Partha Roy, PhD

Director, Office of Bioequivalence (OB), OGD, CDER

Dr. Partha Roy is a recognized senior clinical / regulatory strategist who serves as Director of the Office of Bioequivalence, an FDA/CDER Office that oversees the thorough assessment of bioequivalence (BE) data required to support Abbreviated New Drug Application (ANDAs). Partha manages a multi-disciplinary program, providing leadership and management oversight to OB Division Management and primary and secondary assessors.

Prior to his current role, Partha was Vice President in PAREXEL’s Regulatory and Access Consulting Global Business Unit, providing executive management, regulatory strategy and thought leadership focused on driving corporate growth and delivery. Partha started his industry career as a clinical pharmacologist in both brand and generic companies and spent several years as an assessor in the Office of Clinical Pharmacology, CDER, FDA. Dr. Roy completed his Postdoctoral Fellowship in Drug Metabolism and Pharmacokinetics (DMPK) from Boston University, Boston, MA. He obtained his PhD in Biochemical Toxicology from University of South Florida, Tampa Florida and B.S. in Pharmacy degree from Jadavpur University, Kolkata, India.

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