National Institutes of Health

Description

The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement grant applications to support experimental medicine-based first in human (FIH) and proof of concept (POC) studies of new mechanism of action, IND-ready candidate medications to treat mental disorders. The objective of the FOA is to accelerate the development of innovative pharmacological treatments through support of early phase human clinical testing. FIH pharmacology studies should assess target engagement, pharmacological effects, safety, and tolerability of novel compounds in order to build a pipeline for initial POC or efficacy trials in patients. POC studies of novel compounds should use pharmacologically based dosing, with assessment of target engagement and evaluation of the impact of compounds on clinically relevant physiological systems as well as clinical indicators of effect. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action or combination treatments and to attract private funding for further clinical and commercial development of candidate medications. Partnerships between academia and industry are strongly encouraged.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• 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