#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?
Nancy Dreyer, DIAFellow, PhD, MPH, FISPE
- Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation
- IQVIA, United States
Nancy Dreyer is the chief scientific officer and global chief of scientific affairs for IQVIA Real-World & Analytic Solutions. She leads the Center for Advanced Evidence Generation, focusing on the use of real-world evidence for regulators, payers, clinicians, and patients using minimally interventional and non-interventional study design that rely on primary and/or secondary data collection. She has worked with the FDA, most recently helping to plan a medical device evaluation network, and also has worked with the European Medicines Agency testing new methods for pharmacovigilance.
Mary Jane Geiger, MD, PhD
- Vice President and TA Lead, Drug Development Services
- ICON , United States
MJ Geiger is VP & CV lead for ICON’s Drug Development Services providing scientific, operational and therapeutic expertise spanning the development continuum from concept through development to post-approval activities. She is involved in the Cardiac Safety Research Consortium, serving as Co-Chair of the Scientific Oversight Committee and Program Chair of a Real World Evidence CV Safety Think Tank.
- Professor, Department of Epidemiology, Gillings School of Global Public Health
- University of North Carolina, Chapel Hill, United States
M. Alan Brookhart, Ph.D., is a Professor of Epidemiology at the UNC Gillings School of Global Public Health University of North Carolina at Chapel Hill. Dr. Brookhart’s research has focused on the development and application of innovative epidemiologic study designs, statistical methods, and visualization techniques for research using large clinical and administrative healthcare databases. Substantively, he is interested in the comparative effectiveness of medications in patients with end-stage renal disease. Dr. Brookhart has published over 200 peer-reviewed research papers and serves on the editorial board for Pharmacoepidemiology and Drug Safety and American Journal of Kidney Disease.
Norman Stockbridge, MD, PhD
- Director, Division of Cardiovascular and Renal Products, OND, CDER
- FDA, United States
Norman Stockbridge received his MD and PhD (Physiology) from Duke University. He has been a part of the FDA/CDER Division of Cardiovascular and Renal Products since 1991, serving as Division Director since 2004.