Real World Evidence Conference
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.
Brian D. Bradbury, PhD, MA
- Vice President, Center for Observational Research
- Amgen, Inc., United States
Brian D. Bradbury is Executive Director in the Center for Observational Research (CfOR) at Amgen, Inc, and an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who use real-world data (RWD) to generate evidence to support decision-making. His team is responsible for Amgen’s RWD platform, and for conducting epidemiologic research to characterize target patient populations, help design clinical studies, conduct post-marketing commitment studies, and execute comparative effectiveness and safety research. He received his DSc in Epidemiology from Boston University and has authored/co-authored 70+ publications in the area of pharmacoepidemiology.
Paul M. Coplan, MBA, FISPE
- Vice President, Medical Device Epidemiology & Real-World Data Analytics
- Johnson & Johnson, United States
Paul Coplan, ScD, MBA, is Vice President and Head of Global Medical Device Epidemiology at Johnson and Johnson. He is also adjunct assistant professor in Epidemiology at the University of Pennsylvania Perelman School of Medicine. Paul has been engaged in using RWE in the successful FDA approval of 8 pediatric and 1 adult vaccines and 9 pharmaceutical drugs over the past 24 years in drug, vaccine and biologic development research at Merck, Wyeth, Pfizer, the International Partnership for Microbicides (a non-profit pharmaceutical company), and Purdue Pharma. He has published 72 peer-reviewed journal articles and over 400 conference abstracts/posters and has conducted studies in 15 countries.
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. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health, she also serves on the Clinical Trials Methods Advisory Panel for PCORI. She was named twice to PharmaVOICE’s list of 100 most influential and inspiring individuals in life sciences, and received DIA’s 2019 Global Inspire Award for Author of the Year for “Advancing a framework for regulatory use of real world evidence: When real is reliable.” Her work has been used by global regulators, with recent reference in the new RWE Chinese guidelines for using RWE.
David Martin, MD, MPH
- Associate Director for Real World Evidence Analytics, OMP, CDER
- FDA, United States
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions, and contributes to medical policy development mandated by the 21st Century Cures Act. He led the development of the open source FDA MyStudies mobile app. Other key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs. He completed his M.D. and M.P.H. at the Johns Hopkins University and is board certified in Occupational Medicine and Clinical Informatics.
- Global Head of Real World Evidence Methods, Analytics and Safety
- UCB Pharma, Inc., United States
Robert Reynolds, FISPE
- Vice President, Epidemiology
- GlaxoSmithKline, United States
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.
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.
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.
James Harnett, PharmD, MS
- Senior Director, Lead, Real World Data and Analytics, Patient and Health Impact
- Pfizer Inc., United States
Dr. James Harnett is a Senior Director, Real World Evidence Lead in Pfizer’s Patient & Health Impact organization. Dr. Harnett supported establishing the RWDnA function at Pfizer in 2012 and was previously a Team Lead in Health Economics & Outcomes Research. Dr. Harnett has worked for over 17 years creating and leading research programs across therapeutic franchises in US, Global, and Account focused roles. He founded and oversaw the first payer-manufacturer research partnership with Humana, supported establishing an EHR/NLP partnership with Humedica, spearheaded payer pragmatic clinical trials and serves as a representative for several initiatives on regulatory application of RWE.
Debra Schaumberg, MPH
- Vice President, Scientific Affairs Real World Evidence
- Evidera, United States
Debra Schaumberg is Vice President of Scientific Affairs and Real-World Evidence at Evidera | PPD. An internationally recognized expert in epidemiology, she brings >25 years of experience designing and leading research investigations spanning the spectrum of RCT through all aspects of RWE generation and integration, including designing and leading early to late phase clinical trials, pragmatic and virtual trials, case-control studies, and large cohort studies.