Real World Evidence Conference
Dorothee B Bartels, PhD, MSc
- Head of Global Real World Evidence and Digital Science
- UCB, Germany
Dorothee Bartels is Head of Real World Evidence (RWE) and Digital Sciences at UCB Biosciences. Previously she was Clinical and Real World Data Strategy Lead at X, Moonshot (Alphabet Inc), after 12 years with Boehringer Ingelheim as Corporate Head of Global Epidemiology and Chief Digital Science Officer in the innovation Lab, Bi X. She maintains appointments as Ass. Prof. for Public Health & Epidemiology (Hannover), as Adj. Prof. for Epidemiology & Biostatistics (McGill), and teaches in the Swiss course “Successful implementation of digital health” (Inst. for Communication and Leadership). Dorothee is a fellow of ISPE, founder and immediate past chair of the Special Interest Group Digital Epidemiology.
Mark Stewart, PhD
- Vice President, Science Policy
- Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments in the fastest and safest way possible. Mark leads the development and implementation of the organization's research and policy agenda as well as overseeing the conduct of research projects to inform ongoing policy discussions. He regularly participates in policy discussions and meetings throughout the year to help catalyze meaningful change for oncology healthcare and patients.
Brian Bradbury, DrSc, MA
- Vice President, Center for Observational Research
- Amgen, United States
Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.
Paul M. Coplan, DrSc, MBA, MSc, FISPE
- VP, Medical Device Epidemiology & Real-World Data Analytics
- Johnson & Johnson, United States
Paul Coplan, ScD, MBA, is Vice President and Head of Medical Device Epidemiology at Johnson and Johnson and adjunct assistant professor in Epidemiology at University of Pennsylvania Perelman School of Medicine. Paul has been engaged in using RWE for 25 years in device, drug, vaccine and biologic development at Johnson & Johnson, Merck, Wyeth, Pfizer, Purdue and the International Partnership for Microbicides, with FDA/EMA approval of 3 medical devices, 9 vaccines and 9 pharmaceuticals . He has published 90+ journal articles, 500+ conference presentations and conducted studies in 15 countries. He has a Doctor of Science in Epidemiology from Harvard, MBA from Wharton Business School, and MS from Univ of Massachusetts.
Nancy A. Dreyer, PhD, MPH, FISPE
- Principal, Dreyer Strategies; Chief Scientific Officer Emerita, RW Strategies
- IQVIA, United States
Nancy Dreyer is Chief Scientific Officer Emerita for Real World Solutions at IQVIA, and Adjunct Professor of Epidemiology at the University of North Carolina at Chapel Hill. A Fellow of both the International Society of Pharmacoepidemiology and DIA, she is well-known for her thought leadership. She helped advance the use of real-world evidence for regulatory purposes, influencing the content of recent guidelines by regulators in the US, Europe, and China, each of which cite one or more of her publications. Her substantial executive and field experience have helped hone her pragmatic views.
Robert Reynolds, DrSc, FISPE
- Vice President, Epidemiology & Patient-Centered Outcomes
- GSK, United States
Dr. Reynolds is Vice President, Epidemiology & Patient-Centered Outcomes in Value Evidence and Outcomes, part of Research and Development at GSK. He heads a group responsible for leading the epidemiologic and patient components of integrated evidence plans. He is also an Adjunct Associate Professor of Epidemiology at the Tulane School of Public Health and Tropical Medicine. Prior to joining GSK, he worked at Pfizer for twenty years, most recently leading Epidemiology in R&D. He is a Fellow and former Board member of the International Society for Pharmacoepidemiology. He holds a MSc in Epidemiology and ScD in Population and International Health from the Harvard T.H. Chan School of Public Health.
Robin M. Weinick, PhD
- SVP/Managing Director Americas and Global Program Officer
- DIA, United States
Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also has served as Associate Director for Health at the RAND Corporation, a premier U.S.-based think tank, and on the faculty of Harvard Medical School and Massachusetts General Hospital. She began her career in federal service with the U.S. Department of Health and Human Services. She holds a B.A. in Health and Society from the University of Rochester and a Ph.D. on Population Dynamics from Johns Hopkins University.
