|Wael Abouelkheir, MBA||Roche|
Global Studies Leader, lobal Product Development, Neuroscience
Wael Aboulkheir is visionary leader with a scientific and business background, as well as extensive experience in drug development. He is passionate about adding meaningful value to the patients and organizations by using new technologies and creating novel strategies for clinical projects. He has worked with Eli Lilly and Company, ICON, and Roche, gaining a diverse perspective in clinical trial management and the potential for its innovation. Wael has earned his MBA from the University of Applied Sciences and Arts Northwestern Switzerland and his Bachelor’s from Cairo University in Veterinary Medicine.
|Sina Adibi||Adaptive Clinical Systems|
Sina Adibi has over 25 years of experience in healthcare and life sciences informatics and business process outsourcing. As CEO, founder of Adaptive Clinical Systems, Sina brings to market revolutionary clinical trial data integration software. As a thought-leader in the healthcare industry with previous stints as CTO at Paraxel, Inc. and Thomson-Reuters Scientific and Healthcare, Sina frequently speaks at conferences and educates his constituency on clinical trial data protocol and efficacy.
|Gail Adinamis||GlobalCare Clinical Trials|
Gail Adinamis has 40 years of comprehensive global clinical trials experience is founder and CEO of GlobalCare Clinical Trials, a global patient-centric service organization that conducts study visits at patients’ homes or alternate settings via a global network of mobile healthcare providers to support traditional, virtual or hybrid studies
Director, Patient & Physician Services
As Director of UBC’s Patient & Physician Services, she brings 20 years of industry experience, providing oversight & strategy on site feasibility, patient & site recruitment, and patient retention programs for clinical, late stage, & safety programs. Her work with NIH drives her passion for supporting rare disease programs−especially around patient/caregiver engagement and stakeholder awareness. Her work with patient advocacy groups ensures efficient strategies are in place throughout a clinical program.
|Demissie Alemayehu, PhD||Pfizer|
Vice President, Biostatistics, and Head of Statistical Research and Data Science
Demissie Alemayehu, PhD, is currently Vice President and Head of Statistical Research and Data Science Center (SRDC) in the Global Biometrics and Data Management organization at Pfizer Inc. He has over 25 years of leadership experience in the pharmaceutical industry and has held positions of increasing responsibility within Pfizer since 1995. Over the years, he has been involved in extensive regulatory submissions and life-cycle management in major therapeutic areas. Demissie has been influential externally, with decades of research and teaching experience at major institutions, including Western Michigan and Columbia universities. He has held important offices at key professional societies and has served on editorial boards of major journals. He is an elected Fellow of the American Statistical Association and holds a PhD degree in Statistics from the University of California at Berkeley. He has published extensively on pertinent statistical topics in refereed journals, and his current areas of focus include precision medicine, Big Data analytics, and health technology assessment.
Managing Director, R&D Life Sciences Consulting, Life Sciences
Dawn is a managing director in Deloitte Consulting LLP’s life sciences consulting practice. She has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with biopharma and CRO clients to design and deploy global operating strategy, performance improvement, and technology implementations across drug development.
|Julia Andrews, MPH||UBC|
Strategic Feasibility Manager, Program Delivery
Julia Andrews has worked in the pharmaceutical industry for over five years gaining diverse experience in biomedical research at an academic medical center, a CRO and a pharmaceutical company. She is currently a strategic feasibility manager at UCB, a global biopharmaceutical company where she leads feasibility activities for clinical trials, planning enrollment scenarios and selection of countries and sites. As part of study startup, Julia has worked hard to support CRO partnerships for successful program delivery. She is from Raleigh/Durham and enjoys being a new mom.
|Jonathan Andrus||Clinical Ink|
Chief Buisiness Officer
As Chief Business Officer, Jonathan leads Clinical Ink’s solution management and compliance teams to help organizations better leverage eSource, eCOA and ePRO data. With more than twenty years of experience, Mr. Andrus brings expertise developing eClinical services that integrate data and technology to help companies optimize study execution. At Clinical Ink, Mr. Andrus focuses on P&L across Clinical Ink’s products and services, and he is also focused on building relationships and forging strategic partnerships.
Head, Quality and Operations for Process and Procedures, Quality and Operations
Odette Anyangwe is the Head of Quality and Operations for Process and Procedures at Roche. senior Leader, within the Pharma industry, with extensive experience in shaping strong business performance and strategies, defining and delivering Quality, Compliance and Training objectives with particular focus on a performance driven culture. I have over 15 years of experience in Phase I - III trials in the Pharmaceutical and Public Health sectors, with broad international experience in Medical, Scientific Research and Operations. She works with multidisciplinary teams on major projects across the public and private sectors involving quality practices and an all-encompassing approach to quality risk management. She also has experience in performing audits and supporting regulatory inspections. She is a member of TransCelerate's Quality Management System workstream.
Founder & CEO
Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations and consulting engagements. Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog and much more where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became an Amazon’s #1 New Release in the pharmaceutical and biotechnology category.
Drawing on his engineering background, and inspired by his work in clinical research, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s industry-leading workflow and document management software was born. Since then, Rick has built a world-class team experienced in clinical research. He is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS.
Central Monitoring Manager, Risk Management - Central Monitoring
Ritsuko Ashby is a Central Monitoring Manager in Janssen R&D’s Risk Management – Central Monitoring Group. She has implemented ARBM for Pharma and Medical Device trials. Prior to joining Janssen R&D, Ritsuko had over 10 years of experience in Data Management in Johnson & Johnson Medical Device sector and several years at a local government office in Japan.
Associate Director, Vendor Management
I have almost 20 years of experience in the Biopharmaceutical and Medical Device industries in various disciplines such as project management, software development and validation and auditing with the most recent and current experience in global strategic vendor management to drive sustainable value of outsourcing relationships. I hold an MBA and BA from the Lake Forest Graduate School of Management and The University of Texas at Austin, respectively.
|Justin Bandura, JD||Boehringer Ingelheim|
Contract Manager, Clinical Operations
Justin Bandura is a Clinical Trial Contract Manager at Boehringer Ingelheim and an attorney admitted in Connecticut. Prior to his career in pharma, he was in sales for over a decade in the areas of medical device and industrial outsourcing. Heavily influenced by his time in medical device sales, Justin brings a collaborative approach to clinical contract negotiations focused on long term sponsor-site relationships.
|R. Alex Barbieri, PhD||Tessella|
Senior Analytics Consultant
Alex is a senior analytics consultant with Tessella, Inc, using machine learning and AI techniques to solve problems in a variety of domains including oil & gas, consumer goods, and pharmaceuticals. He holds a PhD from MIT where he studied High Energy Nuclear Physics and has worked on drug discovery acceleration, root cause manufacturing analysis, and predictive modeling for pharmaceutical clients while at Tessella.
|Tricia Barrett||Praxis Communications, LLC|
Senior Vice President, Managing Director
Tricia Barrett is the Managing Director at Praxis, leading the day-to-day management of the business. A member of the Praxis team since 2003, Tricia oversees all Praxis operations from proposal generation through completed, enrolled studies. Her experience encompasses a wide range of therapeutic areas and tactical strategies, which brings a unique approach to patient recruitment that focuses on both sound science and innovative execution.
Distinguished Scientist & Scientific Associate Vice President
Dr. Bateman is currently Scientific Associate Vice President and the Scientific Lead for Bioanalysis in the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck & Co. where he has worked for over 20 years. He is the co-founder of the Merck Smart Trials initiative aimed at enabling a more patient-centric clinical trial approach. A major focus of his research is on developing and implementing patient-centric sample collection technologies to enable remote studies.
Senior Vice President, Safety Solutions, Scientific & Regulatory Review
An expert in the field of safety reporting technology, Steven has 25 years of experience, and has spent over 16 years in pharma. In 2015, he led implementation of the Clinical Trial Safety Portal at a top 5 pharma, which included a data-driven rules engine configured with safety regulations from those countries, which saved this organization millions of dollars. Over 50 million safety alerts have been distributed by these two portals via the cloud.
|Andree Beckerling, PhD||CLARINESS|
Andree and his team are committed to delivering valuable patient focused solutions for pharma, medical device and biotech companies in need of patient recruitment, patient retention and patient insight services. Over the last 20+ years Andree has served as CEO, CMO as well as in multiple other executive and operational leadership roles in the CRO industry. During this time, he gained extensive experience while managing and closely supervising clinical development programs in major therapeutic areas across the globe.
|Jef Benbanaste||Acorn AI by Medidata, a Dassault Systèmes company|
Senior Director, Product Lead
Jef Benbanaste is a Senior Director and Product Lead for Acorn AI’s Intelligent Trials offering. He has 15 years of experience improving business processes and decision-making through the use of technology and analytics.Jef previously led projects at global insurer AIG which applied predictive modeling and machine learning techniques to improve risk segmentation and shape business unit strategies. He has also worked as a technology consultant at Deloitte with customers across different industries.
|Michael Benecky, PhD||GlaxoSmithKline|
Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office
Mike received his BA in Biochemistry from the University of Wisconsin-Milwaukee and PhD in Biophysical Chemistry from Princeton University. Mike continued his academic research career as a Post-Doctoral Fellow at Northwestern University and as an Assistant Professor at the University of Wisconsin Medical School-Milwaukee Clinical Campus. Mike gained expertise in the preparation of FDA IDE and PMA medical device submissions for lasers used for vision correction surgery at Bio-Reg Associates. At QIAGEN (formerly Digene), Mike led the Regulatory /Clinical Affairs Group that prepared numerous FDA PMA submissions for the first FDA approved HPV DNA test for cervical cancer screening. Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in Precision and Digital Medicine located in Research Triangle Park, North Carolina. Mike currently assists GSK Teams in regulatory strategy during use of digital health technology in both clinical trial and commercial settings. Recent projects include the commercial launch of the MyAsthma mobile medical app in the EU and inclusion of digital sensors and mobile apps within GSK clinical development programs.
|Jasmine Benger||Center for Information and Study on Clinical Research Participation (CISRP)|
Senior Project Manager, Research Services
Jasmine Benger is the Research Services Senior Project Manager at CISCRP. She is responsible for supporting the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards and workshops. Prior to CISCRP, she has over 5 years of experience working in the public health field specifically with maternal and child populations in a variety of different capacities. She holds a Bachelor of Science in Nutrition from Framingham State University.
Senior Director, RWE, Clinical Operations
Since joining in 2003, Mr. Berger has held a range of diverse roles leveraging global capabilities in the execution of peri and post marketing product development programs and Real World Evidence generation. In this role, Mr. Berger supports the development of RWD / RWE architectures and solutions to drive greater insight into the safety profile and value proposition of medicines.
No bio available
|Deena Bernstein, MHS||Amplified Clinical Research Consulting Services, LLC|
Entrepreneurial fearless spirit with grit that is unstoppable. During my historical career trajectory, I have been instrumental in designing and building infrastructure of research site management organizations from inception and have led them to achieve success in the clinical research industry. Areas of expertise are creating value to organizations and employees, building high performing teams, developing strategy, patient recruitment and enrollment, conscious leadership, employee empowerment, strategic partnerships, integration, on-boarding, and achieving KPI's.
Process Excellence Leader and QTL Topic Team Lead
Ruma Bhagat MPH, MBBS is a Senior GCP Strategy Lead, Site Innovation Group Lead at Genentech. She has over 15 years of experience in clinical research, specializing in GCP, project management and design thinking. She is also a subteam lead on TransCelerate BioPharma's Interpretation of Guidances and Regulations workstream.
Associate Director, Risk Management and Central Monitoring
No bio available
|Karina Bienfait, PhD||Merck|
Principal Scientist & Head, Global Genomics Policy, Process & Compliance
Karina Bienfait, PhD is a Principal Scientist in Translational Medicine at Merck Research Laboratories, and the head of Global Genomics Policy, Process and Compliance (GPPC). As head of GPPC, Dr. Bienfait works closely with Merck’s global subsidiaries to evaluate global laws and regulations pertaining to genomics and biobanking; and to develop strategies to address countries recalcitrant to genomic research. In this capacity, she works closely with global health authorities and ethical boards to negotiate approvals for genomic research in the context of Merck’s clinical trials. Dr. Bienfait also oversees the development of Merck policies, processes, and consent related to genomic research, and is responsible for ensuring compliant use of biospecimens. Dr. Bienfait 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’ Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a BA in Psychology and French from New York University.
