SOURCES SOUGHT
Q -- Evaluation of Exenatide actions on L-DOPA induced dyskinesia in a progressive Parkinson�s disease mouse model
- Notice Date
- 5/24/2022 8:13:08 AM
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022Q00259
- Response Due
- 6/8/2022 5:00:00 AM
- Point of Contact
- Jeanette Russell, Phone: (301) 827-5140
- E-Mail Address
-
Jeanette.Russell@nih.gov
(Jeanette.Russell@nih.gov)
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Background: Parkinson�s disease (PD) impacts 6 million people worldwide. As it is an age-related neurodegenerative disorder, the figure is estimated to increase to around 10 million by 2030 due to longevity increasing in most Western countries. The social and economic impact on patients and their caregivers is huge and is estimated at $US14.4 billion per year in the USA. Presently available symptomatic treatments for PD are predominantly directed on augmenting of dopaminergic signaling and can provide symptomatic relief for a limited time but have little effect on nonmotor symptoms, and none have been shown to affect the progressive pathological and clinical decline. The most widely used symptomatic treatment for PD worldwide is levodopa (L-DOPA). The use of L-DOPA elevates dopamine (DA) synthesis in the substantia nigra and restores motor functions in PD patients. However, chronic administration of L-DOPA is often associated with abnormal involuntary movements (AIMs), also called levodopa-induced dyskinesia (LID) in PD patients. Early clinical studies have shown that 20�50% of PD patients developed dyskinesia within 5 years after the initiation of L-DOPA treatment (Rascol et al., 2000;�Manson et al., 2012;�Bjornestad et al., 2016). The severity of dyskinesia positively correlates with disease duration, Hoehn�Yahr stage, and duration of L-DOPA treatment (Nicoletti et al., 2016). Other studies also suggest that the disease severity and dose of L-DOPA are more important than the duration of L-DOPA treatment for the development of LID (Nutt et al., 2010;�Espay et al., 2018). LID has also been established in experimental animals. Chronic administration of L-DOPA to unilaterally 6-OHDA-lesioned rats has been widely used to examine AIMs (Lundblad et al., 2002). Similar to the PD patients, LID in the lesioned rats significantly correlates with the dose of L-DOPA and the magnitude of DA depletion (Putterman et al., 2007). LID can severely impact PD patients and new treatments to mitigate it are sorely needed. NIA recently reported that systemic administration of PT320 (a sustained release formulation of the GLP-1 receptor agonist Exendin-4, given once every 2 weeks to unilaterally 6-hydroxydopamine (6-OHDA)-lesioned rats, provides sustained plasma exendin-4 levels (Chen et al., 2018) and had the ability to significantly mitigate L-DOPA/benserazide-mediated dyskinesia in a rat 6-OHDA model of Parkinsonism. Three doses of PT320 were administered over 3 weeks together with daily L-DOPA/benserazide (a peripherally acting aromatic L-amino acid decarboxylase inhibitor). NIA found that PT320 normalized DA turnover in the striatum and reduced LID behavior in these lesioned animals (Yu et al., 2020). This data supports the future clinical use of PT320 as a co-treatment with L-DOPA for PD. However, importantly, before such development and associated resources are committed, the efficacy of PT320 to mitigate LID requires to be cross-validated in a different preclinical animal model of PD associated LID. Purpose and Objectives: The National Institute of Health (NIH, National Institute on Aging (NIA), Intramural Research Program (IRP), Translational Gerontology (TG) Branch shall procure support services to analyze markers of L-DOPA induced dyskinesia in a progressive animal model of Parkinson�s disease (MitoPark mouse). The support services will evaluate whether the drug Exenatide provides a potential treatment strategy and evaluate the efficacy of an approved and well-tolerated type 2 diabetes mellitus drug, Exenatide, in mitigating L-DOPA-induced dyskinesia in a mouse model of Parkinson�s disease; the MitoPark mouse that has parallels to the human disorder. Brain regional tyrosine hydroxylase quantification are required together with quality control studies, and extensive statistical analyses with other behavioral/biochemical data and report generation. Project requirements: Independently and not as an agent of the Government, 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 (SOW) attached to this Sources Sought notice. Anticipated period of performance: Twelve (12) months after receipt of purchase order Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The respondent must also provide their Unique Entity ID from SAM.gov, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. All responses to this notice must be submitted electronically to the Contract Specialist.� Facsimile responses are NOT accepted. The response must be received on or before Wednesday, June 8, 2022 at 8:00 am, Eastern Time. �Disclaimer and Important Notes:� This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).�
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/f94462bb1d7244da9a1db045ec84286f/view)
- Place of Performance
- Address: Baltimore, MD, USA
- Country: USA
- Country: USA
- Record
- SN06337425-F 20220526/220524230127 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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