A0802
Title: Using modeling and simulation to evaluate response variation and optimal dose in clinical development
Authors: Yanguang Cao - University of North Carolina at Chapel Hill (United States) [presenting]
Abstract: Project Optimus is an initiative by the US FDA aimed at revolutionizing the approach to dose selection and optimization in the development of oncology drugs. The challenges and opportunities associated with selecting the optimal doses are explored in the early phases of drug development, especially when faced with limited data and a small patient cohort. Traditional exposure-response (E-R) analyses in drug development are primarily conducted to identify therapeutic doses or subpopulations of patients with distinct response/safety profiles, usually for labeling purposes rather than to pinpoint the optimal doses. However, the scarcity of data and information complicates robust E-R analyses, introducing significant uncertainty in our selection of optimal doses. Therefore, integrating Bayesian methods into conventional E-R analyses promises considerable benefits. The application of these Bayesian approaches and using modeling and simulation techniques to realize the potential of Project Optimus are briefly discussed.
