Dr. Anshu Marathe is an Executive Director in Quantitative Pharmacology and Pharmacometrics at Merck supporting oncology drug development. She previously was a Director in PK Sciences at Novartis and supported 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. At FDA, she also served as a member of OCP’s Biologics Oversight Board, responsible for overseeing biosimilar development. She has extensive drug development experience supporting multiple drug modalities and several therapeutic areas. Throughout her career, she has contributed to clinical pharmacology, pharmacometrics and regulatory research and mentored several fellows and FTEs. She has continued to play a key role in advocating the use of model-informed drug development for enhancing efficiency and streamlining drug 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.

Dr. Snehal Samant is Associate Director of Clinical Pharmacology at Johnson & Johnson Innovative Medicine. With over a decade of experience spanning regulatory and industry settings across several therapeutic areas, she brings expertise in integrating clinical pharmacology, regulatory strategy, and model-informed drug development (MIDD) to inform and optimize drug development strategies.

Before joining Johnson & Johnson, Dr. Samant held roles of increasing responsibility at the U.S. Food and Drug Administration (FDA) in the Office of Clinical Pharmacology, advancing from Clinical Pharmacology Reviewer to Team Leader. During her tenure, she led clinical pharmacology reviews, contributed to regulatory guidance development and model-informed drug development initiatives, and received multiple honors, including the FDA CDER Director’s Special Citation Award and the Office of Clinical Pharmacology’s Excellence in Regulatory Review Award.

Dr. Samant holds a Ph.D. in Pharmaceutical Sciences with a minor in Statistics from the University of Florida, and an M.S. in Pharmaceutics from MCPHS University. She is an active member of ACCP and ASCPT, is a frequent peer reviewer for leading scientific journals and serves on journal editorial boards. Recognized for her collaborative leadership and effective communication, Dr. Samant is dedicated to advancing scientific dialogue and fostering meaningful collaboration across industry, academia, and regulatory sectors.

Ye Xiong is a senior pharmacokineticist in Division of Pharmacometrics at the FDA. She received her PhD in pathobiology and molecular medicine and masters in Statistics and Pharmacokinetics, respectively. Her current role in FDA focuses on review in the area of oncology by applying quantitative clinical pharmacology and model-informed approaches to support regulatory decisions such as dose selection in general and specific populations, evidence of effectiveness and safety in intention-to-treat population, trial design during drug development and post-marketing commitments and requirements, etc. She led multiple research projects and review standardization efforts to enhance drug efficacy/safety evaluation.