Funding Opportunity: AFIRM-002 Advancing Therapeutic Reprogramming for Military Regenerative Medicine

Purpose

As outlined in section 1.2 of the RPP, this solicitation is issued by the Wake Forest Institute for Regenerative Medicine (WFIRM) as the AFIRM Coordinating Center (CC). WFIRM serves as the AFIRM execution management agent through Other Transactions Authority (OTA) award MTEC-23-04-AFIRM-004 issued by the Medical Technology Enterprise Consortium (MTEC). Program priorities, award decisions, and oversight are the responsibility of the Defense Health Agency (DHA) Research and Engineering Directorate (RED) Combat Casualty Care Portfolio and the U.S. Army Medical Research Acquisition Activity [(USAMRAA, part of the U.S. Army Medical Research and Development Command (USAMRDC)]. The AFIRM program and AFIRM CC are responsible to the MTEC and to the DHA RED Combat Casualty Care Portfolio for program execution. This Request for Project Proposals (RPP) is focused on supporting regenerative medicine research to improve prevention, detection, diagnosis, treatment, and/or quality of life. Awards made from this effort are intended to support translational research or clinical trials.

AFIRM Background

As outlined in section 3 of the RPP, the DOD first established the AFIRM in 2008 in the form of two consortia, one led by Wake Forest and the other by Rutgers University. A second solicitation for AFIRM in FY13 (AFIRM II) resulted in an award to a single consortium, led by Wake Forest. A non-Consortium solicitation for AFIRM in FY19 provided funding to partnering project awardees focused on a narrower technical scope which included only peripheral nerve regeneration and skeletal muscle regeneration.

The current AFIRM consortium program was solicited through the MTEC under RPP# 23-04- AFIRM, which resulted in an award to the WFIRM as the CC. The AFIRM CC is expected to facilitate development and translation of regenerative medicine technologies related to Warfighter needs. The intent is to transition several regenerative medicine products to the Warfighter and the commercial marketplace. Due to the specialized expertise of the WFIRM team, this approach will de-risk technology development by providing capability/expertise to companies that have promising technologies. Request for Project Proposals AFIRM-FY25 Page 7 of 20 Additionally, the AFIRM CC works closely with the DHA RED Combat Casualty Care Portfolio in an actively coordinated effort to address the regenerative medicine needs of the DoD.

This allows the AFIRM CC to:

• Assist in the identification and prioritization of regenerative medicine technology of relevance to the DoD,
• Provide recommendations to DHA RED Combat Casualty Care Portfolio for the allocation of funding,
• Support MTEC and DHA RED Combat Casualty Care Portfolio by executing awards and related modifications of regenerative medicine prototype candidates as subawards to the AFIRM CC,
• Facilitate collaborations with intramural DoD laboratories where appropriate, and
• Provide synchronization and integration of Awardee efforts within the AFIRM consortium and with external stakeholders

FY 2025 AFIRM Focus Areas

As outlined in section 3.3 of the RPP, All proposals for FY25 AFIRM funding must specifically address one of the Focus Areas as directed by the DHA RED Combat Casualty Care Portfolio and have direct relevance to activeduty Service Members, Veterans, and/or military beneficiaries. The AFIRM implements a portfolio-driven approach within Focus Areas as a framework to address critical gaps in research and product development. A portfolio approach helps to ensure that all Focus Areas are being addressed with the most relevant science and technology available.

The AFIRM Focus Areas are listed in below:

• Focus Area #1: Craniomaxillofacial Regeneration
• Focus Area #2: Extremity Regeneration
• Focus Area #3: Genitourinary/lower abdomen Reconstruction
• Focus Area #4: Skin Regeneration
• Focus Area #5: Ex-vivo/on demand Blood
• Focus Area #6: Cellular therapies for Trauma and Critical Care

Projects must address development of products that are regenerative in nature or may be carriers for a regenerative factor. As mentioned above, these projects/products may include, but are not limited to:

• Cells (native and modified) and cell components (includes secreted factors, extracellular vesicles, lysozymes)
• Small molecules to include drugs and peptides
• Biologics to include proteins and antibody-drug conjugates
• Gene therapies and CRISPR-based gene editing

Submission & Review Dates

• Request Issue Date: August 18, 2025
• White Paper Due Date: October 17, 2025 Noon EDT
• Peer Review: November 2025
• Programmatic Review: December 2025
• Award Negotiations Begin: February 2026

White Paper Submission

As outlined in section 4.1 of the RPP, White Papers should be submitted by the date and time specified on the cover page via the http://afirm.info website application portal. Submitters will need to establish a secure account within the afirm.info website. Instructions are posted at http://afirm.info. Offerors are encouraged to contact help@afirm.info up until the White Paper submission date/time to clarify requirements.

Offeror Eligibility

As outlined in Section 2.4 of the RPP, MTEC membership is not required for submission of a white paper.