Dear FDA Matters readers: This column is the first in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. I have a second spotlight column in process and am open to recommendations for future topics. Steven
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ARPA-H is a relatively new federal agency within HHS, intended to support breakthrough biomedical research, particularly for projects that are not a good fit for traditional public and private funders.
Max Bronstein, CEO/Founder of Aviva Strategies, was part of the launch of ARPA-H while at the White House Office of Science and Technology Policy (OSTP). In January, he created “ARPA-H GO,” a broad-based group of patient and research advocates, academia, and companies to work for increased resources for the agency.
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Steven: Why was ARPA-H created?
Max: Congress established the Advanced Research Projects Agency for Health, or ARPA-H, in 2022 to bridge a critical gap in biomedical research. Traditional funding models, such as government grants or private venture capital, often favor conservative, incremental progress or demand near-term financial returns. ARPA-H was created specifically to fund the “valley of death”—the time when extraordinarily complex, risky, transformative human health projects flounder for lack of funding to advance from basic to applied research.
Steven: Is ARPA-H similar or different from the Defense Department’s well-known DARPA program?
Max: The agency is explicitly modeled on the Defense Advanced Research Projects Agency, or DARPA. They both have a flat, nimble organizational structure and a highly-focused mission. This empowers term-limited Program Managers to drive rapid, use-driven research, in contrast to the slower, more exacting peer-review process used by NIH and NSF.
However, ARPA-H faces a vastly different operational landscape. DARPA develops technology for a single guaranteed buyer, the Department of War. In contrast, ARPA-H must navigate a highly fragmented commercial healthcare market. For an ARPA-H innovation to truly succeed, it must first be approved by regulators such as the FDA, adopted by healthcare providers, covered by insurers, and ultimately accepted by patients.
Steven: You mentioned FDA. How do the two agencies relate to each other?
Max: Because ARPA-H frequently funds complex programs, including first-of-its-kind technologies, ARPA-H and FDA often work closely from the very beginning of the research lifecycle. This early alignment significantly de-risks projects by ensuring that clinical trials are designed to conform to existing and evolving regulatory standards. Stakeholders, particularly investors and commercial partners, should care deeply about this collaboration because it streamlines the path to market and reduces the risk of regulatory challenges after considerable investments have been made.
Steven: What are some of ARPA-H’s current initiatives, and how do they relate to its mission?
Max: Driven by the overarching mission to accelerate science breakthroughs for health, ARPA-H focuses on broad, disease-agnostic, and problem-driven initiatives. Instead of simply funding basic research on a single disease, the agency launches targeted programs to address systemic health challenges.
For example, a current initiative focuses on proactive solutions to prolong human healthspan by identifying biomarkers to prevent chronic diseases before they start. Other current programs focus on using artificial intelligence to monitor and reprogram the immune systems of critically ill patients and on treating rare hereditary diseases with precision genetic medicines. All of these efforts share a common goal: building tangible, transformative platforms that will make a difference for patients.
Steven: What is special about how ARPA-H selects, funds, and manages projects?
Max: What truly sets ARPA-H apart is how it selects and manages these ambitious projects. The agency’s approach is inspired by a set of foundational questions originally developed at DARPA that evaluate a project’s exact goals, underlying risks, and potential real-world impact. Once a project is selected, ARPA-H Program Managers do not take a passive role. They act as hands-on directors who continuously evaluate and test technical viability.
Steven: How does ARPA-H relate to other government agencies, such as NIH, BARDA, VA, and DOD?
Max: Although ARPA-H is officially housed within the Department of Health and Human Services, it operates as an independent entity that strategically collaborates with other federal agencies. Its relationship with the National Institutes of Health is highly complementary. The NIH excels at basic, foundational science, deciphering the underlying mechanisms of diseases. ARPA-H takes that foundational knowledge and applies it to use-driven research to support the development of novel therapeutics or medical platforms.
Unlike the Biomedical Advanced Research and Development Authority (BARDA), which focuses solely on public health emergencies and national security threats such as pandemics, ARPA-H tackles everyday health challenges like cancer and aging, regardless of timeframe. Additionally, ARPA-H partners closely with the Department of Veterans Affairs and the Department of War to leverage their massive, integrated healthcare systems and patient datasets, which are invaluable for hypothesis generation and providing a well-documented population for large-scale clinical trials and scaling successful innovations.
Steven: How can non-governmental organizations get involved with ARPA–either to undertake projects with the agency or to provide support for the agency and its funding needs?
Max: ARPA-H welcomes important ideas and new collaborators. Universities, biotech startups, and nonprofit organizations can submit project concepts at any time through ARPA-H’s Innovative Solution Openings webpage. Furthermore, innovators can join the nationwide ARPANET-H network, which includes hubs dedicated to investor catalysts and customer experience, allowing them to partner on emerging solutions and respond to specific agency solicitations.
In January, we created “ARPA-H GO,” a broad-based group of advocates, academia, and companies to support the agency’s mission and growth. Interested individuals and organizations can learn more at https://www.avivastrategies.com/arpa-h-go. Additionally, I can be reached at max@avivastrategies.com.
Steven: Max, thank you for providing us with information and insights about ARPA-H and how FDA and FDA stakeholders are affected, and how they can become involved.
