Testing of compounds for block of cardiac ion channels

(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 75N95020Q00008 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; FAR Subpart 13.5'Simplified Procedures for Certain Commercial Items; and FAR Part 12'Acquisition of Commercial Items, and is NOT expected to exceed the simplified acquisition threshold at $250,000.00. 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), Office of Acquisition (OA), 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) for testing services performed by Pharmaron, Inc. located at 201 E Jefferson Street, Louisville, KY 40202-1246. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2020-01, with effective date November 12, 2019. (iv) The associated NAICS code is 541380-Testing Laboratories with associated small business size standard of 15 Million USD. (v) This requirement is for the following general 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 described herein. Specifically, the Contractor shall perform testing of 60 small molecule compounds for block of hERG, hNav1.5 and hCav1.2 in patch-clamp or FLIPR assays that will allow a determination of the compounds activity against these targets and will help to identify any unwanted properties that would need to be removed in subsequent, further testing of compounds at NCATS. The salient characteristics of project requirements for this procurement, deemed essential features needing to be achieved, include the following: 1. Ability to perform IC50-determining experiments, testing each of 60 small molecule compounds at 5 dose concentrations in duplicate, in patch-clamp assays for block of hERG and hNav1.5, and in FLIPR assays for block of hCav1.2. 2. Ability to provide a comprehensive report with the results of the experiments of each of the 60 compounds against hERG, hNav1.5 and hCav1.2, allowing for a giga-ohm seal around the channel. 3. Capability to work with radioactive compounds and biological tissue. (vi) BACKGROUND Prior work at NCATS has produced a series of small molecule IRAK4 / FLT3 kinase dual inhibitors, including NCGC00371481 and its structural analogs. Compounds such as NCGC00371481 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. In order for a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties. For this program, the compounds must display potent inhibition of the desired targets (IRAK4 and FLT3). Candidate compounds also need to be free of various types of cardiotoxicity, for instance any undesired effects on heart rate (bradycardia or tachycardia or abnormally slow or fast heart rate), blood pressure (too high or too low), or the potentially-lethal condition known as - torsades de pointes (translated as "twisting of peaks") that results from prolongation of the cardiac QT interval. These undesired cardiotoxicities can often be traced directly to a block of a key ion channel: hERG for QT prolongation, hNav1.5 for effects on heart rate, or hCav1.2 for effects on blood pressure. Preclinical testing of candidate drug compounds for block of these important ion channels is a widely-used strategy for the early identification of potential sources of cardiotoxicity. Optimization of compounds within a series so that key compounds do not block these channels is typically a prerequisite for identifying a drug candidate that can advance into human clinical trials. A variety of different biological assay formats are available to test ion channel block. These include binding assays, functional assays, and a specific type of functional assay known as patch-clamp. Of these, patch-clamp assays are widely regarded as the - gold standard and are the ones that give the most reliable data. Thus, NCATS prefers the testing of these compounds to be conducted in patch-clamp assays, or in other highly reliable functional assays such as FLIPR assays, as opposed to binding assays, which tend to be less informative. Testing of 60 small molecule compounds for block of hERG, hNav1.5 and hCav1.2 in patch-clamp or FLIPR assays will allow a determination of the compounds activity against these targets and will help to identify any unwanted properties that would need to be removed in subsequent, further testing 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. DELIVERABLES Deliverables will include one (1) report on the study performed, including the data analysis and report of the results of the contents of the scope of work. Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Contractor will be expected to stay in e-mail or phone contact with the government representative as needed. Delivery, inspection and acceptance of any items delivered will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. TRAVEL No travel cost will be reimbursed. CONTRACTOR EXPERIENCE REQUIREMENTS - KEY PERSONNEL N/A DATA RIGHTS NCATS shall have unlimited rights to and ownership of all data including reports. In addition, it includes any additional deliverables required by contract change. The definition of - unlimited rights is contained in Federal Acquisition Regulation (FAR) 27.401, - Definitions. FAR clause 52.227-14, - Rights in Data-General, is hereby incorporated by reference and made a part of this contract/order. Any data schemas will be the exclusive right of the government. Publications and Publicity: Any datasets derived by the TDB from from this work will be a part of scientific publications and they will be made available to the public on the TDB public-facing internet website. The contractor will not publish any result of the work. SECTION 508 - ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS No EIT is anticipated to be generated as a result of this requirement. (vii) Period of Performance/Level of Effort The period of performance will be effective for 12 months from the Effective Date of Contract or receipt of material to analyze. The Government anticipates the vendor will be required to provide 1 PhD level-Manager and 1 Ph.D. level scientist to work for a total 1-2 months of time to fully achieve this requirement. A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is January 10, 2020. (viii) 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: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (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 (Jul 2016) - FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018) - FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018) 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 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (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 (Jul 2016) - FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018). The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items (May 2019) is applicable to this solicitation and inlcuded by reference. 52.222-3 Convict Labor (June 2003) 52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018) 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Sep 2016) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50 Combating Trafficking in Persons (Jan 2019) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008) 52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018) The following provisions and clauses apply to this acquisition and are incorporated as a separate attachment: - NIH Invoice and Payment Provisions (2/2014) - FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. 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. Evaluation will be performed in accordance to FAR 13.106-2 - Evaluation of quotations or offers and may utilize comparative evaluations using price and the following factors as criteria. a) Technical Capability: Ability of the Offeror to understand the SOW and requirements, adequately describe the proposed approach, identify problems and potential challenges, and demonstrate how all contract requirements will be met. Offerors shall provide evidence of sufficient planning to show that the work will be accomplished and how it will be accomplished within time and other constraints specified in the SOW or as applicable. The Offeror shall utilize all available resources to include controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, resolving critical issues and/or mitigating risks and fulfilling all delivery requirements. Personnel Experience: Scientists will have significant experience (>5 years) in the testing of small molecule compounds in same or relevant fields; Ability to test assays described above within the timeframe required. Organizational Experience: Possess access to all critical instrumentation necessary for this statement of work; Possess capability to work with radioactive compounds and with biological tissue. b) Price; and c) Past performance [see FAR 13.106-2(b)(3)] Offerors shall show documented evidence of personnel experience related to the subject requirement. Specific and specialized relevant experience, knowledge, skills, abilities, and education of proposed personnel shall be clearly documented. The offeror must submit with their proposal a list of the last two (2) contracts completed during the past three (3) years and / or contracts awarded currently in process that are similar in nature to the work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Newly formed entities without prior contracts should list contracts and subcontracts as required above for such key personnel. For each contract, subcontract, or reference include: (i) Name of Contracting Organization; (ii) Contract Number (for subcontracts, provide the prime and subcontract numbers); (iii) Contract Type; (iv) Total Contract Value; (v) Description of Requirement; (vi) North American Industry Classification System (NAICS) code. Price Quote: The Vendor shall submit a Fixed-price quote for the period of performance including unit pricing, total price proposed and all other relevant information and documentation that the item(s) quoted meets the salient physical, functional, or performance characteristics as specified in this solicitation. 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) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated in full text. (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: There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) 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. 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 and the offeror representation in FAR Provision 52.204-24, which is attached, MUST be completed and submitted with any quotation or response to this RFQ. All quotations must be received no later than the closing date and time specified in the solicitation. The solicitation number must be referenced on all correspondence submitted for this requirement. Responses must be submitted electronically to Hunter Tjugum at contact@example.gov. Fax responses will not be accepted. (xvi) The name and telephone number of the individual to contact for information regarding the solicitation: Hunter Tjugum, Contract Specialist, +1 (555) 000-0000, contact@example.gov.