Terry Gerton ARPA-H has recently announced awards to develop the ability to bioprint universally matched organs on demand. When I think about that, that sounds like science fiction to me. But at a high level, let’s start there. What problem is ARPA-H trying to solve with this program?
Ryan Spitler The main problem, essentially, is really going after this chronic organ-shortage crisis. Bioprinting is a solution that could potentially in the future scale to be able to produce organs on demand. And even if you think about all the possible solutions and you combine them together, we still would be well short of the hundreds of thousands of organs that we would need to be able to hit our mark, at least of the people that we’re aware of — on waiting lists and on an annual basis when we have transplantations.
Terry Gerton What makes this approach different to prior efforts to solve the organ replacement problem?
Ryan Spitler I think we’re really bringing together some of the best teams out there that are able to work and really revolutionize the field using bioprinting. I think many of the other approaches — there’s been a lot of great efforts and I think we’re additive to, and work in, conjunction with the other efforts. But I think in terms of the lofty goals of being able to have something that’s universally immunocompatible, something that actually has the potential to be able to scale, to actually be able to hit the marks that we’re hitting — none of these individual solutions are quite fully comprehensive in that way to be able address this problem.
Terry Gerton When I think of 3D printing, I think about machines that sit on desktops that spit out something that’s hard and plastic. How does bioprinting work?
Ryan Spitler It starts with the materials, essentially. You have to have all the cells necessary to create the organ. And you think about all the things that have to go in between the cells. So you have to the vasculature, the excess cellular matrix. And a lot of that, they call the “bioinks.” You have the cells, the bioink, and then you have really sophisticated software and hardware that makes the structure of the organs. When you bring all that together, you think about creating really thick, vascularized tissues and when you build those units out they become your organs and fulfill the different functions — metabolic, or you know, whatever it may be, pumping blood. It’s really a unique way of being able to assemble these components with these amazing machines that hopefully will be able to you know branch out into any type of tissue.
Terry Gerton That sounds like one technology on its own, but now you’re adding to it this requirement to be universally matched or universally compatible. So how do you take what is barely understandable to me about printing organs and add to it this unique feature to make them custom engineered?
Ryan Spitler It really comes down to the cells themselves. Where are you getting them from, and what are you doing with them? There’s two main approaches. One, you could take cells from one’s body and expand those into the different cell types of the organ that you want to make. Or you can take an off-the-shelf approach and engineer the cell so that it could do that, but then also engineer it in a way that has the cell be cloaked, essentially, into the body so that the body doesn’t recognize it as a foreign invader and have the immune system attack. So in both cases, we create a system where it can potentially be matched to that individual, but ideally an off-the-shelf solution that could work for anyone. It really comes down to engineering the cells and having really clever, talented experts in the field coming up with solutions to be able to do that.
Terry Gerton Speaking of those clever and talented experts in the field, you’ve awarded multiple teams, each of whom has a different technical approach to this problem. What are you looking for in the early stages?
Ryan Spitler We look at things like experience of the team, the ability to go execute the goals of the program in a timely manner, which is very accelerated. When we think about the program, it’s broken into three main parts: generating all the necessary cells; scaling those into the manufacturing that you needed and the grade to be able to use in the future to hopefully go into humans, but not within the duration of the program; and then have the hardware-software to be able to prescribe that. And so we did is we tried to find some really talented teams of folks that were really good at all aspects, and then diversified between the different approaches so that we have multiple shots on goal. And so you can imagine, really we’re creating these amazing assets that, worst case scenario, you’re going to revolutionize the field decades ahead of what it would have been. Because these are things that folks wouldn’t be able to try normally because it’s very cost-extensive, it’s high-risk. The normal mechanisms don’t support this type of thing, and so that’s why ARPA-H can bring in some horsepower here to really revolutionize the field.
Terry Gerton I’m speaking with Ryan Spitler. He’s the program manager for the PRINT program at ARPA-H. So Ryan, let’s come back to those timelines. This is a five-year program. Are there incremental stages where you’ll be looking for specific deliverables from these teams, and what would those be?
Ryan Spitler In the beginning, essentially, you could think about it as creating all the materials. The bioink, so all the material around the cells that are needed, the actual cells that’ll be used. That’s kind of what happens in the first year. Then going into maybe the midway point, we really look to make sure that, okay, are these cells going to actually, in a model system, can they demonstrate that they’ll be immunocompatible so that we can get those matches? The teams that are successful at being able to show that, and show some capabilities of the printing that could sustain these tissues, will then move on to demonstrating this in a large animal model, which in our case is a pig model. And the reason we use that is because it’s very representative of human physiology.
Terry Gerton So the initial work is all lab science then.
Ryan Spitler That’s correct. The goal really is to get it so that everything’s packaged so in the future, it can be translated, hopefully, first in the human clinical trials. But in the beginning, we really want to make sure that it’s safe and effective and get them packaged to be able to have all the tools necessary to be able to do that. And hopefully at an accelerated pace in the near future.
Terry Gerton From your perspective, what does this effort say about how ARPA-H is trying to operate differently, maybe, from traditional research agencies? Is this a new approach to trying to solve these difficult medical problems?
Ryan Spitler ARPA-H is definitely a unique agency. It’s very complimentary because we can build on the foundational knowledge that a lot of the amazing other government agencies have been able to create and go after things that maybe they wouldn’t have been able to fund. Things that have been too risky, that they have some evidence but they don’t have comprehensive enough to go after maybe, like, an NIH grant. And we’re contract-based, so that means we have clear milestones and deliverables. What we really try to do is create things that don’t exist yet. The way I think about it is, when folks come to me and say, is this an ARPA-H project? It’s like, well, would you be able to do it normally in a reasonable amount of time with the current ecosystem? And if the answer is no, then that’s the kind of thing we go after. We want to get over that critical technical hurdle that’s going to just set the field way in advance than it would have been had we not been able to try this.
Terry Gerton Is there opportunity here, or is it included in the process? Are you deploying AI to help revolutionize the timelines here?
Ryan Spitler I would say given the sophistication of the types of approaches, most of the groups will have some AI component, whether that be modeling or for selection. There’s tons of different potential applications, and the various groups have been able to utilize them very effectively, I think, across the program.
Terry Gerton Let’s switch this back to the patient perspective for a minute. People who are on waiting lists for organ transplants sometimes spend years there, hoping for an opportunity. What should they be thinking about related to this program in terms of timelines, in terms of hope?
Ryan Spitler What we really want to do, especially when we go into the community, we can really feel that need. And I think this is something that does give folks a lot of hope. While this program, within the scope, we’re not necessarily going to be able to get into the patients because it’s so aspirational — we’re trying to accelerate that as fast as possible. When we think about initial touch points for patients, I think at the initial phase, there’ll be opportunities to use some of the initial scaffolding and organs for bridge-types of solutions as we work to build organs that’ll be at a more long-term, sustainable transplantation basis. Hopefully that’ll be on the horizon as this program rolls out some of these really exciting solutions.
Terry Gerton And so if even one of these teams or all of these teams are mostly or partially successful, what would this mean for the future of medical transplantation treatment?
Ryan Spitler For totally successful, in the ideal case, there would no longer be a wait list, because we would be able to create organs on demand and basically be able to meet the patient demand, supplying them with life-saving organs. And similarly, even short of that, we’ll be able to create model systems that will be able to model and develop more effective drugs, tox studies, so there’s a variety of things that will benefit patients, even short of the long-term goal. But I think it’ll completely be the only time in history where essentially we would be able to address this chronic organ shortage.
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