Vice President, RTSM
Kevin is a recognized clinical research senior executive with more than 30 years of operational and business leadership experience, the last 20 years of which have been in the high-growth eClinical technology space. In his current role, Kevin is responsible for driving the growth strategy for the Randomization & Trial Supply Management (RTSM) business. Prior to Bioclinica Kevin led the RTSM and clinical logistics solution business at PAREXEL.
|Jennifer Bolton||Boston Scientific Corporation|
Senior Fellow, Regulatory Affairs
Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions. Jennifer has 24 years of Regulatory experience. She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device. She’s currently working with transcatheter aortic and mitral repair/replacement technologies, facilitates a Regulatory Strategy Board, and volunteers with a local Medtech Accelerator for early-stage startups. Jennifer previously supported global strategies for some of Boston Scientific’s left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons and guidewires, and vascular surgery grafts/fabrics. Prior to Boston Scientific, Jennifer worked with orthopedic implants at US Medical Products (now Consensus Orthopedics).
|Jeffrey Botkin, MD||University of Utah|
Professor, Pediatrics and Medical Ethics
Jeffrey Botkin is a Professor of Pediatrics and an Adjunct Professor of Human Genetics and Internal Medicine at the University of Utah. He is the past Chief of the Division of Medical Ethics and Humanities and served as the Associate Vice President for Research Integrity from 2002 to 2019. Dr. Botkin is the Principal Investigator for the NIH funded University of Utah Center of Excellence for Ethical, Legal and Social implications of human genetics. He is a member of the National Advisory Council for the National Human Genome Research Institute and a member of the NIH Council of Councils. He is the recent Chair of the DHHS Secretary’s Advisory Committee on Human Research Protections and a former member of the Secretary’s Advisory Committee on Heritable Diseases in Newborns. Dr. Botkin chaired the consensus committee for the National Academies of Science, Engineering and Medicine’s for its 2018 report on the Return of Individual Research Results.
|Chuck Bradley||FibroGen, Inc.|
Vice President, Clinical Development
Charles Bradley is VP Clinical Development and Head of Clinical Operations at FibroGen Inc. located in San Francisco, CA. Dr. Bradley is an experienced clinical research professional with an in-depth background in all phases of drug development. He is a seasoned senior manager with knowledge of resource allocation, portfolio management, budgetary processes, outsourcing strategies, and regulatory requirements associated with drug development. He has expertise in driving clinical programs forward in entrepreneurial environments, smaller biotech companies, and large traditional pharmaceutical companies. Chuck received his Ph.D. in bioanalytical chemistry from the University of Delaware, received post-doctoral training in Clinical Pharmacology at Uniformed Services University, and is Board Certified in Applied Pharmacology.
|Loni Brannon||Pharma Intelligence – Informa|
Senior Director, Sitetrove, Citeline Engage, and Strategic Partnerships
Loni Branon is Senior Director of Citeline’s Sitetrove, the pharma industry’s most comprehensive clinical investigator and trial site intelligence solution, and the new Citeline Engage offering, which combines the industry’s most comprehensive clinical trial intelligence suite with the leading online community of verified healthcare professionals (HCPs) powered by Skipta. Loni oversees data content and analyst support services for Sitetrove and Citeline Engage, and works closely with clients on solving their site feasibility challenges by developing strategies to optimize country level decisions and identifying the best, most experienced clinical investigators and trial sites for their clinical programs. Loni is also part of Citeline’s Strategic Partnerships team supporting clients with integrating and analyzing multiple data sources into a technology solution that works best for their work flow.
|Michael Brooks||Covance Inc.|
President, Clinical Development and Commercialization Services , Covance Drug Development
Michael Brooks assumed his role as the president of clinical development and commercialization services on December 20th of 2019. Previously, he served as the Chief Operations Excellence Officer for LabCorp, focusing on its transformation to the “lab of the future,” digitizing the delivery of diagnostics and creating a unique lab experience and providers. Prior to that, he spent mor than 20 years in the CRO industry and held global leadership roles in product development, project management, clinical operations and customer management across multiple therapeutic areas.
MD, DPhil, Chief Medical Officer
Professor Brendan Buckley is a medical graduate of University College Cork and a doctoral graduate in Biochemistry of Oxford University. He brings more than 40 years of experience in academic clinical practice as a physician in endocrinology, diabetes and clinical pharmacology. He chairs the board of Fighting Blindness and is a member of the board of Breakthrough Cancer Research. With more than 150 scientific papers published, Brendan also co-authored the opinion-leading book Re-Engineering Clinical Trials.
|David Burrow, PharmD, JD||FDA|
Director, Office of Scientific Investigations, Office of Compliance, CDER, FDA
David Burrow currently serves as the acting Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, he is responsible for the strategic administration of CDER’s pre-, and post-market Bioresearch Monitoring (BIMO) programs – including all administrative, advisory, and enforcement actions taken by the office.
|Jennifer Bush||Oracle Health Sciences|
Director, Product Strategy, Product Management
With over 20 years of industry experience in both business and IT environments, Jennifer has worked in large pharma, large CRO and IT, managing data transformation and loading, eClinical implementations including implementation of EDC, clinical trial management and other clinical systems. Jennifer now works as a Life Sciences Product Strategist at Oracle focusing on clinical trial planning and management, risk based monitoring and RTSM capabilities.
|Bill Byrom||Signant Health|
Vice President, Strategy and Innovation
Bill Byrom has worked in the Pharmaceutical Industry for 28 years. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, Bill is a key strategic thinker helping to shape the direction and application of eClinical solutions. Bill is a thought leader in patient-facing technologies including electronic patient-reported outcome solutions, the use of wearables and connected devices, and new novel technology-derived endpoints.<
|Walt Cao, PhD||Zeta Therapeutics, Inc.|
Dr. Walt Cao has 17+ years combined experience in academia, pharmaceutical industry (Boehringer-Ingelheim and Abbvie), and U.S. Food and Drug Administration (FDA) for Hematology/Oncology products clinical translation and clinical development and marketing application. Dr. Cao was the Primary Clinical Pharmacology Reviewer for OPDIVO ((nivolumab) 2014) approval in the first indication of melanoma in FDA and had been the primary or secondary reviewer for other over 10 NME NDA/BLA applications, and other over 500 IND phase 1-phase 3 clinical trial protocols and meeting packages. Dr. Cao has extensive experiences for both new chemical entities (NCE) and new biological entities (NBE) drug development and marketing application.
Associate Director, Clinical Budget Management
No bio available
|Cindy Casaceli||University of Rochester Medical Center|
Director, Clinical Trials Coordination Center
Ms. Casaceli has over 20 years of experience in the conduct of multi-center clinical trials and has overseen the operation of the Clinical Trials Coordination Center (CTCC), which is an academic based research organization (ARO). Her background is in Biochemistry and Computer Science. She has an MBA in Computer and Information systems and training in team leadership. Over the last 10 years in her position as the Director of the Clinical Trials Coordination Center she provides oversight and guidance on multiple studies incorporating digital tools.
Section Manager, Clinical Planning & Resource Management
Jamie earned her Bachelors of Science in Allied Medical Professions degree (Health Information Management and Systems) from The Ohio State University. She has been working for Abbott Nutrition for over 16 years where she has held positions of increasing clinical, operational, budgetary, and leadership responsibilities. In her current role, Jamie manages the Clinical Planning and Resource Management department. This group is mainly responsible for project management activities, ranging from creating project plans (cost, timing, resources) for potential clinical studies to negotiating study budgets and contracts for approved clinical studies. The group acts as a clinical research liaison for many departments, including Project Management, Clinical Operations, Legal, Procurement, Nutrition Science, and Finance.
|Emily Castellanos, MD||Flatiron Health|
Associate Medical Director
Emily Castellanos is a board-certified medical oncologist and hematologist who serves as associate medical director at Flatiron Health, where she performs outcomes research focusing on the generation of real-world evidence. She has published in thoracic oncology as well as health services on topics including patient treatment preferences, financial hardship and changes in insurance coverage for cancer patients following the Affordable Care Act. Emily earned her BS with distinction in biological sciences from Stanford University. She then received her medical degree from Vanderbilt University Medical Center, where she remained for her clinical training. She completed her residency in internal medicine, and after serving as chief resident she remained at Vanderbilt for her hematology/oncology fellowship. Prior to coming to Flatiron, she served on the faculty in the division of hematology/oncology at Vanderbilt University Medical Center and earned her MPH with a focus on health policy.
Risk Based Monitoring Program Lead, Clinical Sciences and Operations, Global Product Development
No bio available
Executive Director, R&D Finance
Chris Chan is Senior Director of R&D Finance at FibroGen, Inc, and has over 25 years industry experience, including 20 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). Chris is participating in his 6th SCOPE conference as a speaker.
Senior Director, DevOps
No bio available
|Victor Chen||Kaiser Permanente Northern California|
Managing Director, Clinical Trials Program
No bio available
|Shurjeel Choudhri||Bayer Inc.|
Senior Vice President, Head, Medical & Scientific Affairs
Dr. Choudhri is the Head of Medical and Scientific Affairs for Bayer Inc. He joined Bayer Corporation in 1999 and has had significant experience with the Bayer US and Global medical organizations. Before assuming his current role as Head of M&SA in Canada, Dr. Choudhri was a Global Clinical Leader, Anti-Infectives with Bayer Global Clinical Development. Prior to joining Bayer, Dr. Choudhri was an assistant professor in the Departments of Medical Microbiology and Internal Medicine at the University of Manitoba in Winnipeg.
|Allan Chow, PharmD||Amgen|
Senior Manager, Quality & Compliance Risk Management
Allan Chow received this BS of Pharmacy and Doctor of Pharmacy degree from Rutgers the State University of NJ in 2003. During his studies in pharmacy school, Dr. Chow had worked in retail pharmacies including CVS and Walgreens. After graduation, Dr. Chow took and past his board of pharmacy exam and became a registered pharmacist. Dr. Chow started his career in the pharmaceutical industry back in 2003 when he joined Pfizer as a Drug Safety Specialist, since then he has held numerous positions in both Drug Safety, Regulatory Affairs as well as Quality Compliance. He has more than 15 years of experience in the pharmaceutical industry and has worked in different companies such as Pfizer, Hoffmann-La Roche, Sanofi and presently Amgen. During his time with Sanofi, Dr. Chow completed his MBA program with Northeastern University with a specialization in Healthcare. Dr. Chow moved to the West Coast and joined Amgen in May 2015 working within Global R&D Compliance & Quality and is currently the global business process owner for Quality Risk Management.
|Stephanie Clark||Janssen R&D (J&J)|
Director, Risk Management-Central Monitoring
Stephanie Clark is a Director in Janssen R&D’s Risk Management-Central Monitoring Group, which is dedicated to the implementation of Analytical Risk-Based Monitoring on clinical trials. In this role, Stephanie has contributed to the creation and management of processes, technology, and resources to support an analytical and risk-based model of clinical trial management and monitoring that has now supported more than 170 clinical studies across multiple sectors at Johnson & Johnson (including Pharma, Medical Devices, and Consumer products). She has also participated as a member of the TransCelerate BioPharma Risk-Based Monitoring Initiative. Stephanie has over 15 years of experience in clinical research and drug development. Prior to her ARBM-focused work, she worked in clinical trial and site management at Janssen R&D and Centocor R&D, at RPS, Inc and at ICON in a variety of therapeutic areas and also in basic immunological research at Children’s Hospital of Philadelphia.
|L. Scott Clark, PhD, ASQ-CQA||CRISPR Therapeutics|
Senior Director, GCLP Quality Assurance
L. Scott Clark has over 18 years’ experience in the pharmacogenomics and biospecimen fields. Dr. Clark currently works at CRISPR Therapeutics in Quality Assurance. He is a CAP laboratory and biorepository accreditation inspector was the CAP Biorepository Director at Gentris Corporation/Cancer Genetics.
President & CEO
Ivor Clarke, CEO of SubjectWell, has 15+ years of C-suite experience in online marketing and SaaS solutions. SubjectWell, the first risk-free clinical trial marketplace for patient recruitment, raises awareness to engage patients who have not participated in clinical trials. Previously, Clarke co-founded Brightfire and Hoot Call. He has degrees in human computer interaction and information and decision systems from Carnegie Mellon University.
