Session 1: PDUFA VI Pilot Programs: Overview and Expectation
Dionne Price, PhD
Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
FDA, United States
Cristiana Mayer, PhD
Scientific Director, Statistical Modeling and Methodology, SDS
Janssen Research and Development LLC, United States
As the landscape of drug development evolves, we are faced with new and different challenges. Consequently, the PDUFA VI goals letter outlines several commitments designed to identify and develop strategies to address these challenges. The commitments include the launch of two distinct pilot programs. The Complex Innovative Designs (CID) pilot seeks to facilitate the advancement and use of complex adaptive, Bayesian, and other novel clinical trial designs. The Model Informed Drug Development (MIDD) pilot will aid in the development and application of exposure-based, biological, and other models derived from preclinical and clinical data sources. Speakers in this session will provide a brief overview and highlight key aspects of the CID pilot as well as the MIDD pilot. A panel discussion will follow to expand on expectations from industry and regulators.