ARPA-H is 'open for business' to provide lifeline for a struggling biotech industry

Almost a year ago to the day, the Advanced Research Projects Agency for Health (ARPA-H) launched with sky-high ambitions to tackle cancer and other diseases. Mentioned often in the same breath as President Joe Biden’s "Cancer Moonshot" initiative, ARPA-H was established with the goal of being a less cumbersome bridge between the public and private sector.

Now, it’s time for the rubber to hit the road. Top leadership is in place, the first program managers have been hired and the agency is looking to stake down locations for three hubs across the country. Equipped with $2.5 billion, inaugural Director Renee Wegrzyn, Ph.D., says ARPA is ready to go, funding new research in healthcare and biotech that may span from proof-of-concept studies to long-term projects. 

Headshot of ARPA-H Director Renee Wezrgyn

“The time is right for an ARPA,” Wegrzyn said in an interview with Fierce Biotech. “ARPA is meant to move at the pace of innovation.” 

If that sounds like industry speak, that's because it is. Wegrzyn was named to lead the agency in late 2022 after a stint as vice president of business development at Ginkgo Bioworks, a cell programming biotech that also worked with the U.S. during the height of the COVID pandemic to expand testing for travelers. But Wegrzyn cut her teeth working at ARPA’s namesake, the Defense Advanced Research Projects Agency (DARPA), first as a consultant and then as a project manager. 

The ARPA model was first established in 1958 by the Defense Department when it launched DARPA, a counterpunch of sorts after the Russians launched their Sputnik satellite into space. The agency was tasked with advancing new science and technology that would bolster U.S. national security. The model was replicated in 2007 by the Energy Department when congress authorized ARPA-E (for energy) to increase federal investments in new energy technology. Two hundred companies that received investment from ARPA-E went on to receive a total of $11 billion in follow-up private funding. More than two dozen companies accumulated nearly $22 billion in market value through exits. 

At the core of the ARPA model are program mangers, who act like point guards leading the investment offensive. Wegrzyn said program managers applying for jobs at ARPA-H were asked to describe a health challenge that they want to address. 

The difficult irony is that as ARPA-H launches to capitalize on innovation at biotech and life science companies, those respective industries are undergoing a reset. Wegrzyn says that may actually make ARPA more appealing to those who wouldn’t have previously considered seeking funding from the government. 

“I would suspect as with the volatility, again in the marketplace, that private investors can take less and less risk,” she said. And that’s ARPA-H’s “sweet spot.” It’s a critical distinction as the new agency tries to separate itself from existing ones like the National Institutes of Health. 

“We want to fund … the risks that [the private sector and the rest of the federal government] are not willing to take on,” she said. It’s an environment that’s grown even more unstable in recent days after Silicon Valley Bank crumbled; biotechs continue to lay off workers and shop excess pipeline assets to fund basic operations.

“We have heard from small businesses that are excited for whenever we are open for business to engage because we do represent another funding line for them to advance their innovation,” said Wegrzyn in a media briefing when asked about the impact of the bank’s failure on ARPA-H’s ambitions. 

The grand opening is right around the corner. The agency just announced its first two program managers and mission directors, with prior experience ranging from DARPA to the White House Office of Science and Technology Policy. Wegrzyn says the objective of the project managers is to think like a CEO but to be able to take big risks in the process. The agency hopes to hire as many as 20 of them in 2023. 

The hiring spree comes as ARPA-H has put out its first call for funding requests large and small. Wegrzyn wouldn’t commit to “prescribing” a dollar amount for this initial opportunity, but the agency has the ability to spend $1.5 billion before Oct. 1—the start of a new fiscal year. But that's contingent on the ability to hire staff and facilitate more funding requests. 

What the agency will ultimately fund remains up in the air, with much of the discretion delegated to program managers. Wegrzyn affirmed that the agency is not looking to only make bets where there’s evidence, saying that ARPA-H will try to de-risk promising science that’s yet to accrue significant data. 

“[M]aybe there isn't a financial incentive for this program, that's okay,” she said. We can still explore this and even be market-shaping as we move forward.” 

The agency is also not solely focused on tackling Biden’s moonshot initiative, which looks to cut cancer death rates by 50% over the next 25 years, though it is a point of emphasis. Wegrzyn says she’s constantly working with the White House OSTP and moonshot coordinator Danielle Carnival, with ARPA establishing a “moonshot champion” who can find common threads between cancer-fighting proposals.

Ultimately, ARPA is not immune to the funding constraints that plague most government agencies, particularly in a divided Congress that’s so far been at a stalemate over future funding. ARPA-H was granted $2.5 billion in initial investments (PDF), far lower than the president’s original $6.5 billion request, during last year’s funding negotiations. Wegrzyn feels that she can continue to carve out bipartisan support by appealing to people’s common experience of tending to family and friends dealing with devastating diseases. 

“There's what we can hope for and what we can have. Those are often two different things,” she said. “We want to be on a growth trajectory that we can confidently ask for those budgets moving forward.”