A new agency to accelerate biomedical science can succeed, under the right conditions

The creation of a $6.5 billion Advanced Research Projects Agency for Health, also known as ARPA-H, is one of the most exciting initiatives proposed by President Biden in his full budget request to Congress for Fiscal Year 2022. ARPA-H is to be modeled after the similarly named Defense Advanced Research Projects Agency (DARPA), which has proven successful in accelerating ground-breaking, out-of-the box technologies for the military. According to the budget request, increasing direct federal spending in health will drive transformative and innovative research, as well as quicken application and implementation breakthroughs to enhance health.

The SARS-CoV2 crisis brought to the public light the need for innovative approaches to medical research and because of urgency, commitment, and creative solutions, three successful vaccines were developed in less than a year. It is that same visionary approach that is seemingly behind ARPA-H and found in two recently introduced bills. Both bills express that the goal of ARPA-H is to deliver “breakthrough capabilities, technologies, systems, and platforms to accelerate innovations in health,” medicine, medical product development, and promote highest quality of life for humans.

However, the two bills offer different paths forward for building ARPA-H. In one model, ARPA-H will be under the National Institutes of Health (NIH) umbrella as suggested by Rep. Diana DeGette’s (D-Colo.) bill, the Cures 2.0 Act. The second model, found in a bill introduced by Rep. Anna Eshoo (D-Calif.) (ARPA-H Act bill) would establish ARPA-H as an independent agency outside of NIH. While both bills have the same goals, the establishment and operation of ARPA-H is significantly different. And this difference could determine ARPA-H’s success.

Under model 2 — the Eshoo bill — ARPA-H would function as a stand-alone agency under the Department of Health and Human Services. Thus ARPA-H would be able to act with some measure of independence when it comes to decisions regarding research, funding, and the best ways to meet its ambitious goals. Under model 1 — the Cures 2.0 Act bill — ARPA-H will be subsumed under NIH, as one of its many divisions. Its operation would be overseen by an agency that uses a time-consuming approach to decision making. While the standard NIH approach has worked well for some traditional biomedical research, it lacks nimbleness and rapid response capabilities.

Technologies such as human chip models, cognitive computing technologies, 3D printing of living human tissues and organoids, and virtual humans offer great promise in helping scientists understand the diseases that afflict us and find treatments. Much of their promise lies in the fact that these testing methods are based on human biology, rather than on the biology of other species. The private sector sees the value of these new methodologies, and is developing and using them at a rapid rate. An independent ARPA-H should be a catalyst that pushes these techniques to the next level, fast tracking their application and effectiveness in treating and curing diseases.

Under Eshoo’s bill (model 2), ARPA-H would have the flexibility to act more quickly and independently to meet the ambitious goals set by the Biden administration. ARPA-H would still be able to draw on NIH’s expertise to “ensure that the programs of ARPA-H build on and are informed by scientific research supported by the NIH.” But as an independent organization, ARPA-H could more quickly embrace innovative human-biology based technologies and direct funding toward more advancements in this area. As envisaged by the Cures 2.0 Act (model 1), however, ARPA-H could function very much like another national institute, rather than the rapid response science incubator it needs to be.

Establishing ARPA-H using the Eshoo bill model is a better choice for our nation and our health.  For this new agency to reach its intended goals — and spark innovation and the utilization of new methods —  it must operate in an agile and creative way. As an independent agency within DHHS but outside of NIH, ARPA-H will have the benefit of NIH as a consultant, coach and partner but will be able to operate as an innovator that can push science forward.

Aysha Akhtar, MD, MPH, is CEO of the Center for Contemporary Sciences in Gaithersburg, Md. Paul A. Locke, JD, DrPH, is an Associate Professor of Johns Hopkins Bloomberg School of Public Health in Baltimore. The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.