President Barack Obama’s administration will request $215 million for his precision medicine initiative in the budget he will propose next week for the federal fiscal year that starts October 1.

The initiative, disclosed by Obama last week in his State of the Union address, is designed to promote wider use of patient-specific medical care, with the aim of delivering new and more effective treatments for diseases.

Administration officials fleshed out some details of the precision medicine effort, outlining the initiative’s five objectives: More and better cancer treatments, creation of a voluntary national research cohort, public-private partnerships, regulatory modernization, and protecting privacy.

“We’re not talking just about research, but we are talking also about, ultimately, patients’ access to their own data, so that they can participate fully in decisions about their health that affect them, and have a degree of control over those decisions that absent that information, they simply wouldn’t have” John Holdren, Ph.D., director of the White House Office of Science and Technology Policy, said during a briefing with reporters.

In addition to advancing medicine and speeding up cures, the administration has positioned the personalized medicine initiative as necessary for maintaining U.S. leadership in research: “It’s an ambitious effort, to be sure, but one we think holds tremendous promise to make our citizens healthier, and keep our country competitive,” Holdren added.

Obama’s proposed FY 2016 spending plan will set aside most of the proposed funding—$130 million—with the NIH toward the development of the research cohort, envisioned as including a million or more volunteers. Researchers will be given broad access to the cohort, and its data is envisioned to include medical records; gene profiles, metabolites, microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The administration insists the privacy of data “will be rigorously protected.” A “blue-ribbon panel” will offer advice on design and governance of the research cohort, which is envisioned to draw upon existing research and clinical networks in and outside the U.S., while building new research models enabling patients to be active participants and partners, NIH Director Francis S. Collins, M.D., Ph.D., said.

Another $70 million would go to the NIH’s National Cancer Institute toward efforts to identify genomic drivers in cancer and use knowledge of those drivers toward developing better approaches to cancer treatment.

Dr. Collins said the initiative combines a near-term focus on cancer due to its lethal nature and the discovery in recent years of molecular signatures for many cancers that are useful in developing new personalized treatments: “The initiative will also help us tackle some of oncology’s most vexing problems, including drug resistance, and—a particularly important one—how to combine therapies for maximum effect, to achieve not just a remission, but ultimately a cure?”

The initiative’s longer term goal, Dr. Collins added, will be generating knowledge on disease risk, mechanisms, prevention, and therapies than can be applied not only to cancer but other disorders as well.

The FDA would receive $10 million toward advancing development of curated databases, and the Office of the National Coordinator for Health Information Technology (ONC), $5 million to support development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.








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