Submitted by josh on Fri, 11/19/2010 - 04:56

 The NIH has historically pursued hypothesis-based, discovery-oriented research that seeks to address specific clinical questions. NIH Director Francis Collins announced in May 2010 that the Scientific Management Review Board (SMRB) would be directed to “identify the attributes, activities and functional capabilities of an effective translational medicine program for advancing therapeutics development.” This signaled an agency-wide move towards addressing larger questions of therapy development. 

In December 2010, SMRB released its preliminary study of Director Collins’ directive, clarifying that “the central role of the proposed center would be to establish and provide focused, integrated and systematic approaches for building new bridges that link basic discovery research with therapeutics development and clinical care.”  The proposed center, the National Center for Advancing Translational Sciences (NCATS) would house the following programs:     

 

      · Clinical and Translational Science Awards (CTSA) Program       

      · Cures Acceleration Network (CAN)      

      · Molecular Libraries Program (MLP)      

      · Therapeutics for Rare and Neglected Diseases (TRND)      

      · Rapid Access to Interventional Development (RAID)     

      · NIH-FDA coordinated efforts

 

The overarching scientific goal of NCATS is to accelerate the development of new therapies and to consolidate current scientific knowledge that may otherwise be fractured throughout programs. Steam-lining and improving the process of therapeutics development, expanding the scientific base of knowledge through pre-competitive sharing and supporting novel partnerships are but a few of the specific focuses of the center.

In addition to this, NCATS will strive to “de-risk” drug and therapeutic development projects to render them more attractive for private investment. Therefore, the center will both focus the NIH’s efforts on therapy development while opening up the process to potentially more effective private-sector involvement. There are innumerable opportunities for partnership building within the federal government and the business community.

NCATS would not off-set current therapy development research within the NIH, but would rather stand to supplement those programs. Therefore, the creation of the center presents new opportunities for therapy development institutes such as ALS TDI to get in on the “ground floor” of a fundamentally new program within NIH. 

The proposed center will not affect current grants or contracts, and will be funded through congressionally-directed appropriations for Fiscal year 2012 via the House Energy and Commerce Committee and the Senate HELP (Health, Education, Labor and Pensions) Committee. Public input into the development of the center is highly encouraged throughout the NIH literature, with comments and ideas to be directed through the SMRB.  

On May 11, 2011, NIH Director Collins testified before the Senate Appropriations Committee on the FY 2012 NIH budget. He made a program request for $31.987 billion for NIH in FY 2012 and thanked members of the Senate for sparing his agency from some of the deeper cuts in the FY 2011 Continuing Resolution. In his testimony, Collins addressed the need for NCATS itself, stating that its purpose is to “advance the science of therapeutic development and determine if there are ways [to] re-engineer the drug development pipeline.” The director reiterated that “resources for NCATS will come from the combination of already existing and appropriated programs and so be budget neutral.” In response to committee member questions regarding the lack of adequate detail about the NCATS budget, Director Collins responded that NIH has completed budget planning for the center, and after being vetted by the Department of Health and Human Services and the Office of Management and Budget, it will be sent to the Appropriations Committee in the next few weeks.