

Ye Chin Lee is Vice President of Strategic Operations & Administration in the Chief Academic Office at Mass General Brigham, where she leads strategic enterprise initiatives across clinical research, industry partnerships, data and digital capabilities, and research operations. She leads Mass General Brigham’s Hospital Integrated Research Organization (HIRO), an enterprise platform that integrates Mass General Brigham’s clinical expertise, research infrastructure, and data assets to create a more coordinated, efficient, and data-driven model for pharma-sponsored research. Through HIRO, she leads the development of scalable approaches to study feasibility, startup, execution, and real-world evidence, working across investigators and institutional research capabilities to improve how industry-sponsored research is conducted across the health system. Ye Chin brings more than 20 years of healthcare leadership experience spanning academic medicine, research, digital health, healthcare technology, organizational transformation, and strategic partnerships.

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.

April brings 25 years of experience in clinical R&D, demonstrating a proven track record of leading global teams to innovate and disrupt clinical trial operations. She has played a pivotal role in major transformational initiatives, including the Quintiles/IMS merger and GSK’s “Future Ready” initiative. Currently, April is the Senior Director of Innovative Health at Johnson & Johnson Innovative Medicine. In this role, she oversees the introduction, testing, development, and scaled delivery of novel capabilities, processes, and solutions aimed at enhancing patient and site experiences, increasing operational efficiencies, and setting new standards of excellence.

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

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.

Priyadharshini Lobow, AVP , Data & Analytics at Eli Lilly, is driven by futuristic and inclusive approach to building great organizations. She has depth and breadth of experience setting up and leading teams across clinical data programming, clinical data management and data analytics including transitions and transformation projects. At work, her area of focus is creating and leveraging synergies between the various players in the drug development environment to expedite drug discovery and patient access. Priya’s interests include writing, public speaking and travelling.

Trevan Locke, PhD, is an Assistant Research Director at Duke-Margolis working on issues related to biomedical innovation. He oversees Duke-Margolis' involvement as a founding member of the Advancing Clinical Trials at the Point of Care Coalition and workstreams on evidence generation for Duke-Margolis' Real-World Evidence Collaborative. Previously, he worked as a Regulatory Science and Policy Analyst at the American Association for Cancer Research on regulatory issues impacting cancer care and the development of cancer therapies, including considerations for equitable clinical trial enrollment. Dr. Locke completed a Bachelor of Engineering in Chemical and Biomolecular Engineering at Vanderbilt University and a PhD in Chemical and Biochemical Engineering at Rutgers University, where his research focused on the development of nanoparticles for the delivery of chemotherapy to treat cancer.

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.

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.

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 20 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 President of North American Chapter of ISoP.

Rakesh is a transformative clinical and health data sciences pioneer with 27 years of experience in the Industry. He is a SCDM eSource Implementation Consortium former Co-Chair/Co-founder and TransCelerate eSource Initiative Co-Lead. At Merck, he is the Head of eClinical Technologies, Global Data Management and Standards in the Global Clinical Trial Operations function. His broad range of responsibilities includes strategic evaluation, drive improvements of current technologies landscape, enablement and adoption at scale of innovative eClinical Technologies such as eSource, Digital Health and Decentralized Clinical Trials Technologies in conjunction with data strategy, standards & processes. Rakesh is an author of several scientific publications, and a frequent speaker at industry conferences and symposiums. Rakesh holds MS in Biomedical Engineering from USA and has completed MIT Sloan Executive Education Program in Artificial Intelligence: Implication for Business Strategy.

Mike Mayrosh is an Associate Director, Global Regulatory Policy and Strategy for Eli Lilly and Company. Mike leads Lilly's policy work on E-labeling, Artificial Intelligence, Digital Health Technologies, and Clinical Trial Modernization. Mike earned his PharmD from the University of Pittsburgh and served in FDA's Office of Medical Policy prior to joining Eli Lilly.

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.

Kelly Johnston McKee serves as Vice President, Strategy & Transformation at Science 37 where she leads the design of Science 37’s future-state patient experience, driving growth through modernized trial execution, advancing innovation, and strengthening cross-organizational collaboration to support long-term growth. McKee brings more than 20 years of leadership experience in clinical innovation, patient engagement, and trial optimization. She is widely recognized for building high-impact ecosystems that accelerate enrollment, reduce costs, and elevate the participant experience. Her career includes senior leadership roles at AstraZeneca/Evinova, Medidata, Vertex, Eli Lilly, Merck, and Sanofi, where she specialized in translating innovative concepts into scalable, enterprise-ready solutions across clinical development and operations. Her work has been recognized with multiple industry honors, including 1nHealth’s “25 Leaders Making an Impact in Patient Engagement” (2025), LifeSci Voice's Top Industry Leaders (2022) and PharmaVoice’s “100 Most Inspiring Leaders” (2020), among others.

Kelly McQuarrie is currently a Senior Principal Scientist in the Merck Patient-Centered Endpoints and Strategy (PaCES) team that develops Clinical Outcome Assessment Endpoints Strategies, including Patient Reported Outcomes. Kelly has been developing PRO strategies for 20 years across therapeutic areas, both in industry and as a consultant. Kelly is passionate about this area, because collecting these data is our opportunity in clinical trials to understand directly from patients how they feel and function. She has been involved in developing measures and endpoint strategies across therapeutic areas including endocrine and metabolism, neuroscience, immunology, oncology, infectious disease and vaccines. Kelly has taken her qualitative and quantitative experience to develop COA endpoints, applying these methods to digital endpoints. She holds a BS degree in nursing, and separately a BA in Social Work. Kelly and her husband have three sons and two dogs. Outside of work enjoys spending time with them skiing, bike riding, running and pottery.