Director, Pricing Analysis
Catherine joined Greenphire in August in support of the vision to disrupt the status quo, from study planning to closeout. Prior to Greenphire, she worked in Contracts & Grants at Janssen R&D with passion for and subject matter expertise in Oncology and Infectious Diseases & Vaccines. She received her BA from Drexel University and calls Raleigh, NC home. Her heart and soul are her husband, toddler, and three miniature dachshunds.
Vice President, Global Life Sciences & Healthcare
Evi Cohen has over 19 years of pharmaceutical industry experience in Legal Affairs, Research & Development, Quality Assurance, Regulatory Affairs and Project Management. In his role at Appian he is responsible for ensuring client success and continued steady growth in license revenues across all pharmaceutical and healthcare clients. His previous positions include Vice President of Global Innovation & Portfolio Management at Catalent Pharma Solutions and Director of Legal Affairs at Teva Pharmaceuticals.
Product Lead, Shared Investigator Platform Life Sciences Products & Platforms
Larissa drives adoption of the Shared Investigator Platform across the clinical ecosystem. With extensive experience in clinical trial informatics and technology, especially in oncology, Larissa led strategy and products for Medidata, Thompson Reuters, and Eviti (now NantHealth). She helped transform the Coalition of Cancer Cooperative Groups into a national leader in cancer-trial matching services and patient advocacy during her nine-year tenure. Larissa earned her Masters in Journalism from Temple University.
Executive Vice President, Product Development
No bio available
|Anca Copaescu||Clinical Maestro by Strategikon Pharma|
CEO and Founder
Anca has over 15 years of experience in the industry, working both on the CRO and the Sponsor side. She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical MaestroTM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Prior roles included Head of Clinical Outsourcing and Analytics at BioMarin, Strategy/M&A at both PharmaNet (Syneos) and ICON.
Senior Vice President, mHealth
No bio available
|Erin Creedon||Ethicon (J&J)|
Associate Director, Clinical Operations
Erin Creedon is an RN with over 20 years of experience in clinical research, both in the pharmaceutical and medical device sectors. Prior to her career in research, Erin worked as a medical-surgical RN before transitioning to her role as a research nurse. She then worked with a mid-sized CRO as a lead site manager and training and development associate for over 8 years. She has been with Ethicon’s clinical operations group for over 11 years where she currently is Ethicon’s global clinical operations leader. In this role, Erin and her team are responsible for the oversight and management of all Ethicon’s sponsored clinical trials. Erin led the pilot initiatives to introduce targeted source data verification and adaptive onsite/offsite monitoring into clinical trials at Ethicon. Over the last few years she has partnered with colleagues in the J&J pharmaceutical sector to leverage their ARBM efforts for the harmonization of tools and processes so that ARBM could formally be utilized in the medical device space.
|Cathy Critchlow, PhD||Amgen|
Vice President, Center for Observational Research
As Head of the Center for Observational Research (CfOR), Dr. Critchlow provides operational and strategic leadership for the design and conduct of observational research within Amgen. The CfOR Real World Data (RWD) Platform provides widespread access to patient health data and visualization and analytic tools based on innovative technologies to aid teams in the generation of real-world evidence in support of drug development and commercialization of Amgen products. Dr. Critchlow joined Amgen in 2004 where she led a number of Therapeutic Areas within Global Epidemiology prior to being named Head of CfOR in 2012. Prior to joining Amgen, Dr. Critchlow was a faculty member in Epidemiology at the University of Washington. Dr. Critchlow was a member of the Endocrinologic and Metabolic Advisory Committee of the Food and Drug Administration and has served on a number of research review committees for the National Institutes of Health. Dr. Critchlow earned her Bachelor’s Degree from Stanford University, and both her Master’s Degree in biomathematics and her doctorate degree in epidemiology from the University of Washington. Dr. Critchlow is an Affiliate Professor of Epidemiology at the University of Washington and a Fellow of the American College of Epidemiology.
Digital Platform Leader
Michelle Crouthamel is the digital platform leader of the Clinical Innovation Unit at GlaxoSmithKline (GSK). Michelle’s passion for driving patient-centricity in the pharmaceutical industry led her to become an ‘Intrapreneur’ at GSK, and the founding member of the Clinical Innovation Unit, which focuses on harnessing digital technologies and platforms to improve patient engagement and clinical trials. Michelle is currently leading the strategy and pilot programs of e-Recruitment and m-Health platforms, and is involved in the industry-wide consortium, TransCelerate, eSource work stream. Over past 15 years, Michelle led many successful programs in discovery and development at both Merck and GSK, is an inventor who holds multiple patents, and has published extensively in the areas of Neuroscience, Oncology, and Digital Health. Michelle has a Master’s Degree from the Institute of Neuroscience, and a Bachelor’s degree in Nursing from the National Yang-Ming University, Taiwan. She is currently pursuing a doctoral degree at Fox Business School, Temple University with a research focus on the Patient-Centricity in the pharmaceutical industry.
|Chris Crucitti||Signant Health|
Chief Commercial Officer
Christopher L. Crucitti, MS, leads the commercial functions of Signant Health, as well as the go-to-market strategy, to drive the continued growth of our already market-leading clinical technology solutions. Chris brings significant experience and expertise in the clinical and R&D domains. He has led organizations to significant revenue and profitability growth, while maintaining a high level of customer service and quality delivery. Chris holds an MS from American University and a BS from Ithaca College.
Chief Product Officer
Kyle Cunningham leads the strategic direction of Greenphire’s solution development, ensuring that our product innovation roadmap is constantly evolving to solve relevant healthcare industry problems.
Kyle has two decades of experience across multiple industries and in a variety of roles spanning innovation, operations management and client experience. Prior to joining Greenphire, Kyle worked for SEI Investments (Europe) where he managed product and service innovation for global asset management.
Global Head, Clinical
No bio available
|Laura Davis||Janssen Pharmaceuticals, Inc.|
Business Technology Leader, Biotherapeutic Development, Information Technology
As the Business Technology Leader for Biotherapeutic Development at Janssen, Laura is responsible for the technology strategy that supports the development of safe, quality, biotherapeutic products that comply with Good Manufacturing Practices and International Regulatory Guidelines. In her 12 years of service at J&J, she has spanned roles in R&D, Quality, and IT across the Pharmaceutical and Medical Device industries with major focuses on laboratory integration, Chain of Custody, and Product Complaint/Regulatory Reporting. She is married with a 3-year-old son and lives in the Philadelphia suburb of Pennsylvania. She graduated from University of Pittsburgh with a BA in chemistry.
Director, Development Design Center
No bio available
|Eric Delente||IQVIA Technologies|
Head, Patient Consent
Eric Delente, known as a pioneer of eConsent, heads the patient consent group for IQVIA Technologies. An entrepreneur at heart, Eric has over 20-years of experience leading technical and creative teams in the design and development and of numerous award-winning applications for the medical, academic and research communities. Co-founder of SecureConsent (acquired by DrugDev now IQVIA), he designed and developed pharma’s definitive eConsent solution, used on over 200 trials worldwide.
|Glynn Dennis Jr., PhD||AstraZeneca|
Senior Director, Digital Health R&D & BioPharma AI
Glynn's team works at the intersection of patients, wearables and AI. Glynn holds a PhD in molecular biology and has been applying machine learning to biomedical problems for more than 20 years.
|Robert DiCicco, PharmD||IBM Watson Health|
Deputy Chief Health Officer
Rob DiCicco is currently the Deputy Chief Health Officer at IBM Watson Health. Rob previously served as Vice President of the Clinical Innovation and Digital Platforms Group at GlaxoSmithKline. He was also the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate BioPharma and one of the Team Leaders for CTTI's Novel Endpoints Work Stream as part of the mHealth in Clinical Trials Initiative. Rob has more than 25 years of experience in clinical development in a variety of leadership positions in CRO, mid-sized and large pharmaceutical companies. He received his Doctorate of Pharmacy degree at the University of the Sciences of Philadelphia. Over the course of his career he has had a key role in the development of a number of successful new medicines. Rob’s area of expertise includes clinical pharmacology and experimental medicine, innovative clinical trial design, project management and ethics in human research.
|Sina Djali||Johnson & Johnson|
Head, Clinical and Operations Analytics
Sina Djali has over 25 years of experience in drug and clinical development in various companies and academia. Currently he is the Senior Director Head of Integrated Clinical and Operations Analytics in Global Clinical and Development Organization in Jansen Pharmaceuticals. In this role Sina is responsible for incorporating Risk Management Principals in the day to day R&D clinical operations and coordinating data warehousing and analytics solutions in support of clinical trial conduct. Prior to this role, Sina has served in several functions in Analytical Risk Based Monitoring, Quality, Regulatory Affairs and Neuroscience Research at Janssen R&D, Wyeth Pharmaceuticals and Sanofi Aventis Pharmaceuticals.
No bio available
|Keith Dorricott||Metrics Champion Consortium|
Keith Dorricott is an Ambassador for the Metrics Champion Consortium and the Director of Dorricott Metrics & Process Improvement Ltd. He worked in R&D, process development, packaging technology and manufacturing whilst at Kodak Ltd. In 2005 he moved industry into the area of clinical trials and worked for two major CROs leading corporate process improvement. He qualified as a Black Belt in Six Sigma in 2002 and a Master Black Belt in Lean Sigma in 2007. He assists the Metrics Champion Consortium (MCC) by facilitating work groups on centralized monitoring, central lab metrics, vendor oversight, Imaging, and by developing tools to assist with risk assessment and control. He received the MCC Champion Award in 2016 for making significant contributions to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. Keith regularly presents at conferences on the definition and use of metrics as well as the practicalities of quality risk management and risk-based monitoring.
|Eleanore Doyle||Syneos Health|
Executive Vice President, FSP Strategic Solutions
Eleanore Doyle, Executive Vice President, FSP Strategic Solutions Syneos Health, has a keen appreciation for identifying and optimizing customer objectives. She is responsible for building and maintaining long-term relationships with sponsors, ensuring exceptional customer service, and increasing market reputation for Syneos Health FSP solutions.
|Steven Draikiwicz, MD||Sanofi|
Global Digital Medical Lead
Steven Draikiwicz is the Global Medical Bioinformatics Lead at Sanofi. He is responsible for the global deployment of real-world data, artificial intelligence and digitalization in Clinical Sciences Operations. His background includes a Medical Degree from Drexel College of Medicine, with board certification in Internal Medicine and sub-specialization in Allergy and Immunology. Prior to his current role at Sanofi, he has been a key contributor to the Dupixent and anti-IL-33 programs including the Dupixent submissions for asthma and nasal polyposis.
|Anand Dubey||Saama Technologies|
Associate Director, Business Solution Architect
Anand Dubey joined Saama Technologies in April 2017 as Business Solutions Architect, and is responsible for RWE product and solution development for clinical operations group. Prior to joining Saama, Anand worked at Genpact, a global professional services firm, where he focused on technology-enabled solutions for various groups like clinical, data sciences and commercial teams.
Global Operations, R&D, Lead, Managing Director, Global Operations
Jennifer Duff is a Managing Director in the Accenture Life Sciences North America Operations practice. She has over 20 years of experience in the life sciences industry and over 15 years of experience in business process outsourcing. Jennifer leads Accenture’s Life Sciences Operations business, is responsible for shaping the innovation agenda at our most strategic clients and works extensively in the delivery of Clinical Data Management Services.
|Kate Dugan||Global Specimen Solutions, Inc., a Covance Company|
Client Engagement Director
Ms. Dugan possesses a unique combination of skills and experience in pharmacogenomics, clinical research, business development and operations to understand data needs and the business user to streamline processes and drive improvement. As a trained translational biomarker scientist, she has worked in academia, pharma, CRO, and central labs. Her breathe of experience positions her well to advocate for the voice of the customer and to foster alliance relationships. As a scientific data strategist, she has led many transformational initiatives to implement innovative integrative solutions. Successful partnerships are built with the right mindset and innovative suite of technology tools and services
Feasibility and Recruitment Partner, Director
Marie Eckerd has held leadership positions in clinical data management, project management and global project management throughout a 30- year career in the pharmaceutical industry. Her work today focuses on feasibility and recruitment data analyses for lung cancer studies, serving as chair for the AstraZeneca sponsored oncology clinical study platform, and serves as a member of the EHR strategy workstream, among other special projects. Marie recently completed certification in data analytics to improve drive data-driven decisions in a rapidly evolving clinical development environment.