Marni Hall, PhD, MPH
- Vice President, Clinical Evidence
- IQVIA, United States
Marni Hall is Vice President of Clinical Evidence for IQVIA Real-World & Analytic Solutions, providing scientific oversight and strategic direction on the expanded use of real world evidence for regulatory and other uses, by applying her expertise in regulatory science, drug safety, and patient-centricity. Following her role as Director of Regulatory Science in CDER’s Office of Surveillance and Epidemiology, she served as Senior Vice President of Research and Development, Informatics, and Policy at PatientsLikeMe. Dr Hall received her training in biochemistry and molecular epidemiology at Columbia University, and currently serves as Vice Chair of Board of Directors of Worcester Polytechnic Institute.
Steven A. Anderson, PhD
- Director, Office of Biostatistics and Epidemiology, CBER
- FDA, United States
Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and risk assessment programs. He was previously the Associate Director for Risk Assessment and established a program in quantitative risk assessment for biologics and has led numerous risk assessment projects and epidemiological studies.
Richard Forshee, PhD
- Deputy Director, OBPV CBER
- FDA, United States
Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products, vaccines, and human cell and tissue products. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.
James Harnett, PharmD, MS
- Executive Director, Health Economics and Outcomes Research
- Regeneron Pharmaceuticals, Inc. , United States
Dr. James Harnett is the Executive Director for HEOR for Oncology/Hematology at Regeneron. Prior to this, Dr. Harnett worked at Pfizer for over 20 years, most recently as the Lead in Global Medical Epidemiology for Oncology and Vaccines helping to establish external control arms and generate epidemiological data for COVID-19 vaccine and antiviral programs. Dr. Harnett supported establishing the RWDnA function at Pfizer in 2012, which facilitated Pfizer's first regulatory RWE submission and label expansion for Ibrance and a more recent publication on regulatory use of RWE in the autoimmune space. As a prior Team Lead in HEOR, he established the first long-term research payer partnership with Humana and advanced the first payer rPCT.
Debra Schaumberg, DrSc, MPH
- Vice President, Epidemiology & Head Strategic and Scientific Affairs
- Evidera | PPD, United States
Debra Schaumberg is Vice President, Epidemiology and Head, Strategic & Scientific Affairs at Evidera, a business unit of PPD. An internationally recognized expert in epidemiology and ophthalmology, she brings >25 years of experience in clinical research, designing and leading research investigations spanning the spectrum of RCT through all aspects of RWE generation and integration, including early to late phase clinical trials, pragmatic trials, case-control studies, and large cohort studies. Dr. Schaumberg’s responsibilities cross all areas of the PPD portfolio of service offerings and client solutions. She and her team work collaboratively with clients to provide solutions that advance strategic and scientific aspects of projects.
Simon Dagenais, PhD, MSc
- Senior Director, Real-World Evidence
- Pfizer Inc, United States
Simon is an epidemiologist and health economist with expertise in designing, conducting, and communicating scientific studies related to the clinical and economic value of therapies for neurologic conditions. He was the global head of RWE for neurology programs at Vertex Pharmaceuticals and supported the clinical development of genetic therapies for Duchenne muscular dystrophy and other rare diseases. Prior to Vertex, Simon worked in health economics and outcomes research and pharmacovigilance at Pacira Pharmaceuticals.
Cort Hayflinger, MS
- Hayflinger Analytical Services, LLC, United States
Cort Hayflinger has been working with real world health care data for nearly 20 years in a variety of settings, including pharmaceutical companies, academia, and the federal government. Trained as a biostatistician and SAS programmer, Cort has extensive hands-on experience with developing and executing analyses of large health care databases. He is the President of Hayflinger Analytical Services, which offers consulting services related to real world data, SAS programming, and statistical analyses to a variety of clients in the life sciences industries. Cort often works closely with researchers in health economics and outcomes research, pharmacovigilance, real world evidence, and related functions at pharmaceutical companies.
