SOLICITATION NOTICE
R -- Gliptin Effects in Rodent Model of Parkinson’s Disease - Notice of Intent 4574530
- Notice Date
- 9/14/2017
- Notice Type
- Presolicitation
- NAICS
- #541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-17-485
- Archive Date
- 10/6/2017
- Point of Contact
- Danielle R. Brown, Phone: 301 480 2385
- E-Mail Address
-
danielle.brown2@nih.gov
(danielle.brown2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent 4574530 - Gliptin Effects in Rodent Model of Parkinson’s Disease PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE Solicitation: HHS-NIH-NIDA-SSSA-NOI-17-485 Title: Gliptin Effects in Rodent Model of Parkinson's Disease INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract for the Gliptin Effects in Rodent Model of Parkinson's Disease with Yu (Agnes) Luo, PhD, Department of Neurosurgery, Case Western Reserve University School of Medicine, 10900 Euclid Avenue, Cleveland, Ohio, 44106. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 - Other Scientific and Technical Consulting Services with a Size Standard of $15.0 Million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 05-95, January 19, 2017. STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 - Only one response source and no other supplies or services will satisfy agency requirements. DESCRIPTION OF REQUIREMENT Project Description Parkinson's disease (PD) is a widespread neurodegenerative disorder that impacts approximately 1.5% of worldwide population over the age of 65 years. Presently available treatment is focused towards dopamine (DA) replacement and, although such therapy can at initially be effective in ameliorating PD associated motor symptoms associated with PD, disease progression invariably occurs and the development of motor fluctuations and dyskinesias ensue that detrimentally impact the quality of life and mobility of PD patients. Consequently, there is a pressing present need to develop new effective treatments for PD. Our recent studies with dipeptidyl peptidase-4 (DPP-4) inhibitors - gliptins - indicate that members of this drug class represent a potentially promising new treatment strategy to protect the brain from dopaminergic cell dysfunction and loss in rodent models of PD. Several gliptins are approved for the treatment of type 2 diabetes (Russell 2013; Neumiller 2012) and their inhibition of DPP-4, the critical enzyme responsible for the metabolism of the endogenous incretins, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) (Campbell and Drucker, 2013) allows higher circulating plasma and brain levels of these two peptides. These peptides are generated and released from the L and K cells of the small intestine, respectively, following food ingestion (Campbell and Drucker 2013; Tolhurst et al., 2009), and bind to their respective receptors (GLP-1R and GIP-R) on pancreatic -cells as well as on neurons and other cell types. Receptor stimulation induces activation of adenylyl cyclase, cyclic adenosine monophosphate (cAMP) accumulation, and PKA activation (Campbell et al., 2013; Drucker, 2013). Downstream signaling pathways provide trophic and protective actions across cell types carrying the GLP-1R and/or GIP-R (Russell, 2013; Neumiller, 2012; Campbell and Drucker; Drucker, 2013; Dalle et al, 2014; Janardhan and Satry, 2014) - particularly dopaminergic neurons (Salcedo et al., 2012; Greig et al, 2014; Hölscher, 2014) - as both GLP-1 and GIP readily enter the brain (Hölscher, 2014; Kastin et al., 2002). We hypothesize that gliptin drugs will elevate physiological incretin levels both in the plasma and brain, and provide trophic and protective support to dopaminergic cells within the brain. Our aim is to gain support of this hypothesis by quantitatively evaluating dopaminergic cell number in a 6-OHDA unilateral medial forebrain bundle lesion model of PD in the presence and absence of a gliptin drug (Study 1). In Study 2, the application of a technique termed fast cyclic voltammetry to brain slices derived from animals with and without gliptin administration will evaluate dopamine release to see whether gliptin treatment improves this important parameter. Purpose and Objectives The purpose of this acquisition is to procure commercial support services to aid in the evaluation of a gliptin drug in a rodent 6-hydroydopamine-induced model of Parkinson's disease. Results from this study will in optimizing our understanding of gliptin drugs as a treatment strategy for Parkinson's disease. Period of Performance 20 Weeks from Date of Award CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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. General Requirements: •The contractor must have expertise with the 6-OHDA left medial forebrain bundle lesion model of PD in rodents - with supportive scientific publication(s) relating to successful use of this model in evaluating therapeutics for PD in the scientific literature •The contractor must have expertise in evaluation of dopaminergic neuron function across neurodegenerative disease animal models - and particularly in relation to tyrosine hydroxylase immunohistochemistry - with supporting publication(s) in the scientific literature. •The contractor must have expertise in relation to apoptotic cell death of neurons - and specifically in relation to p53 dependent cell death of neurons (a mechanism hypothesized to be involved in the current studies utilizing PF-00734, 200). The contractor must demonstrate expertize through supporting peer reviewed publications relating to involvement of p53 and neurodegeneration animal models in the scientific literature. •The contractor must have an active animal protocol for use the 6-OHDA left medial forebrain bundle lesion model of PD in rodents approved by their Institutional Animal Care and Use Committee (IACUC). •The contractor's Institution can take up to BUT NO MORE THAN 10% of the contract as overhead charges. LEVEL OF EFFORT: The level of support to successfully complete the contract should be determined by the contractor. GOVERNMENT RESPONSIBILITIES The (Government) will provide the gliptin drug for use in the study. DELIVERY OR DELIVERABLES Deliverables and Timeline (time line = 20 weeks from award of contract) The contractor shall provide: A report on data evaluation/quality associated with the evaluation of 10 mg/kg daily oral administration of gliptin with and without 6-OHDA lesioning re: TH staining of striatum/substantia nigra, behavioral (rotation) outcome, and dopamine/metabolite levels. This will be submitted to the NIH scientist: Nigel H. Greig, Ph.D. Email:greign@mail.nih.gov See attached Statement of Work (SOW) for further information. In addition 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." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by Thursday, September 21, 2017 at 12PM, Eastern Standard Time, and reference number HHS-NIH-NIDA-SSSA-NOI-17-485. Responses may be submitted electronically to Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov. Fax responses will not be accepted. Extensions to the deadline will not be granted. Please contact Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov or (301) 594-1928 with any questions.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SSSA-NOI-17-485/listing.html)
- Place of Performance
- Address: 251 Bayview Boulevard, Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN04678722-W 20170916/170914232952-5fe86a61f7c6b5e619d7c4b5a5d5bcfc (fbodaily.com)
- Source
-
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