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STAT First Opinion – Created correctly, the Advanced Research Projects Agency for Health will accelerate medical innovation

STAT First Opinion – Created correctly, the Advanced Research Projects Agency for Health will accelerate medical innovation

The U.S. needs a bold initiative to achieve transformative progress in the fight against Alzheimer’s disease, cancer, cardiovascular disease, diabetes, and countless other diseases that cut lives short or hold them back. The best way to do this is by building on the incredible scientific discoveries emerging from, or funded by, the National Institutes of Health (NIH) and from the nation’s biotech and pharmaceutical research centers. 

The bold proposal by President Biden to create the Advanced Research Projects Agency for Health (ARPA-H) is the right kind of endeavor at the right time to give a new dimension to medical research and propel faster application of breakthrough innovations. 

Covid-19 has shown that a commitment to breakthrough innovation, directed allocation of resources, and collaborative approaches can turbocharge the speed at which medical discoveries can be transitioned to treatments, diagnostic tests, and vaccines. These lessons learned provide a model for finding treatments for the thousands of currently untreatable diseases and the millions of people who live with them.

Like its namesake, the Defense Advanced Research Projects Agency (DARPA), ARPA-H should be built on strategies for outcome-oriented, time-bound results that are fundamentally different in operation than our nation’s existing federal investment in health research. As NIH Director Francis S. Collins recently testified, ARPA-H would tackle bold challenges requiring large-scale, cross-sector coordination, employing a non-traditional and nimble approach to high-risk research.

We believe that ARPA-H should be structured to develop capabilities to catalyze new discoveries that reach patients in need, with a core set of five characteristics and operating principles to achieve this vision. 

Independence. ARPA-H’s ability to operate independently and transparently will be essential to its success. This new agency must have a culture, organizational leadership, mode of operation, expectations, and metrics for results that are distinct from those that currently underpin the U.S.’s robust biomedical basic and translational research infrastructure. At the same time, ARPA-H should complement — not compete with — existing federal entities that advance health research, regulatory science, public health, and health care access and quality. 

Transformational focus. ARPA-H should be structured to support innovation and transformational capabilities that have broad application across multiple diseases rather than focusing solely on disease-specific research. Areas for investment should be selected based on scientific opportunity, together with the prospective impact on both the human and fiscal burdens of disease, with special focus on underserved populations. 

Partnerships. ARPA-H should embrace the goal of delivering advanced proof-of-concept technologies with the aim transferring intellectual property rights — or licensing options — to partners with external capacities to move projects forward through development and commercialization. 

Coordination. The Biden administration should ensure early and effective coordination of ARPA-H’s work with other federal agencies. Creating effective bridges from ARPA-H to the full set of advanced research project agencies, including DARPA, the Advanced Research Project Agency — Energy, and others will also be important. 
Dedicated funding. ARPA-H should have its own dedicated federal funding. Biden took the right step in proposing $6.5 billion to establish ARPA-H. Congress and the administration must ensure that ARPA-H funding does not reduce funding for the NIH and other federal research agencies. 

Congress should run with Biden’s ambitious plan and create and fully fund ARPA-H to spur innovation and breakthrough research. But the agency must be established with key principles that preserve its independence and enhance its ability to deliver the breakthrough health research that the U.S —and the world — so urgently needs.

George Vradenburg is chairman and co-founder of UsAgainstAlzheimer’s. Ellen Sigal is chairperson and founder of Friends of Cancer Research.…