Paresma (Pinky) Patel, Ph.D., is a Division Director in CDER’s Office of Pharmaceutical Quality. 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 and submission of marketing applications (NDAs and BLAs). The division reviews small molecule related attributes of antibody-drug conjugates, and evaluates CMC information for drugs, linkers, and conjugation chemistry. She served as a Branch Chief, working closely with the oncology divisions, prior to transitioning to her current role. Prior to FDA, she worked as a medicinal chemist at the National Institutes of Health with a focus on target validation and lead optimization of small molecule kinase inhibitors. 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.