Associate Director, Portfolio Relationship Management, R&D Procurement
Krista Emmons is an Associate Director of Portfolio Relationship Management in the R&D Procurement function at Astellas Pharma Global Development in Northbrook, IL where she is responsible for strategic business relationships for a portfolio of service providers. She has more than 15 years of experience supporting clinical research activities with key areas of focus in governance implementation, strategic sourcing initiatives, and clinical technology solutions such as IRT and eCOA. Prior to joining Astellas in 2017, she was a Director of Portfolio Leadership at Parexel Informatics.
|Marina Escudero||Kiniksa Pharmaceuticals|
Vice President, Clinical Development Operations
After working at sites at the start of her career, Marina Escudero moved to sponsor organizations. During the past 16 years, she’s worked at Amgen, Biogen, Synageva, Ziopharm, and Tarveda. At Kiniksa, Marina currently leads clinical operations, data management, and medical writing. She has built the CDO group to oversee three functions and four clinical programs and has implemented automation processes using real-time data dashboards.
|Mike Eveland||PRA Health Sciences|
Executive Director, Business Development
No bio available
|Todd Everhart||Signant Health|
Clinical Vice President, Internal Medicine
An Innovator, educator, and leader in the pharmaceutical and biotechnology industries with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical research. Board-certified in Internal Medicine and a Fellow of the American College of Physicians, he has worked in all phases of clinical development in numerous therapeutic areas and is an expert in medical monitoring, medical data review, data visualization, data analytics, and technology adoption.
Senior Director, Head of Global Feasibility
Michelle Everill, Global Head of Feasibility at Janssen, is developing a global feasibility center of excellence with a significant focus on data analytics and strategic application. She has been working to improve feasibility and site selection in both pharma and CROs since 2010. Before then, her career started working as a study coordinator and patient recruitment specialist at a site and then in Clinical Operations at CROs. Michelle’s passion is developing people and teams to discover new ways of brining more impactful products to market more efficiently, increasing quality of life and finding cures for patients across the world.
|Jane Fang, MD, MS||AstraZeneca|
Director, Leader of Digital Clinical Innovations, RWD/RWE for Clinical Trials
Jane started career as physician scientist with training in healthcare management and informatics. She has 25 years of broad experiences across from medical practice, clinical, immunology research to clinical innovation strategy and advanced analytics in healthcare and biopharmaceutical industries. Jane has provided various leadership roles in building clinical innovations, RWE/RWD practice for clinical trials and digital capabilities to enable better clinical research and trial delivery.
|Jeremy Faulks, PharmD||Thrifty White Pharmacy|
Director, Specialty Pharmacy and Pharmacy Procurement, Pharmacy Operations
Jeremy leads the specialty pharmacy division for Thrifty White Pharmacy. In his current role, he is focused on building and enhancing Thrifty White’s specialty pharmacy offerings. Thrifty White’s pharmacy model is built around driving quality and patient outcomes through the patient-pharmacist relationship, and by creating strong local partnerships across the communities they serve. Prior to joining Thrifty White, Jeremy was senior manager of specialty pharmacy at Target, where he managed all aspects of Target’s specialty pharmacy program, including operations, strategic planning, and team development. Over the past 8 years he has championed specialty at retail programs and the power of the in-person, patient-pharmacist relationship. Jeremy obtained his Doctor of Pharmacy from the University of Wisconsin, where he graduated with a focus on business management.
|Christina Fawcett||PRA Health Sciences|
Senior Director, Operations
Christina is responsible for providing oversight and support for post-marketing and real-world evidence studies. Her role includes developing and overseeing operational strategy and risk mitigation/management, as well as financial and quality oversight. She has experience with a wide variety of study designs, including interventional studies and long-term disease monitoring studies, disease and product registries, and retrospective data collection.
Practice Leader, Applied Analytics & Artificial Intelligence
Gabriela has spent 20 years in various roles across both pharma and CROs with much of her recent focus spent on building and leading highly effective global feasibility, site selection and patient engagement organizations. Gabriela’s current role as Practice Leader within the Data Science and Artificial Intelligence organization has continued to refine this mission with an additional emphasis on extracting maximum value for our patients by leveraging data science to provide valuable insights to better select investigators for clinical studies. Previously she has led global Feasibility, Site Selection and Patient Engagement groups at Covance and UCB. Prior to UCB, Gabi spent over ten years at Quintiles where she held positions of increasing responsibility. Gabi also held positions at Kimberly-Clark and Cordis earlier in her career. Gabi received her B.S. Degree in Chemistry from the University of Florida.
Director, Project Management, Americas
Jennifer Fenwick, Director, Project Management, for the Americas region leads a growing team that manages DTP, distribution and logistics projects for Marken’s global clients. Jennifer has 10+ years’ experience in logistics for major diagnostics and pharmaceutical companies in both clinical and commercial aspects. She understands the critical role DTP/DFP can play in getting drugs to market, and how Marken can fulfill the needs of our partners by offering best in class services and solutions.
|Rosalie Filling||Endo Pharmaceuticals|
Vice President, Clinical Operations, Research and Development
Rosie earned her B.S. in Biology, Minor in Chemistry from the University of Pittsburgh. She has 19 years of clinical trial experience. Rosie began her career at PPD as a Research Assistant and moved into her first management position at PPD. She was responsible for the rapid site start-up and ongoing management of enrollment and site regulatory requirements across all therapeutic areas. After 5 years, she left PPD and began her pharmaceutical Sponsor career at Guilford Pharmaceuticals in Baltimore, MD. At Guilford, Rosie was responsible for the overall strategy for execution of clinical trials including the outsourcing needs and overall budget management for all of Research & Development. Guilford was acquired by MGI Pharma. Post the acquisition, Rosie was chosen to lead the new Clinical Operations team to establish a new set of processes and strategy for the new organization. MGI’s focus was on acute care and oncology. The new organization was very successful and was later acquired by Eisai. During Rosie’s tenure at Eisai, she moved into post-marketing and was responsible for executing Oncology and CNS post-marketing trials. Rosie then joined Teva in 2009, where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Rosie joined Lupin in August 2014 to stand up the Clinical Operations Division. She recently joined Endo Pharmaceuticals in February 2018 as Vice President, Clinical Operations accountable for Clinical Operations, Biometrics, and Medical Writing. She has surrounded herself with highly skilled and energized colleagues and has laid the foundation for a successful clinical operations department. Rosie has been an active contributor to 6 NDAs, 8 SNDAs, and 6 ANDAs. Rosie resides with her husband of 18.5 years, Josh. They have 2 daughters Marlee (17) and Chloe (13) and two adorable boxer puppies, Brutus and Bodi. In her spare time you can find her at the gym, hiking or on the sidelines watching her daughters play soccer!
Gerald Finken, RPh, MS, is a licensed pharmacist and has over 37 years of experience in the biotechnology and pharmaceutical industries focusing entirely on pharmacist related activities. He has worked as a community pharmacist, an independent clinical supplies consultant and has held management positions with Bristol-Myers Squibb Company and PRACS Institute, Ltd. In 1997, he founded CSM, where he invented On-Demand packaging and labeling, Clinical Trial Research Pharmacist (CTRP®) services and pioneered Direct-to-Patient services. In 2013, he founded Center Point Clinical Services and subsequently created the innovative Siteless CRO model. He currently serves as CEO for Center Point. Mr. Finken focuses on innovation, disruptive business strategies, and growth opportunities—including the further development of the role of the pharmacist in clinical research. Mr. Finken received his Bachelor of Science degree from Rutgers College of Pharmacy, in New Brunswick, NJ; and his Master of Science degree from Kean College, in Union, NJ.
Vice President, Global Patient Centric Services
No bio available
|Aaron Fleishman||BBK Worldwide|
Director, Market Development
As Director of Market Development for BBK Worldwide, Aaron helps pharmaceutical sponsors, advocacy organizations, and patient thought leaders to create and deploy award-winning, innovative strategies that generate awareness and engagement surrounding clinical research. Aaron’s efforts have resulted in the development of new educational and interactive resources to help improve the overall study participation experience while ensuring that patients and caregivers remain at the center of every campaign.
|Balazs Flink, MD||Bristol-Myers Squibb|
Head, Clinical Trial Analytics
Graduated as a physician, explored medicine from the academic perspective before joining BMS in 2005. Held roles with increasing responsibilities in R&D most recently have led the full integration of the Clinical Trial Analytics group in the newly formed Business Insights and Analytics organization. My main goal in this new corporate wide analytics group is to challenge the status quo, establish common consciousness in R&D and to drive strategy and execution through data and insights.
|Emmanuel Fombu, MD, MBA||Locust Walk|
Dr. Fombu is a recognized authority on the convergence of digital technologies and healthcare. He is an author, physician and medical futurist with over 10 years combined experience in clinical medicine, drug development, medical affairs, research, pragmatic trials and product lifecycle management strategy in biopharmaceutical industry and private equity. His current focus for Novartis is how digital technologies can be leveraged to better measure Novartis product’s real-world effectiveness and value, and also to design more comprehensive disease management systems in partnership with digital health startups, payers and providers. In addition to his book, The Future of Healthcare: Human and Machine Partnering for Better Outcomes, Dr. Fombu has authored multiple research papers and abstracts in renowned peer reviewed journals. As a medical futurist and 2017 winner of the prestigious New York City Health Business Leaders Boldest Digital Health Influencer Award, Dr. Fombu is a champion and advocate for value-based healthcare, personalized medicine, mhealth, nanotechnology, big data, artificial intelligence, machine learning and digital medicine. He serves as an external advisory board member at the Massachusetts Institute of Technology’s MIT.nano project. Dr. Fombu did his clinical training at Emory-Crawford Long Hospital and holds an MBA from Cornell University’s Johnson School of Business and a certification in Artificial Intelligence: Implications for business strategy from MIT’s Sloan school of management and Computer Science Artificial Intelligence Lab. He lives in New York City.
Vice President, Clinical Operations
Darcy Forman is the vice president of clinical operations at Science 37. She joined Science 37 from Firma Clinical Research, a contract research organization (CRO), where she was most recently vice president of corporate development and had previously led global clinical operations. Prior to Firma, Forman held leadership positions in clinical operations at Clinipace Worldwide, a CRO specializing in supporting growth-oriented and mid-tier pharmaceutical and medical device companies. As vice president of clinical operations at Science 37, Forman will manage all aspects of the clinical trial life cycle, from pre-contract study planning to complete study execution.
|Diana Foster, PhD||Total Clinical Trial Management|
Dr. Diana L. Foster currently serves as the CEO of Total Clinical Trial Management (TCTM). Dr. Foster is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing and positioning tactics. Her early tenure as head of an SMO gave her a unique understanding of how sites operate and what they need to reach enrollment goals within targeted timelines, thus leading to a proven model with results.
Senior Director and Global Head, Data Science
Brooks Fowler is the Senior Director, Data Science, at AbbVie. The AbbVie DS organization covers conventional data management accountabilities, including clinical trials systems development, data capture, data cleaning and data warehousing. In addition, DS provides clinical analytics to key stakeholders across the clinical development functions. Analytics use cases are changing rapidly with the advent of device-driven data, access to eMR data, and real-world data in many forms and from many sources. The required skills to be successful in this environment have prompted a fundamental transformation of the DS organization toward a focus on advanced analytical capabilities and the recruitment of individuals with skill sets to support new use cases. While conventional data management remains a core accountability, the DS organization is quickly preparing for the future. Brooks holds a BS in Information and Decision Sciences from the University of Illinois at Chicago, and an MBA from the Kellogg School of Management at Northwestern University. He worked to start two healthcare companies prior to joining the industry in 2000.
