SBRBPAS Expert
Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
Dr. Baolin Zhang is a Regulatory Affairs Professional with over 20 years of experience leading FDA product reviews and translational research. He currently holds the esteemed FDA Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert position. At the FDA, he has overseen Chemistry, Manufacturing, and Controls (CMC) assessments for a wide range of biotechnology drug products, including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and biosimilars.
Dr. Zhang also leads a multidisciplinary research team dedicated to advancing regulatory science for biotechnology products. His contributions span various fields, including cancer biology, immunotherapy, biomarkers, bioassays, and protein analytics. He has published 200+ articles, book chapters, and abstracts, presented extensively at global forums, and received 20+ distinguished awards, such as the FDA Scientific Achievement Award and FDA Awards for Excellence in Regulatory Science, Analytical Science, Mentoring, Leadership, and Team Excellence.
Before joining the FDA in 2001, Dr. Zhang worked as an Associate Professor at Nanjing University, Deputy Director at the Beijing Center for Biologics Research & Development, and a Senior Scientist at the University of Tennessee School of Medicine. Dr. Zhang earned his Ph.D. in Chemistry from Peking University, in addition to M.S. and B.S. degrees in Chemistry from Lanzhou University.
Integrating Biomarkers in PD-1/PD-L1 Antibody Therapy for Personalized Cancer Treatment
Tuesday, October 24, 2023
9:00 AM – 9:15 AM ET