The National Institutes of Health has announced $55 million in fiscal 2016 awards to begin the process of building the infrastructure needed to launch the Cohort Program of the Precision Medicine Initiative. Vanderbilt University Medical Center (VUMC) will host the Data and Research Support Center, and the Scripps Research Institute will host the Participant Technologies Center.
The PMI Cohort Program will ask up to a million volunteers to contribute a wide range of health, environment and lifestyle information. They will also be invited to answer questions about their health history and status, share their genomic and other biological information through simple blood and urine tests and grant access to their clinical data from electronic health records. In addition, mobile health devices and apps will provide lifestyle data and environmental exposures in real time.
According to a VUMC release, the NIH will provide $71.6 million over five years to VUMC to establish and operate the Data and Research Support Center, making this the largest research grant VUMC has ever received from any source.
This center will acquire, organize and provide secure access to what will be one of the world’s largest and most diverse datasets for precision medicine research. It will also provide research support for the scientific data and analysis tools for the program, helping to build a vibrant community of researchers from community colleges to top healthcare research institutions and industries, and including citizen scientists, who can propose studies using this information.
Josh Denny, M.D., M.S., associate professor of biomedical informatics and medicine, who also serves as co-chair of the PMI Cohort Program Steering and Executive Committees, will direct the center.
“Precision medicine transcends any particular clinical specialty, any disease, and any one patient type. There is a very real human need for better precision medicine tools and approaches,” Denny said in a prepared statement. “I believe the new PMI will positively impact all of health care — and individual health — like nothing else ever has before. In the PMI we will launch a new paradigm of research that puts participants in the center of biomedical discovery and we will do it efficiently, at massive scale, with the goal of supporting the translation of data to discovery as fast as possible.”
In creating the center, VUMC will work with the Broad Institute of Cambridge, Mass., and Verily Life Sciences (formerly Google Life Sciences) of Mountain View, Calif. (Sekar Kathiresan, M.D., co-director of the Broad Institute’s Program in Medical and Population Genetics, is a co-principal investigator on the grant.)
Participant Technologies Center
Enrollment of PMI Cohort Program participants will be through two distinct approaches. One leverages the strengths of healthcare provider organizations that have existing relationships with potential participants, and the other will be through the Participant Technologies Center, which will support direct enrollment.
The Participant Technologies Center has been awarded to The Scripps Research Institute, San Diego, and Vibrent Health, Fairfax, Va. The grant will total almost $120 million over five years. The center will develop, test, maintain and upgrade, as needed, PMI Cohort Program mobile applications. These mobile apps will be used to enroll, consent, collect data from and communicate with PMI Cohort Program participants. Importantly, the center will need to develop parallel platforms to deliver these same functions to those without smartphones, and work with various technology organizations to increase smartphone accessibility.
"Our focus at STSI [Scripps Translational Science Institute] for the decade of its existence has been to advance individualized medicine. Using genomics, mobile apps and biosensors and providing data back to each participant, this study will set the foundation for new medical knowledge and ways of engaging people in research as citizen-scientists,” said the new grant's principal investigator Eric Topol, M.D., in a prepared statement. Topol is director of the STSI, professor of genomics at the Scripps Research Institute and chief academic officer at Scripps Health.
Seattle-based Sage Bionetworks, an integral partner in the design, development and data hosting for many of mobile-app-based research studies on Apple's open source ResearchKit platform, will be responsible for developing symptom measurements from phone, wearable and other sensors, as well as community outreach and participant engagement efforts with the Participant Technologies Center.
The initiative also includes an extensive network of high-profile partners including Walgreens and PatientsLikeMe. Working collaboratively with other entities, the Scripps Participant Technologies Center will be responsible for enrollment of at least 350,000 participant-volunteers.
Network of Provider Organizations
NIH will build a network of healthcare provider organizations (HPOs) over time to ensure that participants in the research represent the geographic, ethnic, racial and socioeconomic diversity of the country. The network will include regional and national medical centers, community health centers and medical centers operated by the U.S. Department of Veteran Affairs (VA). The following organizations have been selected as the initial set of HPOs with another funding opportunity in the coming months. These HPOs will engage their patients in the PMI Cohort Program, help build the research protocols and plans, enroll interested individuals and collect essential health data and biological specimens. The regional medical centers are:
- Columbia University Health Sciences, New York City
- Northwestern University, Chicago
- University of Arizona, Tucson
- University of Pittsburgh at Pittsburgh
These awardees have sub-awards with organizations that extend the geographic reach of the HPO network. In addition, NIH collaborated with the Health Resources & Services Administration (HRSA) to select six Federally Qualified Health Centers (FQHCs), which are community-based HPOs that reach underserved areas and populations. This award supports a pilot program to determine infrastructure needs that will enable a wide variety of FQHCs to participate as HPOs. FQHCs will be critical for bringing underserved individuals, families and communities into the cohort, especially those historically underrepresented in biomedical research. Recipients are:
- Cherokee Health Systems, Knoxville, Tennessee
- Community Health Center, Inc., Middletown, Connecticut
- Eau Claire Cooperative Health Center, Columbia, South Carolina
- HRHCare, Peekskill, New York
- Jackson-Hinds Comprehensive Health Center, Jackson, Mississippi
- San Ysidro Health Center, San Ysidro, California
Another important partner in the HPO network is the VA, which has medical centers across the United States that provide care to America’s veterans. By collaborating with the VA, the NIH will ensure America’s former servicemen and women have the opportunity to participate in the PMI Cohort Program.
An award to Mayo Clinic to build the biobank, another essential component, was announced earlier this year. All awards are for five years, pending progress reviews and availability of funds. With these awards, NIH is on course to begin initial enrollment into the PMI Cohort Program in 2016, with the aim of meeting its enrollment goal by 2020.