Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

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.

M. Alan Brookhart is a Professor of Epidemiology at UNC Chapel Hill. His research is focused primarily on the development and application of statistical and epidemiologic methods for studies of prescription medications, vaccines, and other exposures using large clinical and healthcare utilization databases. In this area, he has made contributions to the development of quasi-experimental approaches that can be used to estimate causal effects in the presence of unmeasured or poorly recorded confounding variables. He has also been involved with the development of propensity score and marginal structural model methodology and has also developed new epidemiologic approaches for studying patterns of use medications and healthcare services.

Norman Stockbridge, MD, PhD has been in FDA/CDER's Division of Cardiovascular and Renal Products since 1991 and has been its Director since 2004.