NIH Move To Consolidate Translational Programs Is Not The Big Shakeup It's Made Out To Be, Agency Says
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The National Institutes of Health's proposed National Center for Advancing Translational Sciences reflects neither a shakeup of existing NIH programs nor any intent to create an agency that functions like a drug company, NIH officials say. The bid to create NCATS has drawn fire from some stakeholders who worry that the agency is moving too fast, the new center will cannibalize existing programs, and NIH is perhaps reaching too far into the drug development space. An NIH study group has been conducting fact-finding on the proposal since May, with efforts including a September public meeting on the idea. The agency has reached out to affected constituents via conference call since the proposal was announced Dec. 7. Nonetheless, the project was apparently proceeding under a lot of radars until recent media reports raised questions, including some from legislators looking for ways to cut, not grow programs. "This is a Congress that is not in favor of creating new entities, even if it is cost neutral. I think they're going to have a hard time with this going through Congress," Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, observed in an interview. During the Q&A portion of a Jan. 27 MassBIO policy breakfast in Boston, Kaitin and the other panelists admitted to knowing little about the proposed changes at the agency, but the speculation in the room was that NIH is somehow edging into drug development and at a cost to popular ongoing programs. But it seems that, at least initially, the proposed center would add nothing new to the activities of the agency, which has been doing high throughput screening in its Chemical Genomics Center, for example, since 2003, when the NIH Roadmap for Medical Research was implemented to pick up the pace on conversion of research findings into drugs, devices and vaccines. Christopher Austin, who directs the Chemical Genomics program, stresses that the center created a pre-competitive space for its kind of science and that it screens targets for diseases "that simply can't be worked on in private sector due to poor return on investment" (Also see "Public Genomics Data Needed, FDA, NIH Say; Patent Protection Still An Issue" - Pink Sheet, 17 Nov, 2003.). Indeed, it is being suggested that a "much larger shakeup of NIH is under way than is actually contemplated," members of the NCATS working group – led by NIH Director Francis Collins – assert in a Jan. 24 posting on the agency's feedback webpage. "NCATS is not intended to be a drug company," but to facilitate translational research complementary to the several billion dollars in ongoing translational research being supported on a large scale by individual institutes and centers, the working group states. "NCATS will seek ways to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value." And, "there are no plans to 'cannibalize' the budgets or programs of other NIH Institutes and Centers" to form the new center, they declare. While the final budget for the new center is as yet unknown, the budget and staff for each relocated program will remain with that program, making the overall budget the total of those programs, they explain. The integration should create efficiencies rather than new spending. NCATS will be assembled primarily from programs that currently exist within the National Center for Research Resources, the NIH Common Fund – initiated in fiscal 2004 with flexibility to act on cross-cutting, multidisciplinary opportunities – and the National Human Genome Research Institute. The specific programs involved are the Molecular Libraries Program, Therapeutics for Rare and Neglected Diseases (TRND), Rapid Access to Interventional Development (RAID), the NIH-FDA Regulatory Science Initiative, the Cures Acceleration Network (CAN) and the Clinical and Translational Science Awards (CTSA) program. TRND has selected five pilot candidates to shepherd though to IND readiness (see sidebar). NCRR Would Cease To Exist One reason the plan is drawing flack is inclusion of yhr very popular CTSA program. It was reated in 2005 as a consortium of academic research centers primed to work with industry as well as to train a new generation of scientists who know how to take their discoveries all the way of the finish line. The group is flourishing (Also see "NIH Translational Research Consortium Mulls How Best To Leverage Agency's Stake In Industry, Academia, Government Relationships" - Pink Sheet, 25 Jan, 2010.). A case in point is the program's superstar, the University of California, San Francisco, which, among other industry link-ups, recently signed a marquee deal with Pfizer (Also see "As Pfizer And UCSF Tighten Ties, More Deals With Academia Could Follow" - Pink Sheet, 29 Nov, 2010.). "NIH is rewarding the institutions that have an infrastructure in place for creating these kinds of partnerships," said Kaitin. "All of the stars are aligned. Industry is desperate for new leads and they're looking to reduce overhead and internal costs. Academic institutions are looking for financial investment. And here you have two entities that are raring to connect, and NIH is giving them money to create these connections." But CTSA is managed by NCRR, and a companion to the plan to create NCATS is a plan to dissolve NCRR, leaving proponents and participants, including Kaitin, worried the CTSA set-up will be broken in the move.
