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FDA-AACR: Oncology Dose-finding Workshop Part II

June 13, 2016 | Walter E. Washington Convention Center, Washington, D.C.

Co-sponsored by the FDA and the AACR

Workshop White Paper

Purpose

Given the recent history of approvals based on the results of early phase trials driven by extraordinary efficacy data, the incentive for conducting rigorous dose-finding trials may not be overtly apparent. However, the increasing need for the development of combination therapy due to resistance to monotherapy and poor tolerance of approved dosing regimens underscores the need for a more efficient process of dose selection in the early stages of study design.

Theme

With the success of the
2015 FDA-AACR Dose Finding of Small Molecule Oncology Drugs Public Workshop, we are pleased to announce the 2016 FDA-AACR Dose Finding Workshop. This year we will broaden the discussion scope to all oncology drugs and focus the theme of the workshop towards drug efficacy. Recent approvals of nivolumab, osimertinib, and pembrolizumab highlight novel dose-finding strategies employed in each respective development program. An interdisciplinary presentation surrounding these development programs along with expert commentary and robust discussion is planned, with particular focus on: exposure-response relationships, modeling and simulation for dose finding, non-clinical models for efficacy, and design for dose-optimization studies.

Workshop Agenda, Bios, and Presentation Slides