About

Zhao Lab advances drug development and regulatory science through cutting-edge research in pharmacometrics, drug delivery modeling, and artificial intelligence (AI)-based tools that will closely impact drug development and regulatory decision-making.

Why now

New technologies are required to keep pace with the plethora of drugs, biologics and medical products that have emerged in recent decades.

1. Regulatory science develops new tools, standards, and approaches to assess the safety, efficacy, and quality of such products in order to help drug developers and regulatory agencies make informed decisions to protect public health via effective medical treatment.
2. Artificial intelligence (AI) is poised to revolutionize regulatory science, offering unprecedented opportunities to enhance medical product review processes, analyze vast amounts of clinical trial data, and assess post-market surveillance data with greater precision. In parallel, AI is transforming drug discovery and development by identifying novel drug targets, modeling the pharmacological activity of molecules, optimizing drug design, and gaining deeper insights into disease mechanisms. Our lab is working to build new AI-based tools and computational models to streamline regulatory science and accelerate drug development.
3. By leveraging cutting-edge technologies, we aim to create more efficient or novel pathways for bringing safe and effective therapies to market, while also advancing our understanding of complex diseases and therapeutic interventions.

Why here

The University of California, San Francisco (UCSF), is a leading academic institution renowned for its cutting-edge research in drug development and regulatory science. Here we have access to world-class research facilities and collaborations with top-tier scientists and industry leaders. We foster a dynamic and supportive research environment dedicated to developing innovative therapeutic strategies as boosted by the entrepreneurial Bay Area culture.

About the PI

Liang Zhao, PhD, MAS, MBA, is a professor in the Department of Bioengineering and Therapeutic Sciences in the Schools of Pharmacy and Medicine at UCSF. He previously 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.

He has demonstrated excellence and leadership in drug development and regulatory science in regulatory and industrial settings for new and generic drugs during his professional tenure of over 19 years, including in: Pharsight as an associate consultant, BMS as a research investigator, MedImmune as an associate director, the FDA as clinical pharmacology reviewer and Pharmacometrics team leader.

He started several regulatory initiatives including concepting model master files for model sharing and implemented model-integrated evidence for generic product development and approval. Zhao has also introduced a broad array of innovative tools in the realm of drug deliveries and bioequivalence assessment, as well as big data tools including machine learning to pharmacometrics.

Prior to joining UCSF, he had also served on the executive board for the newly established Quantitative Medicine Center of Excellence in the FDA and briefly as chair for the FDA Modeling & Simulation Working Group. He has published over 120 articles and book chapters in prestigious journals and in 2023 received the Gary Neil Prize for Innovation in Drug Development from the American Society for Clinical Pharmacology & Therapeutics.