Motor Neurons for ASO Toxicity Project

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NCATS21005362 TITLE: Motor Neurons for ASO Toxicity Project CLASSIFICATION CODE: 66 -- Instruments & laboratory equipment NAICS CODE: 541714 - Research and Development in Biotechnology (Except Nanobiotechnology) RESPONSE DATE: August 13, 2021 at 12:00 PM EST PRIMARY POINT OF CONTACT: Thien Nguyen Thien.Nguyen2@nih.gov Phone: 301-827-0914 DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source bases with BrainXell, 455 Science Drive Suite 210, Madison WI 53711 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541714 - Research and Development in Biotechnology (Except Nanobiotechnology) with a Size Standard of 1000 employees. 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). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 20019-01 dated December 1, 2018. PURPOSE AND OBJECTIVES: he Therapeutic Development Branch (TBD) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) has recently initiated a collaborative project aimed at developing assays for predicative toxicity of antisense oligonucleotides (ASOs). To determine neurotoxicity, a pilot study using cryopreserved motor neurons derived from human induced pluripotent stem cells (iPSCs) (from non-fetal tissue source) was conducting using microelectrode arrays (MEAs) to measure changes in electrical activity following treatment with ASOs. These recently completed pilot studies using iPSC human motor neurons from BrainXell was to determine 1) the number of motor neurons required for the next phase of MEA ASO assays and 2) experimental conditions to optimize neuronal cell growth, health, and spontaneous activity. For the next phase of this study, 150 million motor neurons will be required over the next 6 - 7 months. As these neurons have a limited shelf life even when properly stored in liquid nitrogen, they cannot be purchased in large bulk orders. The motor neuron purchase will be completed in (2) milestones. Milestone 1 will be the immediate (within 30 working days of date of award) shipment of 75 million human motor neurons ([15] vials of 5 million neurons/vial). Milestone 2 will be the delivery of an additional 75 million human motor neurons ([15] vials of 5 million neurons/vial) after 4 - 5 months upon the request from NCATS and will allow all neurons to be of the highest quality and viability for use in MEA assays over the course of this phase of the study. All neuron batches lots must undergo extensive quality control (QC) including, but not limited to, cell morphology and contamination testing before shipping. Following QC validation, motor neurons will be shipped overnight in a liquid nitrogen vapor shipper to ensure proper continued cryopreservation of the neurons. The continues use of BrainXell's iPSC human motor neurons is essential for the successful continuation of the project, as the pilot study was used to optimize experimental conditions for the MEA assay. A change in source of these iPSC neurons might significantly alter such motor neuron parameter as cell growth rates, onset and levels of spontaneous activity, potentially requiring critical last-minute changes to the experiment, necessitating additional testing and optimization of protocols that could complicated data interpretation. 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, Yair Bar-Haim is the only vendor in the marketplace that can provide the services required by NIMH. The intended source is: BrainXell 455 Science Drive, Suite 210 Madison, WI 53711 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond 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 be received by the closing date and time of this announcement and must reference the solicitation number, NCATS21005362. Responses must be submitted electronically to Thien Nguyen, Contract Specialist, at thien.nguyen2@nih.gov. U.S. Mail and fax responses will not be accepted.