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Hyatt Regency Bethesda

Sep 30, 2015 7:15 AM - Oct 01, 2015 4:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

DIA Companion Diagnostics Conference 2015: Connecting Science and Regulation to Advance Innovation in Precision Medicine and Companion Diagnostics

Join key investigators and regulators in exploring the current landscape of companion diagnostics to identify challenges and potential paths to accelerate precision medicine initiatives.

Back to Agenda

Session 6: Advancing Regulatory Pathways for New Frontiers in Molecular Testing, including Next Generation Sequencing

Session Chair(s)

Jennifer Dudinak-Dickson, PharmD

Jennifer Dudinak-Dickson, PharmD

Senior Vice President, Global Regulatory Sciences

Bristol Myers Squibb , United States

The speed of evolution of scientific knowledge to identify molecularly-targeted agents and advancements in technology (such as multiple-marker diagnostics) offers great promise in identifying subsets of patients who will likely benefit (or experience minimal/detrimental effect) from novel therapies. 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 health care 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. This session will explore challenges and opportunities of utilizing a multiple-marker approach, including how stakeholders can partner together to advance the regulatory framework. Pertinent highlights from recent FDA workshops on NGS and precision medicine will also be discussed.

Speaker(s)

Application of Multi-Analyte Testing in Clinical Development: Practical Considerations

Anne-Marie Martin, PhD

GlaxoSmithKline, United States

Senior Vice President, Global Head of Experimental Medicine

Regulatory Perspective of the Diagnostics Manufacturer – NGS for Personalized Medicine

Lynne McBride

Thermo Fisher Scientific, United States

Director Regulatory Affairs & Clinical Life Sciences Solution

Michael Benecky, PhD

Regulatory Considerations for Multiplex Companion Diagnostic Test Development from the Pharmaceutial Perspective

Michael Benecky, PhD

UCB, United States

Senior Director, Global Regulatory Affairs

Xueying Sharon Liang, MD, PhD

Emerging Regulatory Paradigm for NGS

Xueying Sharon Liang, MD, PhD

FDA, United States

Epidemiologist, CDRH

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