A year ago, Renee Wegrzyn signed up for a very cool job.
As the inaugural director of the Advanced Research Projects Agency for Health, she was to prove that the nontraditional, $2.5 billion experiment will yield the kind of high impact its high-risk investment model promises.
Since Wegrzyn joined the agency in October 2022, ARPA-H has awarded hundreds of millions of dollars in cancer-related collaborations, programs, and research projects.
“We’re going to continue taking those big bets,” Wegrzyn said. “Let’s figure out, what does a program look like to actually just demonstrate that something is possible, buy down the risk, and then transition that out into the real world?”
Wegrzyn, a Defense Advanced Research Projects Agency alumna, brings two decades of research and project execution experience to ARPA-H.
At the new agency, she is applying a nonlinear, nimble approach to biomedical innovation and technology development that was founded and honed in the realm of engineering.
Wegrzyn, who received her PhD in molecular biology and bioengineering from the Georgia Institute of Technology in 2003, is a former program manager of biological technologies at DARPA.
Prior to taking the top job at ARPA-H, she was an executive at a genetic engineering biotech company.
“We see this as a portfolio of investments,” Wegrzyn said. “There’s no silver-bullet single investment that’s going to change everything in terms of cancer or any other disease for that matter.
“We are not going to innovate in isolation. We really want to have our customers—that’s the American people, the healthcare providers that need to implement a lot of our tools—they are part of the conversation and are really partners and not just sort of interesting downstream parties here. They’re really part of this process.”
Wegrzyn describes her role in wizarding terms—and calls on the oncology community to submit proposals and abstracts for funding opportunities, and participate in ARPANET-H, the agency’s new health innovation network.
“If you look at whatever your role is in the cancer ecosystem, maybe you’re a patient, maybe you’re a researcher—if you can make a magic wand and wave it and have one thing solved, those are the things that we want to hear about at ARPA-H, because we want to figure out a way to get there,” Wegrzyn said.
A story on ARPANET-H and the agency’s cancer portfolio appears is available in this issue.
“Framing some of the conversations in that context has been really, really helpful for us,” Wegrzyn said. “My pitch for ARPA-H is always just: Think big. Really big.”
Wegrzyn spoke with Matthew Ong, associate editor of The Cancer Letter.
Matthew Ong: Dr. Wegrzyn, thank you for taking the time to speak with me. It’s been a year, of course, since you took the job—what are the perks and challenges of setting up a brand-new federal agency?
Renee Wegrzyn: Yes, it has been a year. I survived a year. Just past Oct. 11 was my one-year swear-in anniversary.
I knew this job was an incredible opportunity coming into it, and now living it, and really, on the day-to-day, seeing the amount of impact that we can make has been incredible, the programs that we’ve launched—of course, I didn’t know those program managers before I took this job—so, recruiting that talent and then being able to launch those programs has just been a real joy and delight, and I think it keeps everybody in the agency going with that mission focus.
As you know, we keep hiring program managers, so there’s much more to come in terms of the challenges. I’ve been in startup environments before, in the private sector, and I’ve said it’s hard to start something up. It’s much harder to start something up in the federal government.
So, starting from scratch, going zero to one in an organization that tends to be very bureaucratic—and, of course, our mandate is to lose a lot of that bureaucracy and be nimble and swift—on the one hand has been a challenge, but every time we overcome some of those blockers, it certainly is a success for us.
And I think we’re garnering some of the attention to other parts of government that say, “Hey, wait, how did you do that?” And so, we want to really share those insights as we move forward.
How are you conceptualizing ARPA-H’s approach to cancer research—and oncology as a field—at a high level? There’s the Cancer Moonshot as a driving force, and thus far, ARPA-H has launched a data initiative, a trials innovation effort, and a precision surgery project. I’d love to hear about how you’re visualizing your approach.
RW: I think you started to tee it up really well there, where we see this as a portfolio of investments. There’s no silver-bullet single investment that’s going to change everything in terms of cancer or any other disease for that matter.
But we know there’s going to be a series of investments, whether it’s surgical interventions, as we have through the Precision Surgical Interventions program, or being better at even just sharing patient data, which hopefully the Biomedical Data Fabric Toolkit is going to help us be able to do.
It’s really a holistic approach, and we’re going to continue to take those big bets. That’s not the end of our investments, of course, in the cancer domain. We continue to look for those going forward.
I’ll add two pieces of nuance that I think are really important in terms of our vision.
So, we make sure that anything we invest in isn’t just good for one disease or one capability. That has been an important cornerstone for all of our programs that if we have these great new surgical interventions through the PSI program that can prevent damage to healthy tissue like neuronal tissue, we want to make sure we can use that across the board.
That is really a central tenet in how we launch our programs. And I think that’s where the dollars invested by ARPA-H have a much broader impact of what we can catalyze downstream.
