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Bethesda North Marriott Hotel and Conference Center

08 mar 2018 7:00 a.m. - 09 mar 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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 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

Mary L Raber Johnson, PhD, RAC

The Ohio State University, College of Pharmacy, United States

Assistant Professor - Clinical

Eugene J Sullivan, MD

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

Eugene J Sullivan, MD

EJS Consulting, LLC, United States

Principal

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

RFH, United States

Chief Science Officer

Brandon  Ashcraft

How Technology is Enabling Patient-Centric Drug Development and Promotion

Brandon Ashcraft

Razorfish Health, United States

SVP, Digital Solutions

Alexander  Bragg

Panelist

Alexander Bragg

Fingerpaint Marketing , United States

Strategic & Planning Advertising Executive

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