Ann Meeker-O’Connell has 25 years of experience in medical product development, spanning trial design, clinical operations, and quality. She currently serves as Executive Director and Monitoring Excellence Head at Novartis. Prior to this role, Ann led the Office of Clinical Policy, Office of the Commissioner at FDA where she had responsibility for cross-cutting policy related to clinical trials. She has also served as the Director of the Division of GCP Compliance at FDA CDER, where she led work to develop clinical quality by design. She has also been an executive quality leader in R&D at Vertex Pharmaceuticals, IQVIA, and Johnson & Johnson. She received her B.A. in Biology and M.S. in Pharmacology from Duke University

Dr. Zhaoling Meng is Associate Vice President, Global Head of Clinical Modeling and Evidence Integration in Data and Data Sciences, sanofi R&D. Zhaoling has 20+ years of experience in Pharma. She built and leads a global team to support and promote modeling & simulation (M&S) and quantitative decision making across drug development stages and various disease areas. Her research interests include development scenario and design decision via competitive landscape modeling, real world data use in informing clinical studies, clinical modeling and simulation to trial optimization, and AI/ML in clinical applications. Prior to sanofi, Dr. Meng also worked at Bill and Melinda Gates Medical Research Institute, Merck, Pfizer and GSK.

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 25 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.

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.

Saumya Mishra is a senior product owner within Global Development IT at Regeneron Pharmaceuticals, where she partners with business, engineering, and scientific teams to deliver enterprise digital platforms with a focus on creating solutions with strong digital process foundations. She supports mission-critical products through phased rollouts and AI-enabled capabilities within the products she owns, bringing a strong product mindset and passion for building scalable, user-centric technology solutions.

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.

Erin Moeller is a clinical research leader with more than 23 years of experience spanning early and late-stage clinical development, continuous improvement, business transformation, and clinical data management. She played a key role in the licensure of Gardasilâ„¢9, has led major transformation projects including modernization of our clinical data ecosystem, and currently serves as Executive Director, Clinical Data Management. Erin holds a Bachelor of Science in Biology from Lehigh University, a Master of Public Health from Drexel University, and PMP and ACRP certifications.

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.

Mark provides strategic and scientific leadership for the development and implementation of digital health measures across the immunology therapeutic pipeline. His work spans the innovation lifecycle—from ideation and early proof of concept through clinical validation and deployment—with a focus on advancing high-impact digital endpoints and biomarkers that strengthen evidence generation, clinical decision-making, and the assessment of treatment benefit. By integrating sensors and sensor-derived measures into early- and late-phase clinical trials, Mark helps translate emerging technologies into scalable clinical solutions. He builds strategic collaborations with digital health leaders, generates clinically meaningful evidence, and contributes to shaping the future of digital clinical measurement.

Kelly Morris is Director of Patient Recruitment at AstraZeneca. She leads patient recruitment and retention initiatives across the BioPharmaceuticals portfolio, focusing on innovative approaches to patient engagement, site support, and clinical trial acceleration. Kelly works across clinical operations, study teams, and external partners to develop scalable strategies that improve trial access, participant experience, and enrollment outcomes.

Dr. Nahab is a board-certified Neurologist and Movement Disorders specialist with over 20 years of experience bridging clinical needs with technological advancements in digital health technologies. He has conducted novel research across all phases of development in various indications, including Essential Tremor, Parkinson’s disease, and Dystonia. In addition, he has led the development of digital technologies for use as objective measures of neurological disorders to enhance the efficiency of clinical development and patient care. In his current role at Neuron23, Dr. Nahab leads the LRRK2-inhibitor Phase-2 clinical development program for treatment of Parkinson’s disease.

Rebecca Nebel, PhD, is Director of Global Regulatory Policy & Intelligence at Amgen, where she leads on a range of U.S. regulatory policy initiatives including artificial intelligence (AI), cloud-based submissions, precision medicine, rare disease, and CMC/manufacturing. In this role, she develops policy positions and engages with regulators, industry associations, and other stakeholders to help shape policies that advance innovation in the development and review of medicines. Prior to joining Amgen, Dr. Nebel served as Deputy Vice President of Science and Regulatory Advocacy at PhRMA, where she led industry advocacy on regulatory policy issues, including AI, digital health, regulatory information technology, real-world evidence, combination products, and vaccines. She also supported PDUFA negotiations, led FDA engagement efforts, and collaborated with stakeholders across industry to advance science-based regulatory policies. Earlier in her career, she held positions at the National Institutes of Health, the Society for Women's Health Research, and the National Academies of Sciences, Engineering, and Medicine. Dr. Nebel earned her PhD in Biomedical Sciences from Albert Einstein College of Medicine and her BS in Biological Sciences from Binghamton University.

Rachel Nering is a globally recognized clinical development leader with deep expertise spanning therapeutics, devices, and diagnostics — from IND/IDE filing through registration. She currently holds dual roles at Sanofi as the Global Head of Early Development Clinical Operations and the Head of eDevelopment, a strategic initiative harnessing AI and digital innovation to accelerate end-to-end clinical development. A critical strategic thinker known for her adaptability and results-driven approach, Rachel excels at managing complex, cross-functional programs within dynamic organizations. She brings strong operational and program management capabilities, with a proven ability to develop talent across all levels and drive results in cardiology, immunology, oncology, rare disease, neurology, and ophthalmology.

I lead the integration of wearable technologies into clinical development to capture meaningful changes in how patients feel, function, and live. With more than 10 years of experience in digital health and translational science, I lead programs that translate wearable data into fit-for-purpose digital measures of symptoms, mobility, and function across therapeutic areas, including neuroscience, neurodegeneration, and immunology. My work spans technology evaluation, digital endpoint strategy, clinical and analytical validation, and evidence generation across early and later-stage development. I drive to integrate scalable, patient-centered wearable measures into clinical trials to strengthen treatment evaluation and development decisions, ensuring that evidence reflects the outcomes that matter most in patients’ daily lives.

