Using humanized mouse models of NNMT and SULT1A1 for follow-up efficacy studies

NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: 75N95024Q00586 2. TITLE: Using humanized mouse models of NNMT and SULT1A1 for follow-up efficacy studies 3. CLASSIFICATION CODE: B-504 Special Studies/Analysis-Chemical Biological 4. NAICS CODE: 541380 - Testing Laboratories and Services 5. RESPONSE DATE: September 17, 2024 at 3 PM EST 6. PRIMARY POINT OF CONTACT: Michelle Cecilia, Contracting Officer Michelle.Cecilia@nih.gov Phone: 301-827-7199 7. DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD ON A SOLE SOURCE BASIS. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. The NCATS Contracts Management Section of the National Institute on Drug Abuse (NIDA), intends to negotiate on a sole-source basis with GemPharmatech, LLC for follow-up efficacy studies that will be conducted to complete work in furtherance of the original scope of work that developed humanized mouse models for NNMT and SULT1A1 for a period of one year. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541611 with a Size Standard of $24.5 million. This acquisition is a sole-source acquisition to GemPharmatech, LLC. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures. Contracts awarded using FAR Part 13'Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6'Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). BACKGROUND, PURPOSE AND OBJECTIVES OF REQUIREMENT The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Early Translational Branch (ETB) is tasked with identifying and developing novel small molecule leads against a wide spectrum of human disease targets, which it accomplishes by screening thousands of small molecules in collaboration with both intra-and extramural researchers. In pursuit of this goal, NCATS is generating mice that have humanized forms of NNMT and SULT1A1 using requisition 75N95023P00824 P00001. Small molecule inhibitors of NNMT and SULT1A1 developed at NCATS have differential activities against the human and mouse forms of the enzyme. Therefore, it is imperative that we develop mouse models that contain the human form of the enzymes to test our molecules in various models. An additional 50? B6-hNNMT homozygous mice at 4-6 weeks of age needs to be produced for evaluation in diet induced obesity models; this will be done in 8X5 groups with lead inhibitor and controls. The hSULT1A1 will be used to conduct a MTD and PK study with YC1 And followed up with liver pathology. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, GemPharmatech requires an additional step in the research to complete the humanized models of NNMT and SULT1A1 that include follow-up efficacy studies. If a new vendor were identified at this juncture, they would have to start completely from scratch resulting in duplication of effort at a significant cost in both resources and time to the Government. Completion of on-going research collaborations between the vendor and NCATS is essential to meeting critical research goals. Only Gem Pharmatech, LLC can complete this project. All the research materials are with Gem Pharmatech, LLC and to ensure the continuity of research Gem Pharmatech, LLC is the only vendor in the position to complete the work contained in the Statement of Work. In pursuit of this goal, NCATS is generating mice that have humanized forms of NNMT and SULT1A1 using requisition 75N95023P00824 P00001. Small molecule inhibitors of NNMT and SULT1A1 developed at NCATS have differential activities against the human and mouse forms of the enzyme. Therefore, it is imperative that we develop mouse models that contain the human form of the enzymes to test our molecules in various models. An additional 50? B6-hNNMT homozygous mice at 4-6 weeks of age needs to be produced for evaluation in diet induced obesity models; this will be done in 8X5 groups with lead inhibitor and controls. The hSULT1A1 will be used to conduct a MTD and PK study with YC1 And followed up with liver pathology. The intended source is: GemPharmatech 9310 Athena Circle, Suite 250 La Jolla, CA 92037-1376 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability by responding to this notice. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must provide evidence that they can provide: Continued coaching services and high level organizational change consultation and support initiatives to execute innovative solutions to hybrid work models and trainings in support of NIA initiatives. The remaining report due to NIA will include a final report of research conducted by the vendor in the furtherance of contract objectives. All responses must be received by the closing date and time of this announcement and must reference the solicitation number 75N95024Q00586. Responses must be submitted electronically to Michelle Cecilia, Contracting Officer, at michelle.cecilia@nih.gov. U.S. Mail and Fax responses will not be accepted.