Opportunity Information: Apply for PAR 23 268
The National Institutes of Health (NIH) funding opportunity PAR-23-268, titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed," supports small businesses that are developing extracellular vesicle (EV)-based therapeutic platforms aimed at regenerative medicine. The award uses the Small Business Technology Transfer (STTR) cooperative agreement mechanisms, meaning projects are expected to involve a formal collaboration between a small business and a nonprofit research institution, and NIH program staff will typically have substantial involvement during the project period compared with a standard grant. The intent is not just to fund basic discovery, but to push EV technologies toward practical, scalable, and reproducible therapeutic development that can ultimately support human use, without supporting clinical trials under this specific announcement.
The scientific focus is on extracellular vesicles as a therapeutic modality for repairing or regenerating tissues and organs. EVs, whether native (naturally produced by cells) or engineered (modified to enhance targeting, cargo, potency, or safety), have shown potential to influence cell behavior and tissue repair through delivery of biologically active cargo such as proteins, lipids, and nucleic acids. This FOA emphasizes the translation of those promising biological effects into real-world therapeutic platforms, with an emphasis on the "industrialization" side of the field: making EV production and use more manufacturable, consistent, and compatible with downstream regulatory and commercialization needs.
A central theme of the opportunity is platform-oriented technology development tied to production, manufacturing, and use of EV therapeutics for regenerative medicine. In practice, this points to projects that tackle persistent bottlenecks in the field, such as scalable manufacturing workflows, robust isolation and purification methods, standardized characterization and potency assays, engineering approaches that can be executed reproducibly at scale, stability and storage solutions, and quality systems that support eventual regulatory filings. Applicants are essentially being asked to build the kind of enabling infrastructure and methods that allow EV therapeutics to move beyond small, variable lab preparations and toward controlled, well-characterized products suitable for broader translational pipelines.
The funding instrument is a discretionary cooperative agreement within the NIH health research portfolio (CFDA 93.350). Because it is a cooperative agreement (UT1/UT2), applicants should expect milestones, close coordination with NIH, and an emphasis on deliverables that demonstrate progress toward translation. The opportunity is explicitly "Clinical Trial Not Allowed," so proposed work should remain in the preclinical and translational development space, such as establishing manufacturing processes, demonstrating reproducibility, conducting non-clinical proof-of-concept and safety-enabling studies as appropriate, and building the toolkit needed to support eventual IND-enabling activities (while not conducting a clinical trial within this award).
Eligibility is limited to small businesses, consistent with STTR requirements. Foreign institutions are not eligible to apply, and non-domestic (non-U.S.) components of U.S. organizations are also not eligible. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowed, which typically refers to specific, well-justified project elements performed outside the U.S. under the umbrella of a U.S. applicant organization, subject to NIH rules and approval. This distinction matters for teams considering specialized testing, unique resources, or collaborations that might involve international partners; the allowable path is usually a defined foreign component rather than a non-U.S. applicant or non-domestic branch of a U.S. entity.
Key administrative details from the source information include the opportunity title and number (PAR-23-268), the agency (NIH), the funding instrument type (cooperative agreement), and the original closing date of 2025-06-06. The listed award ceiling is $295,924. The opportunity was created on 2023-04-18. The expected number of awards is not clearly provided in the source text beyond an incomplete field, so prospective applicants would need to confirm anticipated award counts and budget structure in the full notice of funding opportunity.
Overall, this FOA is aimed at small business-led teams that can pair strong EV biology with practical development know-how, focusing on the hard translational steps that make EV therapeutics credible as regenerative medicine products. Competitive proposals are likely to be those that define a clear platform, identify specific manufacturing and translation barriers, propose measurable milestone-driven work to overcome them, and demonstrate a pathway toward reproducible production and use of EV-based therapeutics that can later support regulatory advancement and commercialization.Apply for PAR 23 268
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
- This funding opportunity was created on 2023-04-18.
- Applicants must submit their applications by 2025-06-06. (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 $295,924.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the funding opportunity number and title?
The opportunity is NIH PAR-23-268, titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed."
Which agency is offering this funding?
The funding opportunity is offered by the National Institutes of Health (NIH).
What is the main purpose of PAR-23-268?
This FOA supports small businesses developing extracellular vesicle (EV)-based therapeutic platforms for regenerative medicine, with an emphasis on translation and "industrialization" (scalable, reproducible, manufacturable development) rather than basic discovery.