Nichole Noel, Director, Global Trial Optimization, has worked for Merck & Co., Inc., Rahway, NJ USA, for1 years. The intersection of health and technology is a huge passion, and she has largely focused her career on how digital technologies can be used to engage and reach people all over the world. Nichole currently supports clinical trial awareness and recruitment via a multichannel digital strategy including Merck’s global clinical trials web platform. Nichole holds a Master of Science in Digital Innovation in Marketing from Temple University and a Bachelor of Science in Management Information Systems from Philadelphia University.

Carrie Northcott, PhD is a Director/ Project Lead within Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD) at Pfizer. She leads a driven and diverse team that is evaluating and validating the use of wearable digital devices to more fully understand and characterize physiological endpoints, such as quantitatively measuring night-time scratch and sleep. Carrie has a diverse scientific background in Pharmacology, Toxicology, and Physiology which provides unique insight into understanding how these novel digital endpoints provide meaningful information to patients, doctors, and researchers to better treat and understand diseases.

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.

Experienced health economics and outcomes researcher with almost 20 years of experience in pharma, consulting, and not-for-profit scientific membership organizations. I'm passionate about finding the right data to influence healthcare decision-making that can have a real impact on improving quality of care.

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.

Lindsey Place is Director of Clinical Drug Supply & Logistics at Regeneron, where she leads global clinical supply strategy and execution across complex development programs. With extensive experience in clinical trial supply chain management, Lindsey specializes in demand and supply planning, investigational product logistics, global distribution, risk mitigation, and cross-functional operational excellence. Throughout her career, she has partnered closely with clinical, manufacturing, quality, regulatory, and development teams to ensure reliable supply for clinical studies while navigating the challenges of an evolving development portfolio. Known for her strategic leadership and collaborative approach, Lindsey is passionate about advancing innovative supply chain solutions that enable efficient clinical trial execution and support the delivery of life-changing medicines to patients.

Scientific and clinical imaging leader with formal training as a radiologic technologist and extensive experience spanning academic instruction, industry research, and global clinical trials. Expertise encompasses imaging protocol design, independent review BICR and data governance across oncology, neurology, and musculoskeletal programs. I hold a unique perspective from site, vendor, and sponsor this includes: Perceptive, Clario, Merck KGaA/EMD Serono, and Amgen, supporting complex trials across the United States, Europe, and APAC. Proven ability to translate advanced imaging principles into standardized, compliant processes that enhance data integrity, reproducibility, and trial outcomes. Recognized for scientific leadership and operational rigor, with a track record of leading multi-disciplinary teams, implementing imaging standards, and delivering high-quality endpoints that drive data-driven decisions and accelerate clinical development.

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.

Dr. Abhi Pratap is currently working on building a strong evidence base for the real-world usage of digital therapeutics to improve mental health outcomes at Boehringer Ingelheim. His primary focus is on utilizing digital health technologies to facilitate early detection and finding appropriate treatment options for patients. Previously, he worked at Biogen, where he managed one of the largest decentralized studies aimed at assessing cognitive trajectories in real-world settings. Prior to Biogen Dr. Pratap led the various real-world studies in academia and industry to help better understand the meaningful experiences that matter to patients. Dr. Pratap is also an adjunct faculty member at the University of Washington, Seattle, and a visiting research fellow at King’s College London, London, and Boston University. He holds a Ph.D. in Biomedical Health Informatics from the University of Washington, Seattle.

Jie Ren is the Director of Data Science in the Global Digital Analytics & Technologies group at Merck. In this role, she leads the digital health data analytics team and focuses on leveraging data science for digital endpoint development. Jie earned her PhD from Duke University in 2013 and her Bachelor’s degree from Peking University in 2007.

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.

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.

Dr. Justine Rochon leads Takeda’s R&D Data and Quantitative Sciences organization, advancing data-driven decision-making across translational, medical, and data sciences. A psychologist and biostatistician with more than 20 years of experience in academia and industry, she holds a doctorate from Heidelberg University’s Medical Faculty. She co-authored the Charter for Data Science in Pharmaceutical R&D and the Manifesto for AI-Driven Clinical Trials. Dr. Rochon continues to champion the responsible use of AI in drug development. She is a former president of EFSPI (European Federation of Statisticians in the Pharmaceutical Industry), serves on the ASA Biopharmaceutical Section Executive Board, co-founded and co-chairs the DISRUPT-DS (Data Science) Roundtable, and was named one of 10 Trailblazing Women 2025 in Pharma by Reuters.

Dr. Lilliam Rosario is Program Director at TransCelerate BioPharma and a former Director of the FDA’s Office of Computational Science in CDER. With more than 20 years of experience in regulatory science, she has led efforts to advance data standards, computational science, AI-enabled approaches, and collaborative data sharing across industry and regulatory settings. Her current work focuses on enabling translational safety insights through the integration of nonclinical and clinical evidence.

Melinda Rottas is the Head of Optimization, Analytics & Recruitment Solutions (OARS), a team that aims to transform clinical trials at Pfizer, establish a new standard for clinical trial experience and deliver analytics and insights for optimized R&D performance. OARS is a talented global team delivering core capabilities spanning clinical trial country & site feasibility; protocol insights & optimization; recruitment & retention strategies; clinical trial investigative site partnerships & site experience; clinical trial participant experience & patient engagement and decision-making analytics & benchmarking. Melinda has over 23 years of experience at Pfizer, starting her career as a Medicinal Chemist in Drug Discovery, followed by additional roles in research including Business Operations and Portfolio Reporting & Forecasting prior to moving to the clinical development space. Melinda holds a BS in Chemistry from the University of Connecticut as well as an MBA from Rensselaer Polytechnic Institute.

Strategic R&D and clinical development leader with 27 years of experience across the pharmaceutical industry, academia, and the Government of India. Experienced in building and scaling global R&D hubs, leading large multilayered teams, and delivering complex clinical development programs across North America, Europe, APAC, Middle East/Africa, and India. Currently leading the creation of Sun Pharma’s first Development Centre of Excellence, overseeing all drug development functions including Clinical Operations, Global Trial Management, Data Management, Biostatistics, Medical Writing, Clinical Development, PK/Translational Medicine and Clinical Quality. As General Secretary of the Indian Society for Clinical Research (ISCR) — India’s leading professional body for clinical research — I play a national leadership role in strengthening India’s clinical research ecosystem. I work closely with regulators, industry, academia, and patient groups to advance ethical, high quality clinical research, build capability across the country, and shape policy frameworks that enhance India’s global competitiveness in drug development.

