Policy

Policy Meetings

During its policy committee meetings, PMC members debate and establish the Coalition's policy priorities and positions. These meetings frequently feature policy leaders, including representatives from the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and Congressional staffers, as guest speakers.

2017 Meetings


February 15, 2017
featuring a question-and-answer period with FDA's Michael Pacanowski, M.P.H., Pharm.D., and an off-the-record conversation with Dylan Scott of STAT News

Members click here to register: http://pmc.site-ym.com/events/register.aspx?id=921385

Documents:
» Personalized Medicine at FDA: 2016 Progress Report
» 12th Annual Personalized Medicine Conference Summary
» Personalized Medicine in the Clinic: A Road Map for Facilitating the Clinical Adoption of Personalized Medicine
» "Best Strategies for Integrating Personalized Medicine into Healthcare Practice" published in Personalized Medicine

Michael Pacanowski, M.P.H., Pharm.D., will join Daryl Pritchard, Ph.D., Vice President, Science Policy, PMC, to share his thoughts on the state of personalized medicine at FDA's Center for Drug Evaluation and Research and PMC's recently published report titled Personalized Medicine at FDA: 2016 Progress Report.  The meeting will conclude with an off-the-record conversation with Dylan Scott, who will offer his perspective on the new administration and answer questions from the audience.

April 27, 2017

June 8, 2017

September 13, 2017

December 6, 2017

2016 Meetings


February 24, 2016
with FDA's David Litwack and Taha Kass-Hout

David Litwack, Ph.D., Policy Advisor, FDA Office of In Vitro Diagnostics and Radiological Health, and Taha Kass-Hout, M.D., M.S., Chief Health Informatics Officer, FDA, and Director, Office of Health Informatics, FDA, delivered remarks on the role of databases in next-generation sequencing (NGS) policy and the intended impact of precisionFDA.

April 21, 2016
with a panel of coding experts from AMA, McKesson and NextGxDx

A panel of coding experts discussed the Centers for Medicare and Medicaid Services (CMS)' options for implementing the Protecting Access to Medicare Act (PAMA) of 2014. The panel featured Jay Ahlman, Vice President, Coding & Reimbursement Products Portfolio, American Medical Association; Judsen Schneider, Ph.D., Vice President of Bioinformatics, NextGxDx; and Matthew Zubiller, Vice President, General Manager, Strategic Growth Portfolio, McKesson.

The membership also discussed the recently proposed Medicare Part B demo project. That conversation informed PMC's May 2016 letter on the topic:

June 21, 2016
Envisioning Value in Personalized Medicine, featuring Rick Chapman, Ph.D., M.S., Director of Health Economics, ICER with representatives from the Global Liver Institute, NPC and PhRMA

Rick Chapman, Ph.D., M.S., Director of Health Economics, Institute for Clinical and Economic Review (ICER), joined Donna R. Cryer, J.D., President & CEO, Global Liver Institute; Dan Leonard, President, National Pharmaceutical Council (NPC); and Randy Burkholder, Vice President, Policy and Research, Pharmaceutical Research and Manufacturers of America (PhRMA), for a discussion on personalized medicine technology value assessment.

The conversation informed PMC's June 2016 letter on ICER's non-small cell lung cancer scoping document:

September 8, 2016
via webinar

Members discussed PMC's work on value assessment frameworks as well as the Coalition's engagement with FDA. 

October 11, 2016
The Map to a Million: An Update on the Precision Medicine Initiative

Stephanie Devaney, Ph.D., Project Manager, Precision Medicine Initiative (PMI), Office of the Chief of Staff, The White House, joined members of the Coalition to provide an update on the administration's progress toward sequencing one million genomes as part of the PMI. Dr. Devaney also gave an overview of its next steps. 

Members also discussed PMC's comment letters on next-generation sequencing (NGS), codevelopment of in vitro diagnostics and therapeutic products, and the Institute for Clinical and Economic Review (ICER)'s call for improvements to its value assessment framework.

December 7, 2016
with PCORI's Joe V. Selby, M.D., M.P.H., and FDA's Elizabeth Mansfield, Ph.D.

Elizabeth Mansfield, Ph.D., Deputy Office Director, Personalized Medicine and Molecular Genetics, Office of In Vitro Diagnostics and Radiological Health, FDA, and Joe V. Selby, M.D., M.P.H., Executive Director, Patient-Centered Outcomes Research Institute (PCORI), discussed how their respective agencies plan to proceed in 2017. The Coalition also discussed its own plans for the new year.

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To learn more about PMC membership, contact PMC Director of Membership & Development Mary Bordoni.