What therapeutic area does this FOA focus on?
The scientific focus is on extracellular vesicles as a therapeutic modality for repairing or regenerating tissues and organs within regenerative medicine.
What are extracellular vesicles (EVs) in the context of this opportunity?
EVs are cell-derived vesicles that can influence cell behavior and tissue repair through delivery of biologically active cargo such as proteins, lipids, and nucleic acids. The FOA includes both native EVs (naturally produced) and engineered EVs (modified to enhance targeting, cargo, potency, or safety).
What does "industrialization" mean for EV therapeutics under this FOA?
In this FOA, "industrialization" points to the practical development work needed to make EV therapeutics manufacturable, consistent, and compatible with downstream regulatory and commercialization needs. It emphasizes moving beyond variable lab-scale preparations toward controlled, well-characterized products and processes.
What types of projects are a strong fit for this announcement?
Projects are expected to be platform-oriented and tied to production, manufacturing, and use of EV therapeutics for regenerative medicine. The FOA highlights bottlenecks such as scalable manufacturing workflows, robust isolation and purification methods, standardized characterization and potency assays, reproducible engineering approaches, stability and storage solutions, and quality systems supporting eventual regulatory filings.
Does this FOA fund basic discovery research on EV biology?
The intent is not just basic discovery. The FOA is focused on pushing EV technologies toward practical, scalable, and reproducible therapeutic development that can ultimately support human use.
Are clinical trials allowed under PAR-23-268?
No. The FOA is explicitly "Clinical Trial Not Allowed," so the proposed work must remain in preclinical and translational development rather than conducting a clinical trial within this award.
If clinical trials are not allowed, what kinds of studies can be supported?
The supported work should remain in the preclinical and translational development space, such as establishing manufacturing processes, demonstrating reproducibility, conducting non-clinical proof-of-concept, conducting safety-enabling studies as appropriate, and building toolkits to support eventual IND-enabling activities (without running a clinical trial under this FOA).
What funding mechanism is used (UT1/UT2), and why does it matter?
The award uses cooperative agreement mechanisms (UT1/UT2) under the STTR program. Cooperative agreements typically involve substantial NIH program staff involvement during the project period compared with a standard grant, and projects are expected to include milestones and deliverables demonstrating progress toward translation.
Is this an STTR opportunity, and what does that imply for collaboration?
Yes. It uses the Small Business Technology Transfer (STTR) mechanism, which means projects are expected to include a formal collaboration between a small business and a nonprofit research institution.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with STTR requirements.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply to this opportunity.
Are non-domestic (non-U.S.) components of U.S. organizations eligible?
No. Non-domestic (non-U.S.) components of U.S. organizations are also not eligible.
Are any international activities allowed at all?
Possibly. "Foreign components" as defined in the NIH Grants Policy Statement may be allowed when they are specific, well-justified elements performed outside the U.S. under a U.S. applicant organization, subject to NIH rules and approval.
What is the CFDA number associated with this opportunity?
The FOA is within the NIH health research portfolio and is associated with CFDA 93.350.
What is the award ceiling listed in the provided information?
The listed award ceiling is $295,924.
When was this opportunity created?
The opportunity was created on 2023-04-18.
What is the closing date listed in the provided information?
The original closing date listed is 2025-06-06.
How many awards does NIH expect to make?
The expected number of awards is not clearly provided in the source information (the field appears incomplete). Applicants would need to confirm the anticipated award count and related details in the full notice of funding opportunity.
What are NIH reviewers likely to look for in competitive proposals based on this description?
Based on the provided description, competitive proposals are likely to define a clear EV platform, identify specific manufacturing and translation barriers, propose measurable milestone-driven work to overcome them, and show a credible path toward reproducible production and use of EV-based therapeutics that can later support regulatory advancement and commercialization.
What does "platform-oriented technology development" mean in practical terms here?
It means building enabling technologies, methods, and workflows that can be applied repeatedly and reliably (not one-off lab preparations), especially those that improve manufacturing, purification, characterization, potency measurement, stability, storage, reproducibility, and quality systems for EV therapeutics intended for regenerative medicine.
Does the FOA include both native and engineered EV approaches?
Yes. The FOA includes EVs that are native (naturally produced) and engineered (modified to enhance targeting, cargo, potency, or safety), as long as the development emphasis is on translation and scalable, reproducible execution.
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