Sau Lee, PhD

Office of Testing and Research, FDA
Deputy Director and Emerging Technology Team Chair
Sau (Larry) Lee is currently the Deputy Director for the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), the acting Team Leader of the OPQ Botanical Review Team, and the chair of the OPQ Emerging Technology Team. Larry and his OPQ Scientific and Research Staff are leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products containing nanomaterials, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ.

Larry joined the Office of Generic Drugs (OGD) in 2005 as a chemical engineer. In 2012 - 2013, Larry was the peptide team leader which specializes in CMC reviews of ANDAs for complex drug substances and products. As a member of the Office of Pharmaceutical Quality (OPQ) TAG Integrated Team-based Review Pilot, Larry led a team to evaluate OPQ’s vision for a team-based product and process/facility quality assessment approach. He also co-led the Risk Based Review Pilot which aimed to increase the review quality and efficiency of injectable products. In early 2013, Larry was promoted to Expert Regulatory Scientist in recognition of his expertise in evaluation of complex drug substances and products. Larry received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University.