Yao-Yao Zhu, MD, Ph.D.
Head of Global Regulatory Affairs
Dr. Zhu brings to Biosion over 13 years of regulatory experience as a senior medical officer/clinical reviewer at US FDA. She has experience in regulating both biologic and small molecule products working in CBER (Center for Biologic Evaluation and Research) and CDER (Center for Drug Evaluation and Research).
Dr. Zhu has reviewed clinical protocols with a wide range of indications at different stages of clinical development. As a primary clinical reviewer, she contributed to the market approval of BYLVAY™, TRALEMENT™, LUXTURNA™, DUCORD™, and LAVIV™. She has over 20 years of clinical experience as an internal medicine physician and teaching faculty in both inpatient and outpatient settings at medical centers such as the Greater Baltimore Medical Center and Johns Hopkins School of Medicine.
Dr. Zhu has over 7 years of research experience in molecular biology. She obtained her M.D. from Peking University Health Science Center, and holds a Ph.D. degree in Neuroscience from Baylor College of Medicine. She completed her post-doctoral training in gene therapy of bone diseases from the University of Michigan.