SPECIAL NOTICE
A -- Combination Drug Therapy for Penetrating Brain Injury
- Notice Date
- 4/28/2016
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- W81XWH-16-R-0032
- Point of Contact
- Flodean Billings, Phone: 3016192648
- E-Mail Address
-
flodean.p.billings.civ@mail.mil
(flodean.p.billings.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent to issue an award on the basis of other than full and open competition in accordance with the Federal Acquisition Regulation (FAR) 6.302-1 only one responsible source and no other supplies of services will satisfy agency requirements. The US Army Medical Research Acquisition Activity (USAMRAA) The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a single source award to Tallarida, Ronald J. at 6 Merion Way, West Deptford, NJ 08051. The total award amount is estimated to be $120,000.00. The requirement is to provide Combination Drug Therapy for Penetrating Brain Injury services to support the Center for Military Psychiatry and Neuroscience at the Walter Reed Army Institute of Research (WRAIR) The contractor shall facilitate the timely and efficient execution of the research by providing the provisions necessary to meet the BTNN objectives and perform the tasks described in this PWS. The primary objective of this Task will focus on evaluating improved therapeutic effects of neuroprotection combination therapies in the PBBI model. For these tasks, a combination therapy is defined as the treatment consisting of a pair of two (or more) neuroprotective agents administered at predetermined dose ratios which are calculated based on their ED50 (median effective dose) generated from their monotherapy D-R curve. While monotherapy evaluation of additional drugs is ongoing, the first 3 drugs to be included in combination studies will be determined by the Principal Investigator based on mechanisms of action and an established dose-response (D-R) profile when tested individually as a monotherapy in the PBBI model. To meet the objectives the contractor: •Shall evaluate two categories of drugs: neuroprotective agents (NA) and anti-epileptic drugs (AEDs) in a rat model of severe TBI. •Shall define the pharmacological nature of the combination therapy as synergism, additivity, or potentiation, the isobolographic analysis of drug-drug interactions will be used, which requires an experimental design in two phases: Phase I (monotherapy) will establish the dose-response (D-R) curve of each individual drug within the respective drug category and Phase II (combination therapy) will evaluate the combined effects of a pair of drugs selected from Phase I within each drug category. •Shall choose compounds that had previously demonstrated therapeutic efficacy in preclinical TBI models and were FDA-approved (in some formulation) for other clinical indications. •Shall provide technical expertise to conduct and analyze the data collected from the Phase I and Phase II studies. •Shall provide scientific and technical support for the research, development, and efficacy evaluation of singular and combination therapies. •Shall provide support to design research experiments to meet the goals of the tasks, process research data files, analyze research data, prepare manuscripts, author and present scientific protocols. This is not a formal solicitation or request for quote. This synopsis of intent is to give notice of the Government's intent to make a sole source award. Contractors who can provide USAMRAA with the required services are invited to electronically submit an affirmative, written response indicating a bona fide ability to meet this specific requirement. Responses should appear on company letterhead and include, at minimum, affirmation of active registration in the System for Award Management (SAM), your Data Universal qualifications, and any applicable pricing data or information. All responses should include a point of contact, telephone number, and electronic mail address. Additionally, respondents should indicate whether they are a large business, small business, small disadvantaged business, 8(a) concern, women-owned small business, HUBZone, service disabled veteran-owned small business, or qualify as socially or economically disadvantaged and whether they are U.S. or foreign owned. Responses to this notice will be used to determine the availability of this type of service. All responsible sources may respond to this synopsis and all responses will be considered by the agency. Responses should be furnished electronically to flodean.p.billings.civ@mail.mil no later than 9:00AM Eastern Standard Time, 09 May 2016.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-16-R-0032/listing.html)
- Place of Performance
- Address: Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN04098331-W 20160430/160428234539-d4faa9d9025b9ac81be9c83291f4dd98 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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