Alan Rwabwogo leads process governance, document and records management, and clinical systems within Regeneron's Global Development organization, spanning Process & Procedures, the Process Owner Network, Trial Master File oversight, Records Management and Translations. Over 20 years’ experience from Preclinical to Commercial across GLP, GCP, GMP & GVP with deep hands on experience in quality systems, Veeva Vault architecture, CAPA/deviation governance, procedures, audits, regulatory compliance and pharmacovigilance oversight.

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.

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 of 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 Samuelsson, PhD, is Associate Director of AI/ML and Agentic AI Lead at Pfizer, where he leads a team building AI products across the drug development lifecycle, from stakeholder ideation through production deployment.

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.

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.

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.

Tara Schultz is an AI Product Manager at Bristol Myers Squibb who leads the development of innovative solutions that improve patient and site engagement across the clinical research ecosystem. With extensive experience in product strategy, artificial intelligence, and digital transformation, she focuses on reducing operational burden, enhancing experiences for patients and research sites, and delivering scalable solutions that create measurable business and healthcare impact.

Josephine is a learning and communications specialist with over 18 years of experience in the pharmaceutical industry. Currently, she serves as a leader in the Clinical Customer Centricity (CCC) team at Bayer, where she is committed to placing Customers—Patients, Participants, and Sites—at the core of their clinical development efforts. She drives the co-creation and implementation of innovative strategies that foster a holistic understanding of their customers, build long-lasting partnerships, and enhance customer experiences. Her extensive background and proven leadership enable her to effectively drive engagement, improve efficiency, and accelerate timelines in clinical development.

Dr. Pratik Shah directs a research program advancing the integration of artificial intelligence, deep learning, and machine learning into medical diagnostics and clinical development. A professor at the University of California, he holds faculty appointments in the departments of Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering. Dr. Shah's research integrates AI, statistics, engineering, and biomedical science to advance the diagnosis and treatment of cancer, infectious diseases, and neurological disorders. His innovations include AI-powered computational staining for cancer diagnosis, non-invasive diagnostic medical devices, and deep reinforcement learning models for optimizing drug dosages—all aimed at reducing healthcare costs and improving patient outcomes. His work focuses on real-world biological and clinical insights and cost-effective solutions to enhance accessibility, precision, and efficiency in healthcare. Dr. Shah is an expert in the clinical translation of research findings, particularly in real-world deployment platforms designed to provide equitable and affordable healthcare. Research from his lab has been published in Cell Press, Nature Digital Medicine, and Journal of the American Medical Association. A strong advocate for the ethical and regulatory advancement of AI in medicine, Dr. Shah actively contributes to discussions shaping AI policies, ensuring that healthcare AI solutions are fair, transparent, and reliable. His work has influenced industry collaborations and frameworks designed to establish responsible AI practices in clinical settings. He serves as an expert reviewer for national grant panels on emerging technologies and as an advisor on responsible AI adoption and deployment. Previously, Dr. Shah was a Principal Investigator at the Massachusetts Institute of Technology (MIT), where he led a computational medicine research program at the MIT Media Lab. He also served as the principal investigator on a memorandum of understanding with the U.S. FDA to help establish AI and machine learning research ecosystems for clinical development. Dr. Shah holds a BS, MS, and PhD in biological and data sciences and completed fellowship training at Massachusetts General Hospital, the Broad Institute of MIT and Harvard, and Harvard Medical School.

Dan Sheeran is Vice President and General Manager of Healthcare and Life Sciences at Amazon Web Services (AWS), where he leads the industry business unit that partners with healthcare providers, payers, pharmaceutical companies, and biotech organizations to accelerate innovation through cloud computing and artificial intelligence. With a career spanning technology and healthcare, Dan drives AWS's strategy for applying generative and agentic AI to some of the industry's most complex challenges, from drug discovery and clinical development to patient care delivery.

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.

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.

With more than 17 years of experience across the pharmaceutical value chain, Carol has consistently worked at the intersection of science, operations, technology, and transformation. She is recognized for her ability to quickly learn new domains, bring stakeholders together around common objectives, and develop innovative approaches that turn emerging ideas into meaningful business outcomes.

I have more than twenty-five years of clinical research experience with the majority spent in contract and budget negotiations in multiple therapeutic areas on a global level. I also manage negotiations, finalization and administration of Master Clinical Trial Agreements.

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.

Alanna Slaeker is an Associate Director in Central Monitoring and Risk-Based Monitoring at Pfizer, specializing in Oncology clinical trials, risk-based quality management, centralized monitoring, and data-driven oversight. She leads initiatives focused on monitoring innovation, AI-enabled solutions, inspection readiness, governance, and organizational capability building. Alanna is passionate about helping teams leverage data and technology to improve decision-making and clinical trial quality. Outside of work, she enjoys gardening, homesteading, camping, cooking, and spending time with her family, where she channels the same curiosity and continuous improvement mindset that drives her professional work.

Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics, and innovation adoption. His research often focuses on protocol complexity, clinical trial participant and site burden, and diversity and representation in clinical trials. He also leads the analysis for the PACT consortium, which collects granular data on the use of DCT solutions and metrics of performance for the trials that deploy them. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida Southern College and received his MA from Brandeis University. He has worked as a research assistant at Harvard University and at the University of Massachusetts and began at Tufts CSDD as a research analyst.

