SOURCES SOUGHT
A -- Neurotherapeutic Resuscitation Research
- Notice Date
- 10/25/2016
- Notice Type
- Sources Sought
- 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
- 0010934241
- Archive Date
- 11/9/2016
- Point of Contact
- Sharew Hailu, Phone: 3016199201
- E-Mail Address
-
sharew.hailu.civ@mail.mil
(sharew.hailu.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for Information (RFI) Neurotherapeutic Resuscitation Strategies in Polytrauma associated with Traumatic Brain Injury General Information: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein. This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI. RFI Response and due date: 11/08/2016 Instructions to Responders: Responses from all capable and qualified sources are encourgaged to respond to this request. White papers should adhere to the following formatting and outline instructions: 1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. 2. Cover Page (1page) •Title •Organization •Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses) •Topic area(s) addressed 3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requriements as specified in the Peformance Work Statement. Please note that responses are due no later than 8 November, 2016. The preferred method of submission is via email. The point of contact for this action is Sharew Hailu, Contract Specialist Sharew.Hailu.civ@mail.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis. Performance Work Statement 1.0SCOPE OF WORK: This Performance Work Statement (PWS) defines the procurement of the technical expertise and support services necessary to refine animal models of military relevant brain injury by better understanding the co-morbidities during the sub-acute and chronic timeframe after injury. This work supports the mission of the Brain Trauma, Neuroprotection and Neurorestoration (BTNN) Branch, Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research (WRAIR). 2.0BACKGROUND: The mission of the Walter Reed Army Institute of Research (WRAIR) is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers life saving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter. Brain Trauma Neuroprotection and Neurorestoration (BTNN) Branch, Center for Military Psychiatry and Neuroscience, of the WRAIR conducts preclinical research of mild-severe traumatic brain injury (TBI), specifically the penetrating ballistic-type TBI and closed head impact concussion for the U.S. Army Medical Research and Materiel Command (USAMRMC). Research specializes in "polytrauma", accounting for the impact of hemorrhagic shock and failure to oxygenate and/or ventilate on the progression brain injury. This research collaboration will evaluate a novel neurotherapeutic resuscitation strategy for treating TBI in the event of hemorrhagic shock during the pre-hospital phase. The findings will be the basis for future preclinical studies with delayed/long-term treatments and will provide important knowledge for future clinical studies. The research will provide insight leading to improvements in clinical practice guidelines to optimize resuscitation approaches for patients with TBI (i.e. approaches to optimize cerebral perfusion and brain salvage). Successful translation of solutions generated from the research will improve stabilization and salvage of neurologic injuries at all echelons of care. 3.0PERIOD OF PERFORMANCE: Base Period: 1 January 2017- 31 December 2017 (or 1 year from date of contract award) Option Year1: 1 January 2018- 31 December 2018 Option Year 2: 1 January 2019 - 31 December 2019 4.0OBJECTIVES: The objective of this requirement is to facilitate the timely and efficient execution of the research by providing the provisions necessary to meet the objectives of this PWS and perform the tasks described in this PWS. The overall objective is to evaluate therapeutic strategies combining colloid resuscitation (Hextend) with drugs targeting cerebral edema via HMGB-1 blockade for pre-hospital treatment of TBI-polytrauma. To meet the objectives, the contractor shall: •Shall provide support to monitoring research animals, conduct research experiments to meet the goals of the tasks, process research data files, analyze research data •Shall provide technical expertise to conduct and analyze brain trauma neuroprotection and neurorestoration research. •Shall have technical expertise to collect and analyze data. •To provide scientific and technical support for the development, validation, and application of animal models of TBI •To provide scientific and technical support for the research, development, and efficacy evaluation of neuroprotection/neurorestoration therapies. •To provide scientific and technical support for research on the molecular and cellular mechanisms of brain injury and neuroprotective/ neurorestorative therapies. •To determine what pathological characteristics are measurable in the acute periods following CCI and polytrauma. •To assess the neurobehavioral outcomes following prehospital treatment of fluid/drugs combination. 