As head of the government’s new federal agency, she’s attacking a wide range of problems from the molecular to the societal.
It’s hard to imagine an ARPA-H founding director more suited to the job than Renee Wegrzyn. She’s been a program manager at DARPA (Defense Advanced Research Projects Agency), a consultant for Booz Allen Hamilton, and the VP of business development at Ginkgo Bioworks.
If you haven’t heard of ARPA-H (Advanced Research Projects Agency for Health), it’s only because you’re not looking for funding to disrupt the American health care system or push the boundaries of what we’re trying to do in life sciences. One of the newest government agencies, it was created in March 2022 as part of the PREVENT Pandemics Act with an initial appropriation of $1 billion in 2022 and a subsequent budget increase to $1.5 billion for 2023.
ARPA-H’s mission is to accelerate better health outcomes for everyone both by advancing medical research and by improving our health care delivery system. They intend to explore solutions that scale from the molecular to the societal, and are looking for proposals that will touch diverse patient populations, can transform communities, or attack a broad array of diseases and health conditions, including ones that support the Cancer Moonshot.
When I first meet Wegrzyn, I can tell right away she’s a woman on a mission. I was invited to interview her on stage at the March 2023 SynbioBeta conference, an occasion she used to emphasize her intention of quickly hiring 20 program managers with brilliant visions for the future of health care in this country, due diligence their ideas as fast as possible, and get them started on their transformative path. I spoke to her again in the fall just before she made a flurry of funding and operational announcements. What follows are comments from both interviews, condensed and edited for clarity.
Proto.life: What is ARPA-H and why is it necessary?
Wegrzyn: We’re modeled after the DARPA business model, which means we are pursuing some of the high risk, high payoff, really bold research ideas. We’re a funding agency, not a research wet lab. You can think of us as investors—we really want to address this gap between the amazing innovation that happens in companies, that happens in labs, but never really makes it into the hands of the public, to the patients, to the health care providers. That’s really what we’re here to address.
Projects that come to ARPA-H are transactions. They should only live at ARPA-H for a few years until we can show that it’s possible—and then they should graduate out of the agency. We’re disease agnostic—there’s not a single disease that we’re focused on or a single technology, but instead, we’re looking at a variety of problems in health that we intend to invest in.
So how are you organizing and prioritizing this?
We’ve identified four technical focus areas that we think are big levers in health:
- Health science futures
Think tools, technologies, and platforms that can advance the state of the art for a multitude of diseases and better yet, may be proof of concept for more than one indication. - Scalable solutions
Not only scale of manufacturing—from 10 doses to a billion doses—but also how do you actually get into people’s homes? Meeting people where they’re at. - Proactive health
Keeping people from becoming patients in the first place. - Resilient systems
What are the investments that we’re making now so that we have resilience against the next pandemic or climate change or economic threats as we move forward?
Those are meant to be really broad categories where everybody can find a place for their technology, and to really level up to address this bold audacious goal that the president has set out for us.
In other words, you’re going to fix everything wrong with American health… with a $1.5 billion budget?
[LAUGHING] Probably not, but we’ll take little bites.
What are the most urgent problems to solve in U.S. health care?
One of them is that we don’t have the design principle of really thinking about the customer. We’re not thinking about the end user when we’re innovating in the lab. That gap between the two is massive, so regardless of whether we’re working on a cancer solution or Alzheimer’s or new technology, built into the design of that program is going to be looking at cost, accessibility, and user experience. We also have a whole transition office dedicated to making sure that we can bridge between the real world and the initial spark of innovation. There aren’t specific problems with the health care system. It’s just that all these gaps exist and there is nobody systematically looking at how to address this.
The second is a little bit of a reflection since we’re based on the DARPA model. At DARPA, the entire Department of Defense has a unified view to how we should approach defense and is an incredible transition partner. We don’t have that in health—that seamless transition doesn’t exist. Yes, we have HHS [the Department of Health and Human Services], but don’t forget, each state gets to pursue health in a very different way that’s dictated at the state level. So how do we at this agency innovate so that we get better linkages across states and better information sharing? We’re creating that ecosystem for transition, where we’re funding something to get it into the clinic or to be translational in that traditional sense for medicine. But it might be that we’re just transitioning something to a company to now manufacture this because we’ve gotten over some technical hurdle.
“Would you share your lab’s data in a pre-competitive way if we were able to give you priority review for whatever it is you’re testing and building?”
I think there’s not enough collaboration between public private partnerships. I’ve been in and out of the private sector and government and there’s such tremendous value that both bring to the table, but they’re not always collaborating and playing to each other’s strengths.
I think another advantage for working with ARPA-H is that we also bring other players to the table. We can bring the FDA to the table to understand what are the types of incentives that we can offer that are beyond financial. We can also bring payers to the table, whether it’s CMS [the Centers for Medicare & Medicaid Services] or folks in the insurance industry. A small company can have a really hard time understanding how to bring all those players together, and at the end of the day, we want to make it so that the only roadblocks to solve for are the technical ones.
Also, we have a special relationship with the FDA that we are working to define right now with the commissioner’s office. Would you share your lab’s data in a pre-competitive way if we were able to give you priority review for whatever it is you’re testing and building? As we think about this tidal wave of AI capabilities, we need data. This whole industry needs data to understand how to engineer cells, but it has to be done in an open source way. We think in collaboration with FDA and NIH that we should be able to help accelerate review in exchange for access to your data.
