In his State of the Union message this year, President Obama announced a new effort in the way research is done when he unveiled the Precision Medicine Initiative (PMI). The stated goal of this initiative is to begin the transition from a world where we lacked information about how individuals respond to medicine to one where medicine is directed more precisely to individuals. As we have gathered the ability to utilize genetic information and we are amassing large quantities of data on patient experiences, it only makes sense to utilize those abilities to better inform treatment for various types of individuals. In particular, the initiative is aimed at developing more targeted cancer treatments.
The PMI began with some initial investment by the Administration – the bulk going to the National Institutes of Health (NIH) and to the National Cancer Institute (NCI), but there was an allocation made to FDA as well. Part of that investment appears represented in the development of a new cloud based platform by the agency.
Called PrecisionFDA, the platform has entered a phase of closed beta testing. What is it? The cloud-based platform does not appear to fulfill a regulatory function, but rather provides a private space for analysis as well as providing a community for researchers who might be the ones who would do that analysis. In the agency’s own words – it provides a private area where individuals or organizations can conduct genome analysis and comparison against reference material as well as a community area where results can be published and shared along with relevant materials and tools. The agency says that this community is in the process of growth and includes genome test and software providers, standards-making bodies, pharma and biotech companies, healthcare providers, academic medical centers, researchers, patients as well as FDA and other governmental bodies.
You can see a very short (but not very informative) video about the effort here. The agency has also set up a Web Page to overview it. But the most information is contained in a Why, What, Who and How set up here. There is also a link provided for those interested in applying for access to the community, though standards for acceptance did not appear clear.
Interested in following the developments of PrecisionFDA? If so, FDA has started a new Twitter feed for the project – @precisionfda, joining the other 16 FDA Twitter feeds of which I am aware. If you are interested – you can subscribe to a page seeing only FDA tweets across their feeds here on the Eye on FDA Twitter Feed or just see the entire FDA Twitter population.