White House, NIH Directors Weigh in on Proposed Health and Human Services Research Arm – Nextgov

An advanced, government-run research center devoted to driving and funding breakthroughs in medicine and health care will need the right culture and a galvanizing first director to succeed, according to federal officials leading the government’s research efforts today.

Among the proposals to boost American research and development capabilities included in President Joe Biden’s 2022 budget is a move to establish a public health-focused version of research organizations like the Defense Advanced Research Programs Agency, better known as DARPA.

The president’s budget included $6.5 billion to create the Advanced Research Projects Agency for Health, or ARPA-H, within the Health and Human Services Department’s National Institutes of Health.

During an informational session held Friday, officials from NIH and the White House Office of Science and Technology Policy, or OSTP, offered some insight into what such an agency would look like, what it’s mission would be and how that would fit with other health-focused agencies—especially the research programs at NIH—and other research organizations, such as DARPA, the Energy Department’s ARPA-E and intelligence community’s IARPA.

While such an agency would be focused on treating and potentially curing diseases and conditions like cancer, diabetes and Alzheimer’s, the big ambition will be to develop new sciences that could be applied to a range of conditions.

OSTP Director Eric Lander suggested using gene mapping to target the cause of a given illness as a prime example.

“The most exciting things that ARPA-H can work on would transcend any one disease,” he said. “It would be platforms that would be, technologies that would be applicable across many diseases.”

The federal government already has research efforts targeting critical public health issues, including ongoing programs at NIH. But ARPA-H would fill a unique role.

“A potential version of the mission could read something like, ‘To make pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, resources, solutions that have the potential to transform areas of medicine and health for the benefit of all patients, and that cannot readily be accomplished through traditional research or commercial activity,” OSTP Assistant Director for Biomedical Initiatives Tara Schwetz said, stressing the last point. “What we’re talking about is doing things that can’t currently be done.”

That includes important breakthroughs that need to be made faster, according to NIH Director Francis Collins.

“What becomes possible with this new entity on the scene: Science that we might otherwise have to delay or which would take a long time, with this approach, maybe could be done twice as quickly,” he said. “To the benefit of everybody.”

Collins and Schwetz both cited the speed with which the U.S. was able to develop a vaccine for COVID-19, hoping ARPA-H could replicate and improve that timeline in a future pandemic.

“We stand on an unprecedented moment of progress that challenges us to ask, ‘What more can we do?’” Schwetz said. “What more can we do to speed, revolutionize, transform medicine and improve the health of all Americans?”

While ARPA-H is still just a proposal awaiting action from Congress, Schwetz laid out some potential goals for such an organization:

  • Build capabilities and platforms that are broadly applicable across a range of diseases and conditions to revolutionize how we treat and cure them.
  • Focus on converting use-driven ideas—those ideas with a direct application—into solutions for patients quickly.
  • Embracing this sense of urgency to speed the application and implementation of breakthroughs at various levels—from the molecular to the societal—so that they serve all people.
  • Help overcome market failures through creative solutions, incentives and de-risking.

Schwetz noted the culture of the program will be key to its success, particularly how it interacts with other research programs at NIH.

“APRA-H is proposed as, and is important to be linked to NIH to draw on the vast knowledge, expertise and infrastructure,” she said. “However, it will be important for it to remain distinct, with its own unique culture, organization and autonomy.”

As such, program managers will be given “broad autonomy” to manage their research areas as they see fit.

As with other research organizations, such as the other ARPAs, ARPA-H will be built with a tolerance for failure—or a certain level of “risk acceptance,” as Schwetz put it.

But APRA-H won’t be exactly like the other ARPAs, Lander said.

“There’s a lot about the DARPA model that is a fantastic inspiration for APRA-H: the way it’s organized with a great deal of autonomy and people coming for limited terms and tolerating—in fact, embracing—failure. All those things are good,” he said.

However, understanding how ARPA-H will differ from other research organizations is just as important, he said.

DARPA, for instance, “has a single customer: the Department of Defense,” Lander noted. “ARPA-H has an entire ecosystem of customers.”

Similarly, while DARPA is mostly focused on physical engineering feats—GPS, self-driving cars, the internet—biological research is very different, including being simultaneously more complicated and less understood. This will mean structuring research programs differently while trying to absorb the appropriate lessons DARPA and others have learned over decades in operation.

“What will come out is something that’s different from, inspired by,” Lander said. “It will be an ARPA; but it will be its own ARPA-H.”

If established by Congress, Schwetz said the agency will have a “flat, dynamic organizational structure to limit the potential for unnecessary bureaucracy,” with the goal of “instilling a sense of urgency, nimbleness and innovation.”

The White House plans to ensure ARPA-H remains “dynamic” by instituting term limits for the director and other top leadership positions.

Schwetz said the first director will be an important choice, as it will set the tenor for all future leaders of the organization. She said the inaugural leader should be someone with deep technical skills and proven leadership qualities.

Lander echoed that sentiment.

“They’ve got to be somebody who’s been around innovation and has a proven track record building an innovative culture,” he said. “Somebody inspiring, but also somebody who knows they don’t have all the ideas.”

Ideally, the first ARPA-H director would be someone who would attract the top minds in medical research to come forward and either join the agency or work directly with one of its programs.

“That person has to be able to recruit those people, support those people and also has to have their back to make sure they feel comfortable taking risks on projects,” Lander said.

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