Valentina Fernandez, Biological Sciences, Fall 2021
Figure: President Joe Biden endorses ARPA-H, with hopes that this new division of the NIH will “end cancer as we know it.”
Image Source: Wikimedia Commons, Gage Skidmore
The Advanced Research Projects Agency for Health (ARPA-H) is President Biden’s most recent effort to foster innovation in the biomedical fields. During Research!America’s 2021 National Health Research Forum, Dr. Francis Collins (Director, National Institutes of Health) and Dr. Eric Lander (Science Advisor to the President) spoke about what we can expect from such a massive undertaking. What is ARPA-H and what does it aim to do?
Background
Currently, the main body responsible for funding healthcare-focused research in the United States is the federal government (specifically the National Institutes of Health) which is the largest public funder of biomedical research in the world (Jefferson, 2021). Although the research projects and experiments themselves are carried out by universities, nonprofits, and government labs, the funding source for all these endeavors can be traced back to the federal government. The NIH supports roughly 83% of federally funded biomedical research, and the remaining federal funds come from other agencies in the Department of Health and Human Services (DHHS), such as the CDC and the FDA (NIH, 2004) .
Each year, the NIH invests about $41.7 billion annually in medical research for the American people (NIH, 2021). About 80% of its budget is used for extramural (outside of the normal courses of a university) research, with almost 50,000 competitive grants awarded to 300,000+ researchers at distinct institutions all around the country (NIH, 2021).
Surely, the NIH efforts are paying off; medical advances (at least in the United States) have undergone incredible growth in recent decades, with the Human Genome Project (HGP) (one of many examples) yielding a 178-fold return on investment, or nearly $1 trillion of economic growth (Lee, 2021). To give a more recent example, less than a year into the pandemic, the world saw the rapid development of the COVID-19 vaccine and mRNA technologies using government funding that will likely open the door for the development of other vaccines (Lee, 2021).
Why do we need ARPA-H?
Despite the impressive & speedy generation of the COVID-19 vaccine, it shouldn’t take a public health emergency to trigger such rapid and impressive medical progress. For that reason, the ARPA-H founders believe the scientific community should be thinking proactively and continuously working to resolve issues before they arise or worsen. For many researchers, novel (and arguably “eccentric” ideas) can often be difficult to investigate, because they don’t fit “the mold” the NIH was designed to accommodate. For instance, the NIH tends to favor “incremental, hypothesis-driven research” that holds promise in achieving return of investment (Collins et al., 2021). While this is a good model, there are many bold ideas that may not make it because they are too high risk, too costly, too long, too broad, or simply too academia-focused (no clinical applications). In fact, only about 10% of all grant applications are approved by the NIH for funding, leaving the remaining 90% of proposals as nothing more than hopeful ideas (Lee, 2021).
ARPA-H was designed to remedy the systemic obstacles that hinder the investigation of bold & risky ideas. ARPA-H, according to a press release from the NIH, hopes to accelerate “biomedical innovation and adoption of technologies and approaches to revolutionize healthcare and medicine” (Krieger, 2021). For these endeavors, the program has requested a reported $6.5 billion budget for the 2022 fiscal year, which will be derived from NIH’s funding (Collins et al., 2021).
ARPA-H will be modeled after the Department of Defense’s DARPA Program
“We want to bring the DARPA attitude to health,” stated Dr. Lander during his chat at the Research!America forum. DARPA is the Defense Advanced Research Projects Agency, created in the wake of Sputnik, with one goal in mind: “to make pivotal investments in breakthrough technologies for national security” (Collins et al., 2021). Fast forward sixty years or so, and there is no question about the crucial role DARPA has played in supporting new innovations, such as the internet, Global Positioning Systems, and self-driving cars (Collins et al., 2021). Currently, one of the most relevant projects fostered by DARPA has been “AI Next,” which invested about $2 billion in 2019 in AI research (Corrigan, 2019). AI Next hopes to give rise to the “third wave” of artificial intelligence, a future in which AI-enabled machines will be “trusted, collaborative partners” capable of reasoning and human-like communication (Corrigan, 2019; DoD, 2019).
The DARPA Model: What makes it unique?
