Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Paresma Patel, PhD
Division Director
Division of Product Quality Assessment XIX (OPQAXIX)
Office of Product Quality Assessment III (OPQAIII)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
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.
Abstract
Dr. Paresma Patel, a division director in CDER’s Office of Pharmaceutical Quality, provides an agency perspective on chemistry, manufacturing, and controls (CMC) regulatory considerations for drug development. Her presentation aims to clarify regulatory definitions and requirements for drug substances and drug products and detail the CMC information necessary for Investigational New Drug (IND) submissions. Dr. Patel emphasizes how CMC evolves throughout clinical development, from limited information at the IND stage to comprehensive data required for marketing applications, ensuring consistent manufacturability. She explains key elements for drug substance information, including general details, manufacturing processes, structural and physiochemical characterization, impurity assessment, and stability data. For drug products, she covers dosage form description, composition, manufacturing, controls, packaging, and stability requirements. The presentation also highlights common CMC safety concerns that can lead to clinical holds, such as insufficient impurity characterization or lack of sterility assurance. Dr. Patel underscores the importance of consistent communication with the FDA through meetings like pre-IND sessions to address potential gaps and avoid issues, ultimately assuring pharmaceutical quality, availability, safety, and efficacy of every dose.