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Multimarker Diagnostics and Development Complexities
Session Chair(s)
Jennifer Dudinak-Dickson, PharmD
Senior Vice President, Global Regulatory Sciences
Bristol Myers Squibb , United States
Multiple marker diagnostics (multiplex) or next-generation sequencing (NGS) platforms offer the ability to test for a wide array of biomarkers and mutations at once. These platforms can be instrumental in fostering efficient healthcare utilization, maximizing sampling for tissue/specimen/biopsy, and advancing innovations in molecularly-targeted therapeutic development and registration across a variety of therapy areas. There are several regulatory and development strategic considerations when employing a multiple marker diagnostic approach in a therapeutic development program.
Speaker(s)
Speakers
Anne-Marie Martin, PhD
GlaxoSmithKline, United States
Senior Vice President, Global Head of Experimental Medicine
Speakers
William J. Pignato, MS
W.J. Pignato & Associates, LLC, United States
Former Global Head of Regulatory Affairs, Companion Diagnostic - Novartis
Speakers
Eunice Lee, PhD
FDA, United States
Senior Scientific Advisor
Panel Discussion - Additional Speaker
Reena Philip, PhD
FDA, United States
Associate Director, Biomarkers and Precision Oncology, OCE
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