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DIA 2018 Global Annual Meeting


Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs

    Session Chair(s)
      Yeh-Fong  Chen, PhD

      Yeh-Fong Chen, PhD

      • Mathematical Statistician, Office of Translational Sciences, CDER
      • FDA, United States
    Under PDUFA VI, FDA committed to developing two pilot programs. The goal of the Complex Innovative Designs (CID) pilot is to facilitate the advancement and use of complex, Bayesian, and other novel clinical trial designs and will focus on highly innovative trial designs for which analytically derived properties (e.g., Type I error) may not be feasible, and simulations are necessary to determine trial operating characteristics. The Model-Informed Drug Development (MIDD) pilot is intended to facilitate the development and application of exposure-based and biological models derived from preclinical and clinical data sources. Drug development programs where clinical data are limited such that integration across non-traditional sources may be needed as well as programs for which MIDD can assess uncertainties about dosing, duration, patient selection, and other factors will be considered for the pilot. In this session, we will discuss the importance of these two PDUFA VI pilot programs, explain the agency’s goals for these programs, and highlight the difference between these two pilot programs.
    Three speakers from FDA are invited to share their expectations and visions for these programs which launch in 2018.
    Learning Objective : Discuss the importance of these two PDUFA VI pilot programs; Explain the agency’s goals for these programs: Identify the difference between these two pilot programs.
    Speaker(s)
      Laura Lee  Johnson, PhD

      Panelist

      Laura Lee Johnson, PhD

      • Deputy Director, Office of Biostatistics, DB III, OTS, CDER
      • FDA, United States
      Representative Invited

      Panelist

      Representative Invited

      • FDA, United States
      Dionne  Price, PhD

      Panelist

      Dionne Price, PhD

      • Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
      • FDA, United States