New HHS research agency embarks on mission to tackle far-reaching health problems

At barely a year old, the Advanced Research Projects Agency for Health may be — as its director, Renee Wegrzyn, describes it — an agency still in its infancy. Even so, ARPA-H has a big agenda and an equally big budget of $2.5 billion to tackle it.

Wegrzyn said she spent the first year building up operational capacity and establishing contracting and budgeting teams. “What we have in place now I like to think of as our minimum viable agency,” she said.

Now, ARPA-H has begun launching its mission, which, broadly stated, is “better health outcomes for everyone,” Wegrzyn said.

The Health and Human Services Department deliberately modeled ARPA-H after the Defense Advanced Research Projects Agency, where Wegrzyn previously worked. Like DARPA, there’s a standing business and support staff that will be joined by a rotating roster of temporary program managers, whose research proposals receive funding and who will take up residency — in many cases virtual — at ARPA-H for the duration of their projects.

An ideal program manager “thinks and acts like a CEO, but they specifically have a problem in health that they want to solve,” Wegrzyn said.

Specificity is the key for ARPA-H, she added. The agency’s mission is to solve important but discrete health challenges, whether advancing cures for a disease or improving existing treatments or diagnostic systems in measurably and significant ways. ARPA-H does not seek to simply consolidate knowledge or come up with incremental improvement, but rather to take big risks for big payoff, Wegrzyn said.

“So what is that specific problem that the program manager is going to define?” she said. In choosing which proposals to back, she said the agency uses a structured framework developed at DARPA called the Heilmeier Catechism. It consists of a series of eight questions for approaching a problem developed by the late inventor and former DARPA Director George Heilmeier. It begins with this: “What are you trying to do? Articulate your objectives using absolutely no jargon.” Would-be program managers must also articulate the current state of the art, what they propose that’s new, why it matters and then the risks, costs and timetable for their deliverable.

Seeking solutions both cost-effective and engaging

“These are big goals, lofty goals, that we’re going to solve,” Wegryzn said. “But we need those incremental steps. How are we going to know that we’re on the right track to that big radical solution?”

To draw that out from program manager applicants, ARPA-H has added two questions specific to the health sector to the original set in the Heilmeier Catachism:

• The first question is: How are you going to make this program or solution accessible to all people?
  “We have the largest customer base of any ARPA — all Americans. How are you going to make it cost effective?” Wegrzyn said. “We all know there’s a lot of great solutions in health, but nobody can afford them.”
• The second question is: How are you going to make it so that the customers actually want to use these tools?
  “We don’t want to create wonderful whiz-bang technologies that sit on the shelf because nobody knows how to use them,” she said.

The research agency has created what she called a lean but intense application process for people interested in becoming ARPA-H program managers.

It consists mainly of applicants submitting their resumes and answers to the catechism questions. “If we’re excited about their submission, … we’ll contact that candidate and have a conversation,” Wegrzyn said.

Her advice to applicants is to go for the big idea. In some cases, the ARPA-H staff might work with a proposer to level up their idea, she said. “We have a lot of great $1 million ideas. We’re trying to get them to think bigger. This is going to change the whole course of your field. Imagine you had $100 million. What could you then achieve and how quickly could we achieve that radical change?”

Unlike other research arms within HHS, particularly the National Institutes of Health, ARPA-H program managers will oversee research partners retained under cooperative agreements, other transaction authorities and milestone-based contracts — not through grants.

Wegrzyn wants ARPA-H to act as what she called a unique part of the health research ecosystem, distinct from NIH not only in how it funds projects but also in the fundamental types of projects that its pursues.

Spreading a wide net when it comes to research topics

“We’ve carved out a very specific role, which is high-risk, high-reward, milestone- based problem solving efforts,” Wegrzyn said. “And that’s our space. We’re here to be a catalyst. We’re here to buy down risk, demonstrate that something is possible.”

That a wide potential field of research areas, which she added is “disease agnostic.” As example, she cited digital histopathology, looking at cells microscopically. Research could result in tools to “augment the doctor’s capabilities to look at radiology images, look at diagnostic imaging in an automated way,” Wegrzyn said. “But we can do that for a number of diseases. It doesn’t have to be only cancer or only diabetes or only Alzheimer’s disease.”

In thinking about game-changing potential developments,  ARPA-H officials will be looking downstream to potential commercialization.

“Even before they launch a program, the program manager needs to be thinking about if this is a two-year or a four-year program and what happens on the last day,” she said. “And they can’t wait till the last day to make sure they’re creating a path to transition.”

ARPA-H also is working to establish an office dedicated to transition.

“We’re bringing in experts from the outside, folks that are familiar with venture funding, private capital,” Wegrzyn said. “We bring them to the table and say, ‘Hey, we’re thinking about creating a program in this area. Tell me about the market. Does a market exist?’ ”

If the market doesn’t appear to exist but the research deliverable is viable, ARPA-H will be prepared to push it forward and create a new market, she said. “We can shape that market, but we need to line up the players to be ready to pick up that technology on the back end.”

Establishing three hub locations

ARPA-H also has some site selection to do. Congress authorized three geographic locations for the agency. It is looking for two regions in addition to the National Capital Region (NCR) to establish hubs from which it and its program managers “can reach our investors and reach our stakeholders.”

The NCR is important because of its proximity to agencies ARPA-H will collaborate with, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, Wegrzyn said.

In its first year of selecting program managers, the goal is to bring on 20 researchers.

“That means 20 different problems in health that we’re going to announce. That should be a very diverse portfolio,” she said. “We may have biomanufacturing programs. We may have an Alzheimer’s program. We may have a pediatric program.”

ARPA-H also has special authority for direct hiring and salary flexibility outside of the government’s General Schedule standards.

“But most importantly, I really want to emphasize we’re looking for people that are driven by the mission and that want to change the course of their field,” Wegrzyn said. “That is the opportunity we’re providing.”

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