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Mechanistic Drug Delivery Models

Wednesday, February 8, 2023

4:00 PM-5:30 PM

BIOMED Seminar


Mechanistic Drug Delivery Models

Liang Zhao, PhD, MAS, MBA
Division of Quantitative Methods and Modeling
Office of Research and Standards
Office of Generic Drugs
Center for Drug Evaluation and Research/FDA

Only 10% of drugs can make it to the market after entering the clinical stage. The high attrition rate can be significantly reduced, although overlooked in the past, via improving efficiency of drug delivery to the site of action. The mRNA based COVID vaccine further exemplified the importance of drug delivery. Mechanistic models that characterize drug delivery dynamics to different sites of action can critically guide drug development. This seminar will highlight the latest progress in modeling drug deliveries for orally inhaled, intra-nasal, and ophthalmic drug products.

Liang Zhao, PhD, MAS, MBA, has been serving as the Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, and the Center for Drug Evaluation and Research (CDER)/FDA since 2015. Dr. Zhao has a broad spectrum of scientific and management experience from industry and the regulatory agency. Through his 16-year professional career, he has established his leadership in industrial R&D, quantitative methods and modeling, and model based strategic decision makings in regulatory and industrial settings for generic and new drugs. He initially joined the FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology in 2009 and worked as a team leader in the Division of Pharmacometrics in 2013-2015.

Prior to joining FDA, Dr. Zhao worked at Medimmune for biotech products, Bristol Myers Squibb (BMS) for small molecule drug development, and Pharsight as an associate consultant for new drug R&D. He has a diversified educational background in Pharmaceutical Sciences, Applied Statistics, and Business Administration. Dr. Zhao has published more than 100 peer-reviewed articles in leading journals and received the 2022 Gary Neil Prize for Innovation in Drug Development from the American Society for Clinical Pharmacology and Therapeutics.

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