The U.S. just created a big new biomedical research agency. But questions remain | Science

President Joe Biden last week got his wish for a new agency to fund high-risk, cutting-edge biomedical research when Congress created the Advanced Research Projects Agency for Health (ARPA-H) and gave it a $1 billion startup investment. That’s a fraction of the $6.5 billion Biden had proposed, but advocates say it’s plenty to launch ARPA-H.

The 2022 spending bill does not resolve, however, a debate over whether to make ARPA-H a standalone agency within the Department of Health and Human Services (HHS) or part of the National Institutes of Health (NIH). Instead, it gives HHS Secretary Xavier Becerra 30 days to decide.

Biden proposed ARPA-H in 2021 as a biomedical version of the military’s Defense Advanced Research Projects Agency (DARPA), famed for its nimbleness and for backing innovations like the internet. Like DARPA, ARPA-H is expected to hire program managers on short-term contracts who would have enormous freedom to solicit research ideas and swiftly fund them with milestone-driven contracts.

Acting White House science adviser Francis Collins, who stepped down as NIH director in December 2021, yesterday told ScienceInsider that he favors placing ARPA-H within NIH (see below for more from the interview). That placement would allow the new entity to draw on NIH’s “brain trust,” he says, as well as the practical expertise needed to quickly stand up a new agency.

But many groups have argued that ARPA-H needs to be an independent agency to break from NIH’s risk-averse funding culture and attract innovative leaders. “If it’s not independent to the outside world,” says Liz Feld, president of the Suzanne Wright Foundation, a pancreatic cancer research advocacy group, “all the people we need to make this effective will see it as more of the same.”

Congress is split on the issue. Today, the Senate health committee discussed a bill that would place the agency within NIH but require it be located far from NIH’s Bethesda, Maryland campus. In the House of Representatives, a bill sponsored by Representative Anna Eshoo (D–CA) would make ARPA-H independent. Given that “difference of opinion,” Collins says it “makes sense” to let Becerra decide.

ARPA-H will have 3 years to spend its initial $1 billion. “The expectation is that this is the beginning of a ramp” to higher funding, Collins says. For now, he says, the agency needs to find an interim director who can work out hiring, contracting processes, and office space. ARPA-H likely won’t make awards until it has a permanent director. But Collins says that appointment could come in just “a couple of months” because the position does not need Senate confirmation, and names are already “kicking around.”

The ideal candidate will have broad experience in academia, industry, and philanthropy, and be familiar with translating basic discoveries into treatments, ARPA-H watchers say. Harvard University chemical biologist David Walt, a former chair of DARPA’s advisory council, stresses the need for “somebody who is really a broad thinker and is not pigeonholed in their own area.” The person must also be willing to divest investments that could pose a conflict.

Experience with one of the government’s other ARPAs—several agencies have one—would also be a plus, Collins said. Here are some other highlights from that 14 March conversation:

Q: Is $1 billion enough to get ARPA-H started?

A: It is 3-year money. That’s important. Because it would be pretty hard in the middle of March to spend $1 billion by [the end of the 2022 fiscal year on] September 30th, for something that’s just now getting launched. And the expectation is that this is the beginning of a ramp that will bring it to a higher base funding level over the coming years.

Q: The omnibus bill creates ARPA-H within the HHS secretary’s office but also allows 30 days for moving it to NIH. Where does the White House stand on ARPA-H’s location at this point?

A: Back in December, when I was still the NIH director, the president certainly indicated his preference that ARPA-H should reside at NIH, although making it clear that it needed to be set up with a firewall so that it was not just the 28th institute. The omnibus leaves this to the secretary to decide which makes sense. If he thinks it would be more successful to utilize the infrastructure of NIH, he can do that. So, this is going to be an interesting month.

Q: Where does this fit with the other bills now in Congress that would authorize the creation of ARPA-H?

A: The [Senator Patty] Murray [D–WA] [and Richard] Burr [R–NC] bill, which was publicly released on Friday, basically says ARPA-H should be at NIH. The [Representative Anna] Eshoo [D–CA] bill, [in the House of Representatives] health subcommittee of energy and commerce, takes a different view and says that ARPA-H should be at HHS, but not necessarily at NIH. So, there’s a difference of opinion. And here is where I think the Congress wisely in the omnibus basically said let’s leave this to the secretary to decide.

Q: Would it really be disastrous for ARPA-H if it was not within NIH?

A: I think it would be a slower start, that’s for sure. Think about all the things you need to do to set up an entirely new enterprise in terms of human resources, finding facilities. NIH has a lot of those capabilities those don’t readily exist free standing in HHS in quite the same way. Having NIH serve as an incubator for it would actually facilitate a quick start. I could also make the case that what you’re going to want to have proximity to other deep thinkers who are also visionary. It’s not that they are going to take it over. But why would you want this [ARPA-H] to exist in a vacuum, when you have probably the most impressive brain trust of biomedical research visionaries available for brainstorming ideas?

Q: I think a lot of the advocacy groups would say NIH is an amazing place, but it has a certain way of doing things.

A: I agree with that. By the way, I don’t think the interim director [of ARPA-H] should be somebody who has worked at NIH. I’m concerned also about any idea that [ARPA-H] would begin to be just business as usual. Could people please look and see what [NIH] did for the last 2 years with COVID? A lot of the things we did with vaccines, with diagnostics, those are very much the same model [as envisioned for ARPA-H]. Comments about NIH being stuck in bureaucracy, I actually don’t think reflect the reality of 2022.

Q: Can ARPA-H start making awards while that search for permanent director is going on?

A: I think there’s a reluctance to start projects until the real director arrives. Everybody wants to be sure that director has a chance to establish the framework of how projects are going to be chosen, how program managers are going to be hired, what are going to be the priorities.

Q: Any idea how long that will take?

A: Once the president appoints the right person, they are appropriately vetted for all kinds of important questions like conflict of interest. And I think that person could be in place in the course of a couple of months.

Q: Does that mean there have been some names out there already?

A: Everybody’s kicking around names. Absolutely.

Q: What kind of person is needed to fill this permanent director position?

A: I do think it would be ideal if this is somebody with experience in one of the ARPAs, DARPA or ARPA-E[nergy] or IARPA [Intelligence Advanced Research Projects Activity]. Perhaps somebody who was once a program manager at DARPA in their biomedical division. Somebody who’s had entrepreneurial experience in the private sector would also be valuable.

Q: Where does the NIH director search stand?

A: It’s coming along quite well. That’s all I will say.