Director
Novartis Biomedical Research, East Hanover, USA
Dr. Anshu Marathe is a Director in PK Sciences at Novartis and supports immunology, hematology and oncology drug development. Prior to joining Novartis in 2019, she worked in the Office of Clinical Pharmacology (OCP) at the US FDA for 10 years in various roles as Clinical Pharmacology Team Leader, Scientific Lead for Biosimilars and as Senior Pharmacometrics reviewer. She has extensive drug development experience supporting multiple drug modalities and several therapeutic areas. At FDA, she also served as a member of OCP’s Biologics Oversight Board, responsible for overseeing biosimilar development. She mentored several fellows for intramural funded research projects to guide regulatory decisions and policy and contributed to regulatory guidance development. She received her Ph.D. in Chemical and Biological Engineering and subsequently completed her post-doctoral fellowship in Pharmaceutical Sciences from the University at Buffalo.