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Bethesda North Marriott Hotel and Conference Center

Apr 23, 2018 1:00 PM - Apr 25, 2018 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

Deputy Director, Office of Biostatistics, OTS, CDER

FDA, United States

Cristiana  Mayer, DrSc, PhD

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 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

    FDA, United States

    Deputy Director, Office of Biostatistics, OTS, CDER

    Issam  Zineh, PharmD, MPH

    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

    Stuart Michael Bailey, PhD

    Panelist

    Stuart Michael Bailey, PhD

    Biogen, United States

    Vice President, Head of Analytics and Data Sciences

    Jose C. Pinheiro, PhD

    Panelist

    Jose C. Pinheiro, PhD

    Janssen Research & Development, LLC, United States

    Head of Statistical Modeling and Methodology, SDS

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