The NCATS working group is contemplating how best to sort the NCRR programs not being assumed into NCATS. A plan on this issue is due in early March. Some have been assigned to other institutes or centers while others, including the National Primate Research Centers, are still in flux. Collins has said all programs will continue at full force during the transition. The NCATS plan is not without support from key stakeholders. It won initial approval from the Biotechnology Industry Organization, the Council for American Medical Innovation, which is supported by PhRMA, and patient groups as a significant step forward for NIH's efforts to translate the discovery research it funds into public benefits (Also see "NIH Center Would Seek To Boost “Repurposing” Of Shelved Drug Candidates" - Pink Sheet, 20 Dec, 2010.). But others, such as the Federation of American Societies for Experimental Biology, a policy umbrella group for 23 scientific societies representing more than 100,000 researchers, urge NIH to slow down and gather more community input before making changes of such magnitude. In a Dec. 20 letter to HHS Secretary Kathleen Sebelius, FASEB President William Talman, University of Iowa Carver College of Medicine, recommends the project be delayed "to allow for a more substantive dialogue with all stakeholders and an analysis of the potential consequences." Creating a new translational research center might have the opposite of the intended effect by creating a new bureaucratic structure that is cut off from the research based in the various institutes and centers, Talman argues. Until the vision for NCATS and the effects of dismantling NCRR are clarified, FASEB remains unconvinced of the proposals value, he says. Collins May Feel Like Kicking The CAN A provision in the Affordable Care Act that creates a new program that would fall to NCATS also has raised the visibility of the plan in Congress. The Cures Acceleration Network, championed by Sen. Arlen Specter, D-Pa., was authorized at $500 million in the health reform law but never received funding because appropriations were never put in place for fiscal 2011. Federal agencies have been operating at 2010 levels as they await congressional action. The next inflection point comes March 4, when the current continuing resolution expires. But increases, as well as new spending for the rest of fiscal 2011 and for fiscal 2012, are unlikely as the Republican-majority House likely will propose substantial budget cuts. The CAN program would award funds through contracts, grants or cooperative agreements to public and private entities, including academic institutions, biotechs, pharmas and disease advocacy organizations, to support "the advanced research and development" of "high-need cures," including "medical products, behavioral therapies and biomarkers that demonstrate the safety or effectiveness of medical products." Award winners also could use the money to comply with FDA standards and meet regulatory requirements at all stages of development, review and approval. High need is defined as "a priority to diagnose mitigate, prevent or treat harm from any disease or condition and for which the incentives of the commercial market are unlikely to result in its adequate or timely development." Both partnership and grant awardees would receive renewable funding in the amount of $15 million. However, one condition of the partnership award is that recipients have to find matching funds from non-federal sources at a ratio of 3:1 to the award. The stipulation can be waived or modified in cases where the objectives of the program couldn't otherwise be carried out. In addition, the NIH director has "flexible authority" to award 20% of the appropriated funds for the program through other mechanisms to projects that won't work under the grant, contract or cooperative agreement models. The issue of whether CAN treads on drug developers' toes was raised during a Jan. 27 hearing on health care reform by the Senate Health, Education, Labor and Pensions Committee. Sen. Richard Burr, R-N.C., questioned Secretary Sebelius as to whether NIH would be "involved in some degree of drug development" through the program. Burr said he detects "a distinct difference between" NIH's traditional research interests and drug development, "which is something private sector and academia has been involved in almost 100%." Sebelius responded that "too many promising ideas die … between the microscope and the marketplace," and NIH is mobilizing any incentives it can to make sure breakthrough drugs get to patients. Still, Burr went on to remark that in addition to the cost of implementing the program, "it will also have a cost on the private sector's inability to chase those promising things if we choose to do it as government." The Timeline On NCATS NIH's Scientific Management Review Board approved the NCATS proposal during a Dec. 7 meeting. A panel of noteworthies from NIH and the broader scientific community, including industry, SMRB was chartered in NIH's 2006 reauthorization. Its purpose is to make recommendations on topics including establishing, abolishing or reorganizing the agency's institutes and centers. Collins approached the board in May for advice on pulling the programs together. Collins accepted the proposal and referred it to Secretary Sebelius, who has the authority to make those kinds of changes with 180-days notice to the appropriate House and Senate authorizing committees. Those letters went out Jan. 14. Sebelius also notified the relevant appropriations committees so that fiscal 2012 funds can be redistributed to programs under the new center. The goal is to launch the new center with the new fiscal year, on Oct. 1, 2011. Why the rush? According to the FAQs on the feedback page, the existing translational research programs are doing such a good job at "forming new partnerships in which NIH-supported investigators work to 'de-risk' drug and therapeutic development projects and render them more attractive for private-sector investment" that it's time to "take bold action" to be better able to accelerate that work. |