Zhaohui Ye

Zhaohui Ye, PhD joined FDA Center for Biologics Evaluation and Research (CBER) in 2016 as a principal investigator. He is currently the Chief of Gene Transfer and Immunogenicity Branch in the Office of Gene Therapy (OGT), Office of Therapeutic Products (OTP) at CBER. In his role, he is responsible for chemistry, manufacturing and controls (CMC) review and policy development in cell and gene therapy products. Dr. Ye received a PhD degree in Immunology from Johns Hopkins University. Prior to joining the FDA, he held faculty positions at Johns Hopkins University School of Medicine. Dr. Ye maintains an active research program on stem cell engineering in CBER OGT.