H Follows D

Xavier Becerra, the former congressman from California, took over as Secretary of Health and Human Services just a few weeks ago and has already found himself in the throes of controversy when President Biden announced the ARPA-H program [see article, p1]. While it is currently envisioned that ARPA-H will be housed within NIH because of its strong alignment with the NIH mission and because of NIH’s leadership position in biomedical research, several members of Congress have been lobbying Becerra to ensure that ARPA-H be completely autonomous and not under the umbrella of the NIH. Others argue that collaboration with the NIH will help to reduce overlap, turf wars, leverage administrative power, and eliminate research redundancies.

According to the most recent set of ARPA-H FAQs, the new agency is seeking physically separate offices from NIH, perhaps even in another region of the country, to “facilitate the development of a distinct culture, as well as to reinforce the independence of ARPA-H.” However, the document highlights the benefit of maintaining some proximity to the Bethesda campus, including operational and administrative support.

The administration originally requested more than $6.5 billion in funding for ARPA-H. But Congress approved a commitment of $1 billion in the FY22 spending bill. At just over 15 percent of the original ask, one billion dollars, while significant, could be insufficient to cover the operational requirements to make the agency autonomous.

While the program mirrors some of the best principles of DARPA, including the high risk, high reward mindset, flat organizational structure, and the “Heilmeier Catechism,” it is yet to be seen how intellectual property generated by ARPA-H funded projects will reach successful commercialization. In the DARPA model, funded projects receive significant interest from investors because the otherwise high-risk projects have been significantly de-risked by the rigorous administration and oversight of DARPA program managers. Projects do not advance if they don’t meet critical milestones. Without DARPA funding, these programs might never see beyond the back of a napkin. In exchange for this significant risk, DARPA retains exclusive rights to the IP for application and use within the military and veteran communities leaving sales and distribution to the general public wide open for start-ups and their investors.

ARPA-H has yet to make clear how IP ownership will be addressed. Without the intellectual property rights that are expected by private equity and investment funders to advance research to commercialization, few, if any, will step up to bring these technologies and therapies to market—unless the government intends to own the IP and serve as the commercializing entity.

JoJo Platt
Contributing Editor