• Gene and cell therapies are delivering remarkable clinical results for diseases that once had no treatments – but the manufacturing processes behind them are so complex, costly, and unpredictable that most patients can't access or afford them.
• BioCurie's AI-powered platform replaces expensive, time-consuming trial-and-error process development with computational modeling – but translating that vision into fundable, scalable reality required navigating an opaque and resource-intensive government funding landscape.
• With support from the Science Center, BioCurie gained the structure, strategic counsel, and hands-on proposal support to secure a $9.3 million ARPA-H contract – bringing curative genomic medicines closer to the hundreds of millions of patients who need them now.
The Birth of BioCurie: Cutting-Edge Genetic Research
Prior to founding BioCurie, Irene was working at the forefront of therapeutic innovation, with the previous decade spent at J&J and Spark Therapeutics.
With a front row to the most promising therapeutic modalities, Irene realized that the genomic medicine researchers had long theorized about were finally coming to fruition. “The clinical impact is potentially quite profound – we were getting a lot of a really fantastic clinical readouts for diseases that previously had no treatments, let alone cures,” she recalled.
The problem was that, unlike traditional modalities such as small molecules or biologics, the processes to manufacture cell and gene therapies are incredibly complex. This leads to unpredictable quality, long production times, and unsustainably high costs. Because Irene was working at the cutting edge, she saw these dilemmas coming and believed that AI offered a potential workaround. This was in 2021, before AI was “hot.”
As it would turn out, Professor Richard Braatz from MIT had the same idea, though he was approaching it from a chemical engineering and data modelling perspective. Following a fortuitous meeting at the NIIMBL Annual Meeting in 2021, they joined forces to start BioCurie.
Launch of BioCurie, and Meeting the Science Center
BioCurie’s plan was to use an AI-powered digital platform, replacing trial-and-error process development with intelligent computational modeling and simulation. A great concept, but the idea might never get off the ground without funding. Wilmington-based Irene had heard about the Science Center’s Capital Readiness Program, which helps promising healthcare technology startups navigate the gap between protype and real-world adoption, assemble credible deal rooms, and get practical advice on topics such as financials, deal structure, and IP. BioCurie was accepted into Cohort 2.
“It was like a week-long bootcamp; it was fantastic,” recalled Irene. Each day, the 10 startups received critical guidance from experienced investors and industry experts, along with strategic challenges like stress tests, where real-world scenarios were simulated to test the startups’ responses. “The stress tests were great, and I’ve managed to avoid a lot of the scenarios that they named,” she advised.
Irene noted that the program helped her approach deal room preparation with greater structure: “I’m happy to say that investors have told us that our deal room is very well-organized and easy to navigate, so thanks to the Science Center for that.”
As part of the Capital Readiness Program, Irene had a unique and personalized medical advisory session with Kevin Baumlin, the Science Center’s Chief Medical Affairs Officer. As a recently retired emergency physician and healthcare leader, Kevin routinely counsels current and alumni Capital Readiness Program companies on the complexities of the health systems they’re trying to break into – and on how to strategize and optimize the path to funding, regulatory readiness, and eventually commercialization.
It was Kevin who suggested Irene pursue ARPA-H funding and showed how the Science Center could support the submission of such a complex proposal.
The BioCurie Team
ARPA-H: A 900-Page Expedition
When Irene first heard of ARPA-H funding, she was struck by the unknowns.
“It was so opaque because – unlike traditional funding paths like SBIR/STTR, or any other kind of government funding – it was so new in 2023 that few knew how it worked,” she explained. “And I thought, I haven’t got time to try and understand the nuances because I’m busy building a company.”
It’s not surprising that ARPA-H felt confusing: introduced in 2022 to support high-risk, high-reward health research, ARPA-H government proposals can be a lengthy and complex process, especially for startups that may not have the resources to support comprehensive proposal development on the front end, or consortium management and sophisticated award management if the proposal is successful.
And that’s where it might have ended for BioCurie, if it weren’t for Baumlin prodding Irene: “Why don’t you apply for this?”
“We had the technology, we had people, but we just didn’t know how to go from here to there to get that access to the funding,” she said.
