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Impact of FDA Oversight of Laboratory-Developed Tests Upon Innovation in the Targeted Therapy Setting
Session Chair(s)
Jeffrey N. Stuart, PhD
Associate Vice President, Global Regulatory Affairs, Merck Sharp & Dohme LLC , United States
The recently-announced FDA framework on regulation of laboratory-developed tests will impact codevelopment and uptake of targeted therapies and their companion diagnostics. This forum will debate the merits of this evolving regulatory paradigm.
Learning Objective : Describe the new regulatory landscape for laboratory-developed tests; Debate the impact upon codevelopment and market uptake of targeted therapies and their companion diagnostics.
Speaker(s)
FDA Perspective
Elizabeth Mansfield, PhD
Vice President of Regulatory, Foundation Medicine, United States
Industry Perspective
Michael Benecky, PhD
Senior Director, Global Regulatory Affairs, UCB, United States
Laboratory Perspective
Elissa Passiment, Med
Executive Vice President, American Society for Clinical Laboratory Science, United States
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