Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness and natural history research, using diverse forms of data including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration. She is a Fellow of International Society of Pharmacoepidemiology (ISPE) and of DIA, and is a Science and Policy Advisor to DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and a member of ISPOR's RWE Leadership Team.

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.