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Jan 26, 2012

Acting Director Opens Up on NCATS’ Early Agenda

  • Thomas Insel is only the acting director of NIH’s new translational science center. In a Q&A interview with Science magazine’s ScienceInsider blog he made it clear he’s not interested in giving up his day job as director of the National Institute of Mental Health to run the fledgling National Center for Advancing Translational Sciences (NCATS).

    Reading the interview also clarified some of NCATS’ early direction and focus, both how much things can be expected to change within NIH and how much things will stay the same. The first impact of NCATS on NIH, according to Insel, may be a restructuring of the Clinical and Translational Science Awards (CTSA) initiative. It encompasses some 60 biomedical institutions nationwide. CTSA announced its latest funding round in July, awarding a total $498 million to 10 institutions.

    “If there's a change, it's going to be the possibility that going forward not every CTSA will be exactly the same thing whether it's in community engagement or whether it's in first-in-man trials. We're going to look at being able to, to the extent possible, cultivate what they do best,” Insel promised.

    It makes some sense to introduce some specialization within CTSA, to avoid the waste that comes with duplicating the same functions everywhere. But if that should indeed happen, the CTSA should be grouped within regions, to ensure a balance of programs nationally, and minimize the disruption that’s sure to happen if clinical trials for one disease were all concentrated in one location. Insel seems to agree, judging by his interest in seeing NIH preserve the range of CTSA activities, even as he says the agency expects the initiative to "evolve."

    CTSA accounted for well above half ($479.8 million) the $576.5 million approved for NCATS in FY 2012. That number is 2.3% higher than the $563.4 million it spent in FY 2011 but 18% less than what was proposed by NIH director Francis S. Collins, M.D., Ph.D. CTSA was housed in the old National Center for Research Resources, which has been dissolved to make room for NCATS, no small factor in all the talk about reorganizing the initiative.

    Insel also said his interim role at NCATS affords him “a chance to try some experiments,” one of which he spelled out in the interview: “One of the questions we're now grappling with is, ‘Can we get away from this rigid separation between intramural and extramural?’”

    He pointed to a model for that internal-external integration within NCATS. One of the center’s components is the Therapies for Rare and Neglected Diseases (TRND) program, which has ramped up to overseeing 10 projects and four pilots. TRND doesn’t fund projects directly but helps academic and biopharma industry partners access drug development capabilities that include high-throughput screening, medicinal chemistry, and toxicology.

    “It becomes really interesting when you think about something like [the rare diseases program] which is technically an intramural program, but 90% of what they do is done with extramural collaborations. They don't have a big intramural faculty that's on a tenure track, they don't have a large number of FTEs [staff positions]; it's a very different way for NIH to operate,” Insel told ScienceInsider.

    But TRND and NCATS may not have a choice, as everyone from President Barack Obama to Congressional leaders promise to cut spending across the federal government this election year. Last summer’s budget deal presents two sobering choices: $1.2 trillion in cuts over 10 years or across-the-board cuts that include 7.8% reductions for NIH. Many fear that talk will translate into cuts for the agency, judging from a recent GEN poll.

    Operating in the rare disease space, where traditional funding has always been difficult to find, TRND projects have been able to cobble together resources from NIH as well as various partners from academia and often industry. Extending that thinking across NCATS will be necessary, not just because tight budgets loom but because Dr. Collins has already ruled out the new center “entering the drug development arena” on its own given the billion-dollar-plus cost of bringing new medicines to market.

    “What NCATS intends to do is advance the science of therapeutic development and determine if there are ways we can re-engineer the drug development pipeline; creating new approaches and methods that will benefit everyone interested in speeding the delivery of new medicines,” Dr. Collins testified in May before the Senate Subcommittee on Labor-HHS-Education Appropriations. It’s now up to Insel and his successor to match those lofty hopes for NCATS with sound policy.


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