Real World Evidence Conference
Dorothee B. Bartels, PhD, MSc
- Head of Global Real World Evidence and Digital Science
- UCB Pharma, Belgium
Dorothee joined UCB from X, Moonshot (Alphabet Inc.), where she was Clinical and Real World Data Strategy Lead. Prior she was 12 years with Boehringer Ingelheim as Corporate Head of Global Epidemiology and then Chief Digital Science Officer in the innovation Lab, Bi X. She maintains appointments as Associate Professor for Public Health and Epidemiology at Hannover Medical School (MHH) and as Adjunct Professor for Epidemiology and Biostatistics at McGill University. She is a fellow of the International Society of Pharmacoepidemiology and 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 D. Bradbury, PhD, 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
- Vice President, 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 (a non-profit pharmaceutical company), with FDA/EMA approval of 9 vaccines and 9 pharmaceuticals . He has published 80+ 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 University of Massachusetts.
Nancy A. Dreyer, PhD, MPH, FISPE
- Chief Scientific Officer and Senior Vice President
- IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA and Adjunct Professor of Epidemiology at the U of N Carolina School of Global Public Health. She leads the IQVIA Center for Advanced Evidence Generation. A fellow of both the International Society for Pharmacoepidemiology and DIA, her current work is focused on COVID-19 along with other issues of regulatory and public health importance. Recent recognition includes the Red Jacket honor from PharmaVOICE in 2020 and DIA’s Global Inspire Award for Author of the Year in 2019. She is also celebrating recent publication of the 4th edition of the popular book “Registries for Evaluating Patient Outcomes: a User’s Guide.”
Robert Reynolds, DrSc, FISPE
- Vice President, Epidemiology & Patient-Centered Outcomes
- GlaxoSmithKline, United States
Dr. Reynolds is Vice President, Epidemiology & Patient-Centered Outcomes in Value Evidence and Outcomes, part of Research and Development at GSK Pharma. 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 global Epidemiology in Regulatory and Safety. 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
- Senior Vice President and Managing Director, Americas and Global Program Officer
- DIA Global, 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 on the Board 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
- Associate Director for Analytics and Benefit-Risk Assessment, CBER
- FDA, United States
Richard Forshee is the Acting Deputy Office Director for the Office of Biostatistics and Epidemiology 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 & 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
- Director, Global Center of Excellence, Real World Evidence
- Vertex Pharmaceuticals, 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 is currently the global head of RWE for neurology programs at Vertex Pharmaceuticals and is supporting 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
- Acorn AI, A Medidata Company, United States
Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI, a Medidata 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 the development of Synthetic Control Arms. 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
- Executve Director, CVRM Regulatory Affairs
- AstraZeneca, United States
Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversee Global Regulatory strategy and implementation for therapeutic products in the cardiovascular disease, diabetes, and NASH. Prior to this role, Charles was a Product Development Team Leader over an 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). Before becoming project team leader, Charles spent 10 years in regulatory affairs where he held global Regulatory leadership roles on programs across a variety of therapeutic areas in different stages of development
- Senior Medical Advisor for RWE, Office of Medical Policy, CDER
- FDA, United States
Amy Abernethy, MD, PhD
- Principal Deputy Commissioner, CIO
- FDA, United States
Amy Abernethy, M.D., Ph.D., an oncologist and internationally recognized clinical data expert and clinical researcher, serves as the Principal Deputy Commissioner of Food and Drugs and acting Chief Information Officer. She helps 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 M.D. at Duke University, Ph.D. at Flinders University, B.A. 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
- President and Chief Science Officer
- 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 Inc., United States
Dr. Critchlow currently leads R&D Data Strategy, where she focuses on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of technical, regulatory and commercialization 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 stakeholders across the healthcare ecosystem. Prior to joining Amgen in 2004, Dr. Critchlow was a faculty member in Epidemiology in the School of Public Health and Community Medicine at the University of Washington. Dr. Critchlow earned her bachelor’s degree from Stanford University, and a master’s degree in
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 20 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
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference on Harmonisation Technical Coordinator; as ICH E15 and E16 topic leader; as Division Director, Regulatory Science Research; as Division Director, Review Planning and Pharmaceutical Affairs Consultation; as Director, Division of Epidemiology; and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group. Dr. Uyama earned his PhD from Nagoya City University and his post-doctoral research focused on promoting science within Japan.