Washington, DC — Putting his money where his mouth is, President Barack Obama will seek $215 million to finance the Precision Medicine Initiative he first mentioned in his State of the Union speech on January 20.
The funding request will be included in his fiscal 2016 budget, which will be sent to Congress on February 5.
"The time is right to unleash a new wave of advances in this area — precision medicine," said Obama today at the East Wing of the White House. And he said he knew the time was right, in part, because "there is bipartisan support for the idea."
A centerpiece of the president's proposal is a million-patient research cohort that will depend largely on physicians and hospitals to help recruit participants and ensure there is continuous and long-term data collection and follow-up, Francis S. Collins, MD, PhD, director of the National Institutes of Health (NIH), told Medscape Medical News.
He likened the Precision Medicine Initiative to the Human Genome Project.
"What is needed now is a broad research program to encourage creative approaches to precision medicine, test them rigorously, and ultimately use them to build the evidence base to guide clinical practice," Dr Collins and Harold Varmus, MD, director of the National Cancer Institute, wrote in a perspective published online January 30 in the New England Journal of Medicine.
The president's request includes $130 million for the NIH to develop the research cohort and $70 million for the National Cancer Institute to develop genomic biomarkers and prognostic and diagnostic markers, in addition to personalized therapeutics. The proposal also seeks $10 million for the US Food and Drug Administration (FDA) to help better craft policies to be able to effectively and quickly review next-generation genomic sequencing.
"Next-generation sequencing technology is clearly integral to the future of personalized medicine," FDA Commissioner Margaret Hamburg said in a January 29 briefing with reporters. "But we must be confident that these platforms and the tests that use these are capable of providing accurate and meaningful results."
Finally, the president asked for $5 million for the Office of the National Coordinator for Health Information Technology. That would support the development of interoperability standards and ways to ensure the privacy and security of data exchange.
The million-patient cohort will be used as a foundation to study all diseases, but oncology will be the first focus, Dr Collins told Medscape Medical News.
"The cancer focus is a natural because cancer is at the leading edge of precision medicine," he said. Accelerating that progress is "timely and very appealing."
The research cohort will underpin that effort. The database will include medical records, genome and microbiome profiles, environmental and lifestyle information, and data from personal health devices and sensors.
The NIH has been in contact with 200 studies that have at least 10,000 enrollees each, which it hopes to integrate into the overall cohort, Dr Collins said. Volunteers will be needed to round it out.
The data will be accessible to qualified researchers and likely also will be used by pharmaceutical, device, and diagnostic companies, he said.
An early outcome "will be to take this field of pharmacogenomics — the right drug at the right dose for the right person — and really put it to the test," Dr Collins said. The FDA has approved more than 100 drugs with labeling urging DNA testing before use. "And yet it's not being done because the logistics are all wrong."
But with a database that offers results on a million people, "it's a click of the mouse for the doctor to figure out whether it's a different drug or a different dose," he said.
NIH Panel Forging the Way
The NIH has already assembled a "blue ribbon" panel to guide the specifics of the initiative, said Dr Collins. "We really need to figure out exactly what the details of this plan should look like."
Richard Lifton, MD, PhD, chairman of the genetics department at Yale School of Medicine in New Haven, Connecticut, will head the panel. The first meeting will be held February 11 and 12, and the first order of business will be putting the research cohort together.
"We have to take advantage of the time we've got to plan, so if there are funds in October or thereabouts, we'll know exactly what we want to do to get this enterprise going," Dr Collins said.
Medscape Medical News © 2015 WebMD, LLC
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Cite this: President Requests $215M for 'Precision Medicine' - Medscape - Jan 30, 2015.