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Session 1: PDUFA VI Pilot Programs: Overview and Expectation
Session Chair(s)
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
Cristiana Mayer, DrSc, PhD
Head of Biostatistics
Johnson & Johnson Vision, 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.
Learning Objective : At the conclusion of this session, participants should be able to:Describe scope and highlights of the complex innovative designs and model informed drug development pilot programsDiscuss benefits and any potential challenges of participation in the FDA pilot programs Understand the expectations from regulators and industry related to the PDUFA VI pilot programs
Speaker(s)
Speaker
Dionne Price, PhD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
PDUFA VI Pilot Programs: Overview and Expectation for Model-Informed Drug Development (MIDD)
Issam Zineh, PharmD, MPH
FDA, United States
Director, Office of Clinical Pharmacology, OTS, CDER
Panelist
Stuart Michael Bailey, PhD
Biogen, United States
Vice President, Head of Analytics and Data Sciences
Panelist
Jose C. Pinheiro, PhD
Janssen Research & Development, LLC, United States
Head of Statistical Modeling and Methodology, SDS