NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: 75N95023Q00327 2. TITLE: Evaluation of PLpro inhibitors in a live virus cell based SARS-CoV2 luciferase reporter assay 3. CLASSIFICATION CODE: Q301 - Laboratory Testing Services 4. NAICS CODE: 541380 - Testing Laboratories and Services 5. RESPONSE DATE: May 26, 2023 at 3:00 PM EST 6. PRIMARY POINT OF CONTACT: Michelle Cecilia, Contracting Officer
contact@example.gov Phone:
+1 (555) 000-0000 7. No set-aside restriction applicable 8. Competition Status: This requirement is posted as non-competitive 9. 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 National Center for Advancing Translational Sciences (NCATS) through the Contracts Management Section of the National Institute on Drug Abuse (NIDA), intends to negotiate on a sole-source basis with SRI International for the evaluation of PLpro inhibitors in a live virus cell based SARS-CoV2 luciferase reporter assay. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541380 with a Size Standard of $19 million. 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 Antiviral Program for Pandemics (APP) is a multi-agency initiative to develop safe and effective direct-acting oral antivirals. As a part of this initiative, NCATS has joined forces with NIAID and BARDA to accelerate antiviral platform through early discovery and preclinical development. The initial priority for APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. As part of this APP initiative, papain like protease (PLpro) has been identified as a novel target for beta coronavirus as one of the major viral protease that helps in the processing of the viral genome inside the human host. PLpro also modulates the host immune response towards coronavirus infection and might be responsible for secretion of proinflammatory cytokines and chemokines, which recapitulates the cytokine storm in COVID patients. At NCATS, we have initiated a preclinical discovery effort towards this target. We are working towards optimizing literature reported hits that has shown in vitro efficacy in enzyme inhibition assays. In our efforts, we are utilizing structure based drug discovery approach to understand the binding site of these literature reported inhibitors and trying to build in handles to bring in potency and drug like properties. We plan to check these inhibitors in live virus cell replication assays to ascertain their efficacy in cell setting. These live virus replication assays are to be conducted in a BSL-3 setting. As a part of this proposal, we plan to have 20 runs of this live virus nano luciferase reporter assay in A549-ACE2 cells. This assay will be done in duplicates in the assay ready plates provided by NCATS. These 20 assay runs are essential to drive the structure activity relationship (SAR) in our design of PLpro inhibitors. The information from each assay run will be used towards performing iterative rounds of SAR to understand change in potency with subsequent compound modifications. The cumulative assay is essential to test the SAR library and will be helpful in guiding towards the next steps of the project. The compounds that will have optimal potency in the above mentioned assay along with decent in vivo pharmacokinetic exposures will then be forwarded to test in the small animal efficacy studies, paving the way for translation to clinic. 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. Only this suggested source can furnish the requirements, to the exclusion of other sources, because the nanoluciferase reporter virus assay that is required (see Statement of Work) is specific to Southern Research Institute and can only be run in a certified BSL-3 setting. Southern Research Institute has an agreement in place for commercial use of this SARS-CoV2 reporter virus assay and we have used their services in past to check the viral inhibition of the novel PLprotease inhibitors. As the nature of the assay is specific to this company, this supports the sole source award Southern Research Institute to support drug discovery and preclinical development of small molecules that have anti viral SARS-CoV2 activity. To maintain the quality of data and to compare it with the original data received via this assay, it is highly recommended that we use the chosen source. Only this suggested source can furnish the requirements, to the exclusion of other sources, because of the specialized and unique nature of this selection and to ensure the continuity in research. Only Southern Research Institute can complete work specified in the Statement of Work. The intended source is: Southern Research Institute 2000 Ninth Avenue South Birmingham, AL 35205 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: Assay ready plates will be provided by NCATS and NLRV (nanoluc reporter virus) assay for SARS-CoV2 would be run in A549 cells expressing ACE2 under BSL-3 conditions. Cell viability for the cytotox assay will be measured using Promega Cell Titer Glo for each run. 20 runs of this assay will be performed in duplicates and the raw data will be provided to NCATS to process and upload in the internal system. All responses must be received by the closing date and time of this announcement and must reference the solicitation number 75N95023Q00327. Responses must be submitted electronically to Michelle Cecilia, Contracting Officer, at
contact@example.gov. U.S. Mail and Fax responses will not be accepted.
