SAMDaily.us | PRESOL | Q | Testing of compounds in kinetic profiling assays

SAMDAILY.US - ISSUE OF JULY 26, 2023 SAM #7911
SOLICITATION NOTICE

Q -- Testing of compounds in kinetic profiling assays

Notice Date: 7/24/2023 12:54:57 PM
Notice Type: Combined Synopsis/Solicitation
NAICS: 541380 — Testing Laboratories
Contracting Office: NATIONAL INSTITUTES OF HEALTH NCATS BETHESDA MD 20892 USA
ZIP Code: 20892
Solicitation Number: 75N95023Q00546
Response Due: 7/31/2023 11:00:00 AM
Archive Date: 08/15/2023
Point of Contact: Morgen Slager
E-Mail Address: morgen.slager@nih.gov
(morgen.slager@nih.gov)
Description: (i)ï¿½ ï¿½This 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)ï¿½ ï¿½The solicitation number is 75N95023Q00546 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 13ï¿½Simplified Acquisition Procedures; ï¿½and FAR Part 12ï¿½Acquisition 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).ï¿½ The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of The National Center for Advancing Translational Sciences (NCATS) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Enzymlogic SL., Calle De Santiago Grisolia, Tres Cantos Madrid 28760 for services in the testing of compounds in kinetic profiling assays. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The essential characteristics of the Testing of compounds in kinetic profiling assays that limit the availability to a sole source are that the assays is proprietary to Enzymlogic. Only this suggested source can furnish the requirements, to the exclusion of other sources, because they are unique in offering significant experience in testing of the aforementioned targets using KINETICfinder assay technology. We have already obtained kinetic data for our project using this specific assay platform (KINETICfinder). Using a different vendor would mean that the data would not be directly comparable to the data weï¿½ve already generated. We are making decisions about which drug candidates to advance, and when we compare their profiles, we need to know that each parameter is measured in the same way for each compound.ï¿½ The only way we can make intelligent decisions about which candidate is best is if the data for a specific parameter are obtained the same way, using the same assay platform (in this case KINETICfinder) for all compounds being evaluated. (iii)ï¿½ ï¿½The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04 dated June 2, 2023. (iv)ï¿½ ï¿½The associated NAICS code 541380 ï¿½ Testing Laboratories and Services and the size standard in number of employees is $16.5. (v)ï¿½ ï¿½This requirement is for the purchase human protein arrays as an unbiased reagent for screening for autoantibodies that bind to conformational and/or post-translationally modified human proteins. (vi)ï¿½ï¿½ï¿½ï¿½Background: The National Institutes of Health (NIH) is the nationï¿½s leading medical research agency and the primaryFederal agency whose mission is to seek fundamental knowledge about the nature and behavior ofliving systems and the application of that knowledge to enhance health, lengthen life, and reduce illnessand disability, conducting, supporting and making medical discoveries that improve peopleï¿½s health andsave lives. The National Center for Advancing Translational Sciences (NCATS) is a translational sciencecenter that prides itself on its productive pipeline and is innovative in a number of ways.NCATS brings together a diverse range of scientists, including medicinal chemists, biologists,toxicologists, and engineers, in order to ultimately translate basic science into real products and servicesthat help improve peopleï¿½s lives. Included in this process is the development of unique small moleculesas potential anticancer agents. Prior work at NCATS has produced a series of small molecule IRAK1 / IRAK4 / FLT3 kinase inhibitors, including NCGC00371481 and its structural analogs. Compounds such as ï¿½1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Further optimization of the biochemical, kinetic, 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. In vivo efficacy in animal model systems and in human patients depends on three key parameters:ï¿½ on-target potency, residence time of the drug on target, and drug concentration or exposure at the target.ï¿½ Residence time (the amount of time a drug stays bound to its target) can be measured using kinetic profiling assays such as KINETICfinder.ï¿½ We are currently synthesizing structurally novel analogs of NCGC00371481 that may show improved properties relative to previous analogs. In order to assess these analogsï¿½ residence times versus targets like IRAK1 and IRAK4, we need to test them in kinetic profiling assays.ï¿½ Testing a set of 20 small molecule compounds vs. 2 kinase enzymes will allow optimization of important kinetic parameters such as residence time in this compound series. Purpose: The purpose of this requirement is to acquire services in testing of compounds in kinetic profiling assays. 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. Specific Requirements: Test twenty (20) novel small molecule compounds in kinetic profiling assays vs. two (2) kinase enzymes. The contractor will: a. Test each of the 20 small molecule compounds in kinetic profiling assays against a set of 2 kinase enzymes, using the KINETICfinder assay platform. i. Compounds will be tested in 4 different doses, which will be determined by theï¿½Government at the time the compounds are submitted. ii. The 4 different doses will be used to generate the kinetic parameters kon, koff, Kd, and residence time. iii. The Government anticipates sending the 20 compounds in two (2) batches of 10 compounds per batch b. Provide two comprehensive reports, one for each batch, providing results of testing each of the 20 compounds against the 2 kinase enzymes. (vii)ï¿½ï¿½The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated delivery is: Period of Performance is 12 months. (viii)ï¿½ 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:ï¿½ https://www.acquisition.gov/browse/index/far ï¿½ï¿½ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html ï¿½ï¿½ ï¿½ (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 (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (MAR 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) 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 ï¿½ï¿½ï¿½ ï¿½https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html ï¿½ (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 (Aug 2020) FAR 52.212-4, Contract Terms and Conditions-Commercial Items (DEC 2022). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.204ï¿½27, Prohibition on a ByteDance Covered Application (Jun 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2023) NIH Invoice and Payment Provisions (APR 2022) (ix)ï¿½ 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)]. (x)ï¿½ ï¿½The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi)ï¿½ ï¿½The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii)ï¿½ ï¿½There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii)ï¿½ï¿½ï¿½ï¿½ The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv)ï¿½ï¿½ï¿½ï¿½ Responses to this solicitation must include sufficient information to establish the interested partiesï¿½ 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. The Unique Entity ID (UEI), 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 offers must be received by 2:00p.m., Eastern Daylight/Standard Time, on July 31, 2023, and reference solicitation number 75N95023Q00546. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.
Web Link: SAM.gov Permalink
(https://sam.gov/opp/969917994c6c4f27836166bfca32218e/view)
Place of Performance: Address: Rockville, MD 20850, USA; Zip Code: 20850; Country: USA
Record: SN06760403-F 20230726/230724230049 (samdaily.us)
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Q -- Testing of compounds in kinetic profiling assays