Amy C. Smith, M.S., is a Senior Director, Regional Operations Head, North America, at Merck Research Laboratories, where she provides regional operations leadership across clinical trial delivery, performance, quality, and compliance objectives. She brings more than 25 years of clinical research experience spanning sponsor, CRO, and site-facing roles, with deep expertise in clinical operations strategy, feasibility, site selection, study start-up, execution, quality oversight, risk mitigation, vendor oversight, cross-functional leadership, and the development of analytics tools to support business insights. A transformational and continuous-improvement-oriented leader, Amy helped identify systemic inefficiencies in country operations’ site feasibility and validation processes and progressed from issue escalation to co-leading business support in the conception, design, and delivery of Merck’s globally scalable, intelligence-enabled decision platform, STRIDE, for clinical trial site selection. Amy holds a master's degree in Health Sciences and Clinical Research from George Washington University, a bachelor's degree in Psychology from the University of California, San Diego, and has completed Project Management Professional, ACRP Clinical Research Professional, and Lean Six Sigma certifications.

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.

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.

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.

Yiwen Sun is an Associate Director and Risk-Based Quality Management Lead at BeOne Medicines, where she drives the implementation of modern RBQM and centralized monitoring strategies across global oncology development programs. She has been instrumental in advancing digital RBQM capabilities, including risk analytics, quality signal management, Site Overall Health assessment, targeted monitoring, and integrated KRI/QTL frameworks. With a background spanning clinical operations and risk management leadership, Yiwen is passionate about leveraging data, technology, and cross-functional collaboration to transform clinical trial oversight and support inspection-ready quality.

Dr. Suprin completed her undergraduate studies in Chemical Engineering at Villanova University, has an MBA from the University of Rhode Island, and is a Lean Six Sigma Black Belt. She also has a Doctorate in Law and Policy from Northeastern University. Her career spans manufacturing, research, quality, EH&S, strategy, and operations. She started with Air Products and Chemicals as a Production Engineer, moved to R.R. Donnelley and Sons as a Manufacturing Supervisor, and then transitioned to Pfizer in 2001. Her roles at Pfizer have given her a breadth of experience across Pfizer’s divisions and functions. Her leadership in operations and expertise in risk management led to her current role at BeOne as the Head of Quality Risk Management for Clinical Development. She is the lead author of the TransCelerate paper on risk management, a contributor to the Quality Tolerance Limits publication and the former lead of TransCelerate’s ICH E6/E8 workstream.

Dr. Rui (Sammi) Tang is a senior pharmaceutical executive and drug development leader with extensive experience spanning research, development, medical, data, and business strategy. She is Senior Vice President and Global Head of Quantitative Sciences and Evidence Generation at Astellas Pharmaceuticals, where she drives data and evidence based enterprise decision making across clinical development, analytics, and portfolio strategy. She also serves as Site Head of the Astellas Life Sciences Center (ALSC), with responsibility for site management and operations across integrated Research, Medical & Development, Business Development, and IT teams, while fostering partnerships across Cambridge and the broader life sciences ecosystem. Dr. Tang is recognized for driving R&D innovation through the application of AI, advanced analytics, and external data, bridging science, data, and business to improve development efficiency, portfolio value, and patient impact. Across her career, she has contributed to the development, regulatory approval, market access, and lifecycle management of therapies across oncology, rare diseases, gene and cell therapy, neurology, ophthalmology, and other therapeutic areas—helping bring innovative medicines to patients worldwide. Previously, Dr. Tang served as Vice President and Global Head of Biometrics at Servier Pharmaceuticals, advancing AI-driven analytics to enhance drug development, and as Therapeutic Area Head of Biostatistics at Shire Pharmaceuticals, overseeing key functions across multiple therapeutic areas. She also held pivotal roles at Vertex, Amgen, Mayo Clinic, and Merck, contributing to drug development innovation and advancements that have supported the approval of life-saving therapies impacting millions worldwide. She has authored more than 50 peer reviewed scientific publications and is an active leader in advancing the integration of science, data, and AI in drug development. Dr. Tang is an Adjunct Professor at Yale University School of Public Health, co-founder of DahShu (a global nonprofit with 6,000 members), and holds a PhD in Statistical Genetics and an Executive MBA from MIT Sloan.

Anthony K. Taylor, DHSc, MSPharm, is an experienced R&D leader, former clinical research scientist, and U.S. Army medic with comprehensive industry knowledge and a proven record for delivering results within large, mid-size, and small pharmaceutical organizations. He is passionate about patient-centricity and focused on enhancing the clinical trial experience for patients, caregivers, and clinical sites. Dr. Taylor is Project Management Professional (PMP) Certified and has a solid background in leading global clinical programs and teams. He has been in the pharma industry for over 20 years and has held positions of increasing responsibility. When he is not leading large cross-functional initiatives, Dr. Taylor enjoys spending time with his family and playing tennis in the U.S. Tennis Association (USTA). He lives in Raleigh, NC with his family.

Reb Tayyabkhan is the Head of R&D Sourcing and Procurement at Merck and oversees a team that supports the Merck Research Laboratories across Discovery, PreClinical, Global Development, Regulatory, HEOR and Medical Affairs. Prior to joining Merck in 2019, he was the Head of Research & Global Development Sourcing at Regeneron and prior to that, held various Clinical Operations leadership roles at Bristol Myers Squibb overseeing Data Management, Regional Clinical Operations and Vendor & Outsourcing Management. Reb previously worked as a management consultant at PwC and a manufacturing engineer at Merck. Reb holds a Bachelors in Chemistry from NYU, a Masters in Chemical Engineering from Cornell and a MBA from NYU Stern.

Senior Director, Therapy Area Strategy & Portfolio Delivery within Development Operations, over 20 years in various roles within Clinical Operations, where I delivered early and late phase clinical studies across different therapeutic areas. I was responsible to ensure project standards and scientific requirements from study design concept through study closeout. Currently, I am working within our Site Management and Monitoring Organization. In this role, I ensure consistent communication and collaboration across clinical operations, study management, and the country teams across the globe.

