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Exploring Responder-Patient Clinical Study Design Approaches

Track:
Project/Portfolio Management and Strategic Planning

Day & Time:
June 19, 9:00AM - 10:30AM (Pacific Standard Time)

Session Number:
402

Room Number:
3

Level:
Advanced

Type:
Session

Title:
Exploring Responder-Patient Clinical Study Design Approaches

Chair(s):
Joan M. Meyer, PhD, MS
Executive Director, Operational Strategy and Planning
Covance Inc., United States

Description:
Finding patients with a better chance of responding to a drug continues to evolve. This session will discuss how clinical trial design approaches can be employed, as well as how stakeholders can collaborate to accelerate advancements.

Learning Objective(s):
Discuss the concept of a responder in a clinical trial; Describe ways to use data to increase the recruitment of responders into clinical studies.

Presentation(s) & Speaker(s):
Industry Perspective
Joan M. Meyer, PhD, MS
Executive Director, Operational Strategy and Planning
Covance Inc., United States

FDA Perspective on Use of Biomarkers to Identify Treatment Responders
Christopher Leptak, MD, PhD
OND Biomarker and Companion Diagnostic Lead, CDER
FDA, United States

Pharmaceutical Perspective
Cecile Holweg
Genentech, A Member of the Roche Group, United States