Contact Points
Cleveland, OH 44106
This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to Case Western Reserve University School of Medicine; 9501 Euclid Avenue; Cleveland, OH 44106. This acquisition is restricted to Case Western Reserve University School of Medicine due to this study being specific to ischemic strokes and the services being rendered require an extensive background in preclinical studies involving the ischemic stroke and the MCAo model of stroke in rodents as well as the demonstration of peer reviewed publications in Pub Med. Previous experience in the use and handling of plasma and brain samples for biochemical/immunohistochemical assessments of neuroinflammatory proteins is also required with demonstration of peer reviewed publications in Pub Med. Lastly, there must be previous experience of handling biological samples associated with Pomalidomide and thalidomide-like drugs with the demonstration of peer reviewed publications in Pub Med.
Acquisition Authority: This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 – Simplified Acquisition Procedures, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-06 dated July 12, 2021.
This contract is to measure inflammatory markers in plasma and brain samples from rodents administered three experimental drugs (3,6'-DP, 1,6'-DP, Pom) or vehicle in rodents challenged with ischemic stroke.
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General Requirements: |
The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work. The Government will provide the plasma and brain samples requiring assessment.
Ischemic stroke is a major, worldwide, central nervous system disorder associated with high disability and mortality rates. Age is a major risk factor for ischemic stroke. Although several clinical treatment methods are currently available for patients with ischemic stroke, including antiplatelet aggregation, anticoagulation, improving the microcirculation and brain metabolism, these do not effectively provide regenerative and reparative actions within the ischemic area. The standard treatment is to either use recombinant tissue plasminogen activator (rt-PA) or to perform mechanical thrombectomy to restore blood flow. However, these treatments have limitations. The effective treatment time window of rt-PA is 4.5 h, and patients with large artery occlusion can be treated by thrombectomy within 6 h or even beyond 24 h of symptom onset. Despite this, nearly 60% of patients do not achieve functional independence or substantial neurological improvement at 3 months after treatment (Rabinstein A. A. (2020). Update on treatment of acute ischemic stroke. Continuum 26 268–286. 10.1212/CON.0000000000000840; Shafie M., Yu W. (2021). Recanalization therapy for acute ischemic stroke with large vessel occlusion: where we are and what comes next? Transl. Stroke Res. 12 369–381. 10.1007/s12975-020-00879-w). As a consequence, new treatment strategies to improve the clinical outcome of patients challenged with ischemic stroke (which represents some 80% of all stroke cases) remain a significant and current major unmet medical need.
Numerous studies have shown an inflammatory response in brain tissue to local or complete ischemia in animals and humans - the severity of which depends on the site, area, course, and type of the ischemic brain injury. Neuroinflammation following ischemic brain injury in rats is evident in microglia and astrocyte responses in different brain structures, but particularly in the CA1 and CA3 areas of the hippocampus and the dentate gyrus, as well as in the motor and sensory cortex. This can be evaluated by immunohistochemistry techniques as well as by biochemical evaluations of cytokine and chemokine levels in brain regions. Additionally, due to chemokine release and a loss of blood-brain barrier integrity, a systemic inflammation ensues that can be evaluated in plasma samples by biochemical techniques – such as by the Meso Scale Discovery (MSD) technology platform.
Specifics:
Animals. Plasma and brain samples will be provided to the Contractor for assessment of neuroinflammatory proteins. These samples will derive from the following groups of animals:
(i) Pure Control animals (without stroke and administered vehicle) N = 5
(ii) Stroke-challenged Control animals (with stroke and administered vehicle) N = 21
(iii) Stroke-challenged treated animals (with stroke and administered one of three experimental drugs)
- Pomalidomide N £ 13
- 3,6’-DithioPomalidomide N £ 13
- 1,6’-DithioPomalidomide N £ 13
The following assessments are required from plasma samples at two (2) time points ((i) baseline (pre-stroke) and (ii) post-stroke): IL-1b, IL-2, IL-5, IL-6, IL-10 and TNF-a. (Total N £ 65 samples x 2 time points for each analyte)
(iv) A subset of brain samples (N = 4) from the above groups of animals will require immuno-histochemical/biochemical assessment of the following: Catalase, SOD2 in plasma and two brain regions (cerebral cortex and hippocampus), as well as of microglial and astrocyte activation (Iba1 and GFAP). (Total N £ 16 x 3 for each protein). In addition, cresyl violet staining and NeuN staining will be used to outline the ischemic core.
Results. Results will require to be tabulated (Mean + standard error of the mean) and graphed.
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Specific Requirements: |
KEY PERSONNEL
- Contractor MUST have extensive background in preclinical studies involving the ischemic stroke and the MCAo model of stroke in rodents – must demonstrate with peer reviewed publications in Pub Med.
- Contractor MUST have previous experience in the use and handling of plasma and brain samples for biochemical/immunohistochemical assessments of neuroinflammatory proteins – must demonstrate with peer reviewed publications in Pub Med
- Contractor MUST have previous experience of handling biological samples associated with Pomalidomide and thalidomide-like drugs.
All aforementioned requirements must be demonstrated with peer reviewed publications in Pub Med.
LEVEL OF EFFORT:
Senior scientist with background in neuroscience/neurodegeneration (with M.D., Ph.D. or both) with background in ischemic stroke, neuroinflammation and knowledge of pomalidomide/thalidomide-like drugs
DELIVERABLES
- Within 12 months of award, a research report providing a written overview of the data (Tables and graphs/figures), methods utilized, and short summation of key results must be delivered as an electronic file.
- The Contractor shall have brief, monthly meetings via conference call with Dr. Nigel H. Greig (NIA/NIH) to highlight the progress and define any problems needing resolution.
DATA RIGHTS
Data generated in relation to the contract will belong to the NIA/NIH and Contractor, and will be used to (i) support decisions whether to further develop the experimental drugs as a new treatment strategy for ischemic stroke, and (ii) will be published in the scientific literature.
CONFIDENTIALITY
The Contractor will keep confidential any documents provided by the NIA/NIH and/or Dr. Nigel H. Greig that are not in the public domain and that are marked as "Confidential".
Contract Type:
A Firm Fixed Price type order award not exceeding the Simplified Acquisition Threshold is anticipated to be awarded resulting from this requirement.
Summary Statement:
The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.
All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”
Quoter Terms and Conditions (To be completed by the Offeror):
1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms:
4. NIH BPA Number, if applicable:
5. DUNS No:
6. Name of Company:
7. Street Address, City, State, Zip code:
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:
The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their quotation.
1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their quotation.
1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
All responses must be received by July 26, 2021 at 5pm EST and must reference announcement / solicitation number NIA POTS 21-010282. Responses may be submitted electronically to katie.cartwright@nih.gov. Fax responses will not be accepted.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.