The Obama administration this month announced a series of new investments, partnerships, and policies to further the Precision Medicine Initiative (PMI), including $55 million in awards from the National Institutes of Health (NIH).
President Obama announced the PMI in January 2015, hoping to revolutionize how to improve health and treat disease with a new model of patient-powered research. Precision medicine takes patient data and tailors treatment and prevention strategies to a unique individual based on their lifestyle, characteristics, genomics, etc.
The newest steps to advance the PMI include:
- NIH awarding $55 million to health care providers, technology companies, and community health centers to recruit research participants into the PMI Cohort Program.
- Development of tools to make data accessible for researchers.
- A Food and Drug Administration (FDA) proposal to streamline genomic testing and ensure safety.
Part of the NIH investment will go toward building foundational partnerships to support the PMI Cohort Program, which hopes to engage at least a million people in sharing their medical, genetic, and lifestyle data.
“This range of information at the scale of 1 million people from all walks of life will be an unprecedented resource for researchers working to understand all of the factors that influence health and disease,” said NIH Director Francis S. Collins. “Over time, data provided by participants will help us answer important health questions, such as why some people with elevated genetic and environmental risk factors for disease still manage to maintain good health, and how people suffering from a chronic illness can maintain the highest possible quality of life. The more we understand about individual differences, the better able we will be to effectively prevent and treat illness.”
NIH has selected four regional medical centers, six Federally qualified community health centers, and the Department of Veterans Affairs as their initial partners in building the Cohort Program. They selected a wide range of providers in order to build a geographically, ethnically, racially, and socioeconomically diverse participant base.
NIH is also funding the development of tools to make patient data secure and useful to researchers. This includes creating a data infrastructure to allow participants to contribute their clinical and lifestyle data securely, and receive study results. It will also ensure that researchers have private and secure access to this data.
Finally, the administration is working with the FDA to accelerate innovation with genomic testing. A new platform, precisionFDA, lets users compare the accuracy of DNA sequencing tests. The FDA is also publishing draft guidance to ensure the safety and effectiveness of genomic tests.
“The FDA values the input we received from genomics experts, industry, health care providers and patients from four public workshops and other outreach opportunities. Based on this input, we crafted draft recommendations that we believe will encourage innovation and advance the goal of precision medicine: to speed the right individualized treatments to patients sooner,” said Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health. “Precision care is only as good as the tests that guide diagnosis and treatment. The FDA’s job is to ensure that doctors and patients can depend upon the accuracy, reliability, and clinical validity of these tests. It’s our hope that this approach will achieve just that.”