Baolin Zhang PhD

Baolin Zhang is a Senior Investigator and a Product Quality Reviewer in the Division of Therapeutic Proteins within the Office of Biotechnology Products of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA). Dr. Zhang has 14 years of FDA regulatory experience in product quality review (Chemistry, Manufacturing and Control) of therapeutic protein product applications under investigational new drug applications (INDs) and biologic license applications (BLAs). He also leads a research team conducting FDA mission-related research aimed at improving drug safety and efficacy.

Dr. Zhang’s scientific expertise lies in the areas of protein biochemistry, cell death and cell growth regulation, cancer drug development, biomarkers, and potency assays for evaluation of therapeutic proteins. He has published over 70 original studies in prestigious journals, and presented at numerous scientific and regulatory conferences on the development of therapeutic proteins. Dr. Zhang serves as an Editorial Board member and as an ad hoc reviewer to numerous scientific journals. He has supervised and mentored many research fellows and regulatory staff. Dr. Zhang earned his Ph.D. in chemistry from Peking University in China. He is a recipient of the FDA Scientific Achievement Award, the FDA/CDER Excellence in Mentoring Award, and the FDA/CDER Excellence in Leadership Award.