Opinion: 3 steps ARPA-H needs to take to accomplish its mission

Since its formation in the 1950s, the Defense Advanced Research Projects Agency, better known as DARPA, has revolutionized the modern world through its model of funding radical innovation.

While DARPA initially focused on space and missile defense, the agency is well-known for its role in broad, revolutionary technological innovation. In the last 60 years, it has paved the way for the internet, touch-screen technology, miniaturized GPS devices, and more — as well as Moderna’s mRNA vaccine through the Pandemic Prevention Program, which dates back to 2013.

President Biden had a vision to extend DARPA’s model to the health sphere with the Advanced Research Projects Agency for Health (ARPA-H). Unfortunately, Congress approved only a fraction of the $6.5 billion Biden requested for the agency: just $1 billion over three years, or roughly the equivalent of one-third of DARPA’s total budget.

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On March 31, Department of Health and Human Services Secretary Xavier Becerra informed Congress that ARPA-H will be part of the National Institutes of Health. That’s not ideal: ARPA-H should be an autonomous agency. Many of the lawmakers who advocated for its independence noted that the NIH lacks boldness and risk appetite for innovation and takes a conservative approach to funding projects due to the high volume of grant applications. Although being linked to NIH doesn’t ensure the fundamental autonomy that ARPA-H needs, it’s helpful that its director would report directly to Becerra instead of the NIH director.

I hope Congress will step in at a later date and mandate that ARPA-H be an independent agency under HHS. But in the meantime, here are three key principles and structures that I believe ARPA-H should incorporate to accomplish its mission to “revolutionize” medicine and foster new technologies.

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First, ARPA-H should retain DARPA’s structure of program managers, having autonomous program managers who work closely with companies/organizations to monitor progress toward programs’ outcomes and ensure success. The NIH’s score-based system and uninvolved program officers are not suitable for ARPA-H’s mission. DARPA’s success at creating radical new technologies is high because of its non-bureaucratic structure with program managers who work extremely closely with awardees to monitor progress and maximize likelihood of success.

Second, ARPA-H should follow DARPA’s “extended pipeline” model of innovation, meaning funding technologies and projects all the way from research to development and commercialization. The NIH, by nature, mostly funds early research and only rarely the development of medicines. ARPA-H should fund projects from early research to clinical development and beyond.

Third, ARPA-H should take a market-shaping approach to innovation. One of the keys to DARPA’s success in shaping technical innovation is not by funding existing technologies but by helping create new technologies. DARPA often starts with defining a strategic problem, sets a specific concept or technical approach, then seeks teams to explore or develop it. The internet resulted from a DARPA initiative that reimagined the concept of computers and how they could be used.

Another consideration is cost. DARPA works extremely closely with awardees on budgeting and monitoring expenses, such as through Federal Acquisition Regulation-based procurement contracts, as opposed to the NIH, which usually gives a block grant with few budget modifications. ARPA-H could also consider adding conditionalities to its awardees to limit profiteering off of medicines it funds (like egregious share buybacks, high drug prices, and exorbitant executive compensation).

New types of innovative medicines in the last decade have ushered in remarkable progress with cell-, gene-, and nucleic acid-based therapies. ARPA-H would be funding similar — if not superior — types of novel therapies to gene therapies and novel living medicines. It would thus have an opportunity to create technologies to improve the cost of manufacturing; enable new technologies like next-generation gene editing, machine learning, and AI-driven drug discovery development; and enable research in areas where therapeutics remain ineffective, such as Alzheimer’s disease, fibrosis, kidney diseases, and cancer.

ARPA-H has enormous potential to transform biotechnology and medicine, but its creation under the NIH, with little funding, has so far been problematic. That said, ARPA-H could blossom if the future ARPA-H director is truly able to act independently — by reporting directly to the HHS secretary — and if ARPA-H can implement an innovation style modeled after DARPA instead of the NIH.

Building the future of medicine requires bolder thinking and more appetite for risk, which ARPA-H could achieve in contrast to what the NIH could achieve alone. An ARPA-H model would ideally exist outside of the NIH, but if structured correctly, it could take emerging science and create new biotechnologies and medicines just as DARPA has successfully shaped new markets. It also can do so affordably and responsibly to ensure access to novel medicines.

Travis Whitfill is an assistant professor adjunct at Yale School of Medicine; a partner in Bios Partners, a venture capital firm; and a graduate researcher at the University College London Institute for Innovation and Public Purpose. He reports serving on the boards of, or consulting for, several biopharma companies, and has previously received funding from DARPA.

Source: STAT