The 21st Century Cures Act and the Need to Create Impact

September 27, 2015

Filling the basic research and development pipeline with money is no guarantee that you will get impact out the bottom

The US House of Representatives approved the 21st Century Cures Act earlier this year by a wide 344-77 margin. In one part of the bill, for the next five years, the National Institutes of Health (NIH) would get $1.75 billion and the Food and Drug Administration (FDA) $110 million annually to address “major challenges” in biomedical research that could potentially lead to important breakthroughs. The bill’s authors say the new spending is fully offset with savings realized in other parts of the legislation. The bill is now awaiting consideration from the full Senate.

NIH funding has been stagnant since the 1990s and there has been fallout. Fewer basic science grants are being funded while the number of grant submissions is skyrocketing. Senior investigators are closing their labs after years of funding and graduate students are rethinking their career decisions. The assumption expressed by politicians and special interest groups who push for more basic science funding is that basic science research funding will directly translate into better treatments that will improve the health of the citizenry. While discovery is the starting point for innovation, there is no guarantee there will be proportional impact from the results. The second part of the equation is how discoveries get to patients through the process of technology transfer, development, commercialization, and deployment.

For basic research to have more impact, we need:

1. Faculty and students with an entrepreneurial mindset.

2. Technology transfer office funding. Only a handful are self-sustaining.

3. Better integration and cross talk between regulatory agencies involved in approval and funding, like the FDA and the Centers for Medicare and Medicaid Services.

4. Digital health clinical research infrastructure.

5. Philanthropreneurs making investments, not donations, in university research.

6. Academic-private investment partnerships with participation in research and development oversight.

7. Promotion and tenure credit for faculty engaging in the scholarship of innovation.

8. Better academic-industry knowledge exchange programs.

9. Better integration with basic grants and SBIR/STTR funding and monitoring.

10. More effective ways to improve the process of translational research and human subject participation.

Filling the basic R/D pipeline with money is no guarantee that you will get impact out the bottom. As many private industries have learned, there is little if any correlation between the amount of R/D funding and the resulting innovation. What's more, there is no Moore's Law for healthcare. Given our perverse system, new technologies drive up the costs of care.

Once again, we will see more calls to "improve the health of Americans" during this election cycle. Once again, while politically unpleasant, we need to expose the reality that getting ideas to patients is about more than funding basic research. Innovation is as much about execution and the difficult process of creating value as it is about inventions and discoveries. Perspiration trumps inspiration and that doesn't get as many votes or smell right.