Head, Global Trial Optimization
Over 19 years industry experience in the management and operation of global clinical trials across a wide range of therapeutic areas and phases. Extensive experience in the design and implementation of cross functional process and directing change initiatives in global organisations. Head of The Global Trial Optimization Group at Regeneron, partnering with teams to optimize operational trial design and placement through the utilization of innovation and data and analytics. A key focus of this group is to centralise efforts to obtain and leverage external expertise from trial participants, disease experts and trial sites in to align the scientific design of a study with the perspectives of patients and study site staff.
|Amanda Fu, MD, MBA||RedBud Pharma|
Founder and CEO
Dr. Amanda Fu has 15 years extensive global clinical trial development and operational experience and an outstanding proven track record in Asia, Europe and North America. She has diverse knowledge, skill sets and training in medical practice, clinical science, public health, and global regulatory affairs. Broad combinations of clinical practice and clinical science, medicine and business management, individual medicine and public health. She has developed and managed global clinical trials across multiple therapeutic areas and at different development phases.
|Lauren Gadsby, MBA||Janssen|
Program Manager, Investigator & Patient Engagement
Lauren Gadsby is a Program Manager, Investigator & Patient Engagement for Janssen R&D. Lauren provides strategic leadership for engagement programs. She translates insights into strategies that deliver a differentiated clinical trial experience for patients and investigators and ensure trials meet recruitment and retention objectives. Lauren works cross-functionally to shape compliant processes for new initiatives and ensure seamless delivery and execution of strategy. She has experience developing and implementing programs to improve diversity in clinical trials and recently won an enterprise award for work to improve diversity in lupus research as one of the leaders on a clinical operations study team.
CEO & Co-Founder
Karim Galil (Co-founder, CEO) is advancing clinical oncology research by applying AI-powered EMR data solutions to current healthcare challenges. Karim is an MD with an entrepreneurial spirit. His first company Kryptonworx led health tech in the MENA region with customers like Pfizer and the Ministry of Health in UAE. Karim has also aided companies, such as Sirona and Straumann, in the field of medical image processing.
Global Head, IQVIA Analytics Center of Excellence
Lucas Glass is responsible for researching, developing and operationalizing machine learning and data science solutions in IQVIA's R&D business. He started his career working on pharmacovigilance data mining algorithms and worked at the U.S. Department of Justice in healthcare fraud.
Lucas holds a BA in physics from Boston University and an MS in biostatistics from Drexel University, and is a PhD candidate at Temple University, researching deep learning embedding techniques on large-scale healthcare data.
|Jennifer Goldsack||Digital Medicine Society (DiMe)|
Jen Goldsack leads Strategy, Portfolio and Operations at HealthMode and serves as the Interim Executive Director of the Digital Medicine Society (DiMe). Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led development and implementation several projects within CTTI’s Mobile Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System.
|Gretchen Goller||ICON plc|
Global Head Patient Recruitment
Gretchen Goller leads the Patient Recruitment and Retention group with a focus on protocol-specific solutions resulting in a holistic, patient-centric approach. The services focus on building patient, caregiver and site awareness, as well as education of the disease and study. Ms Goller has over 20 years of experience gained at pharma and CRO industries across a wide range of therapeutic areas including vaccines, cardiovascular, cardiology, ophthalmology, women’s health, HIV/AIS and endocrinology.
|Melanie Goodwin, MSc||Pfizer|
Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development
Melanie Goodwin is the Director of Patient Recruitment Programs at Pfizer and has been focused on clinical trial enrollment and retention in the pharmaceutical industry for 20 years. Her recruitment and retention experience spans across sponsor, CRO, Patient Recruitment agency, and research site, providing a unique and rounded view of the challenges and solutions. She has developed enrollment and retention strategies for over 200 clinical trials across all study Phases and therapeutic areas. Melanie holds a B.Sc. and M.Sc from Saint Joseph’s University in Philadelphia, Pennsylvania.
Pablo Graiver is Co-Founder of Antidote Technologies Ltd. (a/k/a TrialReach Ltd.) and serves as its Chief Executive Officer and Executive Director. Pablo Graiver served as Vice President of Business Development, Europe of Kayak Software Corporation. He has over 12 years of entrepreneurial and management experience in the online industry. He was an early member of NetJuice, one of the largest Internet incubators in Europe; MD at Donde Comprar.com, the first e-commerce directory in Spanish; and later co-founder and Vice President of Strategy at Kelkoo, acquired by Yahoo! in 2004. Pablo Graiver set up and launched Kayak.com in Europe, and served as European Sales Director at ValueClick (NASDAQ: VCLK). He studied Biology and Business Administration at UAM in Madrid.
|Christina Greene, Esq||Merck Sharp & Dohme Corp.|
Associate Director, Global Site Agreements
Christina Greene (Christy) left her career as a family and estate planning, private practice attorney in 2015 and joined Merck as a site agreements specialist supporting Merck’s clinical trials in North America and Europe, Middle East and Africa (EMEA). In September 2017, she focused her attention on the EMEA region in a new role as the Global Site Agreements Lead supporting EMEA, and additionally assumed the role of acting lead with respect to CRO site agreements process management. In her time with Merck, Christy has driven process and quality improvements with respect to site contracting, including active involvement in updating Merck’s CTRA Negotiation Guidelines, developing global and country templates for all aspects of clinical trials, and delivering clinical trials negotiation and contracting trainings to EMEA Clinical Operation Managers (COMs) and CRO partners. Christy earned her law degree from Widener University School of Law and her B.S. degree from Penn State University (We Are!), and is currently pursuing a masters degree in Business Intelligence and Analytics from St. Joseph’s University.
|Alyson Gregg, MBA||Janssen R&D|
Director, Patient Insights
Alyson Gregg is the Director of patient insights for Janssen. In this role, Alyson is focused on leading Janssen to incorporate direct patient insights on clinical trial protocol. To involve patients more throughout the clinical trial process, Alyson works with compound development teams to modify trials as appropriate, and to improve the patient experience and clinical trial success. Alyson has 20 years of experience at Johnson & Johnson in roles of increasing responsibility, most recently as U.S. Commercial Insights and Strategy Director for the Neuroscience business.
|Anders Gronstedt, PhD||Gronstedt Group|
Anders Gronstedt, Ph.D. (https://en.wikipedia.org/wiki/Anders_Gronstedt) President of The Gronstedt Group, is an author, public speaker and entrepreneur. He is an advocate of using Next-Gen Learning tools to advance real-world skills through virtual and augmented reality training, game and simulation-based learning. The Gronstedt Group has been instrumental in helping global companies like Pfizer, Novartis, DaVita, Walmart, KPMG, Google, HP, and Kimberly-Clark improve performance with innovative learning approaches. Dr. Gronstedt is a former faculty member of the University of Colorado–Boulder School and his articles have appeared in the Harvard Business Review. Watch his TED-style talk: https://vimeo.com/bauser/review/278011047/ea1b8580af
|Glenda Guest||President, Assured of Quality Consulting & Training|
Glenda Guest BS, CCRA, RQAP-GCP, TIACR,FACRP, has an extensive background in the clinical research industry having worked as a monitor, project manager, data manager, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession with Norwich Clinical Research Associates (NCRA) in 1997. Now an independent consultant for her own company, Assured of Quality Consulting & Training, she specializes in clinical quality assurance auditing, development of clinical quality management systems and advanced GCP and FDA Regulations training. With 20+ years of regulated research experience and her extensive background in a clinical CRO she has developed a unique perspective, not only of the regulatory requirements for pharmaceutical and device development and market approval, and insights from collaboration with multiple sponsor companies’ varying approaches in meeting those requirements.
|Tammy Guld||Janssen Clinical Innovation|
Tammy Guld is the Senior Director, Team Leader of Janssen Clinical Innovation (JCI). Janssen Clinical Innovation is dedicated to making clinical trials faster, less costly, and a better experience for all stakeholders, especially our patients. Through the design and conduct of novel trials and demonstration projects, JCI generates data and knowledge about feasibility, impact, and value. Tammy provides strategic and operational leadership to this team and is accountable for the overall performance & portfolio optimization. Tammy joined Janssen R&D after spending 20 years at Bristol-Myers Squibb where she most recently served as the Executive Director and Head of Central Clinical Planning & Solutions. In this role, she was responsible for centralized operational solutions that ensured the best trial experiences possible for patients, caregivers, and investigational sites; capabilities included Clinical Trial Engagement, Alliance Management, Contracting & Payments, Trial Disclosure, and Digital Health. Tammy holds a Master of Science degree in Clinical Pharmacology from Thomas Jefferson University and a Bachelor of Science in Biochemistry from Bucknell University.
Associate Director, Innovation, Global Development Operations
Eric Hajjar has a solid scientific and data background with a PhD and Postdoc in Bioinformatics and Virtual Drug Design. He began working in Corporate Clinical Development over 10 years ago, starting in a small vaccine company then through a merger with Johnson and Johnson and since 5 years now with Novartis in Switzerland. He held several position of increasingly responsibilities, starting in the Trial management function and moving on to Project, Portfolio and Program Management functions in relevance with Clinical Development. In his current role, as part of the Clinical Technology and Innovation Department, Eric oversees key breakthrough innovation opportunities to improve and re-invent development operations. One of the ongoing activity is the Novartis Digital Recruiting project, which aims to inform, attract and enroll patients using digital channels.
Duncan has nearly 20 years' of consultancy experience within clinical R&D, in both CRO and Sponsor organisations. Duncan started TRI in 2002 with the aim of building a global business focused on improving the delivery, quality and value of clinical trials. In addition to leading the strategic direction of TRI, Duncan is highly proactive in delivering customer projects because that gives him the real-world understanding of what Sponsors and CROs really want and need.
|Laurie Halloran||Halloran Consulting Group|
Laurie founded Halloran Consulting Group in 1998 after working for 10+ years in varied positions in Clinical Development in both CROs and biopharma companies. She has built a successful $25MM US consultancy and is recognized as an industry expert in life sciences. Halloran’s focus in clinical research includes integrated development planning and advising and directing FDA regulatory strategy as well as representing our clients to FDA through filings, protocol development and implementation and directing trials and CROs on behalf of small and mid-size clients. She is currently focused on growing and leading a management consulting practice within the company dedicated to using the insights, efficiencies and expertise gained through Halloran’s work with biopharma start-ups to build fit-for-purpose organizations that can become the model for the future of drug development.
|Sarah Halmrast||Clinical Supplies Management, Inc.|
Vice President, Global Project Management
I have worked in the Clinical Supplies industry since 2000 wearing various hats over time, but specifically more tied to Project Management of Clinical Supplies and working with various clients to meet the unique differences of their clinical trials. Directly and indirectly implemented various processes, such as label printing capabilities and On-Demand packaging operations. Developed initial process of Direct to Patient activities at CSM and continue to be involved in process improvement of DtP. Currently, my main focus is on harmonizing Project Management teams between various locations in the US and EU. My husband and I have been blessed with three beautiful, strong-willed children that keep our schedule busy.
Associate Director, Risk Based Monitoring, Project Operations and Business Performance
Gayle is a Lead Risk Based Monitoring Project Advisor at IQVIA with over 20 years of experience in clinical research and over 15 years at IQVIA. In her role, she is responsible for creating and enhancing RBM business processes as well as identifying and prioritizing technology investments to transform the way Clinical Development delivers. Gayle and her team are responsible for integrating and streamlining processes associated with clinical delivery to drive higher quality and productivity-based project outcomes, enabling employees to perform their work more effectively cross-functionally, focusing on the implementation of Risk Based Monitoring processes and methodologies.
|Don Harder||Eli Lilly|
Advisor, Design Hub - Patient Experience & Design Innovation
No bio available
|Matthew Harlin||Otsuka Pharmaceutical Companies|
Associate Director, Clinical Pharmacology
Matt Harlin is Associate Director, Clinical Pharmacology at Otsuka Pharmaceutical Development & Commercialization, where he has worked for over 10 years. During that time, he has held several roles within Clinical Pharmacology, including leading an initiative to implement collection of biospecimens for future use during all interventional clinical trials. He obtained a Master’s in Biotechnology from John’s Hopkins University, and is currently a Clinical Pharmacology lead on several early and late-phase compounds.
Associate Director, Global Patient Recruitment and Engagement
Melissa brings 20 years of industry experience including a tenure at a global award winning vendor agency, creating recruitment programs for all phases of studies including pediatric, rare and hard-to-reach patient populations. Melissa engages all of Covance's propriety data set to harness the benefits of applying innovative solutions toward successful patient recruitment and retention solutions whilst driving health literacy and patient-led trials to reduce study burden and facilitate the study into everyday life.
Clinical Program Benchmark Manager, Patient Engagement & Recruitment
With operational expertise and extensive industry relationships, Lani has worked across all therapeutic categories in Phases I-IV including rare diseases, medical devices, and incorporating innovative technologies. Ms. Hashimoto’s perspective is patient-empathetic while encompassing the whole study context from investigator site needs to patient recruitment’s impact on downstream resources and processes. Lani’s expertise also includes feasibility, patient privacy and advocacy initiatives. Joining Novartis in October 2014, Lani is focused on connecting patients to clinical research. In her current role, Lani supports new indications and programs with early evidence to support decisions, patient engagement facilitation, and patient recruitment strategic planning.
