Overview
The purpose of this Notice of Funding Opportunity (NOFO) is to support the preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics for the treatment of pain. The goal of the program is to accelerate the advancement of promising early-stage therapeutic candidates and facilitate their readiness for Phase II clinical trials. Applicants must have a promising small molecule or biologic lead candidate for optimization,...
Complete grant details
The purpose of this Notice of Funding Opportunity (NOFO) is to support the preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics for the treatment of pain. The goal of the program is to accelerate the advancement of promising early-stage therapeutic candidates and facilitate their readiness for Phase II clinical trials. Applicants must have a promising small molecule or biologic lead candidate for optimization, a strong biological rationale for the proposed approach, and established assays to guide the optimization process. The scope of the program includes lead optimization, early-stage development activities, IND-enabling studies, development of pharmacodynamic and/or target engagement biomarkers, preparation and submission of an Investigational New Drug (IND) application, and Phase I clinical testing. This is a milestone-driven, phased cooperative agreement program that involves active participation by NIH program staff in project planning and ongoing monitoring of research progress.
Eligible applicants Private institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); City or township governments; Independent school districts; For profit organizations other than small businesses; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Public housing authorities/Indian housing authorities; Special district governments; County governments; State governments; Public and State controlled institutions of higher education; Native American tribal governments (Federally recognized)
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Eligibility requirements
Private institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); City or township governments; Independent school districts; For profit organizations other than small businesses; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Public housing authorities/Indian housing authorities; Special district governments; County governments; State governments; Public and State controlled institutions of higher education; Native American tribal governments (Federally recognized)
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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