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One Paddle for Two Boats? Policy Alternatives to Buoy Adoption of Precision Therapies and Their Companion Diagnostics
Session Chair(s)
Jeffrey N. Stuart, PhD
Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States
Precision drug development and adoption are spurred by numerous regulatory initiatives, yet formal mechanisms are lacking for its companion diagnostic. This forum explores policy alternatives to enhance development and proper use of these combinations.
Learning Objective : Describe innovative co-development policies emerging for the most promising precision medicines; Analyze policy alternatives that enhance proper use of precision medicine and companion diagnostic combinations.
Speaker(s)
Navigating the Regulatory Pathway for Drug/Companion Diagnostic Co-Development in Precision Medicine
Kenneth G. Butz, MS
PPD, United States
Director, Regulatory Affairs
FDA Perspective
Christopher Leptak, MD, PhD
Greenleaf Health, Inc., United States
Executive Vice President, Drug and Biological Products
Opportunities and Barriers to Clinical Implimentation of Genomics in Oncology
Eric Padron, MD
H. Lee Moffitt Cancer Center and Research Institute, United States
Assistant Member, Section Head, Genomics and Personalized Medicine
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