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Session Chair(s)
Janet Jenkins-Showalter
Head, US Regulatory Policy
Genentech, A Member of the Roche Group, United States
Learning Objective : Describe CDRH’s current initiatives related to innovative approaches for the review and approval of promising new technologies; Explain the blueprint for accelerating in vitro diagnostics and companion diagnostics for breakthrough drugs; Identify new technologies and possible changes to CDRH’s current regulatory approval pathways.
Speaker(s)
Regulating Diagnostics for Breakthrough Therapies
Mya Thomae, RAC
Myraqa, United States
Founder and Chief Executive Officer
Panelist
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
Panelist
Michelle Taylor McMurry-Heath, MD, PHD
BIO, United States
President and CEO
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