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.

Presenters:

• Dr. Brian Booth – Director of the Division of Cancer Pharmacology I, U.S. FDA
• Dr. Hao Zhu, Director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research, U.S. FDA
• Dr. Tom Sun (Moderator) – Vice President, Strategic Consulting Services