Thamizh (Ted) Thendral is Director of RBQM at Daiichi Sankyo, where he leads initiatives supporting Quality by Design, risk-based approaches, and data-driven quality oversight in clinical trials. Ted has more than 20 years of experience across the clinical trials industry, spanning oncology, hematology, immunology, infectious diseases, neurology, and cell therapy. Prior to joining Daiichi Sankyo, he held leadership roles leading programs focused on risk management, quality, clinical operations, and technology innovation. Throughout his career, Ted has helped organizations improve trial quality, operational efficiency, patient safety, and inspection readiness through the implementation of innovative processes, analytics, and enabling technologies.

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.

Jennifer (Jen) True is a pharmacist with over 30 years of experience in the pharmaceutical industry.  Her career has been focused in the areas of Drug Safety/Pharmacovigilance (PV), Project Management, Quality, and Training. She performed all types of PV activities (e.g., case processing, signal management, aggregate reporting) and managed global safety organizations of various sizes, covering a very broad spectrum of PV activities. Jen spent several years in pharmaceutical consulting with companies and has successfully managed multi-million-dollar projects focused on technology implementation, process redesign, and acquisitions. Over her career, Jen has provided quality support to PV, Regulatory, Clinical (phase I-III), Clinical Labs, Companion Diagnostics, and Sales & Marketing departments. She has redesigned quality systems and managed multiple audits and regulatory inspections (FDA, EMA, MHRA). Jen has worked on numerous human resource initiatives, including improvement of organizational design, development of job descriptions, and creation of competency models. She has actively led training programs, including development of training strategy, training materials and training matrices. She is known for her practical approaches, communication skills, and ability to manage both strategy and  implementation  details.

Nicole Turner is a senior leader at the intersection of clinical development, operations, and data science and technology. She leads global teams in designing and delivering advanced analytics, insights from AI/ML models, and digital solutions that improve the predictability and efficiency of clinical trials. Nicole is passionate about building collaborative, forward-thinking cultures that accelerate progress in clinical research and ultimately improve patients lives.

Vladimir Turzhitsky is a Director of Data Science and Outcomes research at Merck & Co. He received a Ph.D. degree from Northwestern University and obtained postdoctoral training at Harvard Medical School, where he later served as faculty researching algorithms and devices for cancer and other disease prediction. He joined Merck Research Laboratories in 2018, where his focus has been on applying data science methods for observational studies in healthcare.

Benjamin (Ben) Vandendriessche is CEO at the Digital Medicine Society (DiMe), dedicated to advancing digital medicine to optimize human health. His personal drive stems from the conviction that digital health technologies deployed at scale are key to developing better therapies, improving quality of care, and ultimately better patient outcomes. He has more than a decade of experience developing digital health technologies for clinical trials and care delivery, including US and EU market access and reimbursement pathways. Previously, Ben was Chief Medical Officer at health tech startup Byteflies, developing a remote patient monitoring platform for clinical trials and virtual care applications. He trained in molecular biology, systems physiology, and data analytics for vital sign processing. He completed a PhD in Molecular Biology at Ghent University as an IWT Fellow, followed by a postdoc on the interface of Critical Care Medicine and Computer Science at Case Western Reserve University (CWRU) as a BAEF Fellow. He holds an adjunct assistant professor position at CWRU and publishes regularly on all things digital medicine.

James Vernille is a seasoned leader in clinical trial systems and analytics at Amgen, bringing over 22 years of experience and a Ph.D. in Chemical Engineering to the Life Sciences and Healthcare industry. He leads a team of analytics professionals dedicated to advancing technologies that empower Amgen’s Global Development organization with data-driven tools to enhance clinical systems, study operations, and site management through advanced analytics and business intelligence. With a diverse background spanning chemical engineering, process development, and resource management, James is recognized for his ability to translate complex data into strategic, actionable insights that accelerate the development and delivery of innovative medicines to patients worldwide.

Samantha Volkens, RN, BSN, MBA, is Partnerships Lead, Life Sciences at the Digital Medicine Society (DiMe), where she works with pharmaceutical and biotechnology organizations to advance the application of digital medicine across clinical research and drug development. Her work spans strategic partnerships, precompetitive collaboration, digital measurement, evidence generation, and emerging approaches to clinical development. With a background in nursing, healthcare strategy, and business, Samantha brings a multidisciplinary perspective to the opportunities and challenges facing life sciences organizations as they integrate new technologies and sources of evidence into clinical research. She is particularly interested in building collaborations that turn complex challenges across the life sciences into practical, scalable opportunities for progress.

Viral Vyas is a highly accomplished IT executive with a unique blend of science, information technology, and management expertise. With a profound understanding of pharmaceutical research and development, Viral is deeply committed to enhancing patients' lives by aligning IT and business strategies. He is widely recognized as an authentic leader and trusted advisor, renowned for his ability to drive change and digital transformation efforts internally and externally. Currently serving as the Director of IT for Global Clinical Development at Bristol Myers Squibb (BMS), Viral is responsible for devising innovative strategies to enable scientists to deliver life-saving medicines to patients more quickly. He has achieved significant business value by leading a program/project that established a digital platform for ingesting, transforming, conforming, and reporting biomarker data from clinical trials. Viral holds a Master's in Business Administration from the University of Florida, a Master's in Information Systems from the Stevens Institute of Technology, and a Bachelor's in Microbiology from the University of Florida.

As the Global Head of Risk Based Quality Management (RBQM) at Roche, Paula has established and led the RBQM Centre of Excellence team. Her work focuses on the strategic implementation of the RBQM framework across the clinical trials enterprise, from early through to late phase. With over 20 years of experience in clinical trials compliance and governance, Paula is committed to ensuring that patients remain at the center of every decision, using quality as an enabler to bring new medicines to patients faster and more safely. Previously, Paula led significant regulatory and compliance advancements, including serving as Head of Compliance at the MHRA—where she oversaw GCP, GPvP, and GLP inspection teams—and as Head of the GxP Inspectorate during the pandemic. She also spent 14 years as a GCP inspector at the MHRA. Paula continues to collaborate with industry stakeholders, regulatory bodies, and cross-industry initiatives like the IMPALA consortium to enhance transparency, build trust, and leverage data analytics for quality improvement in clinical research.

