Fireside Chat - Charting New Frontiers: CDER's Quantitative Medicine Center of Excellence

Rajanikanth (Raj) Madabushi has over 15 years of regulatory experience. He currently serves as the Associate Director, Guidance and Scientific Policy in the Immediate Office of Office of Clinical Pharmacology.  Dr. Madabushi plays an instrumental role in the FDA’s PDUFA MIDD initiative and is the CDER Point-of-Contact for the MIDD Paired Meeting Program. Dr. Madabushi is also involved in global harmonization activities as the Rapporteur for ICH M12 Expert Working Group – Drug Interaction Studies. Dr. Madabushi received his Ph.D. in Pharmaceutical Sciences from Birla Institute of Technology and Sciences (BITS), Pilani, India.

Dr. Hao Zhu has more than 20 years of working experience in applying quantitative medicine tools to support new drug development and improve patient case. He received his PhD in Pharmaceutics and Master's degree in statistics from the University of Florida. He currently serves as an ISoP board member and promotes the use of modeling and simulation tools.

Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.

A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen. He has more than 30 years of academic, clinical, and industry experience.

Dr. Stein holds a bachelor’s degree in history from the University of Rochester in New York and a medical degree from University of Pennsylvania. He trained at Yale University and Yale-New Haven Hospital in internal medicine and in endocrinology and metabolism.