Speeding Treatments From the Lab to Patients

Despite the growing sophistication and promise of health care technology research, fewer and fewer breakthrough ideas are finding their way out of research institutions and into the hands of experienced clinicians.
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Last Thursday marked the start of the implementation phase of the new health-care law: children can no longer be denied coverage because of pre-existing health conditions and children also can be covered by their parents' policies until the age of 26. Whatever one thinks of the new law, there's one critical issue it doesn't address: Despite the growing sophistication and promise of health care technology research, fewer and fewer breakthrough ideas are finding their way out of research institutions and into the hands of experienced clinicians and medical product development teams. The ultimate victims are patients, who suffer when promising research and innovation are not translated into new treatments.

Progress is being stifled by a crucial gap in the current research and development pipeline: collaboration, expertise and funding for early-stage innovations. Many of the biotech startups, academic institutions and government research centers that perform critical early-stage work do not have the experienced resources to move their breakthroughs further along the commercialization pipeline. At the same time, large pharmaceutical companies and venture capitalists are reluctant to invest in early-stage research that lacks proven market potential and requires a longer period of time to produce returns on investment. And federal investment in medical research is tight--the fiscal 2010 budget for the National Institutes of Health is less than 13 percent higher than its 2003 budget.[1]

But even with nearly $1 trillion of spending on life science research and development in the public and private sectors over the past decade (twice the amount spent in the 1990s), the number of drugs approved by the U.S. Food and Drug Administration (FDA) has plunged--from 53 in 1996 to an average of 21 per year between 2005 and 2009. Roughly the same number of drugs was approved by the FDA in 2008 as were approved in 1950. Yet the cost of funding a breakthrough drug is rising by 13.4 percent annually.[2]

For the past few years, a group of scientists, researchers and philanthropists has been working to bridge the gap between basic research and patient care (known as "translational medicine"). Their effort seeks to connect leading investigators and entrepreneurs with collaborators from the philanthropic, investment and corporate communities. The ultimate objective is to advance the movement of scientific breakthroughs in the lab into new drugs and other patient therapies, often delivered by startup companies.

This October 13-14, leaders from academia, government agencies and pharmaceutical, biotechnology and venture industries will convene in Washington at the Translational Medicine Alliance Forum. The goal will be to spark conversations, and connections, that will help to reconcile the short-term, earnings-driven requirements of today's medical marketplace with the risky, capital intensive, decade-long process usually required to bring transformative medical ideas to fruition.

The gathering will be a small step on a longer journey. But it will be an important step. Because as the United States prepares to rewrite the rules on how Americans pay for their health care, now is the time to turn the focus to ensuring that the best medicines make it to the marketplace. That's not happening today, and for countless patients who could benefit from medical breakthroughs, progress can't wait any longer.

Lesa Mitchell is vice president of advancing innovation at the Ewing Marion Kauffman Foundation.

[1] http://officeofbudget.od.nih.gov/pdfs/FY11/Approp.%20History%20by%20IC%20%28FINAL%29.pdf
[2] Munos, Bernard, "Lessons from 60 years of pharmaceutical innovation," Nature Reviews Drug Discovery, December 2009.

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