[HMCRS] Regulatory Science Forum – FDA’s Review of Real-World Evidence: Lessons from the Fabrazyme Case Study

Speaker: Joel Weissfeld, MD, MPH, is a Real-World Evidence Analyst in FDA’s Office of Medical Policy, where he evaluates RWE submissions for regulatory decision-making. He previously served over 10 years as Senior Medical Officer in FDA’s Office of Surveillance and Epidemiology, where he conducted the primary epidemiological review for the Fabrazyme full approval. Prior to joining FDA, Dr. Weissfeld spent 25 years in academic medicine at the University of Pittsburgh, where he was Associate Professor of Epidemiology and a member of the Cancer Institute. He has authored over 200 peer-reviewed publications and served as principal investigator on major NIH-funded studies, including the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. Dr. Weissfeld holds an MD from Johns Hopkins University and an MPH in Epidemiology from the University of Pittsburgh.

Register using the link below.

When 12:00 pm - 1:00 pm on 2 December 2025
Building Zoom (online)