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.

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. 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.

Andrew C. Hooker, PhD, is a Professor of Pharmacometrics at Uppsala University, Sweden. Andrew received a BS in Physics with a Mathematics Minor at the University of Colorado and received a Masters and then a PhD in Bioengineering from the University of Washington, Seattle. Andrew joined the faculty at Uppsala University in 2006. His research ranges between methodological and applied pharmacometrics, including: optimal (adaptive) experimental design, methodological problems associated with building, evaluating and using pharmacometric models (including using models for bioequivalence evaluation) and the development and use of PKPD models in a range of therapeutic areas and drug classes. Andrew is a co-developer of a number of software programs including Xpose, PsN, Pharmpy and the optimal design program PopED. Andrew has published over 90 papers in peer reviewed journals, supervised 12 students to their PhD degree and mentored 11 post-docs. In 2012, he co-founded the model-informed drug development consultancy company Pharmetheus.

Martin obtained his PhD in Pharmacometrics from Uppsala University. He has 20+ years of drug development experience in areas such as metabolic disorders, autoimmune disease, infectious disease, hematological disorders etc. In 2012 Martin co-founded the consulting company Pharmetheus AB. In the consultant role he has been engaged as strategic advisor on behalf of multiple clients and acted as the main responsible consultant for 50+ pharmacometric data analysis projects on behalf of more than 20 different clients. The projects have ranged from pre-clinical translational projects to submission ready large-scale phase III PKPD analysis. These analyses have among other things contributed to 5+ successful NDA filings. 

Stephen Duffull is a Senior Scientific Advisor at Certara and Professor at the Universities of Otago and Queensland. He has been working in the area of pharmacometrics and PKPD for more than 25 years during which time he has been active in research, model informed drug development, leadership roles and training.

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.

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.