G2G watched the House Energy & Commerce Committee’s Subcommittee on Health hearing on ARPA-H and wanted to share this report. The House Energy and Commerce Subcommittee on Health held a hearing on February 8, 2022 to discuss the proposed Advanced Research Projects Agency for Health (ARPA-H). In her opening statement, Subcommittee Chair Anna Eshoo (D-CA-18) noted that OSTP Director Dr. Eric Lander would not be testifying in the hearing due to his mistreatment of subordinates and called his resignation “the right thing to do.” During the question-and-answer period, members inquired about the placement of ARPA-H (whether it would be placed inside or outside of NIH), the need for streamlined processes with the agency, and potential agency goals. G2G will continue to track ARPA-H authorization and appropriations. Please let us know if you have any questions.
Transparency and accountability
Addressing barriers to innovation
- In her opening statement, Chair Anna Eshoo (D-CA-18) noted that ARPA-H would be an independent agency within HHS designed to make high-risk, high-reward investments.
- ARPA-H would be made of program managers who are not career gov employers but are experts in their fields/academic and computer scientists.
- Chair Eshoo mentioned that she looks forward to working to pass CURES 2.0.
- Rep. Frank Pallone (D-NJ-6) noted that appropriators have introduced legislation that will fund ARPA-H at $3B in the House and $2.4B in the Senate.
- Rep. Cathy McMorris Rodgers (R-WA-5) said ARPA-H lacks a clear mission and does not have clear measurable goals.
Key Takeaways - Witness Statements
Dr. Keith Yamamoto, Vice Chancellor for Science Policy and Strategy, University of CA, San Francisco
- Called for Congress to install safeguards to prevent ARPA-H funding from supplanting NIH investments
- He called for ARPA-H to be an independent agency within HHS rather than as a component of NIH and said the agency would likely fail if placed in NIH
- Projects like the Human Genome Project and Operation Warp Speed could have both been housed under ARPA-H, and would have provided better structure
- The insights of program managers is imperative in identifying derisking opportunities to address areas of research that the industry cannot complete or cannot afford
- ARPA-H can build capacities that will lead to increased capabilities, increased clinical trials, and successful drug therapies
- Gene therapy is the ‘tip of the sword’ to develop cell engineering, which would provide breakthroughs in how cell therapies and therapeutics are developed
- Collection of equitable data can lead to more equitable precision medicine
- ARPA-H will be successful at looking at things that are effective for a number of diseases, not just one
Dr. Geoffrey Ling, CEO, On Demand Pharmaceuticals & Professor of Neurology, Johns Hopkins Medicine
- ARPA-H “NEEDS” to be independent of NIH and said that it must be done now, not later
- Goal of ARPA-H should be to create “capability” while NIH’s goal is to create new “knowledge.” The goals are too different for them to coexist in the same
- ARPA-H should be modeled after DARPA and ARPA-H must be transparent and accountable at every level; process will be top-to-bottom engagement and milestone driven
- Milestones should be transparent, published – to include evaluation of use of tax dollars; funding should be tied to milestone achievement.
- The capacity building of capabilities is necessary for innovation and to reach communities of color, poor communities, and other underserved populations
- There is inherent risk in the success of the research projects undertaken, but ARPA-H should follow the motto of DARPA (fail early, fail fast), and not be afraid to pivot
- Increasing capabilities to work with the private sector should include improved data sharing, that could then better inform and construct clinical trials
- Unmet needs of human health include early diagnostics and data analytics Using meaningful metrics is important to measure the success of the program
Admiral Brett Giroir, Former Assistant Secretary for Health under President Trump, HHS
- Insisted that ARPA-H must reject conventional thinking like that of NIH, called for diverse program managers within the agency, said that ARPA-H staff must have term limits.
- NIH should be more accountable; reviews of performs, program managers, office directors, etc.
- NIH should raise accountability for overseas investigators without being burdensome on US investigators
- Rare diseases within ARPA-H would be successful, drive down cost to cell-based therapy
Dr. Brian Miller, Professor of Medicine, Johns Hopkins University
- Emphasized the need for a goal-oriented strategic plan before spending taxpayer money on the development of ARPA-H. He was hesitant about the creation of ARPA-H without specific guidelines in place
- Indirect cost rates for the US government are unacceptable. (NIH 52%, EU 20%, Gates Foundation 10%)
- Current distribution of NIH grants is inequitable
- Need to break up the cycle of NIH Guide for Extramural Grants; will promote innovation, growth, and free up funds for direct research
- Worried ARPA-H could displace some of those in the private sector; need to look at current regulatory barriers
- The private sector does not invest in particular projects because of a lack of payment policy framework (reimbursements), no path to market, or other regulatory barriers
Esther Krofah, Executive Director, Faster Cures and Center for Public Health at Milken Institute
- Lack of reimbursement in marketplace for innovation in antibiotics
- High risk / high reward projects are the types of projects that will be housed in ARPA-H
- ARPA-H is a model/vehicle to research diseases that may affect some populations differently than others
- Patient advisory board is critical to the success of ARPA-H
- Specific metrics within the strategic plan will improve evaluation
- Importance of understanding different health outcomes equitably