Donald E. Mager is a Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York. He also served as a Visiting Professor at the University Paris Descartes in January from 2007–2013 and 2016. He currently serves on the Clinical Pharmacology Advisory Committee to the FDA and the Editorial Advisory Boards of several journals. Dr. Mager also serves as an Associate or Consulting Editor at CPT:Pharmacometrics & Systems Pharmacology (CPT:PSP), Journal of Pharmacology & Experimental Therapeutics (JPET), and Pharmacology, Research & Perspectives (PRP). He is a former President of the International Society of Pharmacometrics and is a Fellow and member of the Board of Regents of the American College of Clinical Pharmacology. In addition, he is an expert member of the Board of Pharmaceutical Sciences at FIP and serves on the Scientific Advisory Board to Simcyp. His research focuses on identifying molecular and physiological factors that control the pharmacological properties of various drugs, with a focus on anti-cancer and immunomodulatory agents. He has contributed to 120+ peer-reviewed publications. Holly H.C. Kimko-SA"> is a senior pharmacometrician in the Global Clinical Pharmacology department at Janssen Research & Development, LLC, Spring House, PA, and Adjunct Associate Professor in the Pharmacy School of Rutgers University, New Jersey. Dr. Kimko is a Janssen Research Fellow and American Association of Pharmaceutical Scientists Fellow. She championed the use of modeling and simulations in drug development at the Center for Drug Development Science at Georgetown University Medical School, Washington, DC in 1995–2002. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in pharmaceutical sciences from the University at Buffalo, State University of New York. She has published key papers on physiologically-based indirect response modeling and applications of clinical trial simulations and has edited two books on clinical trial simulations. Her research interests include strategic application of modeling and simulation tools in all aspects of drug development and post-approval life cycle management. Among her scientific endeavors is a specialty in pediatric drug development.