06 February 2015
Not nearly as expansive as the draft 21st Century Cures Initiative released earlier last week by a House committee, the president Friday unveiled his $215 million Precision Medicine Initiative focusing on collaborative efforts to leverage advances in genomics, data sharing and health information technology to accelerate biomedical discoveries.
Calling it a "new era of medicine" that could lead to some blind alleys, as well as significant breakthroughs in personalized medicine, President Barack Obama said the time is ripe to harness America's ability to innovate to deliver the "right treatment to the right patient at the right time every time."
Teased in the president's State of the Union address as a way "to bring us closer to curing diseases like cancer and diabetes," the initiative is intended to build the foundation for future innovation that could drive economic growth. The president noted that each dollar spent in mapping the human genome has returned $140 to the economy. (See BioWorld Today, Jan. 22, 2015.)
While "precision medicine" is just another name for personalized medicine approaches industry has been pursuing for years, the initiative includes specific provisions to advance that work. For starters, it would give the NIH $130 million to develop a voluntary national research cohort of at least 1 million volunteers who would contribute their health data to be used in accessible, curated databases.
The NIH's National Cancer Institute would receive an additional $70 million to scale up efforts to identify genomic drivers in cancer that could lead to more effective treatment for more cancers. While the proposed funding increases would boost the NIH's budget by less than 0.7 percent above its fiscal 2014 appropriations, the agency has big plans for the funding.
As part of the effort against cancer, for instance, the NIH intends to support clinical trials, in partnership with drugmakers, to test combinations of targeted therapies that are based on a tumor's molecular signature. Other short-term goals are to develop:
• solutions to drug resistance that commonly limit the effectiveness of targeted therapies;
• approaches that can assess a patient's response to therapy and possible development of resistance, using "liquid biopsies" of blood plasma;
• new tumor cell models to predict response to drug combinations and to define mechanisms of resistance.
The initiative would give the FDA $10 million to acquire the expertise needed to advance the development of databases that would support the necessary regulatory structure to further innovation in precision medicine. For example, new approaches are needed to evaluate genetic tests, Obama said, adding that they can't be regulated like other kinds of medical devices.
The final $5 million of the initiative would go to Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) to support the development of interoperability standards for data sharing, as well as privacy and security requirements.
PART OF FY16 BUDGET
The initiative is one of several requests to be included in the president's fiscal 2016 budget that would blow the deficit control caps on discretionary spending the White House and Congress agreed to in 2011 to pull in the federal deficit. The budget, to be released Monday, calls for $74 billion – about 7 percent – more in discretionary spending than that allowed under the Budget Control Act (BCA).
It would take an act of Congress to raise, or ignore, the BCA spending caps. Otherwise, any excess spending would trigger an across-the-board sequestration. The administration has said it will recommend ways to pay for the additional $74 billion, which would be evenly divided between defense and nondefense discretionary spending.
Despite the budget debates that are sure to ensue, Obama was confident that the Precision Medicine Initiative would meet congressional muster. "How do you know the moment is right?" he asked. "There's bipartisan support here in Washington."
Much of the initiative dovetails with the 21st Century Cures discussion draft the House Energy and Commerce Committee majority released last week. Among the nearly 400 pages of proposals in the draft bill are calls for development of better data-sharing systems, databases and interoperability. While the draft is not an appropriations bill, it would likely necessitate increases in funding at the FDA and NIH.
The result of a year's worth of roundtables and hearings, the discussion draft marks the beginning of the legislative phase of the Cures Initiative intended to accelerate the discovery, development and delivery of promising new treatments and cures for thousands of diseases with no approved therapies. Committee Chairman Fred Upton's (R-Mich.) goal is to have a final bill on the president's desk by the end of the year. (See BioWorld Today, Jan. 28, 2015.)
Meanwhile, the Senate Health, Education, Labor and Pensions Committee has begun work on finding ways to streamline the nation's regulatory process for new cures, including personalized medicine. The committee majority launched its efforts with the release of a report Thursday that looks at what is and isn't working at the FDA and NIH.
Although the president's Precision Medicine Initiative is just one of several proposals apt to be floated this year to speed drug and device R&D, approval and delivery, the NIH and ONC are already making strides on the initiative. Shortly after the president's announcement, ONC released draft versions of an interoperability roadmap and a 2015 interoperability advisory, which is ONC's assessment of the best available standards and implementation specifications for clinical health information interoperability as of last December.
The NIH plans to hold a workshop Feb. 11-12 to discuss building a large research cohort focused on precision medicine. The workshop will feature leading experts from several disciplines and sectors.Print
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