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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
    Speaker(s)
      Mary L Raber  Johnson, PhD, RAC

      Mary L Raber Johnson, PhD, RAC

      • Assistant Professor, Clinical
      • The Ohio State UniversityCollege of Pharmacy, United States
      Eugene J Sullivan, MD

      Progress Toward a More Patient-Focused Approach to Drug Development and Regulatory Review

      Eugene J Sullivan, MD

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

      A Case-Based Review: Does Clinical Trial Design Drive Promotional Strategy or is it the Other Way Around?

      Wolf Gallwitz, PhD, MBA

      • Chief Science Officer
      • RFH, United States
      Brandon  Ashcraft

      How Technology is Enabling Patient-Centric Drug Development and Promotion

      Brandon Ashcraft

      • SVP, Digital Solutions
      • Razorfish Health, United States
      Alexander  Bragg

      Panelist

      Alexander Bragg

      • Strategic & Planning Advertising Executive
      • Fingerpaint Marketing , United States

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