Personalized Medicine Making Steady Progress

With so many burgeoning areas of science coming together to help advance personalized medicine, there was no shortage of topics at the Center for Business Intelligence’s (CBI) 4th Annual Forum for Payers on Personalized Medicine conference last week. Topics like genetic testing, clinical laboratory improvement amendments (CLIA), pharmacogenomics, and companion diagnostics were all discussed with respect to cost effectiveness, regulations, and their impact on the point of care.

The overarching theme of the conference was as follows: there’s an influx of information coming in from all sectors of the personalized medicine industry. The general consensus from all presenters and attendees is that personalized medicine will unquestionably lead to better patient care and, in time, more cost efficiency. The issues right now are how to develop processes that can analyze the vast data coming in from genomic projects and how to utilize that data to customize individual patient care in a way that is affordable for patients and payers. In addition, the US Food and Drug Administration (FDA) and other regulatory bodies must develop feasible regulations that will maintain safety without slowing progress down.

Here are some of the highlights from the 4th Annual Forum for Payers on Personalized Medicine:

Elizabeth Manfield, PhD, Director of Personalized Medicine, OIVD/CDRH, FDA, did an excellent job of addressing some of the concerns mentioned above during her presentation “Development of the Companion Diagnostic Draft Guidance.” Her presentation was about much more than companion diagnostics, and Dr. Manfield was kind enough to continue answering questions throughout the next several presentations when issues regarding FDA regulations and approvals came up. One thing that the audience did learn was that, although there won’t be specific companion diagnostics mentioned on the labels of their corresponding therapies, payers and providers will be happy to learn that the FDA will be producing a list of corresponding therapies that will be accessible on their website in the near future.

Felix Frueh, President, Medco Health Solutions, Inc, spoke about medical claims data and real-world experience in making informed coverage decisions as they relate to personalized medicine. Dr. Frueh has a unique perspective on personalized medicine because he was really at the forefront of the movement about a decade ago when he was Associate Director for Genomics at the FDA and chaired the first FDA-wide interdisciplinary pharmacogenomics review group. In speaking with Dr. Frueh, he mentioned that it has been remarkable to see just how far this division of science/medicine has come and how excited he was to begin sharing real-world examples of how personalized medicine can not only improve health outcomes but can also save payers money in the process.

To find out more about what topics were discussed and to learn more about where presenters from CBI feel the personalized medicine field is headed, please check out our AJMC TV section for exclusive interviews.