SPECIAL NOTICE
A -- customized subdermal implants
- Notice Date
- 3/26/2018
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH18R0048
- Archive Date
- 5/24/2018
- Point of Contact
- Julie L. Burns,
- E-Mail Address
-
julia.l.burns3.civ@mail.mil
(julia.l.burns3.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENT TO SOLE SOURCE Date: Monday, 26 Mar 2018 Contracting Office Zip Code: 21702-9232 Classification Code: 541715 "Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)" Contracting Office Address: US Army Medical Research Acquisition Activity (USAMRAA) 1504 Porter Street Fort Detrick, MD 21702-5014 The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1(a) with the Southwest Research Institute for the production of customized subdermal implants with a specific combination of a drug of choice and ethylene-vinyl acetate (EVA) copolymer using the patented technology ProNeura. Solicitation Number: W81XWH18R0048 Responses Date: 1:00pm eastern, Monday, 09 May 2018 Point of Contact: Julie L. Burns at julia.l.burns3.civ@mail.mil Anticipated Contract Award Date: 01 Jul 2018 Contractor: Southwest Research Institute Description: The Experimental Therapeutics (ET) Branch of the Walter Reed Army Institute of Research (WRAIR) focuses on the development of new drugs to prevent and treat malaria, leishmaniosis, antibiotic-resistant bacteria, and other infectious disease threats to US Service members. The ET branch is currently developing anti-malarial drugs to address current and projected unmet medical needs including a long-term prophylactic regimen for malaria prevention. Drug discovery and development research is attempting to develop anti-malaria prophylactic drug infused implantable matrices that have sustained release. The combination of atovaquone/proguanil (Malarone®) and doxycycline are the only FDA-approved prophylactic drugs for malaria prevention. Because of the relatively short half-lives of the drugs, successful prevention of malaria is highly dependent on compliance with a daily oral dosing regimen. The FDA approved long-term drug delivery platform, ProNeura, is a matrix of ethylene vinyl acetate (EVA) which is readily available to modify this drug administration schedule. By incorporating long term release of FDA-approved antimalarial drugs in a drug matrix of EVA, drug rods can be implanted in service members, which frees the deployed service members from adhering to a daily oral drug dosing schedule and should protect from malaria for the entire deployment after implant insertion. Thus, the combination of atovaquone/proguanil and doxycycline in subdermal implant form will be tested for long-term prophylactic efficacy to replace the current orally administered drug regimens. Scope: The scope of this requirement includes the following: 1. Production of customized subdermal implants with a specific combination of a drug of choice and ethylene-vinyl acetate (EVA) copolymer using the patented technology ProNeura and shipment of the implants to the WRAIR, located in Silver Spring, MD. •2. 2. Production of documentation and technical reports for each batch of implants produced. •3. 3. Development of the analytical methods to support residual payload analysis, performance of residual payload analysis on explants from mice, and production of data reports from the analysis The work for this requirement will be performed at the Contractor's site. This notice of intent is for information purposes only. All sources eligible to provide this service must respond in writing. Responses must be supported with clear and convincing evidence to clearly articulate the ability to provide these exact services outlined above. A request for documentation will not be considered as an affirmative response by a vendor. If no responses are received by the close date of this publication notice to the effect that comparable services are available from other source AND that it is more advantageous to the Government to use another source compared to obtaining these services through a sole-source contract, then a sole source acquisition award will be made to Southwest Research Institute.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH18R0048/listing.html)
- Place of Performance
- Address: WRAIR, Silver Spring, Maine, United States
- Record
- SN04866907-W 20180328/180326231302-91ede5f11835c2358f2ebc19c36114ac (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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