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NIH Earmarks $72M for First Precision Medicine Initiative Programs

NEW YORK (GenomeWeb) – The National Institutes of Health has announced the first set of funding opportunities under the recently unveiled Precision Medicine Initiative, committing up to $72 million in fiscal 2016 for projects that will create the framework for the program's planned broad-scale national research cohort.

The NIH separately said that it has earmarked $15.8 million in fiscal 2016 for programs advancing tools and technologies in support of the agency's ongoing BRAIN Initiative.

Availability of the money, however, remains contingent on Congress' ability to come up with a federal budget before the expiration of temporary funding on Dec. 11. In October, NIH Director Francis Collins warned a Congressional subcommittee that both the Precision Medicine and BRAIN initiatives would be put on hold without a budget agreement.

The Precision Medicine Initiative was launched in January to apply genomics, informatics, and health information technology to speed the development of personalized medical treatments for patients in the US. As part of the initiative, the NIH is tasked with developing a voluntary national research cohort of one million or more individuals and obtaining sequencing data from participants to identify genomic drivers of cancer, improve how next-generation sequencing-based tests are evaluated and marketed, and develop methods for managing and analyzing large patient data sets while protecting individual privacy.

To lay the groundwork for that cohort, the NIH has set aside $72 million to fund the establishment of up to 10 centers that will manage key aspects of the effort.

Specifically, the NIH said that it aims to provide $21 million for the establishment of a coordinating center that will handle communications between organizations participating in the cohort program; oversee direct volunteer activities; and acquire, curate, and provide secure access to the scientific data generated by the cohort program. The coordinating center will also perform data integration across a variety of data types, mange testing and biobank sample submission schedules, and be responsible for various other administrative activities.

The NIH is also planning to use $28 million to fund up to seven healthcare provider organization (HPO) enrollment centers. HPOs will be "key partners" to the success of the cohort program, according to the NIH, and the enrollment centers will recruit and enroll participants, foster study participation, collect data and biospecimens, maintain contact with cohort participants, and facilitate the involvement of researchers in using the program's resources. The agency noted that the enrollment centers will also be responsible for achieving a cohort that reflects the broad diversity of the US population.

A total of $8 million has been set aside for a cohort program participant technologies center, which is responsible for the cohort program's use of mobile phones and sensor technologies. The NIH said this center will develop, test, maintain, and upgrade the program's smartphone applications and related server systems; provide technology platforms for participants without smartphones; help in data acquisition and management; and work with technology organizations to boost participant access to smartphones.

Lastly, the NIH said it will provide $15 million toward the creation of a biobank for the cohort program. This facility will ship and receive biospecimens; store samples under optimal conditions; protect participant confidentiality; and provide security and backup systems in the case of a disaster, among other things.

"These projects will build a solid infrastructure for the … cohort program," Collins said in a statement. "When a fiscal year 2016 budget is enacted, we can hit the ground running to stand up this bold initiative."

Funding for the BRAIN Initiative

The BRAIN Initiative began in 2013 to accelerate the development of new technologies for imaging, mapping, and studying the brain.

In fiscal 2016, the NIH said that it intends to use $8 million to fund between eight and 10 research grants focused on developing and validating novel tools to help in the detailed analysis of neural cells and circuits, and on providing insights into the neural circuitry and structures underlying complex behaviors.

Areas of interest include, but are not limited to, novel transgenic methods that improve cell-specific and circuit-specific manipulation in multiple species; unique combinations of tools for multiplex analysis and/or manipulation of single cells in situ to maximize data content; and in situ sequencing using FISH and other methodologies.

The NIH is also planning to allocate $4 million to six to eight projects that advance the BRAIN Initiative's stated goal of producing a "dynamic picture of the functioning brain by developing and applying improved methods for large-scale monitoring of neural activity."

Funded projects will involve proof-of-concept testing and development of new technologies and novel approaches for large-scale recording and manipulation of neural activity in order to enable transformative understanding of dynamic signaling in the nervous system, the NIH said.

In a related funding opportunity, the NIH said it will contribute $3.8 million to fund five to seven projects optimizing existing and emerging technologies and approaches for large-scale recording and manipulation of neural activity. This opportunity is specifically geared toward the iterative refinement of emergent technologies and approaches that have already demonstrated their potential, the agency noted.