The second piece of it is we are not going to innovate in isolation. We really want to have our customers—that’s the American people, the healthcare providers that need to implement a lot of our tools—they are part of the conversation and are really partners and not just sort of interesting downstream parties here. They’re really part of this process.
And as you know, last week, we officially launched our ARPANET-H Customer Experience hub in Dallas. [On Oct. 26], we officially launched our Investor Catalyst hub. I’m actually calling you from our new Cambridge site.
So, this is getting closer to those customers, but making sure we have that investment on the back end, so that what we seed then has a longer sustainable lifetime.
What you see a lot of our investment now is laying those foundations, so that we can really have this flow of new programs into the future to ensure their success.
What proportion of the ARPA-H budget right now is being spent or allocated for cancer-related projects—if there is such an allocation process?
RW: So, it is a little different than maybe using those words. We don’t look at our total budget, which our initial appropriations were $2.5 billion.
We don’t sit down and say, “X dollars is going to be for cancer.” What we say is, “We are looking for these best innovations where we think ARPA-H investment will really give an asymmetrical advancement of the state-of-the-art.”
We get those ideas from our program managers and from the outside world through our Open Broad Agency Announcement. Many of those ideas happen to have been cancer in this first year.
And so, right now, we have awarded, as of last week, $268 million that are projects that are related to cancer. So, some of them are almost exclusively cancer. Some of them will be those platform innovations like the CUREIT program, where we address the immune response both for cancer, but other autoimmune disorders.
Those types of investments total about $268 million.
And then, in the coming weeks and months, there will be additional announcements and those numbers will be made public when we make those awards, when those negotiations are complete.
But we continue to see a great pipeline that we think will impact the state-of-the-art for cancer.
What is ARPA-H’s process for program design and also determining what kinds of RFPs to offer or projects to fund? You’ve talked about program managers and outside expertise, but does each program manager rely on an external panel of expert advisors as well as internal subject matter expertise?
RW: So, that’s one of the great things about an ARPA—our model is so different.
For the program managers, we identify these folks who come to ARPA-H and say, “I have this great CV. I’m a doer.”
These people, they’ve demonstrated execution in their careers—whether it’s the private sector, government or academia or maybe a mix of those—and then they come to ARPA-H with an idea.
So, if we take the Precision Surgical Interventions program, literally, Ileana Hancu, that’s her program, that was her job talk.
She’s like, “This is what I’m passionate about. I think ARPA-H investment can help patients, and this is a problem worth solving, but I need ARPA-H resources to do it, because nobody else is doing it.
The private sector isn’t doing it in this way, and the federal government is not funding it in this way.”
And so, she convinced us that that was the case. When she came in-house, she had a couple of months to develop that further, and that’s where she brought in subject matter experts, now that she could say, “Hey, this is ARPA-H calling. I’m thinking about a concept in this area.
“Are these metrics ambitious? Would this be exciting to you, a surgeon, to use this tool? And what would it take to bring this into your surgical suite?”
So, she spent a lot of time, probably talked to about 100 experts in the development of that program before she launched.
We also use our [Project Accelerator] Transition Innovation Office to talk to folks in the marketplace—venture capitalists, investors who say, “You know what? I would love to fund this company, but they have to demonstrate X first. We want to know what X is, because that’s what we want to invest in so that we can de-risk it for that downstream investment.”
That’s really all part of that initial development of the program. That then manifests itself as the solicitation with the program announcement, where we look for, then, the teams that are going to do the work; right?
As you know, we’re a funding agency. We’re not labs. So, we look for those teams that we’re going to fund, whether they’re academic or industry, or mixes therein to move forward. That’s the major way that we’re going to spend our dollars at ARPA-H.
But we know that we don’t have all the great ideas. We’re a small team, and while we have some good ideas, we want to hear from the rest of the world.
So, that Open Broad Agency Announcement is the other place where it’s like the kitchen sink—bring us your great idea in health innovation that you think is ready for an ARPA, and we want to hear that.
So, the scope is very broad.
I understand the hub-and-spoke model, speaking of ARPANET-H, but could you explain how it works on the ground? For instance, what can the average clinician, researcher, or industry executive expect to see over, say, the next few months, and how can they participate?
RW: First and foremost, we’ve launched these hub-and-spoke networks. So, they collectively are the ARPANET-H, our Customer Experience and our Investor Catalyst hub.
And if you come to our website, we actually can direct you in very simple ways—it’s a form-fill—on how to be part of that network.
I knew this job was an incredible opportunity coming into it, and now living it, and really, on the day-to-day, seeing the amount of impact that we can make has been incredible.
