Therapeutic development is a costly, complex and time-consuming process. A novel drug can take 10 to 15 years and more than $2 billion to develop, and failure rates occur in about 95 percent of human studies. The high therapeutic development failure rate means there are many existing, partially developed therapeutic candidates that could be repurposed for use in a new disease indication.
NCATS designed its New Therapeutic Uses program to align with one of its primary goals: to foster approaches that improve the translational research pipeline and ultimately accelerate the pace at which discoveries are turned into new preventions, treatments and cures for human diseases.
Launched in May 2012 as part of the New Therapeutic Uses program, NCATS' NIH-Industry Partnerships initiative fosters collaboration between pharmaceutical companies and the biomedical research community to advance therapeutics development. The focus is on matching researchers with a selection of pharmaceutical assets to help the scientists test ideas for new therapeutic uses.
Through this initiative, NCATS is re-engineering the research pipeline, using innovative strategies to identify new uses for existing therapies that have undergone significant research and development by industry, including safety testing in humans. Coordinating the access that scientists nationwide have to existing therapies that have already cleared several key steps in the development process can accelerate the pace of therapeutics development and get more treatments to more patients more quickly.
During the pilot phase of this initiative, NCATS tested the utility of its newly created template agreements, which proved to be effective in facilitating negotiations, enabling the research to begin more quickly. The template agreements reduced the time required to establish collaborations between industry and academia to as few as three months from the more typical nine months to one year.
Participating NIH-Industry partners varies, depending on whether companies have assets that meet the criteria for inclusion in the program for a specific funding opportunity. NCATS partners include the following: AstraZeneca, MedImmune (subsidiary of AstraZeneca), AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, L.L.C, Pfizer, and Sanofi.
Through its NIH-Industry Partnerships initiative, NCATS supports and advances research on a wide range of common and neglected diseases.
In August 2016, NCATS announced a funding opportunity to explore a potential new use of an existing experimental drug or biologic as well as Food and Drug Administration-approved therapies already on the market. Through the Bench-to-Clinic Repurposing initiative, NCATS will support pre-clinical studies to test the utility of an independent crowdsourcing effort, computational algorithm or big dataset from patient records to predict new uses of a drug or biologic.
These pre-clinical studies will serve as an opportunity to demonstrate the usefulness of a drug-indication pairing method. One key goal is to identify therapeutic/indication pairing strategies that prove successful in the clinic and can be adopted by the scientific community to improve the data usability and efficiency of predicting new indications for existing therapeutics.
This new initiative represents an expansion of NCATS' New Therapeutic Uses program and is intended to complement ongoing efforts.