Alliance Discussion: Lauren Bloch – An Update on ARPA-H Legislation
In a recent Alliance Discussion, Lauren Bloch, Director of Health Policy & Regulatory Affairs at Faegre Drinker, provided an update on legislation and action on the Advanced Research Projects Agency for Health, the federal government’s new health innovation incubator. Bloch reinforced ARPA-H is intended to advance high-risk, high-reward breakthroughs in health, and we discussed how ARPA-H may fit within the current research ecosystem. Some of Bloch’s insights:
On what ARPA-H is:
“It is a proposed new agency dedicated to health research that would be modeled on Defense Advanced Research Projects Agency (DARPA). DARPA is famous for having invented the internet and GPS. [DARPA] is part of the Department of Defense, and they are a rather small office that’s designed to be really nimble, really innovative, and to drive forward the development of technologies… The thought is that the same model could be really instrumental in moving the health research field forward. It would be intended to focus on milestone-driven, high-risk high-reward projects.”
On the possible focus of ARPA-H in the health field:
“It could be everything, from prevention, to treatments, to cures, and across all sorts of health conditions. … although I’m sure ARPA-H will eventually support research that benefits treatments and cures for specific diseases and conditions, it is not intended to be structured in the way that current NIH and CDC programs are, where you have dedicated line items to support funding for research on specific diseases. Rather, ARPA-H’s research is envisioned to be broader to support building capabilities, technologies, and platforms that could span multiple diseases. Some examples things like gene editing or advancing imaging technology; things [that may deliver] benefits for multiple conditions.”
On where ARPA-H fits within the current research funding ecosystem:
“The federal government’s current research programs are somewhat limited in what they can do, as is industry, although there are some innovators like Google who are willing to take some of those bigger risks. This could help address the ‘valley of death’ for one, where we have a great foundation of basic research focused at the cellular and molecular level but have yet to be able to get to the point where we can move that to into clinical research. ARPA-H would be able to lend government funding to help get over some of those hurdles that exist in the current research ecosystem.”
On the quick timeline of ARPA-H projects:
“Unlike other federal agencies, the intent of ARPA-H and any other ‘ARPA’ is not that someone comes to this agency and works there for their entire career. Instead, you would have a director who might only be there for four or five years and then program managers would only be there for about three years… This is something that was spearheaded at DARPA and has been found to really create a sense of urgency for everyone working at the agency … and that helps to spur their highly innovative, fast-paced culture because everyone knows they’re on a tight timeline to get something done.”
On ensuring that research failures are not detrimental to the careers of researchers:
“I really think it comes down to the culture… In an ARPA culture, failure is not thought to be a bad thing because it rules out one path that was not viable and leaves other remaining paths that may be viable. Because ARPA-H is intended to be so milestone driven, and because you have program managers working for a relatively short period of time, this is not going to be a situation where ARPA-H is funding a project for a decade and then it ends up completely failing. The intention is that you would learn pretty quickly if something’s not a viable idea, so you can move on to the next thing, and so I think that helps insulate people from those types of risks if they were to be leading a project that ultimately wasn’t successful.”
On the immediate needs to move ARPA-H along:
“Getting the director appointed is the biggest one. Whoever that is will really set the tone for the organization not only in terms of setting research priorities but in terms of building up that really innovative culture. … With the authorities that were granted in the FY22 appropriations bill, ARPA-H does have what it needs to function. While the authorizing language is not essential, at least for the short term, it would also be good if that could eventually be passed to give ARPA-H some of these authorities on a longer-term basis versus just the year-over-year of the appropriation cycle.”