Dr. Baolin Zhang brings over two decades of experience in regulatory affairs at the FDA, specializing in CMC (Chemistry, Manufacturing, and Controls) and translational research in biopharmaceuticals. Currently, Dr. Zhang serves as a Senior Biomedical Research and Biomedical Product Assessment Service Expert (SBRBPAS). In this role, Dr. Zhang has led primary and secondary regulatory reviews for numerous Investigational New Drug Applications (INDs) and Biologic License Applications (BLAs) involving innovative biologics and biosimilars. Additionally, Dr. Zhang directs a research laboratory dedicated to advancing protein science, protein analytics, and the quality assessment of biopharmaceuticals and complex drug products.
Dr. Zhang has authored over 100 peer-reviewed articles and book chapters on various aspects of drug development. He is also a recognized speaker, having given more than 60 invited talks at national and international conferences, including the CASSS Bioassay and the CDER Botanical Drug Seminar Series. His expertise in bioassays has made him a highly sought-after consultant for BLAs and NDAs. He has received over 20 distinguished awards, including the FDA Scientific Achievement Award and the AAPS High Impact Article Award.
Before his tenure at the FDA, Dr. Zhang served 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 Health Science Center. He holds a Ph.D. in Chemistry from Peking University and M.S. and B.S. degrees in Chemistry from Lanzhou University.