Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presenter
Sau (Larry) Lee, PhD
Deputy Director of Operations
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Sau (Larry) Lee is currently Deputy Super Office Director for Operations and oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in the Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ). Dr. Lee has been with the U. S. Food and Drug Administration since 2005, serving as a Regulatory Scientist, Team Lead, Associate Director for Science, Deputy Office Director, Office Director, and Deputy Super Office Director of Science. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance, and policy.
In 2016, Dr. Lee was appointed to the Senior Biomedical Research Service (SBRS) because of his extensive regulatory and scientific contributions to manufacturing science, complex drug substances and products, and emerging pharmaceutical technologies. Prior to joining the U.S. Food and Drug Administration, Dr. Lee received a B.S. degree in Chemical Engineering with a minor in Materials Science from the University of Virginia and a Ph.D. in Chemical Engineering from Princeton University.