She explained that, after they submitted an abstract, the government asked them to submit a full proposal – and they had about five weeks to execute. What was submitted would end up being nearly 1,000 pages of necessary documentation – everything from a detailed technical plan including a 100+ page statement of work, a commercialization plan, a teaming agreement with collaborator organizations, and vendor quotes, to articulating what differentiates the technology and made it special (something Irene excelled at explaining).
As part of its customized services for select alumni companies and partners, the Science Center’s Federal Funding team – under the direction of Heath Naquin, SVP of Innovation & New Ventures – worked directly with Irene and her consortium to manage and coordinate the submission and proposal development process.
Irene said the Science Center was instrumental in the support that they provided in putting the proposal together and making sure everything was completed as requested. Government funding requests can be notoriously difficult to submit correctly: simply including a link to additional information when one isn’t requested, for example, can be enough to get an entire proposal rejected. The Science Center was able to help BioCurie with a huge administrative lift thanks to its in-depth knowledge of government funding.
“We wouldn’t have been able to submit that particular proposal without the support of the Science Center,” she said. “It would have been a very different, a slimmed-down version if we if had to submit [by ourselves].”
BioCurie made significant progress while the proposal was under review. They built and validated a prototype, built out their IP portfolio, assembled a team, got their first major customer – giving them more runway before turning to investors – and raised $2.2 million in seed funding. Then lightning struck: the project was greenlit for up to $9.3 million in funding to accelerate the development of a digital platform for scalable, data-driven genomic medicine production.
Irene Rombel during Cohort 2 of the Capital Readiness Program
ARPA-H Full Speed Ahead
The team’s excitement was palpable. Not only would the ARPA-H contract help BioCurie rapidly accelerate their technology and work toward eliminating a bottleneck to patient access: it also signaled to the larger biopharma community that the underlying technology is credible and gaining real momentum.
“Since 2021, BioCurie has believed that AI will fundamentally reshape how advanced therapies are developed and manufactured,” said Irene. “This ARPA-H award validates our vision and accelerates our ability to deliver a scalable, digital-first manufacturing platform to therapy developers and manufacturers. Our mission is clear: bring disease-modifying and curative genomic medicines to patients faster and more affordably.”
“The ARPA-H contract will enable us to profoundly accelerate what we’re doing,” she explained. “So what would normally take up to a decade, we will get this done in the space of less than three years.”
She noted that it’s an important advance, because the patients who need these medicines need them today – but without a major innovation from a company like BioCurie, they won’t get the treatments they need for rare diseases.
“Why is the ARPA-H funding so important? It’ll allow us to help patients in the very foreseeable future – and not just a decade or two down the road,” she explained. “There are also a lot of network externalities that we’re creating at the same time, which is going to make us go a lot faster.”
The Future for BioCurie: Hope for Millions of Patients
Although the ARPA-H funding is a huge feather in BioCurie’s cap, they’re not resting on their laurels. Instead, the team continues to push forward, building on its existing momentum.
“Later this year, we're launching our first software product for AAV production in HEK293, which is the prevailing system for making gene therapies today. Next year we’ll be launching software products for other modalities.”
No matter what happens, it’s clear that the true winners of this technology are going to be the patients who benefit from receiving it as soon as possible. Irene estimates that there are about 400 million people worldwide living with rare diseases that current medical treatment is insufficiently equipped to treat.
“Once we’re established in these rarer diseases, then we can branch out into more complex diseases that are impacting a lot more people such as Alzheimer disease,” she said, explaining that rare diseases are only the beginning of the technology’s scope. “So now you’re looking at much bigger populations. That’s why you really need processes that can scale up and scale out.”
With BioCurie’s progress and the support of the ARPA-H contract, the barriers to delivering genomic medicines at scale and at a much more affordable rate for patients are beginning to shift.
“With moonshot investments like this one, we can imagine a time in the near future when patients with Sickle Cell disease can receive a curative treatment at a cost of $300,000 instead of $3 million,” said Baumlin, “And they will be able to enjoy a pain-free life of 78 years instead of the 52 years of chronic pain that they currently can expect."
The promise is clear; the path forward comes down to affordability and scale.
“We already know how powerful genomic medicines are,” emphasized Irene. “They’re not going away – it’s just a matter of solving this problem of how to make them without the excessively high costs.”
