NIH Blueprint for Neuroscience Research Grand Challenge: Developing Novel Drugs for Disorders of the Nervous System (U01)

National Institutes of Health

Description

Purpose. The National Institutes of Health (NIH) announces a unique opportunity for investigators working with molecular probe compounds to gain access to a robust virtual pharma drug development network to develop neurotherapeutic drugs. Successful applicants to this initiative will be collaborative participants in this network, receiving both funding and no-cost access to contracted drug development services that are not typically available to the NIH-funded research community. Funding will be provided through a U01 cooperative agreement to conduct biological testing of compound analogs in disease assays and models in the investigators laboratory. No-cost drug development services will also be provided, including medicinal chemistry optimization, IND-directed pharmacology and toxicology, and Phase I clinical testing. Researchers who have disease assays and small molecule compounds that show promise for treating nervous system and psychiatric disorders, but that are not yet suitable for clinical testing, are strongly encouraged to apply. Investigators funded through this FOA will be active partners in the design and implementation of the drug development strategy in collaboration with an NIH-appointed advisory panel of drug development experts. This program is structured to allow investigators to maintain control of the intellectual property generated using their assays and starting compounds and to pursue commercialization of compounds that are developed within the program. This program was established by the NIH Blueprint for Neuroscience and will consider applications for nervous system disorders within the missions of any of the 16 participating NIH Institutes (http://neuroscienceblueprint.nih.gov/blueprint_basics/about_blueprint.htm). Disorders of interest include, but are not limited to, neurological, psychiatric and developmental disorders, dementias of aging, diseases and disorders of the eye or ear, and drug and alcohol dependence and addiction. By initiating development of up to 20 new small-molecule compounds over two years, we anticipate that approximately four compounds will enter Phase 1 clinical trials within this program. The ultimate goals of this Neurotherapeutics Grand Challenge are to produce at least one novel and effective drug for a nervous system disorder that is currently poorly treated and to catalyze industry interest in novel disease targets by demonstrating early-stage success. Mechanism of Support. This FOA will use the NIH Research Project Cooperative Agreement (U01) award mechanism. Funds Available and Anticipated Number of Awards. The participating ICs intend to commit up to $1,750,000 in FY 11 to fund up to 10 awards in the first year of this program. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. It is anticipated that funded projects will carry direct costs of up to $125,000 per year for in vitro and/or in vivo bioactivity screening.

Who can apply

• Public and State controlled institutions of higher education
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH OER Webmaster<br/>FBOWebmaster@OD.NIH.GOV<br/>
FBOWebmaster@OD.NIH.GOV