Regulatory Focus™ > News Articles > NIH Drug Development Acceleration Program Expands to Include New Members

NIH Drug Development Acceleration Program Expands to Include New Members

Posted 12 June 2012 | By Alexander Gaffney, RAC 

A program launched by the National Institutes of Health (NIH) to repurpose existing advanced-stage drug compounds by partnering with pharmaceutical manufacturers has expanded to more than double its existing membership, the NIH announced on 12 June.

The initiative, known as the Discovering New Therapeutic Uses for Existing Molecules program, was founded in May 2012 by the newly-formed National Center for Advancing Translational Sciences (NCATS) to take the existing compounds of pharmaceutical companies and open them up for research by outside groups. The program focuses on compounds that have advanced to phases of clinical testing, but failed to advance for business or efficacy reasons.

Under the agreement, NIH will supply companies with template legal agreements which accelerate the application process while protecting the intellectual property rights of companies. Researchers meanwhile are given the rights to any intellectual properties discovered and maintain the right to publish any information obtained from research on the compound. NIH also said it will support research on the compounds with a total of $20 million in research grants.

The agreement was launched with the support of three pharmaceutical manufacturers-Pfizer, Eli Lilly and AstraZeneca-who pledged to support the initiative with dozens of compounds. The initiative seems to have gained a strong foothold within the industry, and on 12 June NIH announced the addition of five companies to the research partnership: Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceuticals and Sanofi.

NCATS Acting Deputy Director Kathy Hudson, PhD, said the agreement is geared toward not just finding new uses for unused medicines, but getting treatments to patients even faster as well. Because the compounds have already advanced to clinical trial stages of testing, "if researchers funded through this effort can demonstrate new uses for the compounds, they could significantly reduce the amount of time it takes to get a treatment to patients in need," explained Hudson.

Additional companies wishing to participate in the pilot program must submit applications to IH by 14 August 2012.

Read more:

NIH - Five more pharmaceutical companies join NIH initiative to speed therapeutic discovery

Regulatory Focus - NIH Launches New Program to Share Drug Compounds

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