Baolin Zhang

Dr. Baolin Zhang brings over 20 years of experience in regulatory affairs at the FDA, specializing in Chemistry, Manufacturing, and Controls (CMC) and translational research in biopharmaceuticals. He has extensive expertise in the development and evaluation of monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs) for cancer and infectious diseases. He holds an appointment in the FDA Senior Biomedical Research and Biomedical Product Assessment Service Expert (SBRBPAS). In this role, Dr. Zhang has led regulatory reviews for numerous Investigational New Drug (IND) and Biologic License Applications (BLA) involving innovative biologics and biosimilars. He also leads a research lab focused on advancing protein science, analytics, and quality assessment for complex biopharmaceutical products. Dr. Zhang has authored over 100 peer-reviewed articles and book chapters and delivered more than 60 invited talks at academic and industry forums. His contributions have earned him over 20 prestigious awards, including the FDA Scientific Achievement Award, the AAPS High Impact Article Award, and recognition for regulatory excellence, leadership, mentoring, and team collaboration. Before joining the FDA, Dr. Zhang served as an Associate Professor at Nanjing University, Deputy Director of the Beijing Center for Biologics Research & Development, and Senior Scientist at the University of Tennessee Health Science Center. He holds a Ph.D. in Chemistry from Peking University, along with M.S. and B.S. degrees in Chemistry from Lanzhou University.