The Ongoing Struggle Over Translational Research

If the National Center for Advancing Translational Science were a person with feelings and a fragile sense of self-worth, it might be feeling snubbed and even a bit wounded these days. Sure, the Obama administration’s budget proposal released in February called for an additional $64 million for the center — an 11% increase — including a $40 million boost for the Cures Acceleration Network, currently funded at $10 million. But Congress hasn’t expressed the same confidence.

In June, the Senate Appropriations Committee approved a spending bill that included only $30 million more for the Cures Acceleration Network (amidst a 0.3% increase in the overall NIH budget for the 2013 fiscal year; an improvement over the president’s request for no increase). And in mid-July, a House of Representatives subcommittee released a spending bill in which both NCATS and the Cures Acceleration Network would be flat funded.

It wasn’t so long ago — barely a year and a half — that the center was touted as the great new hope in medicine, as the best means to speed movement of discoveries from the lab to the patient.

The number of new drugs introduced by the pharmaceutical industry had been declining over the past decade and a half, and as a result promising discoveries in the areas of depression and Parkinson’s disease, for instance, hadn’t translated into clinical practice. NCATS was designed to bridge this gap, to advance research to the point where it attracts drug companies’ interest — to get new drugs, devices and diagnostics to the bedside generally.

(I should note that the creation of the center led to some consternation among investigators, as it essentially replaced the popular National Center for Research Resources (NCRR); see: Researchers to NIH: ‘If It Ain’t Broke…’).

Some still question the need for NCATS, though. Leave market concerns to the market, they might say. Let NIH concentrate on the discoveries themselves.

I recently talked to Irving Bigio of Boston University about the state of funding for the biomedical sciences, including this emphasis on translational research. Bigio is head of the BioMedical Optics Laboratory at BU and naturally keeps a close eye on trends in NIH funding.

Maybe NIH should focus first on the sort of creative thinking in research that enables breakthroughs, I argued — playing devil’s advocate but also kind of just thinking out loud — and then on the applications made possible by those breakthroughs.

“Well, how do you get from one to the other?” Bigio said. “There needs to be a balance. And that balance has been missing over the years.”

We have seen quite a bit of basic research, of course, and translational research as well. But there is still a gap: namely, the question of what it takes to commercialize the research. “Industry is much more reluctant, especially recently, to take on the risk,” Bigio said. “They want something that’s basically product-ready.” NCATS was established to address this need.

The debate over whose responsibility this actually is — and who is best equipped to tackle the many challenges faced by the pharmaceutical industry — played out in a March hearing before a House subcommittee questioning the need for the center.

“Does anyone in the audience believe that there is something that NCATS is going to do that the industry thinks is critical and that they are not doing?” said former chief executive of Merck Roy Vagelos, according to Nature News Blog in its coverage of the hearing. Roy added that the pharmaceutical industry spends roughly $50 billion a year — some 100 times the NCATS budget — trying to address the problems that lead to many of the failures drug development, so far without success.

But another drug company executive offered a different view. Testifying on behalf of the Biotechnology Industry Organization, Scott Koenig — a former senior vice president of research at MedImmune and now president and chief executive of MacrGenics, a private biotech company — said that NCATS offers an opportunity to fill gaps in the drug development process that the industry is not necessarily incentivized to address.

One example: identification of biomarkers whose clinical benefits may not be obvious until years down the line. “This is not something that the drug industry spends a lot of time and money on,” he said.