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Advertising and Promotion Regulatory Affairs Conference

Session 10 Track B: Innovations in Clinical Trial Design Impacting Promotional Practices

    Session Chair(s)
      Mary L Raber  Johnson, PhD, RAC

      Mary L Raber Johnson, PhD, RAC

      • Assistant Professor, Clinical
      • The Ohio State UniversityCollege of Pharmacy, United States
    Clinical trial designs intended to support product approvals have evolved due to many factors including consideration of the patient perspective. The 21st Century Cures Act described patient-centered initiatives and modified standards of evidence that will likely be part of future approval and promotional landscapes. As illustrated with recent approvals in gene therapy and basket-trial design, there are unique considerations for the patient experience, providing opportunities to evolve promotional practices. This session is a multidisciplinary perspective on the impact of dynamics such as these on product promotion.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Assess patient-focused drug development and FDA approval process per the 21st Century Cures Act
    • Comprehend multi-disciplinary perspectives on how clinical trial designs have evolved promotional practices
    • Describe current and future technological innovations that provide an increased focus on promotion to patients
      Eugene J Sullivan, MD


      Eugene J Sullivan, MD

      • Principal
      • EJS Consulting, LLC, United States
      Wolf  Gallwitz, PhD


      Wolf Gallwitz, PhD

      • Chief Medical Officer
      • Razorfish Health, United States
      Ritesh  Patel


      Ritesh Patel

      • EVP, Chief Digital Officer
      • Ogilvy CommonHealth Worldwide, United States
        Panel Discussion

      Panel Discussion

      • All Session Speakers, United States

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