President Joe Biden is requesting $52 billion in FY2022 for NIH—$9 billion above the enacted FY21 level—of which $6.5 billion is slated for the proposed Advanced Research Projects Agency for Health.
While the $9 billion investment, if approved by Congress, would amount to the largest raise in the history of NIH, $2.5 billion of that increase would be appropriated for regular NIH operations, according to NIH’s Office of Budget. $9 billion is about 21% of NIH’s current budget, whereas $2.5 billion is equivalent to about 6%.
When program-level funds are included, the FY 2021 funding level for NIH is $42.9 billion, and $6.56 billion for NCI. Oncology groups welcome Biden’s proposed FY22 increases, urging Congress to work with President Biden to generously fund cancer research and support innovation in cancer research (The Cancer Letter, April 9, May 28, 2021).
Biden’s FY22 budget proposal for NCI states: “[$6,364,852,000] $6,539,302,000, of which up to $30,000,000 may be used for facilities repairs and improvements at [NCI’s Frederick National Laboratory for Cancer Research].”
Sources say Biden is requesting $6.735 billion for NCI, a $175 million increase—or 2.67% increase—over the institute’s FY21 funding level of $6.56 billion. This proposed NCI funding level includes $194 million for the Cancer Moonshot Program, as well as $50 million for the Childhood Cancer Data Initiative (The Cancer Letter, Dec. 4, 2020).
Biden’s full budget request, released May 28, states that ARPA-H would have an “initial focus on cancer and other diseases such as diabetes and Alzheimer’s … this major investment in Federal R&D would drive transformational innovation in health research and speed application and implementation of health breakthroughs.”
Senate leadership appears to be in agreement with Biden on the necessity of a DARPA-like agency to accelerate biomedical research and innovation, including for cancer.
“Like the defense initiative it is inspired by, ARPA-H is envisioned as breaking the mold for how cutting-edge research is conducted, speeding up the development of medical treatments by funding innovative projects,” Sen. Patty Murray (D-WA), chair of the Senate appropriations subcommittee on Labor, Health and Human Services, Education and Related Agencies, said at a May 26 hearing with NIH officials.
ARPA-H would be one of two proposed DARPA-like initiatives—Biden’s request also calls on Congress to provide $500 million for ARPA-Climate, and an unspecified budget for an ARPA at the Department of Transportation “to accelerate technology that improves infrastructure performance.”
Dr. Collins, I look forward to working with you and Chair Murray and the administration in making ARPA-H a reality. I think there’s a moment, it’s ready for that. I think because of what’s happened in the last two years, NIH is ready for that.
Sen. Roy Blunt (D-MO)
Murray’s Republican counterpart on the subcommittee, Ranking Member Sen. Roy Blunt (R-MO), said NIH is ready for ARPA-H, too.
“I want to work with the administration to support the ARPA-H initiative,” Blunt said at the May 26 hearing. “They’ll have the flexibility and tools necessary to both nimbly and innovatively respond to both the next pandemic and also some of the big health issues we face today.”
NIH Director Francis Collins said ARPA-H could halve the amount of time needed to bring innovative ideas to fruition.
“The president believes that with your help, we can learn from the lessons of the pandemic and transfer this scientific momentum into big improvements in the health of all Americans. I do, too,” Collins said at the hearing.
“Potential areas of transformative research driven by ARPA-H include: the use of the mRNA vaccines to teach the immune system to recognize any of the 50 common genetic mutations that drive cancer; development of a universal vaccine that protects against the 10 most common infectious diseases in a single shot; development of wearable sensors to measure blood pressure accurately 24/7; and leveraging of artificial intelligence technology to advance care for individual patients and improve detection of early predictors of disease,” Collins said in his testimony.
The director of ARPA-H would be appointed for a five-year term, with one possible renewal, Collins said. The director would have the authority to recruit 100 program managers to build “collaborative ventures.”
ARPA-H would be the ideal vehicle for rapidly developing blood tests, i.e. liquid biopsies, to detect early-stage cancers, said NCI Director Ned Sharpless.
“That could have a profound effect on cancer mortality,” Sharpless said at the hearing. “So, getting up a huge trial of that technology as quickly as possible is the kind of thing that I think would be a good fit for ARPA-H.”
Excerpts from the May 26 hearing follow:
Murray: You can never fully predict how the discoveries of today will prepare you for the challenges of tomorrow. That’s why you have to build a robust research enterprise and recruit diverse world-class talent and make sure scientists can do their work free from political interference.
And President Biden’s budget, which proposes over $40 billion for NIH and the largest increase in the agency’s history will go a long ways towards making sure we can continue to prioritize this.