What’s the process for greenlighting a project?
Projects are driven by program managers, who put forward a problem they want to solve and a program concept. Once they are inside and have access to our resources, they can do a lot more discovery and develop a great market landscape analysis and gap analysis. And then they pitch their concept to their director and if that is approved, they pitch the scientific advisory board that I am head of, so I’m the sole decision maker on that board. It’s a very lean process that is meant to be quick and efficient.
It’s a three-year term. And so every two weeks that goes by, 1 percent of their time is up. And so that’s a lot of pressure—but you can’t miss this opportunity to change the course of your field.
ARPA-H programs to date, as of Oct 11, 2023
What kind of person are you trying to recruit to be a program manager, and how might they be different from a more traditional DARPA or NIH program officer?
Other agencies have their technical strategy set many times in a top-down way. And so you hire really talented people to manage an existing vision. [In our case], our program managers bring their vision to the agency. We want to make sure we’re addressing the administration’s priorities, but the way that we address those really comes from the program managers. And that’s unique.
A program manager may fund three or four teams to try to solve that problem, so during the course of, let’s say, a three- or four-year program duration, they have to manage those teams. And if there are some that don’t look like they’re going to cross the finish line, then they’re responsible for pivoting those funds. We call it high-contact program management. And by design we are not issuing grants. We’re doing things like contracts and cooperative agreements.
But you’re still part of NIH, so how does that work?
Our authority is established within NIH so we are able to use a lot of the NIH infrastructure, like payroll, for instance, or their 27 disease institutes full of world class experts with deep subject matter expertise. They also have intramural labs that might provide some internal testing for us, for instance. Because we’re the decision makers, we can confer with them and take their perspective, but we make those independent decisions.
What are the specific things you want to accomplish?
One is to demonstrate that we are funding a diversity of projects. We don’t only want to be looking at one disease or one technology or one demographic, we want to really develop a portfolio approach. And also a portfolio of projects that couldn’t be done anywhere else because the timelines are so ambitious, or it’s just too high risk for the federal government. And so that’s our sweet spot.
The other measure of success is sometimes failure. We know that we’re taking ambitious enough shots on goal if we fail sometimes. But it’s important to be transparent with those failures—were we just technically wrong in this approach? Or is there something fundamentally not ready for this, like the regulatory systems?
And I want to make sure that 20 years from now, we have a pipeline of brilliant program managers that want to come to this agency because they see this not only as a way to change the course of their field, but to level themselves up, too.
DARPA was established as a response to Sputnik. What is biology’s Sputnik event? What made ARPA-H necessary?
There hasn’t been a great place for public-private partnerships in the health arena that could move quickly, and there was urgency around this need well before the coronavirus pandemic. But the pandemic served to shine a light on the problem. We don’t want to do this in an emergency state.
The second factor is initiatives like the Cancer Moonshot, where President Biden has rallied folks around a specific problem with hard metrics that we want to solve. So when the President decided to launch ARPA-H, my interpretation of his words is that we want to create the next moonshots for other diseases.
“There’s a risk of losing U.S. competitiveness if we’re not really moving quickly.”
And last but not least—and this is something that I feel viscerally— is there’s just so much really great innovation around the engineered biology spaces in health in general, and in medtech and biotech specifically. And there’s a risk of losing U.S. competitiveness if we’re not really moving quickly. We saw with the semiconductor industry decades ago that we were leading innovation, but then a lot of it went offshore. I really think that now is the time to double down, if not triple down on medtech and biotech innovation and generative AI in the United States. Yes, we will collaborate with the world health organizations, because health impacts everybody. But for U.S. competitiveness, I think ARPA-H is critical to catalyze some of the most urgent parts of this ecosystem.
At the height of March Madness, you had an open call for ideas from which you curated a field of 64 competitors, like a basketball bracket. There were multiple rounds of public voting, which ultimately netted one winner, who was awarded $15,000 for the idea of developing one drug for all cancers. This “Dash to Accelerate Health Outcomes” sounds rather gimmicky for a government agency. Was this real science?
Yes, we had a bracket challenge to identify some of the biggest problems in health that APRPA-H could be solving. Not only did it put us on the map, but it was also a way to engage in the ideas and engage in the conversations around these ideas. We also wanted to attract a whole new audience, and the folks that participated skewed young, which was exciting.
And that was the first time that we ever had a prize challenge, so the stakes were relatively low. $15,000 isn’t really moving the needle on health. But it was a way of standing up our government agency. It’s like watching a teenager drive a car for the first time, but in our case, it’s the first time that car has ever been driven! So some of what you see ARPA-H doing is not just for health, but also for figuring out how to do things operationally as efficiently as possible so that next time, when we do something like a grand challenge, we’ll have those muscles and we’ll be ready to go.
It’s hard to stand up a government agency—ha, what an understatement—to build a startup in one of the biggest bureaucracies in the federal government… You’re sprinting, and then sometimes you sprint into a wall. And so the day to day is just really intense. But the joy of reading the submissions, the ideas, the passion behind them was a little bit of fuel for the team.
