Armed Forces Institute for Regenerative Medicine (AFIRM)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Combat Casualty Care Research Program (CCCRP) (i.e., Joint Program Committee-6). Proposals selected for award as a result of this RPP will be awarded under the authority of 10 U.S.C. § 4022. Strategic oversight for the award supported by this RPP will be provided by CCCRP.

This RPP aims to develop a multi-institutional, interdisciplinary network of universities, companies, military laboratories, and investigators designed to promote a seamless integration of development, from research through translational and clinical research, as the best means of bringing regenerative medicine therapies to practice. The goal of this program is to accelerate the development of regenerative medicine prototypes to restore function to and heal injured Warfighters using this collaborative network, or consortium. The intent of the RPP is to make a single award to a Coordinating Site that can leverage the combined expertise of the U.S. Department of Defense (DoD), industry, and academia to advance regenerative medicine prototypes to the clinic.

Scope of Work

The intent of this RPP is to award the Coordinating Site, which will then commence studies after approval from the CCCRP. It is the Government’s intent that this initial award will have the potential for significant follow-on funding (pending availability of further funding and technical progress); the initial Period of Performance (PoP) proposed should not exceed 5 years. All full proposal submissions shall include a projection of the studies with Letters of Intent (LOI) to be conducted by the Consortium over the PoP of the award. Submissions shall also detail how the Offeror will accomplish/achieve all aspects of the requirements to include a clear approach to execute all tasks based upon the Offeror’s unique methodology. Therefore, the Offeror shall also clearly identify the major milestones in the Scope of Work (SOW)/Milestone Payment Schedule (MPS) associated with accomplishing these requirements.

Coordinating Site Capabilities to Translate Regenerative Medicine Prototypes:

The effort shall be led by a centralized Point of Contact (POC) at the prime performer to serve as the Coordinating Site. It is possible that several subcontractors will be required to accomplish the full scope of the project and each effort thereunder. Agreements among Armed Forces Institute for Regenerative Medicine (AFIRM) Consortium members shall be handled by the Coordinating Site to the greatest extent possible.

A centralized POC for the AFIRM Consortium at the Coordinating Site shall be named and will be ultimately responsible for official communication and deliverables. Offerors are expected to propose an AFIRM Consortium structure comprising the necessary qualified personnel, facilities, equipment, supplies, services, subcontractors, and related administrative and information technology support to accomplish the objectives. It is preferred that the Coordinating Site has established experience in the advancement and commercialization of technologies related to regenerative medicine; evidence of this experience should be included in the full proposal submission.

Furthermore, the Government recognizes that the composition of the team may change as the project requirements evolve over time. Therefore, the Offeror shall include the overall project management plan as part of the full proposal submission. The Offeror shall also describe its strategy to adjust (i.e., expand) the team as needed throughout the PoP (to include potential follow-on tasks) to ensure the proper level of effort, access to the necessary subject matter experts, etc.

The Coordinating Site’s role may include (but is not limited to) the following activities:

1. Consortium management

• Provide the Consortium Director, who will be the primary liaison with the Sponsor’s Office Technical Representative and the CCCRP.
• Ensure adherence to planned timelines and milestones.
• Manage Consortium-developed procedures for prioritization and implementation of studies.
• Develop, organize, and submit written progress reports and a final written comprehensive report to the USAMRDC.
• Provide a plan/process for establishing CCCRP-directed collaborations that may be outside of the initial Consortium.

2. Market breadth

• Describe the Offeror’s current network of regenerative medicine technology providers and exemplify the breadth and diversity of regenerative medicine areas of interest, with military relevance addressed by the Offeror’s current network and how the Offeror plans to continue market research throughout the PoP.