It’s not “pay-to-play” really, where anybody can participate. There’s a brief vetting process to make sure that it’s legitimate parties, obviously, coming forward. But that’s pretty straightforward. And that is managed, actually, through our consortium management firms.
And so, those awards that went to the hub-and-spoke here in Cambridge where I am today, VentureWell was the awardee. And they’re our conduit, you can kind of think of them as somebody who will maintain those websites for us.
But we do all of the decision-making on any efforts that we run through that network. It’s up to them to help us really recruit those folks, but they need to make it a business-to-business interaction.
So, working with the federal government, loud and clear feedback from the community is very hard—it’s these very complex interactions with the government. But we want to work with the little guys and the non-traditional partners that wouldn’t normally feel up to the task of working with the government because it is so cumbersome. And so, that’s what this network helps to relieve.
And so, through that clinical trial network that we launched last week—it’s a draft right now, we’re looking for feedback—but it is going to be released and say, “Hey, we’re going to actually stand up this Advancing Clinical Trials Readiness network, and they’ll help us recruit those players on the ground, so that when as we launch new initiatives from ARPA-H, we’re able to immediately work with those partners and not wait for a 5-, 6-, 7-month process to bring them on board.”
Just to wrap that out, for folks that come from the private sector and industry, there is this very quick iteration of pilot something out, try it out, learn from that feedback, and then test something new. So, the design-build-test of any experiment or tool happens in real time.
Federally funded science is just super linear. It’s like, “Okay, there’s an at-the-bench Petri-dish discovery, then it’s a preclinical trial, and then it goes to the clinic.”
And oftentimes when you get to that endpoint, it’s maybe not really serving your customer anymore.
So, we want to make sure that we don’t do that. We don’t want to take that traditional path, and we really want to have a contracting mechanism that helps us have those quick, iterative design tests, build cycles, during the course of any product development or program development.
What is ARPANET-H’s role in cancer research and how would it work in tandem with say, NCI-designated cancer centers and their catchment areas? How would NCI and ARPA-H’s missions intersect, from a programmatic standpoint, in this regard?
RW: You should think of us, of ARPANET-H as, yes, we’re augmenting a lot of those great systems.
We’re not trying to recreate any of them. In fact, our hope in some of the conversations with NIH also other partners is that we can roll some of those up to be an extension of ARPA-H, longer term.
But a few things that you should relate is that this contracting mechanism that allows this very rapid [approach]—I’ll use a little bit of government jargon here, it’s called “other transactions”—it allows us to move really quickly.
Other government agencies have this authority, but we actually have real experts on this contracting authority to make this happen quickly. So, it would be a way to work with government quickly.
The other way this Advancing Clinical Trials Readiness network—while not focused primarily on cancer—will be used for cancer: Ileana, for example, has launched her Precision Surgical Interventions program, part of that program is demonstrating these surgical interventions in rural areas.
We don’t all have a Rolodex of rural hospitals that might want to use this, but we can use the ARPANET-H to identify those partners that want to participate, but then we’ll have that contracting mechanism to get them participating very quickly. And so, this way, that contracting matches the timeline of these programs, as just one example.
But the beauty of having this as an existing contract is that we can also, in the future, maybe we want to launch a pediatric cancer program a year from now, we can go ahead and launch that directly on ARPANET-H.
It just allows us to move really quickly.
And then, last but not least, the bookend of that here, this Investor Catalyst hub in the Greater Boston area, makes sure that those investments are sustainable beyond ARPA-H investment.
Yes, some of these projects may transition to other parts of the federal government, but we know a lot of that will end up in the private sector, and we want to make sure that we can become customers of those services downstream.
As you know, many of our readers work with academic cancer centers across the country and have a very thorough understanding of how NIH and NCI works. If you were a keynote speaker at a cancer conference, what would your pitch for ARPA-H be to them?
RW: My pitch for ARPA-H is always just: Think big. Really big. And what are the things that, not the science that’s iterative, but I’m handing you a magic wand.
If you look at whatever your role is in the cancer ecosystem, maybe you’re a patient, maybe you’re a researcher—if you can make a magic wand and wave it and have one thing solved, those are the things that we want to hear about at ARPA-H, because we want to figure out a way to get there. And framing some of the conversations in that context has been really, really helpful for us.
Maybe some of those are still too ambitious, so, we can’t get to them, but more often than not, we’re able to kind of back calculate—okay, magic wand. Outcome.
Let’s figure out, what does a program look like to actually just demonstrate that something is possible, buy down the risk, and then transition that out into the real world?
So, I hope your community has some magic wands they want to wave, because we would love to hear about those, and we have the program manager talent here to help make that a reality.
Did we miss anything?
RW: No, I mean, I’m just so excited for working with your community, for knocking down some of those boundaries. And this is the first, I hope, of many conversations going forward.
Thank you so much.
RW: Thank you.
