Wednesday, December 8, 2010

NIH director wins bid for translational medicine centre

NIH director wins bid for translational medicine centre ; Sixteen months after taking charge of the US National Institutes of Health (NIH), the world's largest funder of biomedical research, director Francis Collins is now on course to lead the agency through its most significant evolution to date.

On 7 December, the NIH's Scientific Management Review Board (SMRB) voted 12-1to establish a new centre devoted to speeding therapies from the lab to the clinic. With all the grant-making powers of any of NIH's 27 existing institutes, the new centre for translational medicine and therapeutics could receive funding as soon as next October, when the US government's 2012 fiscal year begins.

Collins, who has made translational research a top priority for his tenure, celebrated the vote as "a momentous occasion". He noted that, in the past, the creation of new institutes at the NIH was often motivated by congressional politics. By contrast, he said, the current recommendation is driven mainly by scientific arguments. "You could call this disruptive innovation on an institutional scale," Collins added.

Disruptive may prove to be an apt word for the new centre as it jostles for position within the NIH fimament. For example, it is expected to house an existing half-billion-dollar funding programme called the Clinical and Translational Science Awards (CTSAs), which are currently held by 55 centres nationwide. However, such a move might seal the fate of the programme's administrative home, NIH's National Center for Research Resources (NCRR) in Bethesda, Maryland, which provides translational researchers with the training and tools to transform basic discoveries into health gains. The CTSAs comprise nearly 40% of the NCRR's US$1.3-billion budget.

Asked if the NCRR would be dissolved under the new proposal, Collins told Nature: "That is a possibility, but it's not the only possibility."

Barbara Alving, the NCRR's director, said after the vote: "I feel much more discussion needs to be done, absolutely. This is a very confusing process for all of our stakeholders."

Alving questioned, among other things, whether adequate funding would exist to support the new centre in the future, because some of its elements are funded from the NIH director's discretionary 'Common Fund' and are not permanent fixtures of the NIH budget.

Pros and cons

Others cautioned that the rush to launch a new centre may work against the NIH's purposes. The creation of a "new bureaucratic structure" could even end up delaying translational research, argued William Talman, a neuroscientist at the University of Iowa in Iowa City, who is also president of the Federation of American Societies for Experimental Biology. At the meeting, Talman urged the SMRB to delay its vote and make more information available about the role of existing translational research at other NIH centres under the new regime.

But the proposal also has fans. Garret FitzGerald, who directs the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania in Philadelphia, said it will raise the profile of a discipline that bridges basic and clinical research, and which is desperately lacking in personnel. "This can offer the beginning of a brand that can lure the best and the brightest into training. Because the absence of those people has come at an immense price," he says.

The only SMRB member who opposed the new institute was Jeremy Berg, director of the National Institute of General Medical Sciences in Bethesda. "It was done in such a hurried way that there hadn't been time for adequate discussion of the implications," Berg said after the vote. "I didn't really know what I was voting for." Earlier this week, Berg announced he will be leaving the NIH next summer.

Collins had pushed the SMRB to report to him by this month so that the new translational research centre could be funded in the government's 2012 fiscal year. A working group of the SMRB, headed by Arthur Rubenstein, the dean of the University of Pennsylvania School of Medicine in Philadelphia, has since May held half a dozen meetings to gather input. Its charge was to outline how to improve the NIH's existing translational research.

Pipeline push

In its effort to develop drugs, biologics, diagnostics and devices, the proposed centre would draw together several recent programmes that have arisen as part of an increasing push in Congress to speed therapies to the bedside, as new drug pipelines at pharmaceutical companies have languished.

In addition to the CTSAs, the new centre would administer The Cures Acceleration Network, a competitive grant programme for drug development authorized by Congress early this year in the new health reform law. The programme can be funded at up to $500 million annually; congressional spending committees have awarded it $50 million for 2011, although that budget has yet to be finalized. Another congressional favourite, the $24-million Therapeutics for Rare and Neglected Diseases (TRND) programme, would also be housed at the new centre, as would the $113-million Molecular Libraries Program, which allows NIH-funded researchers access to large-scale screening to identify small molecules that can be used as chemical probes to study the functions of genes, cells and biochemical pathways.

Although the Clinical Center, the NIH's huge research hospital in Bethesda, would not be a part of the new centre, the two would work very closely together under the proposal.

Collins immediately charged NIH principal deputy director Lawrence Tabak and Alan Guttmacher, head of the National Institute of Child Health and Human Development, with the three-month task of appraising the mechanics of creating the centre and looking at what might happen to remaining NCRR programmes. Acknowledging the concerns voiced by the parade of public witnesses at the meeting, Collins said: "We need to deal with [the concerns] in a very careful way to make sure that there are not unintended consequences."

Collins will take the proposal for the new translational medicine centre to Kathleen Sebelius, Secretary of the Department of Health and Human Services, as soon as this week. Under the law that created the SMRB in 2007, Sebelius must sign off on the plan and then present it to Congress. The proposal will go ahead unless Congress acts against it in the next 180 days http://www.nature.com/news/2010/101208/full/news.2010.650.html

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