Opportunity
Simpler Grants.gov #PAR-25-327
NIH Solicits R&D Services for IND-Enabling Studies of Gene-Based Therapies for Ultra-Rare Neurological Disorders
Buyer
National Institutes of Health
Posted
December 18, 2024
Respond By
October 08, 2027
Identifier
PAR-25-327
NAICS
541714, 541715
The National Institutes of Health (NIH) is seeking proposals to advance gene-based therapies for ultra-rare neurological and neuromuscular disorders through the URGenT network. - Government Buyer: - National Institutes of Health (NIH) - Scope of Work: - Research and development services for IND-enabling studies and planning activities - Focus on First-in-Human clinical testing of gene-based or transcript-directed therapeutics - Targeting ultra-rare neurological and neuromuscular disorders - Eligibility and Participation: - Open to government entities, businesses, educational institutions, nonprofits, and other organizations - Non-domestic entities are not eligible, but foreign components may participate as defined by NIH policy - Funding and Contract Details: - Cooperative agreement funding instrument - No cost sharing or matching required - Unique Requirements: - Applicants must demonstrate robust biological rationale and proof of concept data for their clinical candidates - Emphasis on accelerating development toward IND filing and clinical trial initiation - No specific OEMs or vendors are named, as the solicitation is for research and development services rather than products.
Description
This funding opportunity supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human clinical testing of gene-based or transcript-directed therapeutics targeting ultra-rare neurological or neuromuscular disorders. The goal is to accelerate the development of promising clinical candidates with strong biological rationale and proof of concept data towards IND filing and clinical trial initiation. Eligible applicants include various government entities, businesses, educational institutions, nonprofits, and other specified organizations. The funding instrument is a cooperative agreement with no cost sharing or matching requirement.