The current approach to drug development in oncology is not designed to identify the optimal dose of anticancer agents and is based on a historical drug development paradigm developed for cytotoxic chemotherapies. For cytotoxic chemotherapies, higher doses of the drug have greater antitumor activity; thus, the labeled dose was established based on the maximum tolerated dose. Most drugs in development today, however, are targeted therapies, and higher doses may not have greater antitumor effects, patients may stay on these therapies for prolonged periods of time, thus increasing the importance of tolerability. In 2021, FDA launched Project Optimus with the goals of working with the oncology research community to improve the current approach to selecting the dose of anticancer agents.

In this presentation, Donald Harvey, a professor at Emory University School of Medicine, will discuss the history of oncology drug development and tools that can be used to improve dose derivation, including improved nonclinical models, trial designs, clinical pharmacology assessments and models, extended adverse event assessment, and patient-reported outcomes.
 

Donald Harvey is a professor in hematology and medical oncology and Pharmacology and Chemical Biology at Emory University School of Medicine. He also serves as medical director of the Clinical Trials Office and director of the Phase I Clinical Trials Section, Winship Cancer Institute of Emory University.