Paresma (Pinky) Patel, Ph.D. is a Division Director in CDER’s Office of Pharmaceutical Quality, Office of Product Quality Assessment III. In this role, she leads groups responsible for the evaluation of chemistry, manufacturing, and controls (CMC) information with a focus on drug substance quality throughout clinical development to submission of marketing applications. She served as a Branch Chief, supporting the oncology and anti-viral clinical divisions, prior to transitioning to her current role. Prior to FDA, she worked as a medicinal chemist at the National Institutes of Health. Dr. Patel completed her Ph.D. in organic chemistry at The Scripps Research Institute and completed a postdoctoral fellowship at the California Institute of Technology.