Adrienne Walstrum has worked in clinical trial operations for twelve years. She is currently a Program Director with Global Trial Operations at Merck focusing on feasibility and patient recruitment strategies across the Oncology and Hem-Onc Portfolios. She holds a Master’s of Science in Management with a concentration in Organizational Leadership from Wilmington University.

Dr. Xiaoyan Wang is a health policy and management scientist, clinical research and evidence-generation expert, and leader in healthcare AI. She is a Professor/Faculty member at Tulane University and a senior executive and chief scientist in health technology, where she leads the development of AI-enabled platforms for evidence generation, systematic literature review, real-world evidence, and clinical research. Her work focuses on integrating fragmented biomedical data with advanced AI and agentic technologies to accelerate evidence generation and improve clinical-development decision making. She has led research and technology programs spanning systematic reviews, real-world evidence, clinical trials, health economics and outcomes research, and AI evaluation, and has extensive experience translating emerging AI capabilities into real-world pharmaceutical workflows. She is a Fellow of the American Medical Informatics Association (AMIA) and has presented her work at major clinical research, oncology, health economics, medical informatics, and life-sciences conferences.

Jingye Wang is a Data Analytics Leader in Early Clinical Development at Genentech, with a multidisciplinary background spanning clinical medicine, including specialization in ophthalmology, biostatistics, and data science. Her work focuses broadly on the application of data, analytics, and emerging AI technologies to support clinical development and operational decision-making. Prior to joining Genentech, Jingye held biostatistics roles in both industry and academic research, with experience spanning clinical studies, diagnostics, healthcare analytics, and regulatory-facing work. She is interested in bringing together clinical, quantitative, and technology perspectives to help advance more efficient and data-driven approaches to clinical research.

Mike Ward, Senior Director of eSource Capabilities at Lilly, has focused his 27-year career at Lilly on advancing clinical trial data collection within Lilly, and across the pharmaceutical industry. Mike leads the implementation of site eSource platforms, deploying Central Source Templates to streamline source data capture and reduce site burden. He leads Lilly’s implementation of EMR-to-EDC interoperability, enabling real-time data flow and improving data quality across studies. In addition to his operational leadership within Lilly, Mike has been an active driver of industry standards through various leadership with CDISC, HL7 and TransCelerate. He currently serves as a sponsor stakeholder for i~HD’s eSource Scale-up Task Force.

Henry Wei, MD, is the Head of Development Innovation at Regeneron, focused on accelerating clinical research. Previously, he worked at Google, the White House, Aetna, and McKinsey. He has authored patents on artificial intelligence, real-world data systems, and drug safety. He completed his M.D. and Internal Medicine residency at Cornell, additional informatics training at Stanford and Harvard, and oncology integrative medicine training at Memorial Sloan Kettering Cancer Center. He earned both his graduate & undergraduate degrees at Harvard University and published research on human neuroelectrophysiology and circadian biology. Dr. Wei is adjunct faculty at Weill-Cornell Medicine in Health Policy & Research.

Scott Welden is the Associate Director, Oncology Portfolio Delivery at Gilead Sciences, where he leads a team responsible for identifying and developing structured, data-driven strategies that streamline operations, improve processes, and guide rials efficiently through to closure. With a strong foundation in clinical trial and project management, Scott brings over 15 years of experience to the pharmaceutical and clinical trial industry. He holds a Master’s Degree in Pharmacology from Thomas Jefferson University in Philadelphia and a Bachelor’s Degree in Chemistry from the University of Richmond, combining a rich scientific educational background with his Industry experience. Scott is known for his commitment to excellence, continuous learning, and passion for identifying creative solutions to complex issues. Known as a strategic thinker and innovative leader, Scott excels at developing structured, data-driven strategies that streamline operations, improve processes, and guide trials efficiently through to closure. His analytical mindset and commitment to continuous improvement have consistently delivered measurable results in performance, quality, and cost-effectiveness.

Chunhua Weng, PhD, FACMI, FIAHSI, is Professor of Biomedical Informatics at Columbia University and a leading researcher in clinical research informatics and biomedical AI. Her research focuses on improving the efficiency, rigor, and generalizability of clinical trials through the integration of electronic health records, clinical trial data, biomedical literature, and computational methods. She has developed data-driven approaches to optimize trial eligibility criteria, improve patient recruitment and cohort identification, advance clinical phenotyping, and automate clinical evidence comprehension. Her work aims to make clinical evidence more computable and actionable across the research lifecycle. Dr. Weng is an elected Fellow of the American College of Medical Informatics and the International Academy of Health Sciences Informatics and received the 2025 AMIA Donald A.B. Lindberg Award for Innovation in Informatics.

Michelle Werner joined Ipsen in March 2026 as Executive Vice President and President of North America. Prior to Ipsen, Michelle served as CEO-Partner at Flagship Pioneering and President and CEO of Alltrna, a tRNA platform company. During her tenure at Alltrna, she built and led a team that unlocked the biology of a brand new modality and advanced the first-ever tRNA therapeutic toward human trials. Michelle also previously served as Worldwide Franchise Head, Solid Tumors at Novartis Oncology, where she was responsible for delivering the disease area strategies across multiple tumors and led business development efforts resulting in a doubling of long-term portfolio value for the franchise. Before Novartis, Michelle was a senior leader at AstraZeneca and as Global Franchise Head in Hematology, she was critical in launching multiple indications worldwide for CALQUENCE. Prior to this, Michelle was Head of US Oncology, where she led the business through dramatic growth in both team and revenue through eight-plus product launches. Before AstraZeneca, Michelle was with Bristol Myers Squibb for 10 years in various positions of increasing responsibility including roles in sales, marketing, and market access in the U.S. and UK, and above market in Europe (based in France) and global almost exclusively in oncology. Michelle started her professional career in R&D, working hands-on with patients at the Oncology Clinical Trials Unit at Harvard Medical School before moving into industry in clinical operations. Outside of her corporate responsibilities, Michelle is a wife and mother to three children and is a member of the rare disease community. She is currently serving Board appointments for the non-profit organizations Rare Disease Renegades and Cure Rare Disease, a purpose that fuels her passions both personally and professionally.