5.0REQUIRED TASKS: The following tasks will support biomedical research to determine the efficacy of a novel prehospital resuscitation strategy targeting high mobility group box-1 (HMGB-1)-induced cerebral edema for treating TBI and hemorrhagic shock. The experiments will be conducted using a mouse model of controlled cortical impact (CCI) with hemorrhagic shock (HS) to include: 5.0.1 Characterize the systemic/cerebral perfusion, oxygenation and intracranial pressure during shock, pre-hospital (treatment) and hospital (after treatment) phases of CCI and HS. Animals will be subjected to CCI+HS and then resuscitated with fluid and drugs at a specified dose (3 drugs with 3 different doses per drug) during the pre-hospital phase. Physiological parameters including mean arterial pressure, intracranial pressure, cerebral perfusion pressure, brain tissue oxygen tension and blood gases will be monitored continuously beginning at baseline (pre-injury), shock, pre-hospital to hospital phase. The volume of resuscitation fluid required to maintain the desired physiological parameters will be recorded. Cerebral edema formation for each rat brain will be examined using wet/dry method at 24 hours post-injury. A total of 100 animals (10 groups; 10 per group) will be used. 5.0.2 Examine the efficacy of the resuscitation fluid/drugs combination on ameliorating the blood-brain barrier integrity, inflammation and oxidative stress via blockade of HMGB-1 pathways. Animal will be subjected to CCI+HS and then resuscitated with fluid and drugs at a specified dose (3 drugs with optimal dose determined in Task 4.0.1). (1) At 2 and 24h after the hospital phase, brain tissue, cerebral spinal fluid (CSF) and blood serum will be collected upon euthanization. Protein expression of nuclear and cytoplasmic HMGB-1, TNF-α, IL-1β, IL-6, p65 subunit of NF-κB, iNOS, 4HNE or 3NT in brain tissue, cerebrospinal fluid, or blood serum will be evaluated using Western Blotting or ELISA. (2) At 4 h and 72 h after the hospital phase, Evans blue dye will be administered intravenously in another cohort of animals and allowed to circulate for 30 min prior to perfusion. The amount of extracted dye from tissue homogenates will be quantified. (3) At 24 hour, transcardial perfusion will be performed in another cohort of animals for immunohistochemistry analyses to examine glial activation (GFAP and Iba-1 staining). Fluorescent immunostaining of HMGB-1 will be performed to confirm its nuclear-cytoplasmic translocation. A total of 120 animals (4 groups; 6 per group; 3 different cohorts of animals) will be used. 5.0.3 Assess the neurobehavioral outcomes following prehospital treatment of fluid/drugs combination. Animal will be subjected to CCI+HS and then resuscitated with fluid and drugs at a specified dose (3 drugs with optimal dose determined in Task 4.0.1). (1) Motor function will be assessed using Rotarod task at 7 days, 14 days, and 1 month post-injury. (2) Cognitive function will be assessed using Morris Water Maze task at 13-17 days, and 1 month post-injury. A total of 60 animals (4 groups; 15 per group) will be used. 6.0GENERAL REQUIREMENTS: 6.1Place of Performance: All work associated with this effort shall be performed and completed at the Safar Center for Resuscitation Research, University of Pittsburgh. 6.2Other Direct Costs: General lab supplies related to the above experiments including animal costs, reagent, consumables, as well as printing/publication and university overhead. 7.0DELIVERABLES: All deliverable shall be delivered to the BTNN Branch, WRAIR and shall include: 7.0.1 All raw data collected from the above tasks will be analyzed and provided to BTNN Branch via electronic mail. 7.0.2 Summary of the data will be provided in the form technical reports every three months. 7.0.3 Data from these studies shall be provided in the form of peer reviewed publications and technical reports as appropriate and prepared in support of Combat Casualty Care Research Program (CCCRP) Task Area H "Brain Trauma, Neuroprotection, and Neuroregeneration". 8.1Contractor Manpower Reporting 8.1.2 The contractor shall report all contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. 8.1.3 Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning 2016. Contractors may direct questions to the help desk at: http://www.ecmra.mil. 8.1.4 Register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA. The Federal Supply Code (FSC) is AN11. 9.0 Contracting Officer's Representative: The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: •Assure that the Contractor performs the technical requirements of the contract •Maintain written and oral communications with the Contractor concerning technical aspects of the contract •Monitor Contractor's performance and notify both the Contracting Officer and Contractor of any deficiencies
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/0010934241/listing.html)
- Place of Performance
- Address: University of Pittsburgh, Pittsburgh, Pennsylvania, United States
- Record
- SN04312799-W 20161027/161025234846-7993567747cfef9f0a7a0c41ef074fc0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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