NIH selects VUMC to play foundational role in PMI Cohort Program

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Vanderbilt University Medical Center (VUMC) has been chosen by the National Institutes of Health (NIH) to be the Data and Research Support Center for the Precision Medicine Initiative Cohort Program, a landmark study of genetic, environmental and lifestyle factors affecting the health of a million or more people, federal officials have announced.

The NIH will provide $71.6 million over five years to VUMC to establish and operate the center, making this the largest research grant the Medical Center has ever received from any source.

"We are honored to be selected to play a foundational role in a program that promises to drive innovation in precision medicine for decades to come. At Vanderbilt, we believe that understanding each person's unique nature is essential to their care," said Jeff Balser, M.D., Ph.D., President and CEO of VUMC, and Dean of Vanderbilt University School of Medicine.

"The Precision Medicine Initiative gives urgency to our shared goal of making patient care far more personal; unlocking the key intelligence we need to tailor diagnosis and treatment for the genetic and environmental features of every individual. Moreover, this competitive grant, the largest in our history, will generate substantial economic impact for Tennessee, while firmly anchoring Vanderbilt and Nashville as a national hub for personalized medicine."

Supported by approximately $55 million in fiscal 2016 from the NIH, the PMI Cohort Program will begin enrolling volunteer participants this fall and aims to meet its enrollment goal by 2020.

"The more we understand about individual differences, the better able we will be to effectively prevent and treat illness," said NIH Director Francis Collins, M.D., Ph.D., in a news release.

The PMI Cohort Program will seek to determine, for example, "why some people with elevated genetic and environmental risk factors for disease still manage to maintain good health," Collins said, "and how people suffering from a chronic illness can maintain the highest possible quality of life."

The Data and Research Support Center will be directed by 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.

"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. "I believe the new PMI will positively impact all of healthcare - 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."

The role of the center is to acquire and organize what will become an enormous and extraordinarily diverse dataset of precision medicine indicators, and to provide research support and analysis tools to the scientists who will mine it.

"What an accomplishment by Josh Denny and the incredible team he is leading at Vanderbilt and with our partners around the country," said Dan Roden, M.D., senior vice president for Personalized Medicine at VUMC and a nationally known pioneer in the field.

"This award represents the culmination of a very long-term set of investments in translational science, informatics and large program management by decades of VUMC leadership," Roden said.

It also demonstrates the tremendous respect the field holds for VUMC and for its precision medicine leaders, including Roden and Denny, added Gordon Bernard, M.D., executive vice president for Research at VUMC and director of the Vanderbilt Institute for Clinical and Translational Research.

"This is truly an exciting next step forward for both medical science and discovery research. This program illustrates how our robust, creative basic research plays a critical role in laying the foundation for precision medicine," said Susan Wente, Ph.D., Provost and Vice Chancellor for Academic Affairs for Vanderbilt University. "I am proud of the strategic vision our faculty have embraced in translating discoveries into national and global impact."

The Vanderbilt Department of Biomedical Informatics is home to the largest group of informatics faculty in an academic medical center. Examples of VUMC's pioneering efforts in precision medicine include BioVU, one of the nation's largest DNA databanks, with 216,000 unique samples of human DNA linked to 2.5 million de-identified electronic medical records, and PREDICT, a clinical decision-support program that tests patients for genetic variations which may affect their response to certain drugs. The goal of PREDICT (Pharmacogenomic Resource for Enhanced Decisions in Care & Treatment) is to give patients the most effective medications based on their genetic response.

The PMI Cohort Program is an effort of unprecedented magnitude, and requires equally expansive and imaginative strategic and operational partnerships, federal officials said. These include a national network of Healthcare Provider Organizations (HPOs) to enroll participants, including such diverse settings as regional medical centers, Federally Qualified Health Centers, and Department of Veterans Affairs medical centers.

The Participant Technologies Center will oversee the direct enrollment of volunteers and develop mobile health technologies and smart phone applications that participants will use to record their record lifestyle data and environmental exposures in real time.

A PMI Cohort Program Biobank, which is being built by the Mayo Clinic in Rochester, Minnesota, will oversee the collection, storage and analyses of blood and urine samples for crucial genomic and other biological information.

Participants also will be invited to provide details of their health history and status, and allow grant researchers access to clinical data from their electronic health records, with the assurance that numerous safeguards are being built into the system to protect their data.

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