Associate Director for Therapeutic Review
Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
Silver Spring, Maryland
Jayabharathi Vaidyanathan, Ph.D is the Associate Director for Therapeutic Review in the Division of Cardiometabolic and Endocrine Pharmacology in the Office of Clinical Pharmacology, CDER, FDA. She received her Ph.D. in Pharmaceutical Sciences from the Medical University of South Carolina. Previously, she was the clinical pharmacology team leader for general endocrinology, lipid lowering and obesity therapeutic areas. Her work involves applications of clinical pharmacology principles to development of drug products in the cardiometabolic and endocrine area. Her interests include bioavailability/bioequivalence, drug interactions, dosing in specific populations and risk/benefit assessment. As a subject matter expert, Dr. Vaidyanathan has contributed to FDA guidance development working groups – Bioavailability and Bioequivalence studies submitted in NDAs or INDs – General considerations and Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on Biopharmaceutics Classification System (BCS).
Keynote: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and Unicorns
Monday, October 23, 2023
1:30 PM – 2:30 PM ET
Keynote: Towards Development of Translational PBPK Models for Biologics
Tuesday, October 24, 2023
1:30 PM – 2:30 PM ET