Q: What is HARPA?
A: HARPA stands for the “Health Advanced Research Projects Agency”. The Suzanne Wright Foundation, along with supporters within the research and private sector communities, are advocating to establish this agency within Health and Human Services (HHS). Modeled after the Defense Advanced Research Projects Agency (DARPA), HARPA would work within an innovation ecosystem that would drive innovation and results. HARPA would develop biomedical capabilities - detection tools, treatments, medical devices, cures, etc. - for the millions of Americans who are not benefitting from the current system.
Q: What is DARPA?
A: In 1958, the Defense Advanced Research Projects Agency (DARPA), was established with a national sense of urgency amidst one of the most dramatic moments in the history of the Cold War. Since its creation after the launch of Sputnik, DARPA has played a critical role in the development of a broad range of transformational technologies for the nation including the Internet, stealth aircraft, GPS- based precision navigation, night vision, autonomous vehicles, speech recognition and robotic prostheses. Accountability, flexibility and efficiency are cornerstones of DARPA’s success. DARPA proves there is an effective government model for translating science into product. You can learn more about DARPA HERE.
Q: Why was the proposal to create HARPA developed?
A: Suzanne Wright died from pancreatic cancer in July 2016. Her husband, Bob Wright, was stunned to learn there are no early detection tests and no curative treatments for this disease. 91% of patients die within the first five years of diagnosis, and the mortality rate has not improved in more than 40 years. Bob Wright founded the Suzanne Wright Foundation in Suzanne's honor, and developed the proposal to create HARPA. Wright recognized that pancreatic cancer is not alone. Despite medical innovation over the last century, millions of Americans with deadly and debilitating conditions have seen no progress. There are more than 9,000 known diseases and we have treatments for only 500 of them. Two out of five Americans have a disease with no cure. It takes far too long for detection, treatments and cures to make the journey from the lab to the patients. HARPA would be devoted specifically to developing these capabilities. DARPA has changed the world with its innovations. HARPA would too.
Q: What types of diseases will HARPA tackle?
A: HARPA will not be focused on one disease. It's mission will be to develop capabilities that will have broad applicability for diseases that have not benefited from the current system.
Q: Has the DARPA model been replicated successfully in other areas of the government?
A: Yes, the DARPA model has been replicated with great success in the intelligence, homeland security, bioterrorism, and energy fields. BARDA, the Biomedical Advanced Research and Development Authority, was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID). To-date, BARDA has supported 34 FDA approvals for 30 unique products addressing CBRN, PI, and EID threats. You can learn more about BARDA HERE.
Q: The National Institutes of Health (NIH) funds biomedical research, so why do we need another agency?
A: HARPA will optimize the nation's current investment in health and science. Through its $37B annual budget, the NIH funds research that is critical to building foundational knowledge. However, the current path from basic science to applied research to commercial viability is too slow. There is an institutional reliance on a program of small grants, spread across many investigators, over many years, with little demand for accountability or a demonstration of ROI. There is nothing urgent about this system. HARPA would leverage these existing federal research assets with advancements in biotechnology, supercomputing, big data, and artificial intelligence to cure disease. It would be synergistic with existing federal research efforts, neither duplicative nor competitive.
Q: Why does HARPA fund projects with contracts, and not grants?
A: The 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. There is very little accountability to deliver results with the traditional granting system. Contracts will contain language that enables the government to terminate contracts at the government’s discretion, ensuring accountability and demonstration of ROI.
Q: How will HARPA avoid becoming another bureaucracy?
A: HARPA will be a flat, nimble, and non-bureaucratic agency. Program Managers (PMs) will typically stay at HARPA for 3-5 years. There will be no career PMs, which will reduce the bureaucratic mentality and ensure that the Agency is scientifically current and flexible to new avenues of investigation. HARPA PMs will also be empowered to explore new directions with small contracts called “seedlings.” Funding authority for these smaller efforts will reside with the PMs and the Office Director. This will ensure minimal bureaucracy and will optimize quick research advances. Successful seedlings will lead to larger programs.
Q: Why is it so essential for HARPA to be “autonomous” within HHS?
A: HARPA must exist within HHS independent of the NIH and other agencies. Autonomy and flexibility, hallmarks of DARPA. are essential for HARPA to conduct high-risk, high-reward research. This approach is inconsistent with the NIH’s conservative model of "safe bets".
Q: How can HARPA be created?
A: HARPA could be established by the President of the United States through Executive Order, directing the HHS Secretary to develop a HARPA blueprint. Authorization and appropriation legislation are required by Congress.