Fall Forecast: Personalized Medicine Policy and Events

Labor Day has come and gone, Congress is preparing to go back in session, and shortening days remind us that Daylight savings will be here before we know it. Even as the long days of summer draw to a close, the fall promises to be a busy and productive time in advancing policies to support personalized medicine, as well as convening industry stakeholders to connect, share ideas, and collaborate toward advancing the science, business, and policy of personalized medicine.

This fall we expect to see a maturing of activities started over the summer.  FDA hosted a 2-day meeting in July on the regulation of laboratory-developed tests (LDTs).  The meeting docket (FDA-2010-N-0274) provides a good overview to any who missed the event.  After that meeting, the House of Representatives held a hearing on consumer genomics.  This hearing made it clear that Congress is not satisfied with how gene scans are regulated, and sometimes that dissatisfaction was aimed at LDT regulation in general. The Senate is also concerned; GenomeWeb reported that Senator Hatch (R-UT) is considering legislation on the subject. 

In other legislative news, Rep. Patrick Kennedy (D-1^st RI) partnered with Rep. Anna Eshoo (D-14^th CA) to introduce an updated version of the Genomics and Personalized Medicine Act (HR 5440). PMC will continue our work to strengthen this bill through inclusions of research  incentives for personalized medicine and other improvements in the Senate version as we look for it to be re-introduced  in the next Congress. 

Next week, I will be joining Carolyn Clancy, Francis Collins, and  many other leading experts at the 2nd National Comparative Effectiveness Summit which will feature presentations and discussion on the legislative history and future of comparative effectiveness research (CER), how federal stimulus dollars for CER are being put to use, as well as the intersection between CER and personalized medicine. The focus of this meeting is particularly timely as the expected announcement of the federally-appointed Board of Governors for the Patient-Centered Outcomes Research Institute (PCORI) is expected later this month. The discussion on balancing CER and personalized medicine objectives will continue in October at the Comparative Effectiveness and Personalized Medicine:  An Essential Interface meeting hosted by the ECRI Institute, Agency for Healthcare Research and Quality, and the National Institutes of Health.

There are a number of other meetings taking place throughout the fall focused on a variety of topics and issues relevant to personalized medicine, beginning with the 6th Annual Burrill Personalized Medicine Meeting on September 27 & 28. Hosted by Burrill & Co and the Duke Institute for Genome Sciences & Policy, the meeting will focus on the impact of healthcare reform on personalized medicine. On October 14 & 15, the 3rd Annual Personalized Health Care National Conference is taking place at Ohio State University Medical Center’s Center for Personalized Health Care. This conference will include discussion of the challenges of making predictive, preventive, personalized, and participatory medicine a reality.

The conference season will culminate on November 17 & 18 with the 6th Annual Personalized Medicine Conference. Each year, the Partners HealthCare Center for Personalized Genetic Medicine, Harvard Medical School, and Harvard Business School bring together representatives from academia, diagnostic and pharmaceutical companies, healthcare providers, policymakers, and other industry experts making contributions to advancing personalized medicine. This year we’ll explore the ways personalized medicine impacts clinical care, and how lessons from these experiences can inform policies and plans to implement personalized medicine to improve patient care.

For more information on these and other conferences of importance to personalized medicine, please visit the Events page at The Age of Personalized Medicine website. And throughout the fall, stay tuned to The Age of Personalized Medicine Blog as an opportunity to engage in discussions stemming from these events and new policy developments.