There’s also proposed $6.5 billion for a new initiative—the Advanced Research Projects Agency for Health. Like the defense initiative it is inspired by, ARPA-H is envisioned as breaking the mold for how cutting-edge research is conducted, speeding up the development of medical treatments by funding innovative projects.
Blunt: I want to work with the administration to support the ARPA-H initiative. This will be a new institute or is proposed to be a new institute. And I think that that’s what should be the case. They’ll have the flexibility and tools necessary to both nimbly and innovatively respond to both the next pandemic and also some of the big health issues we face today.
This is a critical moment in a rapidly changing healthcare world, finding those things that the kind of [Operation] Warp Speed, shark-tank RADx relationship, could enhance in cancer and Alzheimer’s, and every disease where there’s an opportunity where we see that moment and know that this is something that doesn’t necessarily call for a five-year research grant, but some sort of partnership different than that, that moves toward a real conclusion sooner than we might otherwise be able to do that.
ARPA-H should not do what the other institutes do, it should do what the other institutes can’t do and a cross-cutting way that goes throughout the institutes looking for opportunities, frankly, and the other institutes where there’s a breakthrough moment that we could look at differently. I think we can help fill gaps here that otherwise would not be filled and look forward to that discussion.
Now, also, as someone working with Sen. Murray for the last eight years to increase the funding and the focus in what NIH has been doing, we clearly want to be sure that this somehow doesn’t take away from the solid research that proved so effective in getting this ready for what we just saw.
So, Dr. Collins, I look forward to working with you and Chair Murray and the administration in making ARPA-H a reality. I think there’s a moment, it’s ready for that. I think because of what’s happened in the last two years, NIH is ready for that.
Collins: This new agency within NIH will catalyze novel strategies to speed transformational and innovative ideas, ideas such as simple blood tests to detect free-floating DNA or protein markers that signal a cancer is growing somewhere in the body, a micro-needle patch that delivers a vaccine to hard-to-reach communities in the mail, using an innovation funnel, to recruit, test, and scale up new technologies for ambulatory blood pressure measurement, with the potential to transform the management of hypertension.
These are just a few of the bold ideas that ARPA-H could tackle, but they are not science fiction. With standard approaches, well, they might happen in a decade or two. With ARPA-H, we believe it could take half that time. The president believes that with your help, we can learn from the lessons of the pandemic and transfer this scientific momentum into big improvements in the health of all Americans. I do, too. My colleagues and I would be pleased to answer your questions.
Murray: As you had just talked about, the president’s budget includes $6.5 billion to create the ARPA-H within NIH that is modeled after DARPA. DARPA is a small, $3.5 billion agency composed mostly of program managers and empowered to push the limits of their disciplines and shape some milestone-driven breakthrough technologies in short three to five-year stints.
Given that the nature of NIH’s work is different, relying on a peer review system or multi-year grants that is traditionally risk adverse, where progress is often measured in decades, how do you envision ARPA-H fitting into the NIH ecosystem?
Collins: Senator, it’s a great question. I think you are right that much of what NIH does requires this kind of careful, deliberative, investigator-initiated hypothesis-driven research, and that’s going to be the mainstay of what we do going forward.
That’s been the success story of NIH for many decades, but there are opportunities, as we have seen happening during COVID—such as the need to develop diagnostics in a hurry, develop vaccines in a hurry, that aren’t really amenable to that approach—where you need to have program managers that are empowered to move things swiftly and have the flexibility and the resources to do so. And that is the DARPA model. We’ve studied that closely.
And we do think that there are projects in biomedicine now that would be greatly advantaged by that. That is not the typical peer review process that may take a year from the idea to the first award. With RADx, we made those first awards five days after Congress gave us the budget for it, and that played out really well.
So, we want to incorporate that mindset and we want to bring on perhaps 100 of these program managers, give them the opportunity to build the kind of collaborative ventures that include such organizations as small businesses that might otherwise not be likely to write an NIH grant, ride herd over these things carefully so that if they’re not doing well, they get basically stopped immediately; we expect there will be failures—this is high risk—but identify the areas of greatest opportunity.
And every institute at NIH is now coming forward saying I’ve got at least five ideas of what I would like to do with ARPA-H that I can’t do right now. So, this should not be seen as competing with the institutes. It is going to be a synergistic relationship that will allow us to do things otherwise that would take a very long time.
Murray: Well, you’ve said that it should be within the Office of the Director in that structure. How would decisions be made about what projects to fund?
Collins: So, we will need to hire a director for ARPA-H who will need to be a visionary person, and the idea is to bring on somebody, who’s not probably going to be doing this as their long-term career, but maybe for one term, five years with one possible renewal.
