SOLICITATION NOTICE
H -- 3D Fibrosis Modulation with ExVive Liver Tissue
- Notice Date
- 3/27/2018
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, NCATS, National Institute on Drug Abuse, National Center for Advancing Translational Science (NCATS), 6001 Executive Boulevard, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIHDA201800128
- Archive Date
- 4/21/2018
- Point of Contact
- Jessica Adams, Phone: 3044438761, Jeffrey Schmidt,
- E-Mail Address
-
jessica.adams@nih.gov, jeffrey.schmidt@nih.gov
(jessica.adams@nih.gov, jeffrey.schmidt@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE 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 Center for Advancing Translational Sciences (NCATS) Section within the National Institute on Drug Abuse (NIDA) Office of Acquisition, intends to negotiate and award a contract for 3D InSight Human Liver Fibrosis Evaluation services. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325414 - Biological Product (except diagnostics) Manufacturing with an employee number of 1250. 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) 2005-96 (dated November 6, 2017). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source. DESCRIPTION OF REQUIREMENT Title: 3D Fibrosis Modulation with ExVive Liver Tissue The purpose of this acquisition is to test the efficacy and potency of two compounds in reducing induced fibrosis in 3D liver tissue models. Alternative cell-based assay models of disease that are more predictive of efficacy and toxicity of compounds in clinic are being developed to help prioritize compounds for in vivo testing, reduce use of animal testing, and possibly reduce time to clinic and cost of drug development. Manufactured 3D tissue models that mimic a human tissue in cell composition and architecture, and produced with human primary or iPSC-derived cells are now available for some tissues, including liver. 3D liver tissue models of fibrosis have been described in recent worldwide publications and provide a unique opportunity to test compounds for their ability to reduced induced fibrosis in a tissue model that it is possibly more predictive of activity in clinic. The contractor shall test compounds for modulation TGFβ induced fibrosis in human liver tissue that include Kupffer cells. The Contractor shall test the two compounds in at least three doses in 3D liver tissue models of induced liver fibrosis: •The 3D liver tissue models of fibrosis can be either 3D bioprinted or organoids. •3D liver tissue models should include human primary hepatocytes, kupffer cells, liver endothelial cells, and liver stellate cells. •Published reports demonstrating assay performance, validation and pharmacological qualification should be provided. •TGF-β induction of fibrosis for 7 days or more and be measured by IHC using pro-fibrotic markers including aSMA and collagen I, and CD68. •Additional makers that provide information on the effects of compounds on the 3D liver tissue will be positively considered. •At least one assay/marker of cell viability will also be included in the test •Compounds will be tested in N=4, and at least at three different concentrations •A positive control compound treatment will be done in parallel with the test compounds All data obtained from the tissues, processed IHC tissue slides, and unprocessed/unused tissue blocks and slides will be provided to NCATS for potential additional analysis at the end of the study. Quantity: NA DELIVERY DATE 60 days ARO 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 notice must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. 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 1:00 PM Eastern, April 6, 2018 and must reference number NIHDA201800128. Responses must be submitted electronically to Jessica Adams, Contract Specialist, at jessica.adams@nih.gov and must reference the solicitation number NIHDA201800128 on your electronic request. FAX requests are not accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/3b2f140d377201d912c979c5e139b249)
- Place of Performance
- Address: Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN04868665-W 20180329/180327231914-3b2f140d377201d912c979c5e139b249 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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