HARPA will work within an innovation ecosystem that includes: the commercial market; biotech and healthcare companies; venture capital and philanthropy; academic institutions; and other government and regulatory agencies. Private sector partners and federal regulatory agencies will be integral to the program planning process from the outset.
HARPA is modeled on DARPA’s key operating principles:
HARPA will exist within Health and Human Services (HHS), and work synergistically with the NIH, FDA, CDC, and CMS. Autonomy and flexibility are essential for HARPA to conduct high impact research.
HARPA will be a flat, nimble, and non-bureaucratic agency. There will be no career Program Managers, which will ensure that the Agency is scientifically current and flexible to new avenues of investigation. It will attract world-class Program Managers recruited from top industry or research universities.
HARPA must be funded appropriately to be able to run large, multidisciplinary teams that can address complex healthcare problems quickly enough to meet aggressive milestones.
HARPA will give out contracts, not grants, that are aggressive and milestone-driven. Program Managers will have the authority to select project partners and withdraw or move funds to reward successes or cut off failures.
The HARPA contract mechanism will allow government control over work performance. Milestones on a cost-reimbursed basis will ensure that scientific progress is made in an efficient and timely manner.
HARPA will not have “entitled constituencies or intramural efforts” and will be able to fund efforts in industry, universities, and national labs.
HARPA proposals will be openly competed, but the HARPA Program Managers select the winners and can assemble a “portfolio” of projects intended to achieve a particular goal. The HARPA Director and technical office Directors will have authority to approve funding allocations.
HARPA Program Managers will design projects (i.e., HARPA-initiated requests for proposals to solve a specific problem) and choose partners across disciplines. This differs from NIH-style investigator-initiated projects with peer review panels.
HARPA programs will be designed with regulatory demands and commercial transition strategies in mind from the start, not as an afterthought. Often this will require industry partners to be identified early; co-funding agreements with other government agencies or not- for-profit foundations; and healthcare and regulatory experts included in the project design and proposal selection process.