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Session 10 Track B: Innovations in Clinical Trial Design Impacting Promotional Practices
Session Chair(s)
Mary L Raber Johnson, PHD, RAC
Assistant Professor - Clinical, The Ohio State University, College 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
Assistant Professor - Clinical, The Ohio State University, College of Pharmacy, United States
Eugene J Sullivan, MD
Principal, EJS Consulting, LLC, United States
Progress Toward a More Patient-Focused Approach to Drug Development and Regulatory Review
Wolf Gallwitz, PHD, MBA
Chief Science Officer, RFH, United States
A Case-Based Review: Does Clinical Trial Design Drive Promotional Strategy or is it the Other Way Around?
Brandon Ashcraft
SVP, Digital Solutions, Razorfish Health, United States
How Technology is Enabling Patient-Centric Drug Development and Promotion
Alexander Bragg
Strategic & Planning Advertising Executive, Fingerpaint Marketing , United States
Panelist