Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01 Clinical Trial Optional) | PAR 18 218

Opportunity Information: Apply for PAR 18 218

The Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01 Clinical Trial Optional) funding opportunity (PAR 18-218) is an NIH program led by the National Institute on Drug Abuse (NIDA) that is designed to move promising medication candidates for substance use disorders (SUDs) forward faster and more efficiently on a path toward FDA approval. The central idea is to fund projects that are not just basic research, but that clearly advance a compound through a defined stage of the drug development pipeline. In practice, NIDA is looking for well-structured, milestone-driven development plans that use a blend of federal support and meaningful outside contributions so that candidate medications can progress more quickly than they typically would under standard, slower-moving research grant models.

A defining feature of this FOA is the emphasis on “strategic alliances.” Applicants are encouraged to form collaborations that combine NIDA funding with the strengths, assets, and infrastructure of external partners, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, nonprofits, and small businesses. These alliances are meant to provide real-world development capacity: things like medicinal chemistry expertise, manufacturing and formulation capability, clinical operations, regulatory experience, and access to specialized equipment or patient populations. While multi-organization partnerships are clearly encouraged, applications from a single organization are also acceptable when that organization can demonstrate substantial internal resources and a serious, concrete commitment to the project. The FOA gives examples of what that commitment might look like, such as providing salary support for key personnel or taking responsibility for producing and formulating clinical trial materials.

The scope of supported work is broad as long as it is clearly tied to medications development for SUDs and is positioned to support eventual FDA review. Projects can range from advancing a new molecular entity (a novel drug candidate) through preclinical and early development steps, to expanding the clinical indications of an existing medication (for example, testing a drug already used for one condition to see if it can be approved for an additional SUD-related use). Regardless of where the project starts, each application is expected to define a clear “entry point” and “exit point” in the development pathway. This means reviewers will look for applicants to state exactly what stage they are beginning at (for example, late preclinical development, IND-enabling work, early clinical testing, or later-stage clinical evaluation) and what specific development milestone will be achieved by the end of the award that meaningfully advances the compound toward FDA approval.

The program uses the R01 grant mechanism and is labeled “Clinical Trial Optional,” meaning applicants may propose studies that include clinical trials, but they are not required to do so if the proposed work is better suited to preclinical development, manufacturing, formulation, regulatory preparation, or other steps necessary to reach the next FDA-relevant milestone. Importantly, the FOA signals that both the budget level and project period are set with speed in mind: it is structured to support a more accelerated development pace than a traditional investigator-initiated research project, with the expectation that the combination of NIDA support plus partner resources will shorten timelines and reduce common development bottlenecks.

Eligibility is intentionally wide to attract the mix of organizations typically needed to develop medications. Eligible applicants include many types of U.S. government entities (state, county, city or township governments; special district governments; and eligible federal agencies), education entities (independent school districts; public/state-controlled and private institutions of higher education), tribal governments and organizations (including federally recognized tribal governments and other tribal organizations), public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (including those other than small businesses as well as small businesses), and other organizations. The FOA also explicitly calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This breadth reflects the program’s goal of building development teams with the right technical capabilities and community reach to bring SUD medications to real-world use.

From an administrative and funding perspective, this is a discretionary NIH grant opportunity in the health and education activity category (CFDA 93.279). The listed award ceiling is up to $3,000,000. The source information also notes an original closing date of July 25, 2019, and a creation date of November 21, 2017. Overall, the FOA is best understood as a targeted push to close the gap between promising scientific leads and actual approved treatments for substance use disorders by encouraging applicants to bring credible development partnerships, concrete resource commitments, and clearly defined FDA-relevant advancement milestones to the table.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2017-11-21.
• Applicants must submit their applications by 2019-07-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
• Eligible applicants include: 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 tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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