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President Biden’s FY2022 discretionary budget request to Congress includes $6.5 billion for creating an Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH). Authorization for ARPA-H is also included in the Cures 2.0 bipartisan draft legislation that was released on June 22. The goal of the agency will be to “drive transformational innovation in health research and speed application and implementation of health breakthroughs.”

NIH Director Francis Collins, together with White House Office of Science and Technology Policy (OSTP) Director Eric Lander, OSTP’s Tara Schwetz, and NIH’s Larry Tabak published a commentary in Science outlining how ARPA-H would focus on time-limited projects with goals, benchmarks, and accountability to develop a flexible and nimble strategy for preventing, treating, and curing a range of diseases. The article was followed up with a webinar conducted on June 25, where Collins and Lander answered questions.

ARPA-H is a new model for NIH, which usually supports peer-reviewed fundamental research in university, non-profit, and government labs. Scientists funded by NIH have discovered molecular and cellular mechanisms underlying health and disease, which have led to new clinical treatments. The commentary cites two articles (1,2) showing that fundamental discoveries supported by NIH have been critical for new therapeutics approved by the US Food and Drug Administration. To be sure, the model by which NIH supports fundamental research will not change. But the authors argue that high risk/high yield innovative ideas do not always fit existing NIH support mechanisms — most proposals are directed at solving practical problems.

President Biden stated that ARPA-H should be modeled after the Defense Advanced Research Projects Agency (DARPA) that embraces a nimble, flexible research strategy that accepts failure. The DARPA approach has driven breakthrough advances for the Department of Defense for more than 60 years. Building on DARPA’s success, Collins et al. argue that an initial mission could be, “To make pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions that have the potential to transform important areas of medicine and health for the benefit of all patients and that cannot readily be accomplished through traditional research or commercial activity.”  The commentary stresses that those projects supported by ARPA-H would develop solutions that foster breakthroughs to serve patients at levels ranging from the molecular to the societal and to drive those solutions to the point of adoption.

Although an exciting concept for NIH, Collins acknowledges a lot of work and community input are needed to organize this new approach. DARPA can serve as a model, but biological systems are much more complex than the engineered systems on which DARPA focuses. ARPA-H will need to pioneer new approaches.

It is important to note that ARPA-H is to be funded with new appropriations that will not cut into increasing base budgets for NIH’s 27 institutes and centers. And any new medical treatments that come out of ARPA-H will still need to go through the long road of clinical testing and regulatory approvals. Although there is widespread enthusiasm supporting opportunities to improve the way NIH operates, the authors acknowledge that a focus only on short-term results would undermine approaches that have made possible advances to technologies for detecting, treating, and curing diseases.

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