Liang Zhao, PhD, MAS, MBA, is a Professor in the Department of Bioengineering and Therapeutic Sciences within the Schools of Pharmacy and Medicine at the University of California, San Francisco (UCSF). Prior to joining UCSF, he served as director of the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards in the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) from 2015 to 2024. His professional career spans over 19 years with experience at Pharsight, Bristol Myers Squibb (BMS), MedImmune, and the FDA. Dr. Zhao's research focuses on pharmacometrics, drug delivery modeling, and artificial intelligence-based tools that impact drug development and regulatory decision-making. His work encompasses mechanistic models for brain drug delivery, regulatory science modeling and simulation, AI-driven drug discovery and development, drug interactions, biological availability, generic drugs, clinical pharmacology, therapeutic equivalency, computer simulation, and FDA regulatory processes. He has pioneered innovative approaches including model master files for model sharing and model-integrated evidence for generic product development and approval. His research integrates machine learning tools into pharmacometrics to advance drug delivery and bioequivalence assessment methodologies. Dr. Zhao has published over 120 articles and book chapters in prestigious journals. His recent publications demonstrate strong focus on applying advanced modeling techniques, machine learning algorithms, and pharmacometric approaches to solve complex problems in drug development and regulatory science. His work shows consistent innovation in developing quantitative methods to enhance bioequivalence assessment, improve drug product characterization, and support regulatory decision-making for generic drugs. FDA Group Recognition Award, FDA, 2024 Gary Neil Prize for Innovation in Drug Development, American Society for Clinical Pharmacology & Therapeutics (ASCPT), 2023 Commissioner's Special Citation, FDA, 2021 Humanitarian Award, Victims' Rights Foundation, 2020 30+ FDA CDER team and Individual Awards, CDER, FDA, 2011 Academic Award for Executive MBA Class 2009, Judge Business School, University of Cambridge, 2011 Dr. Zhao leads the Zhao Lab at UCSF, which advances drug development and regulatory science through cutting-edge research in pharmacometrics, drug delivery modeling, and artificial intelligence. His work bridges academic research with regulatory applications, demonstrating leadership in translating scientific innovations into practical regulatory frameworks. His experience across industry, regulatory agencies, and academia provides a unique perspective on drug development challenges and opportunities.
