More Vaccines in ‘Record Time’ Seen for $6.5 Billion Medical Lab

President Joe Biden’s plan to incubate breakthrough biomedical discoveries in a new entity within the National Institutes of Health could lead to one of the largest shakeups to the medical research agency in at least a decade.

The proposed Advanced Research Projects Agency for Health would embrace the public-private partnership approach that was used to develop Covid-19 vaccines in record time. Potential project ideas include a single shot to protect against the top 10 infectious diseases and an mRNA vaccine to shield against common cancers.

The White House is driving the plans for the $6.5 billion agency. It’s gaining momentum as the lawmakers behind the landmark 2016 biomedical innovation law folded the proposal into their long-awaited follow-up bill. One of the key players behind ARPA-H is Francis S. Collins, the NIH director who’s been leading the agency since the early days of the Obama administration.

Collins spoke to Bloomberg Law about why now is the right time for creating ARPA-H, how it will differ from other big ticket initiatives, and what are the next steps.

The following conversation has been edited for length and clarity.

Where does ARPA-H stand now in terms of getting off the ground?

It’s been well received so far by members of Congress—and of course, that’s crucial.

The appropriations folks are interested in looking closely at how they might be able to do this. This is probably the largest percentage increase for NIH in a long time, this $9 billion increment, of which $6.5 billion would be for ARPA-H.

But the timing seems right to people looking at the opportunity here, especially after the experience we’ve had with Covid-19. We did a lot of those same kinds of ARPA-H things because we needed to for vaccines, getting those developed and tested in record time, and likewise for diagnostic tests.

So I think we’re ready for this. People see it as an opportunity to take this approach and extend it broadly across our portfolio covering lots of different diseases and applications. And it’s great to be able to work so closely with the White House on this because this is a personal priority for the president.

How are big-ticket initiatives like Biden’s Cancer Moonshot playing into the administration’s plans for ARPA-H?

I guess I have been accused of being favorably inclined towards big, ambitious, bold initiatives.

All of these projects fit that mode. The Human Genome Project did too going back a little further. (Collins led the genome project when he was director of the NIH’s genome institute.)

The ability to pull together teams of researchers who might otherwise not have coalesced, provide them with funding and rapid turnaround responses to new ways to steer the project— that’s something that has served us well in certain circumstances. And this is a chance to apply it even more broadly across all diseases.

Most of NIH’s success over all these decades has been a really solid, foundational basic science that we will continue to do. I worry a little bit that people will think we are downgrading the importance of that. We’re not downgrading at all. But if there’s an opportunity to speed up and accelerate the clinical benefits of that foundation, then we should always try to do that.

If this is the kind of advance that’s going to make something happen for cancer, or diabetes, or heart disease, or rare diseases that otherwise is going to take a long time, we shouldn’t let anything get in their way.

How would ARPA-H decide which projects it can fund?

We are going to take a big page out of the DARPA experience (the Defense Department agency that ARPA-H is modeled after) where basically, the director of ARPA-H will need to have a lot of authority to decide what projects are going to be pursued.

Project managers, most of whom will come for a period of maybe three or four years—but not for life—will arrive with their vision of what they want to do. They’ll have to pitch the idea to the director and get the director’s acceptance of that. But there’s no study section built into this, there’s no advisory council that looks at a particular set of grant applications (the two layers of peer review).

How would the agency make sure those funds are being used wisely?

Right, and that is the balance of course. You want to have accountability.

So the review is largely going to be at a very high level. We do expect there will be an advisory committee, probably populated by people who have experience with DARPA and ARPA-E (the Department of Energy’s counterpart), to make sure that we’re living up to those kinds of cultural changes.

But we would not want the director’s hands to be tied by an onerous, upfront kind of review process that says you can’t even start a project until 35 people have agreed to it. That’s not the idea.

What kind of person are you looking for to lead ARPA-H?

A very entrepreneurial person who has experience in moving forward projects that are high risk, but high reward, and quickly. Maybe somebody who also is experienced with failure, because we want to be sure we know how to see that when it’s coming and make decisions quickly. Most likely, this will be somebody from the private sector, or at least somebody who’s had significant private sector experience.

The ARPA-H head would have a reporting line to the NIH director, who would need to be pretty hands off as far as interfering with the decision process and what projects to pursue, but very hands on in terms of providing the kind of administrative support that’s going to be necessary to get this agency started as quickly as possible.

There is a debate going on about whether this should be a presidential appointment. The weight of evidence would say no because then it starts to seem political. And there might be risks involved there, so they will probably be appointed by the health and human services secretary.

What are the next steps?

We have sent to the Hill some specifics about what kind of authorizations ARPA-H is going to need beyond funding.

We will need to have the hiring ability to bring on these project managers who will not be typical NIH employees, as well as some flexibilities in contracting, which we don’t currently have. (NIH has used a faster contracting mechanism called the other transactions authority, but it requires congressional approval.)

DARPA has used the other transactions authority to great advantage, and we would like to have that as well.