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

Frequently Asked Questions (FAQs)

What is the Strategic Alliances for Medications Development to Treat Substance Use Disorders funding opportunity (PAR 18-218)?

PAR 18-218 is an NIH funding opportunity led by the National Institute on Drug Abuse (NIDA) that supports medications development for substance use disorders (SUDs). It is designed to move promising medication candidates forward faster and more efficiently along a drug development pathway that supports eventual FDA review and approval.

What is the main goal of this program?

The main goal is to accelerate the progression of promising compounds toward FDA approval by supporting projects that clearly advance a medication candidate through a defined stage of the drug development pipeline. The program emphasizes milestone-driven development plans and encourages combining NIDA support with meaningful external partner contributions to reduce bottlenecks and shorten timelines.

Is this a basic research grant?

The program is not intended to fund basic research in isolation. Projects are expected to be positioned to advance a compound through a specific, FDA-relevant development stage, with clear deliverables and milestones that move the candidate meaningfully closer to FDA approval.

What does “strategic alliances” mean in this FOA?

“Strategic alliances” refers to collaborations that combine NIDA funding with the strengths, assets, and infrastructure of external partners such as academic institutions, pharmaceutical and biotechnology companies, private and public foundations, nonprofits, and small businesses. These alliances are meant to bring real-world development capacity (for example, manufacturing, formulation, regulatory expertise, and clinical operations) to speed progress.

Are partnerships required, or can a single organization apply?

Multi-organization partnerships are encouraged, but a single organization may apply if it can demonstrate substantial internal resources and a serious, concrete commitment to the project. The FOA provides examples of commitment such as salary support for key personnel or taking responsibility for producing and formulating clinical trial materials.

What kinds of outside contributions are expected from partners?

The FOA emphasizes “meaningful outside contributions” that complement federal support and help accelerate development. Examples of partner strengths and assets mentioned include medicinal chemistry expertise, manufacturing and formulation capability, clinical operations capacity, regulatory experience, access to specialized equipment, and access to patient populations.

What types of projects are in scope for this opportunity?

The scope is broad as long as the project is clearly tied to medications development for SUDs and positioned to support eventual FDA review. Supported work can include advancing a new molecular entity through preclinical and early development steps, or expanding the clinical indications of an existing medication (such as testing a drug already used for one condition for an additional SUD-related use).

Can the project focus on an existing medication rather than a brand-new drug?

Yes. The FOA explicitly includes expanding the clinical indications of an existing medication as an example of an in-scope approach, as long as the work advances the compound toward an FDA-relevant milestone for SUD-related use.

What does it mean to define an “entry point” and “exit point” in the development pathway?

Applicants are expected to clearly state the development stage where the project begins (the entry point) and the specific development milestone that will be achieved by the end of the award (the exit point). The exit point should represent a meaningful advancement toward FDA approval.

What development stages can serve as an entry point for an application?

The FOA provides examples of possible starting stages, including late preclinical development, IND-enabling work, early clinical testing, and later-stage clinical evaluation. The key requirement is that the application clearly identifies where it starts and what milestone it will reach.

What is the grant mechanism used for this opportunity?

The program uses the NIH R01 grant mechanism.

What does “Clinical Trial Optional” mean for this FOA?

“Clinical Trial Optional” means applicants may propose studies that include clinical trials, but they are not required to do so. Projects may instead focus on preclinical development, manufacturing, formulation, regulatory preparation, or other steps necessary to reach the next FDA-relevant milestone.

If clinical trials are optional, what other activities can be supported?

Based on the FOA description, supported non-trial activities may include preclinical development work, manufacturing and formulation efforts, regulatory preparation, and other development steps that enable advancement to the next FDA-relevant milestone.

How does this program aim to accelerate development compared to a traditional research grant?

The FOA is structured to support a more accelerated development pace than a traditional investigator-initiated research project by emphasizing milestone-driven plans and leveraging both NIDA funding and partner resources. The intent is to shorten timelines and reduce common drug development bottlenecks.

Who is the lead NIH institute for this program?

The program is led by the National Institute on Drug Abuse (NIDA).

What types of organizations are eligible to apply?

Eligibility is intentionally broad. Eligible applicants include 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), and for-profit organizations (including small businesses and other-than-small businesses), as well as other organizations.

Are specific institution types like HBCUs and Hispanic-serving institutions included in eligibility?

Yes. The FOA explicitly calls out additional eligible applicant categories including 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), and faith-based or community-based organizations.

Can organizations in U.S. territories or possessions apply?

Yes. The FOA includes U.S. territories or possessions among the explicitly listed eligible applicant categories.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The FOA explicitly includes non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.

What is the maximum award amount listed for this opportunity?

The listed award ceiling is up to $3,000,000.

What is the CFDA number and activity category for this program?

The FOA is described as a discretionary NIH grant opportunity in the health and education activity category with CFDA 93.279.

What were the creation date and the original closing date noted for this opportunity?

The source information notes a creation date of November 21, 2017, and an original closing date of July 25, 2019.

What kinds of internal commitments might strengthen an application from a single organization?

The FOA gives examples such as providing salary support for key personnel and taking responsibility for producing and formulating clinical trial materials, as ways to demonstrate substantial internal resources and a concrete commitment to the project.

What is the overall intent of the FOA in the SUD treatment landscape?

The FOA is positioned as a targeted effort to close the gap between promising scientific leads and approved treatments for substance use disorders by supporting credible development partnerships, concrete resource commitments, and clearly defined milestones that advance candidates toward FDA approval.