Hussein Ezzeldin, PhD
Senior Staff Fellow, Office of Biostatistics and Pharmacovigilance, Division of Analytics and Benefit-Risk Assessment, Analytics & Real World Evidence Branch
FDA
Hussein Ezzeldin, PhD earned his PhD in 2012 from the University of Maryland, College Park. He joined the FDA, Office of Biostatistics and Pharmacovigilance (OBPV) in the Center for Biologics Evaluation and Research (CBER) in 2013. Dr Ezzeldin worked on multiple modeling and risk assessment, policy, and research projects. Dr Ezzeldin works on advancing the science of patient input as part of the FDA regulatory-science strategic goals, and he is leading the natural history study for metachromatic leukodystrophy, HOME. Currently, Dr Ezzeldin co-leads the Biologics Effectiveness and Safety Innovative Methods Initiative (BEST IM), which aims to develop new and innovative methods for a semi-automated adverse events (AEs) reporting system for CBER-Regulated Biological Products. Dr Ezzeldin is the acting CBER Lead for the digital health technology review team (DHT-RT), supporting the use of DHTs in regulatory submissions.