That person will be very much engaged in and bringing on board these very creative program managers who have to make a pitch about what kind of projects they think are worth investing in and convince the director that that’s the case. And then, they are given the flexibilities to go out and find the right partners and see what can happen.
But that’s all going to be done in a way that’s quite nimble. It’s not going to involve our traditional peer review process.
Blunt: Dr. Collins, on the ARPA-H financial request, $6.5 billion. One part of the question would be, how do you think that number was arrived at, and is that a realistic number to commit in year one? And two, our concern would also be that we don’t get in the moment.
So, we’ve already given NIH $6.5 billion, a sort of level fund everything else. I do like the president’s $2.5 billion. I’m sure you could figure out how to spend more than that. And the other institutes, that’s pretty close to the average of the last six years from our committee.
I’d certainly like to stay at at least that level, but how do you think those two numbers compete with each other? And how do you feel about actually being able to commit $6.5 billion in that first fiscal year of ARPA-H?
Collins: That’s a great question, senator, and we have thought a lot about it. I am pleased the president’s budget proposes that this would be three-year money, because obviously you’re going to start from a standing start whenever the budget actually gets approved for FY22, we hope that’ll be Sept. 30? Well, it might not be.
So, at any rate, we would then really be benefited by being able in that first year to stretch those dollars over a little bit. I do think we could, with 100 program managers readily come up with a number of projects that would fit within that envelope on an annual basis. But I hear what you’re saying about a concern, cause I’ve heard it also, that this might in some way, compromise the interests of the institutes.
I guess I’d look at it a different way though. As I said earlier, every one of the institutes is coming forward with great ideas about how they’d like to use ARPA-H. They think of this as an augmentation of their capabilities, not a subtraction. And so they will be feeding ideas into this and have a lot to do about how those are chosen. So, even though the base number that’s being proposed, $2.5 billion for the ICs, may sound like a sort of average one in terms of the science they can do, ARPA H is going to add to that.
Blunt: Thank you. Well, Dr. Sharpless, one of the things the president of course talks about in this issue in this topic is more rapidly moving toward ending cancer. Obviously, we want to do that. We also want to make the point that that’s not the only thing that ARPA-H would be focused on, nor would it just be cancer or Alzheimer’s.
But on that topic, how do you envision the ARPA-H role in cancer research and what might you be able to do with ARPA-H that you’re not able to do in the traditional restraints of the institute?
Sharpless: Thanks for the question, Sen. Blunt. As the president has said, ending cancers as we know it is a top domestic priority for this administration where, obviously, the cancer research community is galvanized by this notion and, and is very excited.
I think, as you know, the National Cancer Institute does some things really well. We fund basic foundational science very well; we can do clinical trials quite well. But there are some areas where we’re challenged, where we have struggles, and I think the scale and nimbleness and the ability to interact with industry is very appealing about ARPA-H for certain kinds of cancer projects.
I think a good example of that is this blood-based, cancer-detector technology that Dr. Collins mentioned in his opening statements, where you can find cancers at a very early stage and in otherwise asymptomatic healthy people, and that could have a profound effect on cancer mortality. So, getting up a huge trial of that technology as quickly as possible is the kind of thing that I think would be a good fit for ARPA-H.
Blunt: Thank you, Dr. Sharpless. Dr. Tromberg, let me see if I can get one more question. I think what you were part of at RADx is one of the reasons it gives me real optimism about new kinds of relationships that we might develop at ARPA-H.
Would you talk just a little bit about RADx and how that partnership continued right through the entire process of these companies that you were choosing to invest money with, going ahead and making the first home-based test and I think producing well over two million tests every day now, in addition to the tests that would have come through the regular process.
Bruce Tromberg [director, National Institute of Biomedical Imaging and Bioengineering]: Yes. Thank you so much, Sen. Blunt. And thank you for your question and for your generous support of the RADx program. The bioengineering technology community has formed partnerships all across the government—that’s included working with BARDA, FDA, DOD, CDC, HHS, the White House Testing Board, where the 900 scientists are working across government, academia, and the private sector in a very unique way to make this work.
And as you’ve mentioned, if we fast forward to now, about one year later, we now have 33 RADx supported companies that have increased the nation’s testing capacity by more than 300 million new tests, and there have been 23 new FDA authorizations. We’ve really changed the dialogue from laboratory testing of symptomatic folks to over-the-counter, widely available tests, point-of-care tests that are accessible to all—greater choice and greater capabilities.
And this has really happened because of all of these partnerships that we formed, the accelerated innovation. We’ve brought out new technologies—about 20% of our portfolio, actually not many people know about, has been based in nanoscience and nanotechnology. So, it’s been a tremendous surge for innovation.