Robert Ball, MD, MPH, MSc
- Deputy Director, Office of Surveillance and Epidemiology, CDER
- FDA, United States
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.
Ruthie Davi, PhD, MS
- Vice President, Data Science and Statistician
- Medidata, a Dassault Systèmes Company, United States
Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI by Medidata (a Dassault Systèmes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Acorn AI Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is her Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.
Jon D. Duke, MD, MS
- Director of Health Informatics
- Georgia Tech Research Institute, United States
Charles Lee, MBA, MS
- Executive Regulatory Science Director
- AstraZeneca, United States
Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversee Global Regulatory strategy and implementation for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader over a 10 year period at Astrazeneca and at Roche where he led cross-functional project teams for programs in the early development phase (Ph0 to Ph2b). Previous to that, Charles spent 10 years in Global Regulatory affairs where he held leadership roles on programs across several therapeutic areas in different stages of development. Charles holds BS in Biology from The Johns Hopkins University, MS from University of Virginia, MBA from Columbia Business School
- Senior Medical Advisor for RWE, Office of Medical Policy, CDER
- FDA, United States
Amy Abernethy, MD, PhD
- President of Clinical Research Business
- Verily, United States
Amy Abernethy, MD, PhD, an oncologist and internationally recognized clinical data expert and clinical researcher, served as the Principal Deputy Commissioner of Food and Drugs and acting Chief Information Officer. She helped oversee FDA’s day-to-day functioning and directs special and high-priority cross-cutting initiatives. As acting CIO, she oversees FDA’s data and technical vision, and its execution. She has held multiple executive roles at Flatiron Health and was professor of medicine at Duke University School of Medicine. Dr. Abernethy received her MD at Duke University, PhD. at Flinders University, BA at the University of Pennsylvania and is boarded in palliative medicine.
Anne Heatherington, PhD
- Senior Vice President, Head of Data Sciences Institute
- Takeda Pharmaceuticals, United States
Harlan M. Krumholz, MD
- Harold H. Hines, Jr. Prof of Medicine and Director, Center for Outcomes Research
- Yale University, United States
Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine, is a cardiologist and Director of the Yale Center for Outcomes Research and Evaluation. He is an expert in the science to improve the quality and efficiency of care, reduce disparities, and improve integrity in medical research. He founded HugoHealth, a patient-centric platform to engage people as partners in research and leverage the secure movement of digital health data. He is a member of the National Academy of Medicine, American Society for Clinical Investigation, and Association of American Physicians. He received a BS from Yale, an MD from Harvard, and a Masters in Health Policy and Management from the Harvard School of Public Health.
Jeremy A Rassen, DrSc, MS
- Co-Founder and President
- Aetion, United States
Jeremy A. Rassen, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory agencies. Prior to founding Aetion, Dr. Rassen was Assistant Professor of Medicine at Harvard Medical School, where he focused on methods to improve the quality and validity of real-world data studies. He also worked in Silicon Valley in a variety of tech companies. Dr. Rassen received his bachelor’s degree in Computer Science from Harvard College and his master’s and doctorate degrees in Epidemiology from the Harvard T.H. Chan School of Public Health.
Frank W. Rockhold, PhD, MSc
- Professor of Biostatistics
- Duke Clinical Research Institute, Duke University Medical Center, United States
Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.
- Head, Epidemiology Analytics
- Janssen Pharmaceuticals, Inc., United States
Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of the Observational Medical Outcomes Partnership (OMOP), a public-private partnership chaired by the FDA. Patrick received his PhD in Pharmaceutical Outcomes and Policy from University of North Carolina at Chapel Hill.
