Testing of compounds for inhibition of LATS1 and related kinases
INTRODUCTION This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government’s potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 541380 – “Testing Laboratories” with associated small business size standard of 15 Million USD. BACKGROUND 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 tremendously 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 services that help improve people’s lives. Included in this process is the development of unique small molecules as potential anticancer agents. The kinase enzymes LATS1 and LATS2 are part of the Hippo signaling pathway, which is involved in a variety of biological processes, including tumor suppression. Emerging evidence suggests that inhibitors of LATS1 or LATS2 could be useful as treatments for a variety of cancers, and could also be used in regenerative medicine (wound healing, nerve regeneration, etc.). No selective inhibitors of LATS1 or LATS2 have yet been reported in the literature. Small molecules that selectively inhibited these kinases would thus be useful as tools for interrogating the biological roles of LATS1 and LATS2, and as leads for drug development. NCATS has previously profiled the activity of ~60 known preclinical and clinical small molecule kinase inhibitors against a panel of >350 kinase enzymes. From that profiling, NCATS has identified AT-7867, a compound that was initially reported as an inhibitor of AKT1 kinase (also known as PKB kinase), but which also potently inhibits LATS1 and LATS2. AT-7867 may thus prove useful as a starting point for the development of novel LATS1 and LATS2 inhibitors. Structural modifications of AT-7867 will be performed, with the aim of improving the potency of LATS1 and LATS2 inhibition, and decreasing the potency of AKT1 inhibition. In this way, the chemical series embodied by AT-7867 could be repurposed toward the goal of developing novel, selective inhibitors of LATS1 and LATS2. AT-7867 was previously tested for activity against LATS1, LATS2, AKT1, and other relevant kinase enzymes using Kinase HotSpot assay technology performed by Reaction Biology Corporation, located at 245 Amity Road, Woodbridge, CT. This vendor prepared tee initial sets of analogs and were tested using Kinase HotSpot assay technology. To ensure consistency in the data, the current set of compounds should also be tested using Kinase HotSpot assay technology. Purpose and Objectives This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain results for the following types of testing: 1. Initial testing of 120 novel small molecule compounds for inhibition of the kinase enzymes LATS1 and two related kinases. This testing will inform on kinase inhibitory activity in a compound series that originates from a known AKT1 inhibitor and related scaffolds Project Requirements This Small Business Sources Sought notice seeks responses from qualified sources that are capable of providing the following salient service requirements of this potential government requirement deemed as the essential features needing to be achieved. Specifically, Offerors to this Small Business Sources Sought notice shall possess the capability to provide the following types of testing as essential requirements: 1. Perform experiments using the Kinase HotSpot assay platform testing each of 120 small molecule compounds for inhibitory activity against LATS1, LATS2, and PKB (AKT1). 2. Provide a comprehensive report with the results of the 10-dose IC50 titrations of each of compounds against LATS1, LATS2, and PKB (AKT1) 3. Contractor will offer testing using the Kinase HotSpot assay platform against the kinase enzymes LATS1, LATS2, and PKB (AKT1). 4. Contractor will have access to all critical instrumentation necessary for this statement of work. Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features identified in this notice and provide documented evidence to be able to fully achieve the characteristicis of the subject requirement described herein. Period of Performance / Contract Type The contractor is expected to deliver results within tee (3) months of receiving material from the Government to analyze. The Government will send the contractor the material to synthesize after the effective date of contract award. The period of performance will be 18 months. A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Teshold is anticipated for any contract resulting from this requirement. The anticipated award date is March 30, 2020. Delivery/Warranty A comprehensive report with the results of the data analysis will be required. Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Offerors must indicate an estimated delivery time in full after receipt of an order and any other warranty considerations applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. CAPABILITY STATEMENTS/INFORMATION SOUGHT Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. Respondents must provide clear and convincing evidence of possessing the knowedge, skills, abilities and experience to successfully perform the requirements described in this announcement. Detailed prior experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided. Technical experience can include, but is not limited to: Experience (> 5 years) in the testing of small molecule compounds for kinase inhibitory activity using the Kinase HotSpot assay platform; Access to all critical instrumentation necessary for this statement of work; Testing the aforementioned compounds in all the assays described above in <3 months’ time. Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and services specified in this notice. Respondents must provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. The Respondent must also provide information in sufficient detail of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, or other related information. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, CV’s or references, if requested. The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. Respondents must reference the announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement. CONCLUDING STATEMENTS Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). 75N95020Q00046 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
2/19/20, 4:15 PM Testing of compounds for inhibition of LATS1 and related kinases
(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 75N95020Q00046 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 teshold at $250,000. 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) to Reaction Biology Corporation, located at 1 Great Valley Pkwy, Ste 2, Malvern, PA 19355-1423 for services for compound testing for inhibition of Kinase enzymes. 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 tough Federal Acquisition Circular (FAC) Number 2020-05, with effective date March 30, 2020. (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 will perform initial testing of 120 novel small molecule compounds for inhibition of the kinase enzymes LATS1 and two related kinases. This testing will inform on kinase inhibitory activity in a compound series that originates from a known AKT1 inhibitor and related scaffolds. (vi) The salient characteristics of project requirements for this procurement, deemed essential features needing to be achieved, include the following types of testing: Perform experiments using the Kinase HotSpot assay platform testing each of 120 small molecule compounds for inhibitory activity against LATS1, LATS2, and PKB (AKT1); Provide a comprehensive report with the results of the 10-dose IC50 titrations of each of compounds against LATS1, LATS2, and PKB (AKT1); Contractor will offer testing using the Kinase HotSpot assay platform against the kinase enzymes LATS1, LATS2, and PKB (AKT1). Additionally, the Contractor shall have access to all critical instrumentation necessary for this statement of work. AT-7867 was previously tested for activity against LATS1, LATS2, AKT1, and other relevant kinase enzymes using Kinase HotSpot assay technology and follow up confirmation. Tee initial sets of analogs were prepared, and were also tested using Kinase HotSpot assay technology. The prior analogs in this series were tested against relevant kinase enzymes using Kinase HotSpot assay technology. To ensure consistency in the data and to make a direct comparison, there is no other known technology for the current set of compounds to be tested other than using Kinase HotSpot assay technology. 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. DELIVERABLES Deliverables shall consist of providing results for the testing described herein. Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Contractor will provide the data analysis and report for the contents of this statement of work. All deliverables will be completed and finalized within 18 months of contractor receiving compounds and commencing work with the Government. 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: The Contractor shall not write or publish articles of data produced as a result of the requirements of the SOW. SECTION 508 – ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS No EIT is anticipated to be generated as a result of this requirement. (vii) Period of Performance: The contractor is expected to deliver results within 18 months of the effective date of contract award and batch of material to analyze. The Government will send the contractor the material to synthesize after the effective date of contract award. A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Teshold is anticipated for any contract resulting from this requirement. The anticipated award date is May 1, 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. 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 tee (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 Hunter.Tjugum@nih.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, 301-827-5304, hunter.tjugum@nih.gov. 75N95020Q00046 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
4/6/20, 3:43 PM