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Vol. LXIII, No. 6
March 18, 2011
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‘Time Is Right’
Teleconferences Illuminate NCATS Creation Process

On the front page...

Back-to-back teleconferences on Feb. 23 shed light on both the mission of, and rationale for creating, a new National Center for Advancing Translational Sciences and making it operational by next Oct. 1.

At both a late-morning meeting-by-phone of the Scientific Management Review Board and a subsequent telephone media availability, NIH director Dr. Francis Collins emphasized two themes in defending the NCATS proposal: it will “advance the discipline of translational science and catalyze the development of novel diagnostics and therapeutics,” he said.

Collins explained that NIH has a long history of conducting both translational science and drug development; the AIDS drug AZT and cancer drug Taxol, for example, were developed by NIH-supported investigators. He also cited a recent paper in the New England Journal of Medicine showing that, from 1990 to 2007, one-fifth of all new molecular entities submitted to the FDA for priority review as potential therapies were discovered by NIH intramural or extramural scientists.

Collins added that all 27 institutes and centers “have been involved for quite some time” in translational research and that a 2010 survey of the field showed “more than 550 activities involving drugs, vaccines, biologics and devices” in NIH’s research portfolio.

Continued...

So why create a new center now? “As Will Rogers once said, ‘Even if you’re on the right track, you’ll get run over if you just sit there,’” said Collins. “There has been a deluge of discoveries of potential new targets,” he explained, and the “genomics revolution” has also offered a tempting array of possible therapeutic avenues that are going unexploited.

The proposed NCATS, said Collins, would “serve as a catalyst to enhance NIH’s longstanding involvement” in translational research and drug development. “This is not an effort to turn NIH into a drug development company,” he warned. The goal is to move promising products far enough along that drug companies would take over development eventually, resulting in what Collins called a triple-win situation: NIH pioneers new therapeutics, pharma takes the ball over the goal line and the public benefits from better medicines.

The goal is to move promising products far enough along that drug companies would take over development eventually, resulting in a triple-win situation: NIH pioneers new therapeutics, pharma takes the ball over the goal line and the public benefits from better medicines.

The morning SMRB session, the 9th meeting of that body, primarily served to describe how three working groups are determining how NCATS will be assembled and how the National Center for Research Resources will be abolished as its major programs are either absorbed by NCATS or transferred to other institutes or the Office of the Director.

The first working group, composed of senior leadership across NIH and co-chaired by NIMH director Dr. Thomas Insel and NHGRI director Dr. Eric Green, is charged with outlining the mission and function of NCATS; its report was due Mar. 1 to Collins.

The second group, a subset of the advisory committee to the NIH director chaired by Dr. Maria Freire of the ACD, is examining how NCATS can best partner with the private sector. This group held its first all-day meeting Feb. 4.

The third group, the NCRR task force co-chaired by NIH principal deputy director Dr. Lawrence Tabak and NICHD director Dr. Alan Guttmacher, offered “final interim recommendations” that assigned NCRR ’s programs, including the Clinical Translational Science Awards (CTSAs, which fund 55 research centers nationwide), to new homes. These were posted Feb. 22 at http://feedback.nih.gov/index.php/ncats/task-force-recs/.

One SMRB member, Dr. Thomas Kelly of the Sloan-Kettering Institute, acknowledged “a fair amount of angst out there over the redistribution of NCRR programs” and elimination of the center, and said he didn’t think the board had adequately discussed the repercussions. Why not leave NCRR intact and simply move the CTSA program elsewhere?, he wondered.

Tabak said the first thing his task force considered was determining whether that solution might work, but concluded that the “coat of many colors” that NCRR has evolved into over time is not the optimum arrangement, given new scientific opportunities. Tabak also said his group had conducted a thorough analysis of the proposed change.

“At no time was there ever an intention to eliminate extant NCRR programs,” he said. All programs will be maintained, but moved around organizationally, he said, “to enhance scientific opportunities, based on adjacency.”

Insel said his group, the IC directors NCATS working group, had met seven times since Jan. 4, including a Feb. 4 joint meeting with Freire’s group. He predicted the new center will serve “as a catalyst for translation.” Especially strengthened will be the field of clinical pharmacology, which has been languishing, he added.

Eight individuals spoke up during the public comment portion of the SMRB meeting; virtually all applauded the proposed new center. Said Amy Comstock Ricks of the Parkinson’s Action Network, “A dried-up pipeline of new therapies is unacceptable.”

At a 50-minute press telebriefing a half-hour after the SMRB session ended, Collins said the NCATS mission “has been embraced by the institute directors” and said it would herald a new era of collaboration with FDA, pharma, biotech, advocacy groups, non-profits and academia.

He hoped that the President’s FY 2012 budget, which includes $100 million to start the Cures Acceleration Network, wins passage; CAN is to be part of the proposed NCATS. Collins also hopes that NCATS, by bringing a raft of new therapies across the so-called “Valley of Death,” would turn into “a valley that leads to life.”

In responses to questions from seven reporters, Collins said: the NCATS budget would be around $700 million (not including possible CAN funding) and will require a budget amendment from the White House; NIH will soon advertise globally for an NCATS director-designate; intellectual property issues arising out of NCATS will follow a model already in place; and CAN could potentially have “a DARPA-like authority” (the Defense Advanced Research Projects Agency begat both the Internet and GPS technology, Collins noted).

In conclusion, Collins emphasized that he “understands that people are unsettled by change…The goal is not to diminish the importance of programs but to empower them. I am optimistic that the impression [of standing up NCATS so rapidly] will improve.

“This is not an attempt to replace, but to augment what the ICs have done traditionally,” he continued. “Five years ago, this [undertaking] would have been premature; 5 years from now, it would be a missed opportunity. The time is right…maybe especially in a difficult budget environment.”.NIHRecord Icon

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