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DIA/FDA Biostatistics Industry and Regulator Forum


Session 1: PDUFA VI Pilot Programs: Overview and Expectation

    Session Chair(s)
      Dionne  Price, PhD

      Dionne Price, PhD

      • Acting Deputy Director, Office of Biostatistics, OTS, CDER
      • FDA, United States
      Cristiana  Mayer, PhD

      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.
    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 programs
  • Discuss 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)
    Dionne  Price, PhD

    Speaker

    Dionne Price, PhD

    • Acting Deputy Director, Office of Biostatistics, OTS, CDER
    • FDA, United States
    Issam  Zineh, PharmD, MPH

    PDUFA VI Pilot Programs: Overview and Expectation for Model-Informed Drug Development (MIDD)

    Issam Zineh, PharmD, MPH

    • Director, Office of Clinical Pharmacology, OTS, CDER
    • FDA, United States
    Stuart  Bailey

    Panelist

    Stuart Bailey

    • Vice President - Early Development and Discovery Biostatistics
    • Novartis Institutes For Biomedical Research, Inc., United States
    Jose C. Pinheiro, PhD

    Panelist

    Jose C. Pinheiro, PhD

    • Head of Statistical Modeling and Methodology, SDS
    • Janssen Research & Development, LLC, United States