2024 PDA/FDA Joint Regulatory Conference

Patrick J. Lynch, PhD U.S. FDA

Patrick J. Lynch, PhD

Patrick J. Lynch, PhD U.S. FDA Director, Division of Product Quality Assessment XIII, OPQ, CDER

Patrick Lynch is the Director of the Division of Product Quality Assessment XIII (DPQA XIII) of the Office of Product Quality Assessment III (OPQA III), located in the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) at FDA. OPQA III is responsible for assessment of product quality information submitted in regulatory applications for small molecule active pharmaceutical ingredients and biotechnology biological products. He first joined FDA in 2009, where he has served as a research fellow, product quality reviewer, team leader, and review chief for assessment biological products. He received his Ph.D. in Biochemistry from Duke University in Durham, North Carolina, and his Bachelor of Science from the University of Georgia in Athens, Georgia.