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 affair specialist with 20 years of FDA regulatory review and translational research experience, currently serving as an FDA Seniar Biomedical Research and Product Assessment Service (SBRBPAS) Expert. Dr. Zhang has had primary or supervisory oversight for the product quality regulation of numerous biotechnology products under Investigational New Drug Applications (INDs) and Biologic License Applications (BLAs). He serves on FDA working groups to develop regulatory policy on the manufacturing and quality controls of drug products, and on surrogate biomarkers for accelerated approval. Dr. Zhang also directs a laboratory research program focused on devising bioassays and predictive tools for assessing the impact of critical quality attributes on safety and efficacy. Dr. Zhang has authored more than 200 peer-reviewed articles, book chapters, and invited presentations. Dr. Zhang received numerous FDA awards for his scientific achievements and collaborative regulatory efforts. Before joining FDA, Dr. Zhang worked as an Associate Professor at Nanjing University, Professor and Deputy Director at the Beijing Center for Biologics Research & Development, and Senior Scientist at the University of Tennessee School of Medicine. Dr. Zhang holds a Ph.D. in Protein Biochemistry from Peking University, and M.S. and B.S. in Chemistry from Lanzhou University.
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Wednesday, October 19, 2022
10:30 AM – 11:00 AM ET