B01-RFI.docx

Request for Information (RFI) - Hydrogel Embedded Dexamethasone for the Traumatic Brain Injury (TBI)

This is a non-personal services contract for the Traumatic Brain Injury (TBI) at the Walter Reed Army Institute of Research (WRAIR). The services are for Hydrogel Embedded Dexamethasone support.

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

1. SUBJECT: The WRAIR, is conducting market research to assess commercial availability of performing Hydrogel Embedded Dexamethasone support for the Traumatic Brain Injury (TBI). In line with the above goal, the WRAIR wishes to obtain information from sources who possess the ability to perform the tasks required.

2. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

3. DESCRIPTION: The purpose of this requirement is to provide the technical expertise and support services necessary to perform traumatic brain injury and neuroprotection research in support of the BTN Branch at Walter Reed Army Institute of Research (WRAIR). The Contractor shall deliver and determine the pharmacokinetic (PK) profile of dexamethasone delivered via PEG-hydrogel, and conduct studies that specifically evaluate the therapeutic efficacy of dexamethasone-embedded PEG-hydrogel treatment on neurobehavioral (i.e. motor and cognitive) outcome measures. Additionally, the Contractor shall evaluate the acute post-injury dexamethasone-embedded PEG-hydrogel treatment on measures of injury-induced edema, inflammatory cytokine upregulation, and neuroinflammation.

4. REQUIREMENTS: Please provide the following information about your organization:

4.1. Organization Information: Please provide the following:

4.1.1. Organization’s full legal name

4.1.2. DUNS Number

4.1.3. Socio-economic status (Large business, small business, 8(a), VOSB, SDVOSB, etc.)

4.1.4. Address

4.1.5. Point of contact name, phone number, and email

4.2. Capability Statements: Through this RFI, the Government is looking for capability statements that demonstrate experience in the following:

4.2.1 The Contractor shall provide primary support for a multi-arm study to examine the following research objectives:

4.2.1.1 Evaluating the effect of dexamethasone embedded hydrogels in attenuating pro-inflammatory cytokine levels when administered at different time points following PBBI.

4.2.1.2 Evaluating the ability of dexamethasone embedded hydrogels in attenuating behavioral dysfunction following severe TBI.

4.2.1.3 Quantifying dexamethasone levels in brain and blood when administered through PEG-hydrogels after PBBI/CCI injury in rats.

4.2.1.4 Evaluating the ability of dexamethasone embedded hydrogels in reducing tissue following severe TBI.

4.2.2 Specific Tasks / Requirements: The contractor shall:

4.2.2.1 Conduct research experiments to meet the stated objectives in Section 6.1, process the research data files, and analyze the resulting research. In support of this task, the contractor shall:

4.2.2.1.1 Assist with the monitoring of research animals, at the direction of WRAIR personnel.

4.2.2.1.2 Provide the technical expertise necessary to conduct and analyze TBI Hydrogel-dexamethasone research.

4.2.2.1.3 Ensure all support is provided by personnel with the necessary technical expertise to collect and analyze data.

4.2.2.1.4 Provide scientific and technical support for the following areas:

4.2.2.1.4.1 The research, development, and efficacy evaluation of dexamethasone-neuroprotection therapies.

4.2.2.1.4.2 Research on the molecular and cellular mechanisms of brain injury and dexamethasone-neuroprotective therapies.

4.2.2.1.5 Determine the pharmacokinetic (PK) profile of dexamethasone delivered via PEG-hydrogel.

4.2.2.1.6 Evaluate the acute post-injury dexamethasone-embedded PEG-hydrogel treatment on measures of injury-induced edema, inflammatory cytokine upregulation, and neuroinflammation.

4.2.2.1.7 Evaluate the therapeutic efficacy of dexamethasone-embedded PEG-hydrogel treatment on neurobehavioral (i.e. motor and cognitive) outcome measures.

4.2.2.1.8 Provide guidance on handling and application of the hydrogel-drug matrix to brain-injured animals (WRAIR-PBBI model).

4.2.2.1.9 Participate in data analysis and manuscript preparation/submission along with WRAIR researchers.

4.2.2.1.10 Provide biological samples to WRAIR for histological analysis, within 14 business days from collection.

4.2.2.1.11 Provide biological samples (rat tissue) following hydrogel treatment for pharmacokinetics and histological analysis to WRAIR researchers, within 14 business days of completion of each experiment, in a temperature sensitive manner.

4.2.2.1.12 Provide quarterly research progress reports to WRAIR researchers.

5. SMALL BUSINESS SET ASIDE: The Government has not determined the set-aside capability, if possible, at this time. The Government will use the RFI results in analyzing small businesses’ capacity to perform this requirement and make its decision.

6. INSTRUCTIONS FOR RESPONDING

Submission: Please submit an electronic copy, in a “.pdf” file type, of your response to Moriah Bartlett at email address: moriah.s.bartlett.civ@mail.mil. Please use the title in your email “Hydrogel Embedded Dexamethasone – RFI Response.”

Due Date: RFI response submission is due by 10:00 a.m. E.S.T., 3 June 2020.

Page Limit: Limit your total written response to five (5) pages (single-sided). The cover page and table of contents does not count towards the page limit. Beyond the five (5) page limit, the Government may only review examples of media and graphic design, as requested above.