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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
Foundation Medicine, United States
Vice President of Regulatory
Industry Perspective
Michael Benecky, PhD
UCB, United States
Senior Director, Global Regulatory Affairs
Laboratory Perspective
Elissa Passiment, MEd
American Society for Clinical Laboratory Science, United States
Executive Vice President
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Ways to register
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