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SAMDAILY.US - ISSUE OF FEBRUARY 01, 2023 SAM #7736
SPECIAL NOTICE

A -- MTEC Solicitation Summary: The Armed Forces Institute for Regenerative Medicine (AFIRM)

Notice Date
1/30/2023 1:21:50 PM
 
Notice Type
Special Notice
 
Contracting Office
W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
 
ZIP Code
21702-5014
 
Solicitation Number
MTEC-23-04-AFIRM
 
Response Due
3/16/2023 9:00:00 AM
 
Point of Contact
Lauren Palestrini
 
E-Mail Address
lauren.palestrini@ati.org
(lauren.palestrini@ati.org)
 
Description
The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for a Request for Project Proposal (RPP) for an Other Transaction for prototype project which 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 Department of Defense, industry, and academia to advance regenerative medicine prototypes to the clinic. � As stated at the end of this announcement, the full RPP is posted to the MTEC website (https://www.mtec-sc.org/solicitations/; this notice is intended only to notify interested parties of the available solicitation. Background: The initial award mechanism for AFIRM, which was first established in Fiscal Year (FY) 2008, resulted in awards to two consortia. A second solicitation for AFIRM in FY 2013 (AFIRM II) resulted in an award to a single consortium. A third solicitation for AFIRM III in FY 2019 provided funding to partnering project awardees focused on a narrower technical scope which included only peripheral nerve regeneration and skeletal muscle regeneration. Additional information regarding previous AFIRM awards and performers can be located on the following website: https://afirm.health.mil/. Objective: This funding opportunity is intended to support a goal/product-driven consortium of universities, companies, military laboratories, and investigators to accelerate development of regenerative medicine therapies. The award will be made to an organization able to serve as the Coordinating Site of the AFIRM Consortium to facilitate development and translation of regenerative medicine technologies related to Warfighter needs. The intent is to transition several regenerative medicine products over the period of performance (PoP) to the Warfighter and the commercial marketplace. Due to the Coordinating Site�s team with specialized expertise, this approach will de-risk technology development by providing capability/expertise to companies that have promising technologies but lack the ability and experience to bring their technologies to market. This structure also allows flexibility to replace failing prototypes with more promising ones throughout the PoP. Scope of Work: The intent of this RPP is to award the Coordinating Site which will then commence studies after approval from the Combat Casualty Care Research Program (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 PoP proposed should not exceed 5 years. All full proposal submissions shall include a projection of the studies with Letters of Intent 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 Statement of Work/Milestone Payment Schedule associated with accomplishing these requirements. Potential Follow-on Tasks: Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the PoP. Potential follow-on tasks may include (but are not limited to) the continued development of prototypes and/or inclusion of additional prototypes related to Warfighter regenerative medicine needs. Further development opportunities will be open and coordinated by the AFIRM Consortium�s Coordinating Site through MTEC. Potential Funding Availability and Period of Performance: The Government currently has available a total of approximately $19.1 million of FY 2022 Research, Development, Testing, and Evaluation (RDT&E) funds for this effort. Additional funding may be later available to the performer to continue prototype development. Award and funding from the Government is contingent upon the availability of federal funds for this program. MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work with an initial PoP not to exceed 60 months. Acquisition Approach: Full proposals will be required in response to this RPP thus reflecting a single stage acquisition approach. MTEC membership is required for the submission of a full proposal. The due date for Proposals is found on the cover page of this RPP. Proposals may not be considered under this RPP unless the Proposal was received on or before the due date specified on the cover page. The Government will evaluate Proposals submitted and will select those that best meet their current technology priorities using the criteria set forth in this RPP. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. The following resources may help Offerors form a more complete team for this requested scope of work. The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: Business Expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction Advisory], and Technical Expertise [i.e., chemistry, manufacturing and controls (CMC), clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps. MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the �MTEC Profiles Site� tab on the MTEC members-only website (https://private.mtec-sc.org/). A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity.� The chat forum can be accessed via the �Team Portal� on the MTEC members-only website - https://private.mtec-sc.org/. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters� health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, �nontraditional� defense contractors, academic research institutions and not-for-profit organizations. Point of Contact: For inquiries, please direct your correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator, mtec-contracts@ati.org Technical and membership questions should be directed to the MTEC Research Associate, Dr. Chuck Hutti, Ph.D., chuck.hutti@ati.org� All other questions should be directed to the MTEC Chief of Consortium Operations, Ms. Kathy Zolman, kathy.zolman@ati.org
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/a371df13a99241858ae769b45444594c/view)
 
Place of Performance
Address: Frederick, MD 21702, USA
Zip Code: 21702
Country: USA
 
Record
SN06576344-F 20230201/230130230103 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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