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.

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Session 8: Emerging US Legislation and Policy in Precision Medicine

Session Chair(s)

Gregory Daniel, PHD, MPH

Vice President, Head of Public Policy Innovation and Evidence

Eli Lilly and Company, United States

Given promising approaches to the development and regulatory review of companion diagnostics, this session will explore the remaining policy and infrastructure challenges to further harnessing targeted therapies to improve patient care. What key stumbling blocks remain? How might current policy and legislative proposals – including the U.S. House of Representatives’ 21st Century Cures Initiative and Obama Administration’s Precision Medicine Initiative – help to address these challenges? Where could other policy efforts be best directed? Panelists will discuss current proposals and their impact on clinical development, regulatory science, patient and provider decision-making, and other policy areas where companion diagnostics may have a significant role.

Speaker(s)

Panelists

Bray Patrick-Lake, MS

FDA, United States

Senior Digital Health Specialist, DDH, CDRH

Jeff Allen, PHD

Friends of Cancer Research, United States

President and Chief Executive Officer

Scott Van Buren McGoohan, JD

Vertex Pharmaceuticals, Inc., United States

Director, US Regulatory Policy and Intelligence