Peter Richard Arlett, MD, FFPM, FRCP
- Head Data Analytics and Methods Task Force
- European Medicines Agency, Netherlands
Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Honorary Professor, London School of Hygiene and Tropic Medicine (2020). Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – 2020; Principal Administrator, Pharmaceuticals Unit, European Commission 2003-2008; UK MHRA 1996-2003; Hospital Physician, Oxford and London, UK NHS 1991-1996.
Cathy W Critchlow, PhD, MSc
- Vice President, R&D Data Strategy
- Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational Research, providing strategic leadership in use of RWD to inform decision-making by multiple internal and external stakeholders. Prior to joining Amgen in 2004, Dr. Critchlow was on the Epidemiology faculty at the University of Washington. Dr. Critchlow earned her bachelor’s degree from Stanford University, and her MS in Biostatistics and PhD in Epidemiology from the University of Washington.
Michael Kattan, PhD, MBA
- Department Chairman, Quantitative Health Sciences
- Cleveland Clinic, United States
I am chair of the department of Quantitative Health Sciences at Cleveland Clinic. My collaborative and research interests center around the development and validation of statistical prediction models.
Zoe Li, MBA
- Director, Life Sciences
- COTA, United States
As a leader in the Life Sciences group at COTA, Zoe builds partnerships with pharma and biotech companies to support and accelerate clinical development with the use of real world data. She brings expertise from the pharma, tech, and consulting industries to thoughtfully design and execute real world data strategies. Her current areas of focus are helping companies along the adoption curve of real world data with concrete steps towards value realization and improving COTA's data and partnering models to best support clinical development efficiency.
Robert J. Temple, MD
- Deputy Center Director for Clinical Science, Office of the Center Director, CDER
- FDA, United States
Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND). Bob is a consultant to the OND director on matters related to clinical program objectives. Dr. Temple received his MD from the NYU School of Medicine in 1967. In 1972, he joined CDER as a Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products.
Jeff Allen, PhD
- President and Chief Executive Officer
- Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology from Bowling Green State University.
Ying Bao, DrSc, MD
- Senior Director, Center for Observational Research and Data Science
- Bristol Myers Squibb, United States
Ying Bao is Senior Director in the Center for Observational Research & Data Science at Bristol Myers Squibb. She leads a team of epidemiologists and biostatisticians who use real-world data to characterize patient populations, optimize trial design, evaluate treatment effectiveness and safety, and develop value-based contracting strategies. Before joining BMS, Dr. Bao was Assistant Professor of Medicine at Harvard Medical School and Associate Epidemiologist at Brigham and Women’s Hospital. She received her ScD in epidemiology from Harvard School of Public Health and MD from Tongji University, and has authored 50+ peer-reviewed articles in major medical journals such as New England Journal of Medicine, Nature Medicine and JAMA Oncology.
Stefan James, MD
- Professor of Cardiology
- Uppsala University, Sweden
Christina Mack, PhD, MPH
- Vice President, Epidemiology and Clinical Evidence
- IQVIA, United States
Dr. Mack is Vice President of Epidemiology and Clinical Evidence and Head of the Surveillance and Analytics team at IQVIA, where she oversees development of large evidence platforms and novel studies that augment primary data collection with existing data. She also holds an academic appointment as adjunct Associate Professor of Epidemiology at the University of North Carolina at Chapel Hill, serves on the Advisory Board of the Carolina Health Informatics Program, is co-Chair of the MDEpiNet Scientific Oversight Committee as well as co-Chair of the International Society for Pharmacoepidemiology (ISPE) Medical Devices Special Interest Group.
Yoshiaki Uyama, PhD, RPh
- Director, Office of Medical Informatics and Epidemiology
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment initiative) and MID-NET®(Medical Information Database Network). He has many experiences in regulatory science of benefit/risk assessment of a new drug, including the role in ICH as ICH Technical Coordinator (2004-2009), the topic leader of ICH E15 and E16, Rapporteur of ICH E17 Expert Working Group (2014-2017) and Rapporteur of ICH Pharmacoepidemiology Discussion Group (2019-2021).