Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed
ID: PAR-23-268Type: BOTH
Overview

Topic

Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: STTRPhase: BOTHYear: 2023

Topic Link

https://www.sbir.gov/node/2388459

Additional Information

https://grants.nih.gov/grants/guide/PA-files/PAR-23-268.html
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the industrialization and translation of extracellular vesicles (EVs) for use in regenerative medicine. EVs are membrane-enclosed carriers of bioactive substances that are used for intercellular communication. This funding opportunity aims to support the development of novel EV-based therapeutic platforms for tissue and organ repair in regenerative medicine. The focus is on the production, manufacturing, and use of native or engineered EVs as therapeutics. The goal is to address challenges in the field, such as the production of sufficient quantities of EVs, labor-intensive isolation procedures, and non-specific isolation methodologies. The funding opportunity is open for both Phase I and Phase II (Fast track) grant applications. Phase I applications should focus on feasibility and therapeutic applications, while Phase II applications should optimize and scale-up technology platforms. The validation of therapeutic benefits is required for Phase II applications. The funding opportunity prioritizes IND enabling therapeutic platforms that have the potential for regulatory approval and commercialization. Applicants are encouraged to engage with the FDA Center for Biologics Evaluation and Research for regulatory guidance. The application deadline is June 6th, 2023, with subsequent deadlines in 2024 and 2025. More information can be found on the grants.gov website.

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