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Webinar: Project Optimus: Oncology Dose Optimization Based on Clinical Pharmacology Strategy and MIDD Approach

Since the FDA initiated Project Optimus, considerable effort has been stimulated to better select doses of new oncology products. In this webinar, participants will hear the regulatory perspective from two guest presenters: Dr. Hao Zhu, director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research at the U.S. FDA; and Dr. Brian Booth, Director of the Division of Cancer Pharmacology I (DCP I), in the Office of Clinical Pharmacology at the U.S. FDA.

Drs. Zhu and Booth will review some of the recent approaches and data collection to select doses, including randomized dose cohorts, before segueing into the next big hurdle in dose selection, that being dose selection of combination regimens. Questions about how to select the dose of new therapeutic added to another approved agent, to established regimens with multiple agents, and two novel therapeutics will be discussed.

Model-informed drug development (MIDD) has been an invaluable set of tools, which is playing an increasingly important role for oncology dose selection, especially for novel modalities such as monoclonal antibodies, bispecific antibodies, antibody-drug-conjugates, oligonucleotides, or cells. MIDD tools have been invaluable for the exploration of the treatment of various cancers. These novel modalities are associated with unique mechanisms of actions and pharmacology features. It has been shown that modeling and simulation tools that are developed based on small molecules can be readily applied to support new drug development for these novel modalities. The focus of the modeling and simulation work may differ to reflect the unique issues in the development programs for these novel modalities. Drs. Zhu and Booth will also share some of the modeling work that has been conducted for dose selection of novel modalities as case examples. Overall, modeling and simulation play important roles in the development of novel modalities for oncology.

Tuesday, May 26, 2026
8:00 am - 9:00 am PDT

Speakers

Dr. Hao Zhu

Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research
U.S. Food and Drug Administration

Dr. Hao Zhu is the director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Zhu received his Ph.D. in pharmaceutical sciences and Master in statistics from the University of Florida. He started his career in modeling and simulation teams in Johnson & Johnson and Bristol-Myers-Squibb. He joined FDA as a pharmacometrics reviewer more than 18 years ago. Dr. Zhu has been a clinical pharmacology team leader for more than 6 years and a QT-IRT scientific lead for 2 years. Then he became the deputy director at the Division of Pharmacometrics. His division reviews the pharmacometrics related submissions and supports pharmacometrics-related policy development.

Dr. Brian Booth

Director of the Division of Cancer Pharmacology I (DCP I), Office of Clinical Pharmacology
U.S. Food and Drug Administration

Brian Booth, Ph.D. is the Director of the Division of Cancer Pharmacology I (DCP I), in the Office of Clinical Pharmacology at the U.S. Food and Drug Administration. Dr. Booth obtained a Bachelor of Science in Physiology at McGill University in 1988, and subsequently pursued a Doctorate in Pharmacology and Toxicology at Queen’s University (1993) in Canada. Following a Post-Doctoral Fellowship in the Department of Pharmaceutics at the State University of New York at Buffalo, where he studied the interaction between nitric oxide donors and the neuropeptide calcitonin gene-related peptide, Dr. Booth joined the Office of Clinical Pharmacology and Biopharmaceutics, FDA, in 1998. In 2004, he became the Acting Team Leader in the Division of Oncology Drug Products, after serving as a reviewer/pharmacometrician in this division. In November 2006, Dr. Booth was appointed as Deputy Director of the Division of Clinical Pharmacology V, until he was selected as Director of DCP I in 2019. At the FDA, Dr. Booth has been involved with the clinical pharmacology development of several hundred new oncology drugs, ranging from phase 1 to phase 4. In addition to IND and NDA/BLA reviews, Dr. Booth has been involved with teaching and development of new clinical pharmacology reviewers and medical officers, development of the analytical method validation, food effects, ARA drug-drug interactions, ADC- drugs, liposome drug product, PD-1/PD-L1 and studies in hepatic impairment Guidances for Industry, and clinical pharmacology modeling and simulation projects. He has authored or co-authored 85 peer reviewed articles and book chapters.

Dr. Tom Sun

Vice President, Strategic Consulting Services, Clinical Pharmacology & Pharmacometrics (Moderator)
Simulations Plus

Tom Sun is Vice President, Strategic Consulting Services, at Simulations Plus. Dr. Sun has more than twenty years of pharmaceutical industry experience at Genentech (1998-2002), ALZA/Johnson & Johnson (2002-2004), Amgen (2004-2015), and Janssen (2015-2022). Prior to this current role, Dr. Sun was the Oncology Therapeutic Area Head, Clinical Pharmacology & Pharmacometrics Department and the Licensing & Acquisition Evaluation Head, Quantitative Sciences at Janssen R&D.

Dr. Sun received his B.S. in Pharmacy from Taipei Medical University (formerly known as Taipei Medical College) and his Ph.D. in Pharmaceutical Sciences from the University at Buffalo. He is specialized in translational Pharmacokinetic/Pharmacodynamic (PK/PD) research, Clinical Pharmacology, Modeling & Simulations, and product registration for small molecules, biologics, and CAR-T therapies. His recent research focus has been the application of model-based drug development in oncology. Dr. Sun has authored more than 40 peer reviewed articles and book chapter, and is an invited reviewer for eight scientific journals in the field of Clinical Pharmacology and PK/PD.

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