• NIH's New Agency
  • March 17, 2011
  • Law Firm: Whiteford, Taylor & Preston L.L.P. - Baltimore Office
  • A couple of weeks ago, the National Center for Research Resources unveiled its "Final Interim" recommendations for the National Center for the Advancement of Translational Science (NCATS). After several years of waiting, we are beginning to see some policy decisions take shape.

    BACKGROUND - NCATS was proposed by Dr. Francis Collins, Director of the National Institutes of Health, back in November 2010, as a new agency to be formed within NIH and open for business on October 1, 2011.
    His proposal followed some earlier attempts to promote translational science. NIH created the Clinical and Translational Science Awards (CTSA) Consortium in 2006. Some of the other agencies within NIH also created their own programs to promote translational science. In December of 2009, however, the Scientific Management Review Board recommended that all of these efforts by the different agencies within NIH be moved into one agency, leading to the proposal by Dr. Collins a year later. In the process, it was contemplated that the National Center for Research Resources (NCCR) would be dissolved and its programs disbursed among various NIH agencies, andthat various other programs would be reassigned among agencies.

    HIGHLIGHTS OF LATEST PLAN - The NCRR'S "Final Interim Recommendations" can be viewed at www.nih.gov/blog/feedback/NCRR&under;Task&under;Force&under;Recs.pdf.

    One key proposal is to create a permanent new Infrastructure Entity (IE) to handle many of the programs funding extramural capacity building support programs.

    Somewhat curiously, Comparative Medicine Programs are to be placed in the IE, on the grounds that they are "infrastructure and capacity building." It is unlikely, in our opinion, that this is the last word on the Comparative Medicine Programs.

    Some stakeholders appear to hope for additional funding under the new structure. Others worry about changes in their traditional funding if it's handled by a new Institute.

    Still others read too much into a New York Times article that appeared on January 11, 2011 ("Federal Research Center Will Help Develop Medicines). That article misinterpreted the new federal initiative as creating a new drug developer, a competitor in the industry.

    It is probably just wishful thinking that the realignment will create extra funds, at least initially; NIH stresses that this is supposed to be a fiscally neutral reorganization, and current awards are not to be disturbed. NIH responded to the Times article stressing that the NCATS is not a drug developer.

    However, NCATS is apparently intended to allow funding priorities to be re-oriented and to make non-grant support available:

    • It would appear from NIH's policy statements that one area of greater emphasis will be therapeutics and diagnostics for rare and neglected diseases.
    • It would also appear that the new science support paradigm would increase the availability of "free" expertise and support for existing research programs (i.e. provided outside a grant). That support would provide access to services such as high-throughput screening, assay development, medicinal chemistry and preclinical modeling. These services, which complement and expand the research capacities of basic science investigators, are intended to reduce the risk of unknown developments during steps to bring research results closer to products.