Darren Weston is Senior Vice President, Head of Integrated Data Analytics & Reporting (IDAR) and Janssen Clinical Innovation (JCI), Janssen R&D. In this role he is responsible for leading the IDAR organization in delivering our portfolio on time, within budget, and with robust quality while continuously improving to optimize efficiency and drive innovation through JCI in how we execute our programs. IDAR and JCI have a globally distributed workforce of more than 1000 internal and external employees who are responsible for the operational execution of all Phase I – IV studies (including Medical Affairs programs) across all therapeutic areas and all geographic regions. They are accountable for identifying and implementing innovative clinical trial approaches and technologies that meet the current and future needs of our portfolio while also shaping our environment to build for the future. IDAR is comprised of six global functions: Data Management, Clinical & Statistical Programming, Risk Management-Central Monitoring, Regulatory Medical Writing, Clinical Data Standards & Transparency, IDAR Business Operations, in addition to IDAR Therapeutic Area leadership. Prior to joining Janssen in 2017, Darren was the Vice President of Data Sciences & Scientific Operations at Novartis where he had spent 16 years holding positions of increasing leadership scope within the Biometrics area. He has served as an external advisor to several technology companies, and supported several key industry groups such as PhUSE and PSI. He is a UK graduate in Applied Statistics of Brighton University (BSc 1st Class/summa cum laude), and Sheffield Hallam University (MSc Distinction/summa cum laude) and lives in Mendham, NJ. In his spare time, when not playing with his two children, Darren has a passion for learning and mastering new skills ranging from playing guitar, piano, singing, close-up magic, playing soccer/football, brewing beer to name just a few.

Mandy White is a Senior Quality Lead at Roche/Genentech with extensive experience and over 15 years of quality assurance and regulatory compliance. She holds a master’s degree in Epidemiology and Public Health and previously served as an FDA Investigator, bringing a wealth of expertise in regulatory standards, public health, and quality systems to her current role.

Dr. Ken Wiley, Jr. is the Chief of the Clinical Research Resources Section within the National Center for Advancing Translational Sciences, where he manages, coordinates, and provides technical and scientific leadership and guidance for activities related to the planning, implementing, and conducting NIH-supported clinical research and clinical trials, and resources to develop products to improve the recruitment and safety of participants in clinical trials by using standardized and agreed-upon metrics by various stakeholders and key informants. He is a recognized expert in data interoperability, clinical Informatics, regulatory science, and clinical trial participation.

Kate Wilson is the Head of Clinical Trial Diversity at Biogen. Kate has over 22 years of experience in clinical research with an undergraduate degree in Chemistry. She’s held multiple roles within Clinical Operations and worked across many therapeutic areas including multiple sclerosis and Alzheimer’s disease. Currently at Biogen, Kate is leading Biogen's clinical trial diversity strategies and goals to increase the awareness, access, and participation of diverse and representative participants in their clinical trials.

John Woodson leads Budget & Resource Management for Global Clinical Operations at Novartis, a global team responsible for clinical trial cost pricing, budgeting, and resource forecasting. He previously led business operations for Novartis's data42 clinical data platform. He holds a degree in Chemical Engineering from the University of Oklahoma and an MBA from Harvard Business School.

Amanda has over 20 years of experience across multiple functions in the clinical research industry, beginning her career as a Clinical Research Coordinator at an integrated network of clinical research sites, PMG Research. She has served in leadership roles that include operations, patient engagement, business development and marketing. Currently, Amanda leads Integrated Solutions where she applies her expertise and passions on intersecting strategic partnerships and collaborations that serve to innovate business process, patient engagement, and predictive modeling. In addition, Amanda has previously served for 10 years as the Executive Director of a clinical research non-profit, Greater Gift (501c3) designed to celebrate clinical trial participation and global health and well-being. Amanda is a graduate of UNC-Chapel Hill as well as various leadership programs.

Ms. Yanak is a Pharmaceutical & Central Lab executive known for successfully translating scientific strategy into clinical operations, via technology and innovation. She developed an Innovation Operating Model to pilot digital health and other ideas to transform drug development, and envisioned and led a multi-year strategic program to operationalize Precision Medicine at a Top 5 pharma, including transformation of the end-to-end specimen management policy, process, and technology infrastructure: standardizing protocols, digitizing informed consent, developing virtual specimen tracking, and using artificial intelligence to automate clinical study reports to expedite creation of big datasets for mining new biomarkers. Brenda has led transformative initiatives at several major companies, and acts as an Advisor to the Summit for Clinical Operations Executives (SCOPE).

Demetris is currently VP and Global Head of Data Monitoring and Management at Pfizer. Demetris started his career as a Laboratory Scientist in 1991 and transitioned into the Clinical Development space where he held roles of increasing responsibilities in Trial Management and Monitoring and led the implementation of the company’s first Clinical Trial Management system. In 2000, Demetris was a member and eventually the leader of the team which executed the industry’s first Tech-Transfer of a web based EDC system. He eventually led the Data Management and Standards organization and continued on to Merck & Co. following the merger in 2009. Subsequently Demetris was Vice President of Data Management at Novartis AG from 2014 to 2017. Since 2017 Demetris leads Pfizer’s Data Management and Risk Based Monitoring line functions in a new transformation; developing and transitioning into an internal operating model across multiple geographic sites in support of Pfizer’s portfolio. He also leads the Data and Automation work stream as part of Pfizer’s Development-wide transformation effort. He currently serves on multiple Boards, including SCDM’s Advisory Board, has served on the Board of Trustees and was the 2016 Chair.