Director, Site Contracts
Jenn is an experienced Site Contracts leader bringing 15 years' expertise working across both the Pharmaceutical and CRO industries. She has extensive knowledge of global contract and budget negotiation and enjoys the complexity of work when engaging with internal and external stakeholders to foster collaborative relationships and drive engagement. Jenn is currently the Director of the Site Contracts department at Synteract, Inc leading a global team of site contract managers and local negotiators.
Group Head, Clinical Data Management
No bio available
|Heather Hirsch||CRISPR Therapeutics|
Senior Director, Translational Pharmacology, Head of Clinical Biomarkers and Exploratory Research
Dr. Heather Hirsch is currently a Senior Director in Translational Pharmacology and the Head of Clinical Biomarkers and Experimental Research at CRISPR Therapeutics. Prior to CRISPR, Heather was the Director of Translational Genomics at Jounce Therapeutics Inc where she focused on immuno-oncology therapies. Her group, which encompassed both informatics as well as wet bench genomics capabilities, contributed to target identification, pipeline support of specific therapies, indication selection and biomarker support in clinical trials. Prior to Jounce Therapeutics, Heather was an associate principal scientist in Genetics and Discovery Pharmacogenomics at Merck Research Laboratories focusing on Oncology and Immunomodulatory Regulators. She worked on many preclinical and clinical stage small molecule and biologics-based programs including Keytruda. Much of the work in this setting was using genomics technologies to understand mechanism of action for drug therapies as well as understanding how genomics can help identify potential responders. Heather received her PhD from Michigan State University in Cell and Molecular Biology and did a postdoctoral fellowship at Harvard Medical School.
|Kyle Holen, MD||AbbVie|
Head, Development Design Center, Research and Development
Kyle Holen was trained as a medical oncologist and practiced in an academic setting prior to joining AbbVie in 2009. Since then, he has worked as a medical director, project lead, and executive medical director in oncology. His most recent role, as head of the development design center, is focused on shaping the future of clinical research at AbbVie.
|Alison Holland, MS||Medable|
Head, Virtual Clinical Trails
Alison (Ali) Holland is Head of Virtual Trials at Medable and is chartered to design and expand the end-to-end capabilities needed to partially or fully virtualize clinical studies, building on the commitment to reduce clinical trial times by 50%. Ali has over 20 years of experience in a variety of leadership roles, including Feasibility Head and Six Sigma Black Belt at Covance, and Business Head and global General Manager at Roche/Genentech in one of their therapeutic area business groups. Having been engaged in over 300 studies across Biotechs, Pharma and all geographies, Ali brings an incomparable level of insight and technical excellence on the matter of operational needs for sites and patients.
|Rose Holub||Circuit Clinical|
Head, Regulatory Affairs & Compliance, Clinical Operations
Rose Holub serves as the Head of Regulatory Affairs & Compliance at Circuit Clinical, and Integrated Research Organization (IRO) where she oversees regulatory affairs for all clinical operations and compliance for the company. Rose holds a Bachelor of Science degree in Nutrition Management from Rochester Institute of Technology with concentrations in Psychology, and Service Management, and a Master of Science degree in Clinical Research Management from Arizona State University with a concentration in Regulatory Science. Rose has been immersed in the clinical research ecosystem for 7 years, her vision, drive, and unique skill set has driven her to obtain extensive knowledge and proficiency regarding end to end optimization in clinical trial site operations, regulatory compliance, and emerging clinical trial technology. Prior to joining Circuit Clinical, Rose held various leadership and technical positions in Regulatory, Site Operations, and Quality at a dedicated research site. Rose is committed to constructively providing site insight to the industry that would lay the framework for allowing clinical trial participation to be a part of everyday life.
|Angelique Hopkins||Bristol-Myers Squibb Company|
Director, Clinical Trial Analytics, Business Insights and Analytics
No bio available
Associate Director, Asset Lead – Oncology
Ashley has over 10 years’ experience in Clinical Data Management both within the CRO and Pharmaceutical industries. Ashley started his career in the late phase Data Management department at PAREXEL working on numerous trials, across multiple therapeutic areas and in a variety of EDC systems. He progressed into a Data Management operational leadership position where he had overall accountability, as an account lead, for the execution of the Data Management strategy on numerous complex Oncology studies. Ashley joined the Oncology team within the Data Monitoring and Management department at Pfizer in 2018 and is currently assigned to a number of key pivotal trials. He is an Oracle InForm EDC SME and is putting his knowledge and experience to good use working on a number of internal AI process development initiatives.
Associate Director, Global Clinical Operations
An innovation award winning operational strategy expert, blockchain advocate and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion. Currently part of the DIA Patient Engagement Voluntary Community Leadership team. Experience across various therapeutic areas and phases of trials in drug development include creation and execution of successful strategies for research protocols and CRO oversight, patient and site feasibility, expertise in technologies such as eCOA and IVRS, creation of optimal drug packaging and administration concepts, mapping the patient journey, planning and executing effective global site and patient engagement campaigns using direct to patient methods, leading and coaching remote and complex global teams.
|Jane Jacob, PhD, CCRP||Orthofix|
Vice President, Research and Clinical Affairs
With over 15 years’ experience in clinical research, following 15 years in academia, Dr. Jacob ‘s experience working within the corporate infrastructure as well as establishing successful sponsor/site relationships, has allowed her to successfully develop and launch both large and small clinical trials across the research spectrum – retrospective, post market and IDE studies. She has been a study coordinator, then a CRA, a manager, director and is now Vice President of Research and Clinical Affairs at several medical device companies.
Central Monitoring Manager, Integrated Data Analytics and Reporting, Global Clinical Development Operations
Joi Jenkins is a Central Monitoring Manager in Janssen R&D’s Risk Management-Central Monitoring Group, which is dedicated to the implementation of Analytical Risk-Based Monitoring in clinical trials. In this role, Joi leads the preparation, conduct and follow-up of the cross-functional Central Monitoring Working Group for ARBM studies. She has also participated as a member of the TransCelerate BioPharma Shared Investigator Platform team, recently helped lead Janssen’s Site Staff Training Process Improvement and is an Investigator Engagement Ambassador, within Janssen R&D. Joi has over 26 years of experience in clinical research and drug development. Prior to her ARBM-focus, she worked in a variety of therapeutic areas of clinical trial and site management at Janssen R&D, Cephalon, Inc. and Drug Research and Analysis.
|Mark Joing, MBA||Menlo Therapeutics Inc.|
Vice President, Clinical Operations
Mark Joing is Vice President, Clinical Operations at Menlo Therapeutics. He joined Menlo in 2016 and is responsible for clinical trial execution and project management. Mr. Joing brings 20+ years of drug development experience at large and small pharmaceutical companies to Menlo. For five years prior to joining Menlo, Mr. Joing was VP of Clinical Operations and Project Management at Nora Therapeutics, a biotechnology company focused on developing therapeutics to address significant unmet needs in reproductive medicine. As part of the senior management team at Nora, he led multiple Phase 1 and 2 clinical studies in the US and Europe. Prior to Nora, Mr. Joing headed Clinical Operations and Project Management at Nuvelo, a late-stage drug development company. He was the recipient of Nuvelo’s inaugural George Rathmann Award to recognize his significant contribution to Nuvelo’s mission of improving the lives of patients through the discovery, development and commercialization of novel acute cardiovascular and cancer therapies. Earlier in his career, Mr Joing held roles in Supply Chain and Production Management at 3M Pharmaceuticals and Abbott Laboratories. Mr. Joing holds a B.S. in chemical engineering from Northwestern University and M.B.A. from Stanford University.
|Charlotte Jones-Burton, MD, MS||Otsuka Pharmaceutical Development & Commercialization, Inc.|
Vice President, Global Clinical Development
Dr. Jones-Burton is dedicated to creating healthier communities globally through drug development, patient advocacy and people engagement/empowerment. Her three-pronged approach reflect her personal values of community, service and health and wellness. Charlotte combines her leadership in research/drug and people development with her clinical acumen in order to positively impact the lives of patients and communities who suffer with chronic diseases. Charlotte is a pharmaceutical executive who has spent over a decade in the pharmaceutical industry leading clinical trial development for multiple medicines across various disease areas including cardiovascular and renal diseases. She is currently VP, Global Clinical Development, Nephrology at Otsuka Pharmaceutical Development & Commercialization, Inc. She earned a medical degree and Master of Science degree in Epidemiology and Preventive Medicine, with a concentration in Clinical Research, from the University of Maryland School of Medicine. Charlotte’s postgraduate training included an internal medicine residency and a nephrology fellowship at the University of Maryland Medical Systems. Charlotte is active in numerous professional associations and organizations and co-founded Women of Color in Pharma, a non-profit professional society focused on transforming the pharmaceutical landscape with women of color. As its president, Charlotte is leading the growth of the organization in the US and EU.
|Hassan Kadhim||Bristol-Myers Squibb|
Director, Clinical Trial Business Capabilities, GCO
No bio available
|Sujay Kakarmath, MD||Partners Healthcare Pivot Labs|
Lead Scientist, Data Science and Artificial Intelligence
Dr. Kakarmath is a digital health scientist at Partners Healthcare Pivot Labs and an Instructor at Harvard Medical School. His research is focused on the evaluation of the clinical utility of digital health solutions, including machine learning and artificial intelligence-based products. Dr. Kakarmath's team works closely with technology innovators from academia, startups and industry giants to guide the ideation, design, prototyping, validation, and deployment of digital health solutions. His work has been published in prestigious journals and showcased at major academic conferences such as those of the American Academy of Neurology, the American Medical Informatics Association, the International Society for Pharmacoeconomics and Outcomes Research, the Connected Health Conference, Precision Medicine Summit and HIMSS.
|Aaron Kamauu, MD||PAREXEL|
MS, MPH, Vice President, Scientific Data Assets
Dr. Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) leads innovation in leveraging healthcare data supporting a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, and data-driven patient recruitment. He has a unique combination of clinical, biomedical informatics, drug development, and public health experience in the application of innovative biomedical informatics methodologies that supports individual patient care and population-based observations.
Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development
Nechama Katan, Associate Director at Pfizer, is a “Data Wizard with Personality.” She helps organizations access and use their data to drive business decisions. Nechama blends an ability to write code and provide prototypes with an interest in driving the “business conversation." In addition to working with various organizations, she is an experienced instructor in Statistics, Operations, Data presentation and Metrics development. Her education includes an MSc from NYU in Mathematics and an MA from Columbia University in Statistics.
Head, Clinical Analytics
Nareen Katta works as a Senior Director and Head of Clinical Analytics at AbbVie. Nareen has over 15 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the clinical analytics strategy for AbbVie’s clinical development organization. In addition, Nareen engages in active dialogue and collaboration with cross-functional leaders and industry peers, on topics like big data, robotic process automation, artificial intelligence, machine learning, digital health, interoperability etc. Nareen has a Masters in Electrical Engineering from The University of Texas at Arlington, and MBA from University of Chicago Booth School of Business.
Senior Director, Head, Outsourcing and Procurement
Ly is a well-known expert and leader in the operations, outsourcing, and vendor management with more than 25 years of experience in the biotech/pharmaceutical industry in large and small companies across all phases of research. Ly has extensive background in both clinical and R&D in clinical operations and outsourcing and contracts management. Ly expertise includes business and operations strategies, strategic sourcing, governance management, and quality/compliance. Ly has built and lead multiple groups at Genentech, Allergan, Ultragenxy, and currently at MyoKardia. In her current role, she heads the clinical outsourcing, site budget/CTAs, and business analytics functions.
|Mike Keens||Firma Clinical Research|
Mr. Keens serves as Chief Operating Officer for Firma Clinical Research. He leverages his knowledge and landscape experience to help Biotech and Pharmaceutical Sponsors identify project/program needs and examine how Firma may deploy expertise and resources to support these needs to achieve their drug development goals. Mr. Keens earned his undergraduate degree in Biology/Psychology from James Madison University, and his Master’s degree in Public Health from The University of Virginia.
|Michael Kelsh, PhD||Amgen|
Executive Director, Center for Observational Research
No bio available
Senior Director, Biostatistics & Programming
Francis has been working in the Life Sciences industry for over 30 years working in and leading Biometrics functions for larger companies like Pfizer, Novartis and Roche. He has always been interested in how new technology and access to data can improve Health care and how Life Sciences will have to adjust to the new paradigms that are created by these factors. Francis has a keen focus on Innovation and how Data can help improve the Healthcare ecosystem.
|Patrick Kenney||UCB Biosciences, Inc.|
Director, Strategic Partnering Lead, Global Clinical Sciences & Operations
Patrick Kenney is a Director in the Strategic Clinical Partnering department at UCB Biosciences. He has served in a variety of roles over his 25 years in the industry starting out as a clinical microbiologist in a research and development setting. This lead to work in various project and people management roles at both CRO and Pharma organizations providing a strong background for his current role which includes the operational oversight of key strategic partners.
|Shameer Khader, PhD||AstraZeneca|
Senior Director, Advanced Analytics, Data Science & Bioinformatics
No bio available
|David Kiger||Datacubed Health|
Chief Commercial Officer
David has spent his career at the intersection of the technology and life science world, executing and managing business development, client management, innovation, go-to-market offering strategies, as well as product and services marketing.
