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Washington Highlights

AAMC Comments on NCATS-Industry Activity, Drug Repurposing Awards Announced

June 21, 2013—The AAMC June 14 submitted comments  on ways the National Center for Advancing Translational Sciences (NCATS) might avoid “duplication, redundancy, or competition” with industry.  NCATS, a newly formed center of the National Institutes of Health (NIH), invited public comments in a Federal Register notice published on May 15.

Congress on occasion has expressed concerns that NCATS, which seeks to catalyze the translation of federal research findings into medical application, not duplicate or encroach on the role already played by the private sector in developing drugs, vaccines, or devices.

In its comments, the AAMC endorsed the mission of NCATS to explore and improve the development pipeline for promising new compounds, which the association sees as complementary to — and not inherently duplicative of — research conducted in commercial firms as well as nonprofit research organizations.

The AAMC also described much of this research as “precompetitive” and facilitating later development, and noted that, “complementary and precompetitive research engender inherent risks for some overlap with industry or other sector activities, and the issue of avoiding potential duplication or competition is fundamentally one of managing this risk.”

The association advised that these risks could be minimized through broad participation of the various sectors involved in drug discovery and development, including academic organizations, and open communication and transparency, so that instances of potential overlap be more quickly identified and ameliorated.

The AAMC also urged that NCATS continue to provide for rigorous peer review of research projects, maintain a focus on health disparities and needs across the population (areas traditionally underserved by industry), and strongly focus on workforce development and training for translational scientists, which benefits the entire research and development system.

On June 18, NCATS announced new research collaborations with industry and academic institutions under its drug repurposing program, which makes industry-developed compounds available to academic and government researchers to explore for new uses (development of these compounds had largely been abandoned from their original purpose for business reasons).

As such, the repurposing program is a high profile demonstration of the role NCATS may play in promoting complementary and non-duplicative research.  Any new uses identified for these compounds can be licensed or transferred back to the donating companies under terms arranged in these programs. 

Among the institutions participating in the newly awarded collaborations are: Baylor College of Medicine, Indiana University, the Mayo Clinic, University of Pittsburgh, University of Virginia, University of Washington, Virginia Commonwealth University, and Yale University (two awards).

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org