ACoP Special Session-The Future is Now: Envisioning the Next Era of Pharmacometrics

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.

Dr. Cynthia J. (C.J.) Musante is Vice President of Scientific Research and Global Head of Pharmacometrics & Systems Pharmacology (PSP) at Pfizer Inc. She received her Ph.D. in Applied Mathematics from North Carolina State University and has more than twenty years of experience in model informed drug development (MIDD). At Pfizer, her team is responsible for developing and applying model-based approaches across the portfolio to enhance the robustness and quality of decision-making at the program- and therapeutic strategy-levels. CJ is an advocate for MIDD, both internally and externally. She is a frequent organizer and invited speaker at national and international conferences and is the Immediate Past President of the International Society of Pharmacometrics (ISoP).

Dr. Liang Zhao is currently a professor and director for the center of regulatory science at the School of Pharmacy, University of California San Francisco (UCSF). Prior to joining UCSF, he had served as the Director of Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, CDER/FDA between 2015 and 2024. He has demonstrated excellence and leadership in drug development and regulatory science for new and generic drugs during his 19-year professional tenure including in Pharsight as an associate consultant, BMS as a research investigator, MedImmune as an Associate Director, and FDA as Clinical Pharmacology reviewer, Pharmacometrics Team Leader, and Division Director. Dr. Zhao and his team have introduced a broad array of innovative tools in the realm of drug deliveries, bioequivalence assessment, and big data tools including machine learning to pharmacometrics. They have also implemented the Model Integrated Evidence (MIE) Industry Meeting Pilot to support regulatory communications between generic applicants and the FDA and proposed a regulatory mechanism of using Model Master File to support regulatory submissions. Liang currently serves as the Chair of the FDA ModSim WG for the Modeling & Simulation community cross FDA centers and offices. He has published over 120 peer reviewed publications and 8 book chapters. He received the 2023 Gary Neil Prize for Innovation in Drug Development from ASCPT in recognition to his contribution to clinical pharmacology and pharmacometrics.