Associate Director for Innovation and Development
US Food and Drug Administration
Hui-Lee Wong is Associate Director Innovation and Development at the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). In this capacity, she is actively engaged in the CBER Surveillance Program efforts aimed at advancing CBER surveillance systems. At the US FDA since 2009, her regulatory experience encompasses post market surveillance of biologics, drugs and medical devices. She also leads projects in building capacity for pharmacovigilance in Democratic Republic of Congo and Kenya. She was seconded to the U.S. Centers for Disease Control and Prevention Ebola Response Team in Sierra Leone in 2015. Prior to US FDA, she completed a post-doctoral fellowship at the U.S. National Institutes of Health and received a Ph.D. in Molecular Epidemiology from the University of Southern California.