Payal Agarwal, Ph. D is currently a Biopharmaceutics assessor in the Division of Product Quality Assessment VI, in the Office of Pharmaceutical Quality (OPQ), CDER. Her responsibilities include biopharmaceutics assessment of NDAs (original and supplement), ANDAs (original and supplement), INDs, and Pre-ANDAs. Before joining the FDA, Dr. Agarwal served as a Senior Manager Advisory Services, Research Scientist I at Avalere Health. In this role she applied her comprehensive blend of expertise on multiple regulatory policy and strategy projects for diverse group of clients. She was engaged in providing regulatory policy advice and guidance based on legislative trends to Avalere’s internal and external stakeholders. Prior to Avalere Health, Dr. Agarwal was a tenured faculty and worked as an Associate Professor of Pharmaceutics and Biopharmaceutics in the Department of Pharmaceutical Sciences at the School of Pharmacy, Notre Dame of Maryland University for 12 years. Due to her exceptional dedication, knowledge and skills, and service to students, in addition to her caring and compassionate personality, Dr. Agarwal was awarded as the Teacher of the Year. Along with teaching, research, and mentorship roles, she held several leadership positions at the institution. She has been actively involved with many scientific organizations, served as an editorial board member and as a scientific reviewer for various peer reviewed journals, meetings abstract, and book chapters. She authored and edited the textbook “Pharmaceutical Calculations” for the PharmD curriculum. She has executed, managed, and led multiple scientific and regulatory projects.
Dr. Agarwal has made significant contributions in the areas of oral delivery of proteins and peptide-based drugs. The novelty and significance of her research has been recognized and awarded by several scientific communities. Dr. Agarwal received her Ph.D. in Industrial Pharmacy from St. John’s University, NY, MS in Pharmacometrics from University of Maryland, Baltimore, MS in Pharmaceutics and Bachelor of Pharmacy from Dr. H.S. Gour University, India.