Before coming to Datacubed Health, David was Chief Commercial Officer of Bioclinica, accountable for global business development, corporate marketing, sales operations, and technical solutions. Prior to that, David ran the services innovation strategy and marketing for PAREXEL Informatics. David also led the PAREXEL North American eClinical and Medical Imaging business development. David has also worked at Commerce One, Siebel Systems, and Accenture where he led management consulting client services and delivery. David is a graduate of The University of Wisconsin, Whitewater where he graduated summa cum laude.
|Jessica Kim||BBK Worldwide|
Director, Research, Digital Strategy
As the Director of Research and Digital Strategy for BBK Worldwide, Jessica has her pulse on the latest in healthcare consumer trends. She leverages her insight to ensure BBK's patient recruitment and engagement efforts align with the needs of today's patient, while ensuring they contribute a positive study experience.
No bio available
|Joseph Kim, MBA||Eli Lilly|
Senior Advisor, Patient Experience and Design Innovation
Joseph Kim serves as a Senior Advisor in Patient Experience and Design Innovation at Lilly, focusing on developing and implementing innovative patient engagement solutions. He has spent nearly 20 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors. He has a robust combination of experience that includes early and late phase clinical research, and a well-known history of innovation in the clinical research industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova. He can be reached at email@example.com and on Twitter: @JoPeKim
|Jeff Kingsley, DO, MBA, CPI, FACRP||IACT Health|
Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices in multiple cities in two states. The family of companies conduct phase Ib through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006. Dr. Kingsley is the current COO and Chair for hyperCORE International, LLC Centers of Research Excellence. He is also the past Chair of the Board of Trustees for the Association for Clinical Research Professionals which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees. Dr. Kingsley obtained his CPI in 2009 and his FACRP in 2017.
Director, Life Sciences & Health IT
Serving as Exostar’s Director of Health IT & Life Sciences, Kenny has consulted and advised some of the world’s largest Healthcare and Biopharmaceutical companies in enabling on-demand access to eClinical technology using digital identities that securely extend trust across traditional enterprise boundaries. In his tenure, his thought-leadership supported the development of Federal Health IT Standards during the advent of Electronic Health Records (EHR’s).
|Andrew Kornberg||The Royal Children's Hospital Melbourne|
Associate Professor & Senior Neurologist
A/Prof Andrew Kornberg is a paediatric neurologist with considerable neuromuscular experience. He completed Paediatric Neurology and Neuromuscular Fellowships in the United States working in St Louis, USA. He has had extensive laboratory and clinical experience in immune-mediated neurologic syndromes, including Guillain-Barré syndrome, Miller Fisher syndrome, multifocal motor neuropathy, chronic inflammatory demyelinating polyneuropathy (CIDP), childhood multiple sclerosis and acute disseminated encephalomyelitis.
Jeff is a healthcare entrepreneur with over 18 years of pharmaceutical experience. Prior to TrialScope, Jeff was the founder of two successful healthcare technology companies, HeroLinx and Verilogue. HeroLinx is an online crowdsourcing platform for accelerating clinical trial awareness and patient recruiting. Verilogue is a global leader in the capture and linguistic analysis of physician-patient exam room dialogues. Jeff remains an active angel investor and advisor to a half-dozen software and analytics companies.
|Jim Kremidas||Association of Clinical Research Professionals (ACRP)|
Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he 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. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials. He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the FDA. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals.
|Harlan Krumholz, MD||Yale-New Haven Hospital Center for Outcomes Research and Evaluation|
Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine, is a cardiologist and the Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. He leads initiatives to improve the quality and outcomes of clinical decisions and healthcare delivery, reduce disparities, enable transparency in practice and research, and avoid wasteful practices. His team has led national improvement initiatives, architected national measurement strategies, developed a platform for research and clinical care improvement in China, promoted patient-centric approaches to research and care, and created strategies and tools to enable open science and advance scientific integrity. He led the Robert Wood Johnson Foundation Clinical Scholars Program at Yale for more than two decades. He founded the American Heart Association Quality of Care and Outcomes Research Council Annual Conference and was the founding editor of Circulation: Cardiovascular Quality and Outcomes. He founded HugoHealth, a patient-centric platform to engage people as partners in research and facilitate the secure movement of digital health data. He is a member of the National Academy of Medicine and was a founding Governor of the Patient-Centered Outcomes Research Institute. He has published more than 1000 articles and has an h-index of 192. Dr. Krumholz received a BS from Yale, an MD from Harvard Medical School, and a Masters in Health Policy and Management from the Harvard University School of Public Health.
|Delphine Lagarde, PhD||F. Hoffmann-La Roche AG|
Ethics Lead in Biosample & Repository Management
Molecular Biologist by training, obtained her PhD in Plant Sciences at the University of Montpellier, France in 1996. Worked for a couple of Biotech companies before joining Roche in summer 2002 to lead a team working on SNP discovery in Type 2 Diabetes. With her team, implemented and supported the automated RNA profiling and protein biomarker analysis in Roche clinical trials until 2007 when decided to focus on Ethics and Compliance in Sample Management. Was Head of the Roche Biosample Repository between 2008 and 2014, and is since 2014 fully dedicated to Ethics related questions and Consent management in her role as Ethics Lead in Biosample & Repository Management.
|Jim Lane||Longboat Clinical|
Chief Buisiness Officer
Jim has worked at the forefront of online investigator site support since 2006, having been a key member of the management team behind the success of the first-to-market investigator portal. Following the acquisition of that product by ICON plc, Jim enjoyed a highly successful 3 years with ICON's Business Development team before joining Longboat. Previously, Jim has held senior positions at various industry-leading IT companies including Symantec, Microsoft, NETg (Skillsoft), and AST Computers (Samsung).
|David Lanham, BSc (Hons), MSc||Eurofins BioPharma Services|
Principal Scientific Director, Eurofins Pharma Bioanalysis Services UK Limited
David has 25+ years of experience in the pharmaceutical CRO industry, managing research and regulated bioanalytical projects in the pre-clinical and clinical arenas. Experience includes cell-based assay modelling, pre-clinical toxicology assessment and clinical trial bioanalysis, with key-focusin biomarker bioanalysis and immune function assessment using ligand binding technology and flow cytometry. David is a member of the AAPS Flow Cytometry Action Program Committee.
|Jacob LaPorte, PhD||Novartis|
Vice President, Global Head, Digital Development
Jake LaPorte, PhD, is Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts within their Global Drug Development organization. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey in Asia-Pacific, however, where Jake read Ray Kurzweil’s The Singulatiry is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine – he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry, with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development and manufacturing, with the ultimate goal of fully digitalizing chemical synthesis. Most recently, Jake has held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his Ph.D. in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his B.Sc. in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.
Corporate Vice President, WW Head, Real-World Evidence
Leanne has 25+ years experience in pharmaceutical product development/marketing, clinical research, and care delivery. She is an industry thought leader in observational, late-phase, and outcomes research with expertise in strategy, design, implementation, and analysis of patient registries and outcomes research programs. She has been instrumental in advancing the science and application of outcomes research throughout the pharmaceutical, biotech, and medical device industries.
|Andy Lawton||Risk Based Approach Ltd.|
Director & Consultant
Andy Lawton has extensive experience in computing, statistics, data management, system design, Quality Management and Risk Based Approach in both Computer System Validation and clinical trials. He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held a variety of position at Boehringer Ingelheim. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His publications include the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal, for which he won “best author of the year 2015 and 2016” from the DIA.
|Nirosha Lederer, PhD||Duke-Robert J. Margolis, MD, Center for Health Policy|
Managing Associate, Real World Evidence
Nirosha Mahendraratnam Lederer, PhD MSPH is a Managing Associate at the Duke-Margolis Center for Health Policy, where she helps lead the Center’s real-world evidence (RWE) portfolio. Immediately prior, she was a Subject Matter Expert in the Oncology Center of Excellence at FDA. While there, she helped implement patient-focused drug development in cancer products including clinical trial study design and product review, as well as foster consensus across US and ex-US healthcare stakeholders on best practices for patient-reported outcome capture, analysis, and communication. Dr. Lederer has over a decade of pharmaceutical policy and health economics and outcomes research experiences including providing evidence-generation advisory services at Avalere Health, working in commercial and medical roles at Genentech and Bristol-Myers Squibb, respectively, and serving on Capitol Hill during the passage of the Affordable Care Act. She received her PhD in Health Outcomes and Policy from the UNC Chapel Hill with a focus on large database analyses and decision-sciences. She received her MSPH in Health Policy & Management from the Johns Hopkins Bloomberg School of Public Health and BA in Public Health from the Johns Hopkins University.
|Disa Lee Choun, EMBA||UCB|
Head, Innovation, Global Clinical Sciences and Operations
Disa has years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation, GCSO at UCB, she is responsible for evaluating and piloting innovative solutions in clinical trials. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and BS in Pharmaceutical Chemistry. In 2017, Disa started a cross-industry collaboration on blockchain via PhUSE. Recently, she was awarded Top 100 Women in Technology and featured on the cover of CIO Look celebrating Women in Tech 2019. Her passion is on closing the gap for patients with unmet needs and exploring the right technologies (Blockchain, Internet of Things, Artificial Intelligence/machine learning, robotics, data discovery tools, and others) to accelerate the implementation of end-to-end patient solution.
|Hugh Levaux, PhD||Protocol First|
Founder & CEO
Dr. Hugh Levaux is Founder CEO of Protocol First. The company offers innovative software solutions for clinical research. Leading products are P1 EDC, a full eClinical research platform and Clinical Pipe, the industry’s first system-agnostic EHR-to-EDC connector application. Dr. Levaux has over 2 decades of clinical research experience.
Senior Director, Clinical Trial Experience
No bio available
|Henry Levy||Veeva Systems|
General Manager, Veeva Vault CDMS
As general manager of Veeva Vault CDMS, Henry is responsible for the Veeva Vault CDMS product and sales. Henry has spent 25 years in the life sciences industry. Prior to Veeva, Henry was chief commercial officer for PPD, as well as the global head of Accenture's life sciences R&D practice.
Sr. Director, R&D Technology
April currently leads clinical technologies for site and patient engagement at GSK. Previously April spent several years at IQVIA where she served as the Head of IQVIA’s Clinical Design and Planning suite of technology solutions. There she led the strategic development and delivery of a portfolio of SaaS technology products that address critical business needs for Sponsors and CROs worldwide with a focus on protocol design, trial optimization and cost optimization. Prior roles included data management, clinical operations, consulting and site selection with various Sponsors (GSK was one!) and CROs.
Director, Project Management, Project Management Office, Global Clinical Trial Operations
Rachel Lewis works in the Project Management Office of Global Clinical Trial Operations at Merck & Co, where she leads global cross-functional teams in designing and deploying RBM processes and advanced analytical systems. She is also a member of TransCelerate's RBM workstream. Rachel started her biopharmacuetical career in Sydney, Australia, as a Medical Information Associate and has since held various roles within Clinical Operations including Clinical Research Associate (CRA), Clinical Project Manager, and Clinical Research Manager. In recent years, Rachel led the melanoma and merkel cell carcinoma clinical research program at Merck & Co, USA, overseeing clinical scientist activities and contributing to numerous successful filings. Rachel received her Bachelor of Pharmacy from the University of Sydney, Australia with honors in Pharmacology.
|Gen Li, PhD, MBA||Phesi|
President & Founder
Gen Li, Ph.D., MBA is a pharmaceutical industry leader with a passion to improve patients’ lives. Prior to founding Phesi in 2007, Dr. Li held various roles in academia, at Pharmacia and then Pfizer - as Head of Productivity for Pfizer Worldwide Clinical Development, and at Bristol-Myers Squibb - where Dr. Li led the creation of the first computer-automated resource management system. He earned his Ph.D. in Biochemistry from Beijing University, and an MBA from the Johnson Graduate School of Management at Cornell University.
