Congressional negotiations over the FY2019 budget look promising for bio-optics technologies that stretch the edges of discovery for personalized medicine, neuroscience, biosensing, and more. If the numbers now under discussion hold up, 2019 funding will help keep the U.S. at the forefront of biomedical research, development, and manufacturing.
"I'm very pleased to see the work that Congress has done to ensure investments are made in a thoughtful way," says Robert Gropp, co-executive director of the American Institute of Biological Sciences. "They're investing in science to keep that engine rolling." But an even more "aggressive championing of all of the sciences" by both Congress and federal agencies would help alleviate the chaos and uncertainty that has marked recent funding cycles.
Gropp is guardedly optimistic about reaching agreements before the fiscal year begins on October 1. Such action would relieve agencies of the scrambling needed to manage research portfolios when funds remain tied up in committee.
Here's a quick overview of potential wins for biophotonics at the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA):
NIH's biophotonics implications
The FY2019 request for NIH sits at $34.8 billion. But Congress will likely boost that number closer to just over $38 billion. At the May 17 congressional hearing on the NIH budget, Sen. Roy Blunt (R-MO) noted that over the last three years, Congress has increased NIH funding by 23%—$7 billion above 2015 funding levels.
Although multiple NIH initiatives include funding opportunities for research to advance biomedical imaging, two components of the FY2019 request should be of particular interest to the bio-optics community: The All of Us Research Program, which supplants the Precision Medicine Initiative, will likely become NIH's flagship effort. Set to record the health data of over 1 million volunteers, the All of Us program will also sequence DNA samples from participants, which could both improve sequencing technologies and drive down their costs. Imaging will also play a role in the program. According to NIH budget documents "as implementation proceeds, this program will be considering technologies for participants to share biomedical images in the future." The second relates to the Cancer Moonshot Initiative, which includes a goal of developing diagnostic imaging technologies to identify patients likely to respond to cancer immunotherapies. Other ongoing NIH programs that promote imaging research are the BRAIN Initiative, the Human Connectome Project, the Quantitative Imaging Biomarkers Alliance, and the Imaging Tools for Cancer Research program.
Funding opportunities for biophotonics also exist in gene therapy research programs, Alzheimer's research and immunotherapy research efforts. Congress is particularly keen on Alzheimer's research, providing sustained funding over the last several years, and immunotherapy because of its early successes in halting cancer progression. These areas will likely see sustained or increased funding now and in the future. Another opportunity for bio-optics is The Partnership to Accelerate Cancer Therapies (PACT), a new public-private initiative for research to identify and validate biomarkers of response and resistance to cancer therapies.
FDA targets novel device development
As part of FDA's $5.8 billion FY2019 request, $400 million would be used for programs to advance innovation and competition. The agency has set a goal of making the U.S. the preferred market for novel device developers by the end of 2020. One initiative aimed at bringing medtech manufacturing back to the U.S. would establish a voluntary program for device manufacturers to receive certification for meeting certain manufacturing and product quality criteria. The agency developed its criteria working with stakeholders through the Medical Device Innovation Consortium. FDA Commissioner Scott Gottlieb, himself a physician and cancer survivor, wants to ensure his agency can respond to public health needs quickly. Modernizing drug manufacturing includes supporting development of novel technologies like optics and photonics. In an interview with BioPharm International, Gottlieb noted, "We're now at a tipping point. The agency will develop further guidance and standards to reduce uncertainty for industry in adopting high-technology platforms."
Passing budget legislation for FY2019 may be a bit easier for the Senate this year, as Majority Leader Mitch McConnell (R-KY) recently announced the Senate would cut its August recess from four weeks to three (though the House will apparently not follow suit).