SPECIAL NOTICE
A -- Joint Warfighter Medical Research - Adaptive Orthopaedic Biologics for Highly Targeted Regeneration
- Notice Date
- 3/3/2015
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH15C0028
- Archive Date
- 3/2/2016
- Point of Contact
- Jamie Diggs, 301-619-2663
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(jamie.l.diggs.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Materiel Development Activity (USAMMDA) intends to issue a firm-fixed price contract for the work addressing the Joint Warfighter Medical Research - Adaptive Orthopaedic Biologics for Highly Targeted Regeneration for Extremity Injury by utilizing the Joint Warfighter Medical Research Program (JWMRP). Extremity injury is the top-ranked priority focus area for DoD and targets the two most common injuries that service members suffer in combat and peacetime. Service members suffer from traumatic bone injury and spinal disc degeneration from years of physical stress. In this requirement, the contractor will conduct preclinical evaluation of a binding variant of bone morphogenetic protein in models of long-bone segmental defect and spinal fusion in order to support Investigational New Drug (IND) filings. The work will advance the drug to a stage where it will be ready for Phase 1 human clinical trials. In accordance with Federal Acquisition Regulation (FAR) the statutory authority permitting other than full and open competition is 10 U.S.C. 2304 (c) (1). The FAR citation is 6.302-1(a)(2) with application at 6.302-1(b)(1)(ii). As directed by Congress in the Department of Defense Appropriations Bill, 2014 Report 113-85, page 190, $100M quote mark shall be used to augment and accelerate high priority Department of Defense (DoD) and Service medical requirements and to continue prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. The funds shall not be used for new projects or for basic research. quote mark For this reason, the undersigned determined that the cited statutory authority permitting other than full and open competition is supported and required. This Bill essentially limits the competition to contractor's that have existing Congressional Special Interest Funded Research Projects (contracts or assistance agreements) and have a military relevance. The Bill also states that funds shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps. The strategy in executing the JWMRP was to find highly valued research efforts on a research grant or contract that could meet critical service requirements and that were not being continued through other appropriations. Based on a comparative analysis by the scientific and programmatic reviewers from USAMRMC, approximately 45 JWMRP research projects were selected for a follow-on effort to the previous effort (Contracts and Assistance Agreements.) The Geneva Foundation's research is the only known research that can be considered when viewed in the context of the statutory mandated program described above. The Geneva Foundation was identified for its promising develop in procedures to safely target the delivery of the bone-inducing agent to the site of traumatic bone injuries from explosive devices, and back pain caused by spinal disc degeneration. The objective is to conduct preclinical evaluation in models of long bone segmental defect and spinal fusion in order to support investigational new drug (IND) filings for these indications. The five specific aims are to (1) establish a production method for the drug, (2) conduct studies in rats to test efficacy of the drug, (3) compare the drug to the current standard drug, (4) perform good laboratory practices toxicity tests in two species, and (5) prepare an IND application for a Phase I trial. This sole source requirement is deemed to be available only from The Geneva Foundation as a follow-on effort. Competing this requirement would result in substantial duplication of costs and unacceptable delays. This notice of intent is for information purposes only, therefore, no solicitation will result from this announcement. All responsible sources may submit a capability statement, proposal or quotation, which shall be considered by the agency. A request for documentation will not be considered as an affirmative response. The action will be awarded without further notice. The Point of Contact (POC) for this action is jamie.l.diggs.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH15C0028/listing.html)
- Record
- SN03657089-W 20150305/150303234810-e6dab797f4755d2ff6e5c4373d339f72 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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