Senior Director, Regulatory Policy
Gracie Lieberman is a Biostatistician with 30+ years of experience in oncology clinical trials. Gracie is a Senior Director of Regulatory Policy at Genentech, and one of her focus areas is utilization of Real-World Evidence in regulatory decision-making. For the past 26 years at Genentech, Gracie has gained experience in all phases of drug development, from pre-IND to post-marketing, drug/diagnostic co-development, and collection/evaluation of Patient Reported Outcomes (PROs). Gracie served on review and oversight committees, advising and guiding molecule development teams. She participated in select internal strategic initiatives and external cross-industry workshops. During the first 8 years of her professional career, Gracie worked at the Institute of Tuberculosis and Pulmonary Diseases in Warsaw, Poland, where she assisted surgeons and oncologists collect, analyze and interpret data from lung cancer trials. Gracie has a Master’s Degree in Biostatistics from the University of North Carolina at Chapel Hill.
Senior Director, Strategic Partnerships
Holger Liebig is a Senior Director Strategic Partnerships at Parexel International. He supports and consults some of Parexel’s Strategic Partnerships on internal and external governance, KPI definition, change management and process alignment. Holger is a certified Lean Six Sigma Black Belt with over 29 years of industry experience.
|John Linnell||Patient Advocate|
Clinical Trial Participant and Member of AZ’s Patient Partnership Program
John was diagnosed with COPD in 2005. His career was as a retail District Manager then as a Marketing Director. He left the workforce in 2011. After engaging in an educational internet video on COPD and sharing his story at conferences, John realized his efforts would be best spent doing advocacy work for the COPD community. John is a member of the Board of Directors for the US COPD Coalition, the Executive Board of Directors for EFFORTS, and on the Governing Board for the COPD Foundation PPRN (Patient Powered Research Network). John also sat as a Patient Reviewer for Peer Review Medical Research Programs for the Department of Defense for several years. John is also currently a Co-investigator for a 3-year PCORI funded study at Johns Hopkins University School of Medicine: “Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers”.
Independent Advisor, Former Head of Clinical Innovation
No bio available
Vice President, Global R&D Quality
Janis Little is Vice President, Global R&D Quality at Allergan. In this role she is responsible for oversight of the R&D quality function, setting strategic direction for the organization and ensuring development and implementation of a risk-based audit program, inspection management, product development quality assurance, and medical device quality oversight. Janis currently leads TransCelerate’s Clinical QMS Workstream and was a co-author of the Clinical QMS conceptual framework.
|Jeffrey Litwin, MD||WCG|
Chief Operating Officer
An experienced senior executive for both public and private companies, accomplished cardiologist and entrepreneur, Dr. Litwin joined WCG in 2017. In 2018, he was promoted to COO of WCG. Before assuming his current role, Dr. Litwin was president of Litwin Consulting LLC and he also co-developed and launched Patient Genesis, an innovative software platform used by health care providers to create, share and transfer knowledge to patients during the informed consent process.
|Victor Lobanov, PhD||Covance|
Vice President, Informatics
Victor Lobanov, Ph.D. is Vice President of Informatics at Covance, a division of Laboratory Corporation of America® Holdings. He is responsible for the conception, development and delivery of the Xcellerate® information technology solutions for clinical trial design, monitoring, reporting, and analytics. He received his Ph.D. in computational chemistry from the University of Tartu and his undergraduate degree in chemistry from Lomonosov Moscow State University.
Senior Director, Digital Data Integration and Analytics, Value Evidence & Outcomes
Nick has over 20 years of experience in clinical research, statistical consulting and digital data integration. This includes 15 years in clinical research at GSK in the Respiratory Therapeutic Area, and more recently, working in the electronic health records (EHR) space in the Value Evidence & Outcomes group. In his current role, he leads internal projects and academic collaborations which focus on collecting EHR and remote patient data using digital and sensor technology, with the goal of advancing in-stream data collection, data visualization capabilities and development of digital biomarkers and outcomes. In prior roles, Nick drove clinical strategy in conjunction with project physicians as part of medicines development teams for both late stage and early phase assets. Earlier in his career, he co-led a team that transformed GSK’s Respiratory studies from paper case report forms to electronic data collection. He has been the study statistician for over 20 clinical trials across Phase I/II/III/IV and has over 40 peer-reviewed publications. Nick has a PhD in Statistics from the University of North Carolina at Chapel Hill.
Associate Director, Clinical Metrics & Analytics, Global Development Operations
Ankit Lodha has high-end expertise in big data analytics and interpretation of clinical operations data in the pharmaceutical/ biotechnology industry. In his current position, Ankit is responsible for building the Takeds's (L-Shire) organization capability as a world-class leader in measuring CROs clinical analytics performance dashboard and functional health metrics. He is also responsible for designing meaningful metrics, setting the data strategy supporting the measurement of CRO performance, generating real-time dashboard for patient enrollment, site quality and forecasting study start-ups and cycle times. Before this position he has worked at Amgen, AstraZeneca and Pfizer within their respective Analytics and Innovation groups providing strategic services, supporting metrics and data management needs of senior leadership teams. He holds a Bachelors in Biotechnology Engineering from Dr. D.Y. Patil University, Masters in Business of Bioscience from Keck Graduate Institute and MBA from University of Redlands - School of Business.
|Kelly Loughner||Boehringer Ingelheim|
Senior Associate Director, Site Enablement
Kelly Loughner is an experienced Senior Associate Director Of Clinical Contracting with a demonstrated history of working in the pharmaceuticals industry. Skilled in Negotiation, Medical Devices, Biotechnology, Management, and Healthcare.
Head, Data Collection Solutions
No bio available
Associate Director, Process/Technology/Analytics, Centralized Monitoring Services IQVIA Risk-Based Monitoring
Zabir Macci represents Centralized Monitoring for IQVIA, focused on optimizing risk-based monitoring (RBM). He brings expertise spanning RBM, continuous process improvement, business analysis, and analytics for clinical trials. He currently leads the process for Centralized Monitoring, including advanced analytics, for clinical trial design and execution. He holds a Bachelor’s degree in Computer Science from India and has a MBA in Management and Marketing from USA.
|Andy MacKelfresh||Duke Clinical Research Institute|
Project Leader, Clinical Research Informatics
Andy MacKelfresh is a Project Leader who partners with faculty and clients to advance clinical care by accomplishing research studies that require advanced harmonization of data from networks of clinical and real-world sources. Andy has 17 years’ experience in the clinical trials industry, focusing on innovation and research informatics. Andy holds an MBA, BS in Mathematics, and a Certificate in Clinical Research Conduct and Management.
Global Head, Real World Evidence Strategy
Charles Makin leads Biogen’s Real World Evidence Strategy team, overseeing RWE projects across all therapeutic areas for marketed and pipeline products. Before joining Biogen, Mr. Makin served as the General manager/VP for ICON’s RWE-Late Phase Research unit, the world’s second-largest research group dedicated to prospective data collection; and led the team – comprised of several hundred biostatisticians, medical affairs personnel, project/program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Prior to that, he held leadership positions in major drug commercialization research companies such as IMS, Mapi and Optum, including the roles of VP/Americas Head, Real-World Strategy and Analytics, Head of Observational Outcomes Research (Americas) and Global Head of Research Design and Proposal Development. He has also worked on the payer side (Anthem and Humana), where he led RWE initiatives, economic evaluations and health outcomes research studies. In nearly two decades in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for most of the top 20 pharmaceutical companies to influence payers, clinicians and HTA bodies and positively impact market access. He has served as Principal Investigator on over a 100 retrospective database analyses (EMR, linked, claims), global registries, medical chart reviews, economic models, PRO studies, physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area. He has also developed >25 value development plans and product market profiles and published on health policy. He has authored over 70 peer-reviewed manuscripts and scientific presentations, serves on the editorial board for multiple journals, and is an invited speaker at several conferences in the US and EU. Mr. Makin holds a BS in Pharmacy from the University of Pune, an MS in Pharmacy Administration (major in outcomes research) from Purdue University, as well as an MBA (Marketing), summa cum laude, and a Master of Management, summa cum laude, both from Goldey-Beacom College. He has also completed a Pharmacoeconomics and Outcomes research Fellowship from Humana.
|Marina Malikova, PhD||Boston University School of Medicine|
Executive Director, Surgical Translational Research: Operations and Compliance
Marina Malikova, PhD, MSci, MA, CCRA, RAC Executive Director, Surgical Translational Research: Operations and Compliance. Dr. Malikova has over 14 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and board certified in Regulatory Affairs (RAC). In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance. Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also serves as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine. Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).
Chief Product Officer, Product Management
As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 23 years of experience in life sciences and software development, Michelle has been at the forefront of transforming clinical trials through innovative technology and analytics and previously held the positions of Vice President of Product Management at Veeva and Vice President of Product Strategy at Medidata Solutions.
Before making the shift to the technology sector, Michelle worked in data management roles at GlaxoSmithKline and AstraZeneca. There she experienced firsthand the industry’s struggle outdated processes and systems. Michelle earned her bachelors of science degree in biology and mathematics from Coventry University.
Chief Product Officer
Fred Martin has built a career in healthcare over the course of nearly two decades, and has developed healthcare systems, BI/Analytics solutions, workflow tools for hospitals, and more. As Chief Product Officer at Medrio, he has overseen the development and release of Medrio eConsent, major upgrades to Medrio eSource, and numerous feature releases in Medrio EDC. Martin holds an MBA from the University of Michigan, Ann Arbor; an MILR from Cornell University; and a BA from the University of Colorado, Boulder.
Senior Resource Manager, Clinical Operations
I started my career in Finance at AT&T back in 1987. I spent 11 years in the Telecommunications business during which time I earned my BA and MBA degrees. In 1998, I moved into the Pharmaceutical business, joining J&J in Raritan, NJ, providing financial support to the clinical teams in preclinical, development and medical affairs. In 2008, I started my career at Bayer Healthcare as the US R&D Controller. Since then, I have moved into the role of Sr. Resource Manager, supporting the Oncology study teams with clinical trial budgeting, forecasting and resource planning. As an integrated member of the study teams, my role often leads to special initiative support such as implementing an automatic site payment solution in the US.
Global Trial Manager
Christine is currently working as a Central Statistical Surveillance Specialist at Janssen Pharmaceuticals, a J&J company. Christine has over 13 years of global clinical trial operational leadership experience between both early and late phase clinical development trials in various therapeutic areas, with a focus in Neuroscience. Christine was an instructor for Clinical Project Management for 3 years as a part of a post-graduate Clinical Research program at Humber College in Toronto. Christine has a MS in Neuroscience from the University of British Columbia and a BS in Physiology with a minor in Chemistry from the University of Toronto.
|Megan McBride, MPH||Janssen, The Pharmaceutical Companies of Johnson & Johnson|
Associate Director, Janssen Clinical Innovation, GCDO, R&D
Megan McBride is an Associate Director with Janssen Clinical Innovation. As part of this core clinical innovation function within Janssen R&D, she leads patient engagement initiatives to drive innovation into the clinical operating model to improve clinical trials for all stakeholders. She currently leads projects focused on data transparency, access and a global trial community for trial participants for Janssen’s R&D programs. With 20+ years’ experience leading global clinical programs in the US, EU, Africa and Asia, Megan has worked across diverse teams and communities, NGOs, global foundations, government organizations and pharma. Building on this diverse background she is dedicated to bringing new perspectives and approaches to the trial process. Megan holds an MPH from the Johns Hopkins University Bloomberg School of Public Health.
|Ann McCabe||Daiichi Sankyo|
Director, Process Excellence & Risk Management
Ann McCabe is currently the Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked in the areas of Clinical Operations, Quality, Process Improvement and Training and is PROSCI certified. She is currently leading implementation efforts for Risk Based Quality Management (ICH E6 R2), study/partner metrics and CRO Oversight for Daiichi Sankyo. She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.
No bio available