Pharmas, Academics Partner on New Treatments from Old Drugs

(FDA.gov)

Researchers from pharmaceutical companies and academic labs are partnering on finding therapies for eight types of diseases from drugs tested to treat other disorders. The $12.7 million pilot program, led by National Center for Advancing Translational Sciences (NCATS), part of National Institutes of Health, funds nine separate projects combining industry and university scientists for up to three years.

A key objective of the program, called Discovering New Therapeutic Uses for Existing Molecules, is reduce the long period of time now needed to develop new treatments, that can take as long as 13 years from discovery of a new drug target to final regulatory approval. The program also aims to mine the collection of compounds that may have been found safe to use, but not shown to be effective against their initial targets.

Last year, NCATS recruited eight pharmaceutical companies to take part in the initiative, who offered existing compounds and biologics from their portfolios, particularly those that are safety tested and approved to treat specific diseases, as candidates to test for further applications. In a crowd-sourcing exercise, NCATS then asked academic scientists to propose new ways of using these drugs, with the new nine collaborations resulting from those proposals.

The diseases addressed in this initiative are alcohol dependence, Alzheimer’s disease, calcific aortic valve stenosis — hardening of the heart valve that makes it difficult to pump blood out of the heart — nicotine dependence, peripheral artery disease, schizophrenia, Duchenne muscular dystrophy, and lymphangioleiomyomatosis, a progressive lung disease. Duchenne muscular dystrophy and lymphangioleiomyomatosis are considered rare diseases.

The nine projects in the pilot program include researchers from AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Pfizer, Sanofi, Janssen Research & Development — a division of Johson & Johnson — and AbbVie, a spin-off company from Abbot Laboratories. They and their academic partners will conduct pre-clinical validation and safety tests as required, followed by clinical feasibility or proof-of-concept studies that show potential effectiveness.

Universities and research institutes taking part are Indiana University in Indianapolis, Yale University, Virginia Commonwealth University, University of Pittsburgh, University of Rhode Island, Kennedy Krieger Institute in Baltimore, University of Washington, University of Virginia, Baylor College of Medicine in Houston, and Mayo Clinic in Rochester, Minnesota. Yale University scientists are taking part in studies in two types of disease — schizophrenia and Alzheimer’s disease. Researchers from National Institute of Drug Abuse are also participating in the research on alcoholism.

An additional feature to be tested in the pilot projects are new procedures to streamline the often time-consuming process of setting up industry-university collaborations. These template agreements, as NCATS calls them, have a standard format for memorandums of understanding between the companies and institutes, as well as a catalog of the companies’ confidential disclosure statements and standard collaborative research agreements.

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