The originality of the DARPA model lies in its rejection of “safe-thinking” and hierarchical systems, in addition to its embracing of failure (Collins et al., 2021). The DARPA model, often described as “flat and nimble,” employs 100+ program managers (PMs) and office directors every three to five years. Program managers are usually prominent leaders from top research institutions or industry centers that are recruited to this division of the DoD. DARPA fosters a culture that encourages autonomy—program managers are given the authority to review and select proposals of projects. This independence, combined with a plethora of resources (financial and institutional), allow the program managers to pursue their bold ideas (Collins et al., 2021). DARPA is not a “free for all,” however, and it must be noted that there are many measures implemented to mitigate risk, such as metric-driven accountability strategies (Collins et al., 2021). According to the DARPA 2019 Framework, the agency thrives on “risk and rewards,” but also “insists on metrics and milestones to measure progress,” which guides their decisions on when to stop projects deemed ineffective (DARPA, 2019). Ultimately, their main goal is not to focus on the immediate return of investment, but rather to create a true breakthrough with the potential to be transformative.
This is exactly what ARPA-H aims to do. In contrast to DARPA (which serves the need of a single customer- the DoD), ARPA-H will arguably be a more complex undertaking for the government, since it will (i) completely challenge the norm of ‘thinking’ and the standard mechanisms of operation at the NIH; (ii) will involve many stakeholders- patients, hospitals, physicians, biopharma companies, and payers; and, (iii)) will inevitably meet many challenges, one notable one being the cooperation of regulatory bodies. Like mentioned before, the type of research usually favored at the NIH is “incremental” and “hypothesis-driven,” meaning that it focuses on answering fundamental questions (Collins et al., 2021). Although this model may inadvertently result in a scientific breakthrough, in its core, it will prioritize return of investment and risk aversion (Collins et al., 2021). For DARPA, the model and circumstances are different. DARPA’s main goal, as stated earlier, is to make “pivotal investments in breakthrough technologies for national security;” these goals align perfectly with the main objectives of the Department of Defense- to enhance national security and deter war (DARPA). In addition, the work of DARPA serves one sole customer- the DoD; advances like the Internet happened to be side benefits that helped a more broad population. As Dr. Tara A Schwetz, the Associate Deputy Director of the NIH put it, “while the customer base of DARPA is the DoD, the customer base for ARPA-H would be the full American population” (Lee, 2021).
For this reason, within the Department of Health and Human Services, ARPA-H will also need to effectively collaborate with other key agencies, such as the FDA, CDC, Medicare & Medicaid, to identify the most pressing issues in healthcare and craft sophisticated solutions to serve the needs of an entire ecosystem and all populations.
So, will ARPA-H yield breakthroughs or more bureaucracy? Only time will tell. But one thing is for sure, President Biden’s call to “end cancer as we know it” , while possible, will require ARPA-H to embrace the right attitudes, collaborations, and radical thinking necessary to generate transformative developments.
References
Collins, F. S., Schwetz, T. A., Tabak, L. A., & Lander, E. S. (2021). ARPA-H: Accelerating biomedical breakthroughs. Science, 373(6551), 165–167. https://doi.org/10.1126/science.abj8547
Corrigan, J. (n.d.). The Crazy Government Research Projects You Might’ve Missed in 2019. Nextgov.Com. Retrieved September 22, 2021, from https://www.nextgov.com/emerging-tech/2019/12/crazy-government-research-projects-you-mightve-missed-2019/161977/
Jefferson, R. S. (n.d.). How The Largest Public Funder Of Biomedical Research In The World Spends Your Money. Forbes. Retrieved September 22, 2021, from https://www.forbes.com/sites/robinseatonjefferson/2018/12/21/how-the-largest-public-funder-of-biomedical-research-in-the-world-spends-your-money/
Lee, B. Y. (2021, July 07). President Biden Proposes ARPA-H, New $6.5 Billion Health Entity To Transform How Research Is Done. Retrieved from https://www.forbes.com/sites/brucelee/2021/07/06/president-biden-proposes-arpa-h-new-65-billion-health-entity-to-transform-how-research-is-done/?sh=39bd0caf4dab
Owermohle, S. (2021, July 06). Skeptics question if Biden’s new science agency is a breakthrough or more bureaucracy. Retrieved from https://www.politico.com/news/2021/07/05/arpa-biden-cancer-disease-treatment-497915
Sources of Funding for Biomedical Research—Strategies to Leverage Research Funding—NCBI Bookshelf. (n.d.). Retrieved September 22, 2021, from https://www.ncbi.nlm.nih.gov/books/NBK215472/