September 26, 2011

Senate Endorsement of NIH Translational Science Focus

The Senate Appropriations Committee has centered on the funding level for NIH in the coming 2012 fiscal year: $30.5 billion.  This near-maintenance of 2011-level funding is useful to note in the current climate of budget-cutting, but the committee also endorsed some specific NIH proposals within the appropriation.  NIH has sought to establish the National Center for Advancing Translational Sciences (NCATS) as a new center within the NIH enterprise, which will will "strive to reengineer the process of developing drugs, diagnostics, and devices."  This has been strongly advocated by NIH Director Francis Collins, who published his argument for a more aggressive role for NIH, noting  "the triple frustrations of long timelines, steep costs, and high failure rates bedevil the translational pathway. he average length of time from target discovery to approval of a new drug currently averages ~13 years, the failure rate exceeds 95%, and the cost per successful drug exceeds $1 billion, after ad­justing for all of the failures."  In shorthand, this push attempts to reduce the classic bench to bedside translation of medical discoveries, and identify the translation process itself as ripe for innovation.  The Senate bill creates the new center; additionally, it authorizes $20 million for a new program, the Cures Acceleration Network (CAN), which grants the Director wide latitude to distribute funds targeted at "High Need Cures." CAN was supported by then-Senator Arlen Spector, who specifically noted the need for efforts to speed up treatments for "cancer, autism, Parkinson's, Alzheimer's, and diabetes" - and embedded its establishment within the Patient Protection and Affordable Care Act in 2009 (health reform bill). Both of these NIH initiatives are likely headed for approval, with the end result being that frustrations with the lab to market pipeline could increasingly lead to novel interventions by the federal research institutes, which cannot per se "go to market" but which can target speed bumps that prevent promising federally funded research discoveries from leaving the laboratory.  It's a recognition of a larger mission for federal science authorities - to ensure that the science that taxpayers are purchasing is actualized in usable form.

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