B01-Notice of Intent to Sole Source.doc

Notice of Intent to Sole Source Date: 6/4/2020 Contracting Office Address – US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

Contact Points: Contracting Officer – Laura Tomitz laura.a.tomitz.civ@mail.mil or 301-319-2051 or Contract Specialist – Moriah Bartlett, moriah.s.bartlett.civ@mail.mil 301-619-2579 Subject: Notice of Intent to Sole Source – The services are for Hydrogel Embedded Dexamethasone support, for the Traumatic Brain Injury (TBI) at the Walter Reed Army Institute of Research (WRAIR).

Solicitation Number: W81XWH20R0066 The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1 with the Clemson University performing support for Hydrogel Embedded Dexamethasone for TBI.

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.

This requirement is for support necessary to perform traumatic brain injury and neuroprotection research, which requires a degradable, synthetic hydrogel. The use and method of making this degradable hydrogel is patented to Clemson University under Patent No. US 7,754,241 B1. The referenced patent cites a method that “comprises obtaining a hydrophilic polymer having at least two hydroxyl groups, reacting the hydrophilic polymer with a di-functional monomer comprised of an acid halide group and an alkyl halide group to form an intermediate having an ester bond and a terminal alkyl halide group, reacting the terminal alkyl halide group of the intermediate with a metallic salt of a vinyl acid monomer to form a macromonomer comprised of an ester, an alkyl group spacer, and a terminal vinyl group, and polymerizing the macromonomer to form a degradable hydrogel. A method is also disclosed for varying the degradation rate of the hydrogel as a function of the chemical composition of the alkyl group spacer in the terminal linkage of the macromonomer.”

This method of cross-linking the degradable hydrogel, while exclusive to Clemson University, is also ideal for end-user applications including, but not limited to, biomedical applications, such as dexamethasone and minocycline, that are specific to BTN’s research priority. This degradable hydrogel being exclusive to Clemson University makes pursuing full and open competition for this requirement not only impracticable, but impossible.

REQUIREMENTS:

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

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

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

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

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

· Specific Tasks / Requirements: The contractor shall:

· 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:

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

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

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

· Provide scientific and technical support for the following areas:

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

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

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

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

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

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

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

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

· 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.

· Provide quarterly research progress reports to WRAIR researchers.

The period of performance shall be a one, twelve month base period with four, twelve month option periods. The NAICS Code for the contract is 541715 and the PSC code is AJ51.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible, interested parties may identify their interest by submitting capability information, in writing, by 10:00 p.m. est. 13 June 2020 to Moriah Bartlett at Moriah.s.Bartlett.civ@mail.mil. Supporting evidence must be furnished in sufficient detail to demonstrate the contractor’s ability to provide the stated capability.

Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, USAMRAA will proceed with the sole source contract.