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Fact or Fiction: Patient Engagement in the Drug Development Process

Track:
Regulatory Affairs and Submissions

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
134

Room Number:
30AB

Level:
Intermediate

Type:
Session

Title:
Fact or Fiction: Patient Engagement in the Drug Development Process

Chair(s):
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States

Description:
This session will involve a discussion on experiences with patient engagement and the benefits and challenges faced by industry and regulators. The panel will include representatives from a patient advocacy group, industry and a regulatory authority.

This forum has been developed by the DIA Patient Engagement, Regulatory Affairs, and Clinical Trial Disclosure Communities.

Learning Objective(s):
Describe benefits of engaging patient and patient advocacy groups in the drug development process; Discuss regulatory agency experiences with including patient and patient advocacy groups in the decision-making process.

Presentation(s) & Speaker(s):
Industry Perspective
Michael Maher
Executive Director, US Regulatory Policy and Global Intelligence
Pfizer Inc, United States

FDA Perspective
John J. Whyte, MD, MPH
Director, Professional Affairs and Stakeholder Engagement, OCD, CDER
FDA, United States

Patient Perspective
Marcia K. Horn, JD
President and Chief Executive Officer
International Cancer Advocacy Network (ICAN), United States