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Evaluation of Exenatide in a MitoPark Mouse Model of Parkinson�s Disease

General Information

Document Type:PRESOL
Posted Date:Aug 26, 2020
Category: Special Studies and Analyses - Not R&D
Set Aside:N/A

Contracting Office Address

NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA

Description

This is a combined synopsis/solicitation for noncommercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 75N95020Q00171 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a noncommercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).� The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute on Aging (NIA), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Case Western Reserve University, School of Medicine, 10900 Euclid Avenue, Cleveland, OH, 44106, for the Evaluation of Exenatide in a MitoPark Mouse Model of Parkinson�s Disease. This acquisition is conducted as non-competitive for a non-commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2020-08, with effective date August 13, 2020. The associated NAICS code is 541990 and the small business size standard is $16.5 million.�� This requirement has no set-aside restrictions. This requirement is for the following services: Evaluate the efficacy of an approved and well tolerated type 2 diabetes Mellitus drug, Exenatide, in a disease progressive mouse model of Parkinson�s disease � the MitoPark mouse that has parallels to the human disorder. An interesting and well characterized preclinical model that mimics many aspects of the human disorder is the MitoPark mouse in which a selective and progressive degeneration of dopamine neurons occurs within the substantia nigra leads to adult onset degeneration of nigrostriatal dopamine circuitry with resulting motor deficits that can be mitigated by LDOPA administration. This degeneration is induced by a cell type-specific inactivation ofmitochondrial transcription factor A, a protein indispensable for� mitochondrial DNA expression and preservation, within dopamine neurons that leaves them respiratory chain deficient. The focus of this contract is to evaluate the efficacy of Exenatide in the MitoPark mouse model of PD. Salient Characteristics include: The preclinical evaluation of Exenatide in a MitoPark mouse model of Parkinson�s disease. The SOW includes outcome measures: Histochemical Behavioral Biochemical Animals. The breeding scheme for generating MitoPark mice has been described previously (Ekstrand et al. 2007, Galter et al. 2010, [Ref 1, 2, above] and must comply with this. Briefly, MitoPark mice will be generated on a C57BL6 background, in which the DA transporter (DAT) promoter will be used to drive cre-recombinase expression, and these will be crossed with mice in which the Tfam gene has been loxP-flanked. Use of IRES technology allows both DAT alleles to be maintained. All animals used in the studies will be either males or female � but not mixed (due to gender differences in disease progression). Age-matched wild type mice will be used as controls. Genotyping of mice is essential, and all studies must be undertaken on approved Animal protocols. � Exenatide studies. Exenatide will be provided by the Government� who will oversee the scientific basis of the project. The Exenatide will be in the form of the sustained release form, PT320. This will be clinical grade material and will be administered subcutaneously once every two weeks. The dose of PT320 will be 0.6 mg/kg, subcutaneously once every 2 weeks. As Exenatide represents only 2% of the drug available within the formulation of PT320 (the remaining 98% is polymers from which it is slowly released from), the total amount of material used is 30 mg/kg of PT320. (This is equivalent to 0.6 mg/kg of Exenatide). Notably, the PT320 microsphere powder will NOT go into solution � but will form a suspension. It is important to �vortex� just before injecting the PT320 into animals, and that the PT302 material is in suspension immediately prior to each injection Behavioral Studies Locomotor activity. 5-10-week-old mice will be habituated to a low-noise experimental environment for 1 h and then placed in an open-field chamber (20 cm x 30 cm x 30 cm) in this environment. A digital camera will be mounted on the ceiling to allow filming the animals while moving freely for 1 hour. The videos will be analyzed by dedicated software (TopScan�, Clever Sys Inc., VA, USA) to detect rodent movements and behaviors based on video-tracking of multiple individual body parts, posture and frequency of movements. The horizontal movements for 1 hour were taken as distance traveled. Cylinder test. The cylinder test will be performed to evaluate vertical movements and axial set. The mice will be habituated to a low-noise experimental environment for 1 h. After habituation, the mice will be placed in an open-top, clear plastic cylinder (diameter: 20 cm, height 30 cm) for 5 min and behavior recorded by a video camera. Rearing will be counted from video records. Rotarod test. Rotarod tests will be performed to evaluate motor coordination and balance. During a training phase, mice will be introduced to walking on the rotating rod (47650 Rota- Rod NG, Ugo Basile, Comerio, Italy) one day before being tested. The training will be completed when all mice were able to walk forward for 720 s at 15 rpm. The accelerating speed (from 5 rpm to 80 rpm within 240 s) rotarod test will be performed 3 times a day every 2 weeks. The time until the animal falls off the rotating rod will be recorded by observers blinded to the mice genotypes. Trials will be separated by at least 30 min. [18F]FE-PE2I PET scan imaging for Dopamine Transporter function (or alternative imaging -depending on approval of Dr. Greig TGB/NIA/NIH). Longitudinal imaging studies will be performed to evaluate the dopaminergic system in brain at approx. 8 and 16 weeks. NAc and striatal brain slice preparation. Brain will be were prepared as described previously (Chen et al. 2008, Good et al. 2013) for evaluation of immunohistochemistry in NAc and striatal brain slices. Tyrosine hydroxylase levels will be evaluated at approx. 8 and 20 weeks. Fast scan cyclic voltammetry and dopamine measurements in brain slices. FSCV recording will be performed as described previously (Chen et al. 2017, Cho et al. 2006) at 8 and 12 weeks. Statistics. Statistical analyses of data for DA release input/output curves and behavioral tests will be performed using a two-way analysis of variance (ANOVA) followed by a Bonferroni post hoc test for multiple comparisons. All statistical tests will be two-tailed and performed using appropriate software (GraphPad Prism 5.02, GraphPad Scientific, San Diego, CA, USA). A p-value <0.05 using a two-tailed test was considered significant. Level of Effort. enior scientist with background in neuroscience/neurodegeneration (with M.D., Ph.D. or both) with background in PD and knowledge of GLP-1 receptor agonist drugs. Deliverable: A research report providing a written overview of the data (Tables and/or graphs/figures), statistical analyses, and short summation of key results � as an electronic file. The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months after date of award. The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:� https://www.acquisition.gov/browse/index/far�� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html�� (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far���� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html� (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) 52.213-4 Terms and Conditions � Simplified Acquisitions (Other than Commercial Items) (Aug 2020) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text: FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020) 52.204-26�Covered Telecommunications Equipment or Services-Representation (Dec�2019) NIH Invoice and Payment Provisions (2/2014) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. Technical and past performance, when combined, are significantly more important than cost or price. Offerors must include a completed copy of the following provisions with their offer: 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020) 52.204-26�Covered Telecommunications Equipment or Services-Representation (Dec�2019) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.� � Responses to this solicitation must include clear and convincing evidence of the offeror�s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. 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. All quotations must be received by 3:00 pm Eastern Daylight Time, on Friday, Septemeber 4, 2020, and reference Solicitation Number 75N95020Q00171. Responses must be submitted electronically to Diedra Prophet, Contract Specialist, at diedra.prophet@nih.gov. Fax responses will not be accepted. The name and email address of the individual to contact for information regarding the solicitation: Diedra S. Prophet, diedra.prophet@nih.gov Karen Mahon, Karen.Mahon@nih.gov

Original Point of Contact

POC Diedra Prophet, Phone: 3014028070, Karen Mahon

Place of Performance

Address:
Cleveland, OH 44106, USA
44106, USA
Link: SAM.gov Permalink
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