3. Project portfolio expansion

• Implement an objective technical review process for the evaluation of project information papers. Information papers will undergo a two-tiered evaluation process that includes a highly competent technical evaluation panel, followed by discussion and prioritization by the Executive Advisory Board (EAB) that will serve as the programmatic review panel. The Offeror is required to propose a Technical Evaluation Panel (TEP) that is objective and represents a diverse set of organizations so that a single organization does not have the majority viewpoint. The TEP must include people with different focus areas of interest, strengths, and organizational ties. The Offeror must also present a comprehensive Conflict of Interest (COI) plan and will be expected to manage/mitigate any COIs (including the perception of COIs). Full evaluation of the portfolio of projects will be executed by the CCCRP and the EAB. All regenerative medicine prototype projects will require approval by the CCCRP prior to addition to the AFIRM Consortium award.

4. Support the development activities required to advance prototypes related to regenerative medicine along their maturation pipeline. It will be the responsibility of the Coordinating Site to seek, initiate, and manage commercial partnerships. The Consortium is expected to leverage institutional capabilities or partners, or to employ external resources to identify and promote, commercial collaboration. The Offeror shall propose how to address specific challenges related to regenerative medicine prototype development and provide Letters of Support in their proposal from organizations of interest, including but not limited to:

• Non-clinical testing (to include pre-clinical, bench, and animal testing).
• Biocompatibility studies.
• Prototype refinement/maturation progressing toward a clinical product
• Stability and shelf-life studies.
• Establishment of Good Manufacturing Practice capabilities for clinical trials and for market release (Contract Manufacturing Organization capabilities).
• Clinical feasibility and pivotal studies (as needed) to support regulatory approval/clearance.
• Regulatory and reimbursement strategy.
• Clinical Research Organization (CRO) capabilities.
• Regulatory affairs and compliance capabilities.
• Investigational New Drug/Investigational Device Exemption Holder/Sponsor Responsibilities as per 21CFR312 subpart D.
• Prototype delivery for military-relevant testing, if required.
• Draft product support documentation (e.g., training guides, product inserts, etc.).
• Development of a business and/or commercialization plan for market release.

5. With coordination with CCCRP, oversee and manage the project portfolio to enhance the likelihood of prototype success.

• Conduct strategic planning to ensure successful transition of candidate prototypes to the commercial marketplace and the Warfighter.
• Provide resources and collaborative events for early translational activities, such as team building, strategy, project management and planning, etc.
• Conduct routine (e.g., Quarterly and/or Milestone) performance reviews.
• Provide routine technical and programmatic review of projects.
• Make recommendations to the EAB for approval regarding project status (e.g., termination, modification, continuation, changes to SOWs, re-partnering, terminations, reallocation of funding to current projects, etc.).

6. Results dissemination

• Conduct a yearly symposium that brings together key personnel from the Government, projects, and other key stakeholders. (Offerors should plan for this to be tagged onto the MTEC Annual Membership Meeting or Military Health System Research Symposium (MHSRS).)
• Manage Consortium-developed procedures for the timely publication of major findings and other public dissemination of data.
• Publish a yearly report that summarizes performance.

Proposed regenerative medicine prototypes must meet the following criteria:

1. Prototype Maturity: The AFIRM Consortium is expected to propose a portfolio of regenerative medicine prototypes that spans the pipeline of maturity, ranging from Technology Readiness Level (TRL) 3 to TRL 7.

2. Types of Prototypes: Proposed regenerative medicine prototypes may span the breadth of the U.S. Food and Drug Administration (FDA) classification list, including devices, drugs, biologics, combinations thereof, etc.

3. Military Relevance: The ultimate goal of this program is to accelerate the development of regenerative medicine prototypes to heal and restore injured Warfighters. Events in the Russia-Ukraine War have emphasized the need to change the trajectory of healing by providing better solutions closer to the point of need that can provide the framework for restoring form and function to combat casualties. Proposed prototypes must be relevant to the health care needs of the DoD and fall under one of the following focus areas:

• Craniomaxillofacial egeneration
• Extremity regeneration (bone, muscle, and/or nerve)
• Genitourinary/lower abdomen reconstruction
• Skin regeneration
• Ex-vivo/on-demand blood
• Cellular therapies for trauma and critical care

4. Commercial Partners: It is preferred that proposed prototypes shall include partnerships with commercial entities/industry partner(s) committed to bringing the product to market.

5. PoP: PoP for each proposed prototype shall not exceed the PoP of the award.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.