SOLICITATION NOTICE
99 -- Testing of compounds in mouse pharmacokinetic experiments - Attachments
- Notice Date
- 9/4/2019
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- 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
- 75N95019Q00323
- Archive Date
- 9/25/2019
- Point of Contact
- Jessica Adams,
- E-Mail Address
-
jessica.adams@nih.gov
(jessica.adams@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Invoice and Payment Provisions FAR 52.212-5 NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Testing of compounds in mouse pharmacokinetic experiments (i) This is a combined synopsis/solicitation for commercial 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. (ii) The solicitation number is 75N95019Q00323 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, 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), NIDA Office of Acquisitions - NCATS Section, on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Charles River Laboratories, Inc., 251 Ballardvale St., Wilmington, MA 01887 for testing of compounds in mouse pharmacokinetic experiments. Pursuant to FAR Subpart 13.501(a)(1)(iv) the rationale for the brand name justification is that Charles River Laboratories, Inc. has conducted several previous studies for NCATS. The studies must continue to be performed by the same lab to allow for continuity of science and to allow for an apples-to-apples comparison of the data generated from this service with data previously generated. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-05 dated August 13, 2019. (iv) The associated NAICS code is 541380 and the small business size standard is $15,000,000.00 No set-aside restriction is applicable. (v) The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its productive pipeline and is innovative in several ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, to ultimately translate basic science into real products and services that help improve people's lives. Included in this process is the development of unique small molecules as potential anticancer agents. Prior work at NCATS has produced a series of small molecule inhibitors, including NCGC00371481 and its structural analogs. Compounds such as ‘1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Further optimization of the biochemical, physiochemical and pharmacokinetic properties of these compounds is required, and may eventually produce a clinical candidate that could be used to treat cancers such as MDS and / or AML. (vi) For a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties. For this program, a potential clinical candidate must display potent inhibition of the desired targets. It must also display suitable pharmacokinetic (PK) properties in a range of preclinical species, including at least one rodent species (mouse or rat), as well as at least one higher preclinical species (dog or monkey). Good PK profiles in these species are required 1) to build models that predict good pharmacokinetic properties in humans, and 2) so that compounds can be given at high doses and high plasma exposure levels in preclinical safety studies. To characterize and optimize the pharmacokinetic properties of our compounds in mice, we need to run a series of mouse pharmacokinetic experiments. Testing a set of 11 small molecule compounds in mouse PK experiments will provide critical data that identify the strengths and weaknesses of our current compounds' PK profiles and will help us optimize those profiles so that we can identify a suitable candidate for clinical trials. For a given compound, pharmacokinetic properties may vary considerably across species. That is, properties in mouse, rat, dog, monkey or humans may vary. Preclinical drug discovery programs that want to advance compounds into human clinical trials ultimately need to test pharmacokinetics in mouse, rat, dog, and monkey prior to human testing. To maintain consistency, we prefer to run our mouse pharmacokinetic experiments using a vendor who can also provide future pharmacokinetic testing in rat, dog, and monkey. Project requirements: 1. Test each of 11 small molecule compounds in mouse pharmacokinetic studies comprised of two dosing arms (one oral, one IV, n = 3 mice per arm). 2. Provide a comprehensive report for each of the 11 compounds detailing results from the pharmacokinetic experiment as described below in the Specific Requirements section. Specific Requirements 1. Contractor will run the assays using scientists that have significant experience (>5 years) in the testing of small molecule compounds in mouse pharmacokinetic experiments. 2. Contractor will have significant experience (>5 years) in running mouse pharmacokinetic experiments. 3. Contractor must offer the option of follow-up pharmacokinetic testing in rat, dog, and monkey. This will allow continuity of service, and an ‘apples-to-apples' comparison of pharmacokinetic data across all species. 4. Contractor will test compounds in mouse pharmacokinetic studies comprised of two dosing arms (one oral, one IV, n = 3 mice per arm). Test compounds will be administered as a single dose (either oral or IV, depending on the study arm), and in each study arm, 7 serial blood draws will be taken at 7 different time points covering a range of at least 8 hours post-dose. Plasma samples will be analyzed by LCMS to determine the concentration of test compound at each time point. That data will be used to construct a plot of test compound concentration in plasma vs. time for each dosing arm. A final report will be issued that contains these plots, as well as the calculated oral bioavailability (F%), clearance rate (Clp), half-life (t1/2), area under the curve (AUC), maximal concentration (Cmax), and volume of distribution (Vd) for the compound. The report should list the formulation used for dosing and should include a table of raw data showing the plasma concentration of test compound at each time point in each mouse, as well as the average or mean concentration across all 3 mice, and the standard deviation or standard error for each mean value. 5. Contractor will have access to all critical instrumentation necessary for this statement of work. 6. Contractor will be capable of testing the aforementioned 11 compounds in all the assays described above in <2 months' time after receipt of compounds. GOVERNMENT RESPONSIBILITIES Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. Government will have the responsibility to review and approve the final report. Government will have the responsibility to provide sufficient quantities of the lead compound in order to contractor to accomplish the necessary work. DELIVERY OR DELIVERABLES Contractor will provide the data analysis and report for the contents of this statement of work. REPORTING REQUIREMENTS Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Data Rights Any data generated as a result of this contract will be the property of NCATS. Publications and Publicity Contractor will not publish the results of the work. Confidentiality of Information Contractor will keep the results of the acquisition confidential. (vii) Delivery shall be to: The National Center for Advancing Translational Sciences (NCATS) 9800 Medical Center Drive Rockville, MD 20850 Delivery/Period of Performace shall be within 2 months ARO, FOB destination. Offers must include shipping costs. (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) Offers will be evaluated for technical criteria, price, and past performance. Technical criteria consist of matching the line items identified above. Technical and past performance, when combined, are significantly more important than price. OR The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) technical approach (ii) price (iii) past performance (cite applicable FAR clause> Technical and past performance, when combined, are significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with offers. (xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addendum applies: SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 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 clause may be accessed electronically at these addresses: For FAR clauses: https://www.acquisition.gov/browsefar For HHSAR clauses: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (end of clause) The following FAR provisions or clauses are incorporated by reference: 52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Entity Code Reporting (Jul 2016) 52.204-18, Commercial and Entity Code Maintenance (Jul 2016) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services of Equipment HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015). 52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions (2/2014). (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. (xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) 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 sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. A determination by the Government whether to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered to determine whether to proceed on a non-competitive basis as indicated above, or to conduct a competitive procurement. 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. (xvi) 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. All responses must be received by September 10, 2019 at 5:00pm, Eastern Standard Time and reference solicitation number 75N95019Q00323. Responses must be submitted by email to Jessica Adams, Contract Specialist at jessica.adams@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/16e42a1b3c74b41036a236ba91f85830)
- Place of Performance
- Address: 9800 Medical Center Drive, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN05429969-W 20190906/190904230931-16e42a1b3c74b41036a236ba91f85830 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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