HEAL Initiative: Studies to Enable Analgesic Discovery (R61/R33 - Clinical Trial Not Allowed)

The HEAL Initiative's "Studies to Enable Analgesic Discovery" grant from the National Institutes of Health (NIH) aims to foster the development of innovative, non-addictive pain treatments, advancing research on alternatives to opioid-based therapies. This funding opportunity, led by the NIH and supported by multiple institutes including NINDS, NEI, NIA, and others, supports early-stage drug discovery, assay development, and the identification of therapeutic agents such as small molecules, biologics, and natural products. The initiative prioritizes projects developing assays and screening methods that can identify promising analgesic candidates, especially those targeting pain mechanisms without significant addiction liability. Selected projects will have the potential to meet the entry requirements for NIH's Pain Therapeutics Development Program or related translational research programs. Eligible applicants for this R61/R33 Phased Innovation Award include a range of higher education institutions, nonprofits, for-profit organizations, and state and local governments. Applicants must register with several entities, including SAM.gov, eRA Commons, and Grants.gov. Foreign institutions and non-domestic components are not eligible, although U.S.-based entities can collaborate internationally if justified. Each application should be distinct scientifically if an institution submits multiple applications. Budget limits are set at $350,000 in direct costs per year, with a maximum project duration of three years (up to two years for the R61 exploratory phase and up to two for the R33 developmental phase). Funded projects may include in vitro characterization of therapeutic agents, pharmacokinetic/pharmacodynamic studies, and early efficacy studies in animal models, though projects focused solely on computational studies, clinical research, or target validation are not eligible. The program requires applicants to outline the biological rationale linking their therapeutic approach to specific pain conditions and demonstrate the novelty and therapeutic potential of their research. Assays should be validated and capable of supporting medium- to high-throughput screening. Projects are encouraged to incorporate diverse, multidisciplinary teams and include plans for engaging individuals with lived experience of pain or addiction to inform research goals and outcomes. Applications are evaluated on scientific significance, innovation, rigor, feasibility, and the expertise of the research team. Review criteria emphasize the development of reliable assays, identification of promising therapeutic agents, and clearly defined milestones for transitioning from the R61 to the R33 phase. NIH also requires a comprehensive intellectual property (IP) strategy, ensuring that proprietary or patented resources will not hinder the development or commercialization of successful candidates. Budget requests should be justified in terms of the proposed research needs and timelines. Key dates for submission include the earliest submission date on December 28, 2024, with the first application deadline on January 28, 2025. Subsequent application cycles occur semiannually through January 2027. Letters of intent are encouraged 30 days before the application due date. Compliance with HEAL’s rigorous data-sharing and open-access publication policies is mandatory, with requirements to deposit data and study metadata into a HEAL-compliant repository to foster transparency and collaboration across the research community. NIH will evaluate progress against specific project milestones and maintain oversight through an annual HEAL Scientific Meeting and other program coordination activities. Applicants are encouraged to consult with NIH staff early in the process to ensure alignment with HEAL’s mission and discuss the project’s goals. Additionally, the grant includes comprehensive instructions for application submission and reporting, emphasizing data transparency, standardized data elements, and methods to integrate broad consent for data sharing.