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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives

    Session Chair(s)
      James E. Valentine, JD, MHS

      James E. Valentine, JD, MHS

      • Attorney
      • Hyman, Phelps & McNamara, PC, United States
    This forum will review lessons learned from the Patient-Focused Drug Development meetings held to date, including externally-led meetings, and provide patient perspectives on their experiences and what has changed in their field as a result. Representation will include both rare, life threatening and chronic disease communities, as well as FDA.
    Learning Objective : Appraise recent examples of FDA’s current efforts to incorporate the patient perspective into regulatory decision-making; Discuss implementation of patient engagement provisions in 21st Century Cures Act and PDUFA VI; Evaluate current proposals of methods collecting patient experience data.
      Theresa  Mullin, PhD

      FDA Perspective on the Value and Potential of PFDD

      Theresa Mullin, PhD

      • Associate Director for Strategic Initiatives, CDER
      • FDA, United States
      Amy  Leitman, JD

      Experience From an FDA-Led PFDD Meeting - NTM Case Study

      Amy Leitman, JD

      • Director of Policy & Advocacy
      • NTM Info & Research, United States
      Steven L. Roberds, PhD

      Experience From an Externally-Led PFDD Meeting; TSC Case Study

      Steven L. Roberds, PhD

      • Chief Scientific Officer
      • Tuberous Sclerosis Alliance, United States