SAM_-_Pre-Solicitation__75N94024Q00083_1.pdf

75N94024Q00083

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to award a purchase order without providing for full and open competition to SYNTHEGO CORPORATION for Gene Variant Editing Services.

BACKGROUND

The mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is to support and conduct research on the impact of alcohol use on human health and well-being. NIAAA supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics using state of the art methodologies. Gene variant editing is a part of the ongoing research projects in the NIAAA Lab of Neurogenetics, which aims to analyze functional effects of relatively common missense variants of the genes implicated in alcohol use disorder, and neuropsychiatric and behavioral phenotypes. Therefore, it is important that we have a service provider capable of delivering the gene variant editing service that meets our needs.

JUSTIFICATION

Gene variant editing using CRISPR-Cas9 method is a part of the ongoing research projects in the NIAAA Lab of Neurogenetics, which aims to analyze functional effects of relatively common missense variants of the genes implicated in alcohol use disorder, and neuropsychiatric and behavioral phenotypes. There are 5 missense variants from 5 genes to be edited on iPSC lines for this list. Synthego specializes in CRISPR-Cas9 gene editing service. It uses a proprietary methodology for sgRNA design, Cas9 protein expression, donor DNA design, RNP alteration to the iPSC cells, which is critical for our gene variant editing project because these technical elements are essential for the accuracy and effectiveness of gene variant editing. They ensure that the intended gene variants and cell line products can be delivered in a timely manner with high quality, which is critical for our gene variant editing project. Synthego has shown their proven technical expertise previously by delivering 264 edited iPSC clones-- 12 variants per gene across 22 targets-- as part of the iPSC Neurodegenerative Disease Initiative (iNDI) project from NIH. Their proprietary screening strategy is also essential for the edited clone isolation because Isolation of correctly edited clones is an elaborative and time-consuming process. An effective strategy and technic for clone isolation not only ensures a speedy recovery of cells carrying the correctly edited gene variants but also is essential for the success of the whole editing process. Their specialized technical expertise make them the only service provider capable of delivering the highly specialized gene variant editing services at the level of performance needed for our research. Synthego has proven track record on quality in this gene editing technology and their services provide a short time frame for the delivery of the edited cell line product, which is critical to the success of our project because Gene variant

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

editing is a lengthy process, involving multiple steps from sgRNA design, transfection, clone isolation, to variant verification. A service provider with technical expertise and proven records will ensure that the product will be delivered in time. Failure to do that could result in losing multiple months of time and severely impact our research project. To our knowledge, Synthego is the only company capable of providing the highly specialized gene variant editing services needed by our research projects. Alternative services could impact our research projects, not only because we have to restart the feasibility assessments on the gene variants, which may take a few additional weeks, but also bring uncertainty to the technical aspects which may result in delays and failure for the delivery of the edited cell lines with corrected gene variants.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size standards in millions of dollars: $19.0.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2024-03 effective 02/23/2024. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106(b)(1) Soliciting from a single source - For purchases not exceeding the simplified acquisition threshold.

PLACE OF DELIVERY

NIH/NIAAA

Lab of Neurogenetics 5625 Fishers Lane, Room 3S32 Rockville, Maryland 20852

DESCRIPTION OF REQUIREMENT

Gene variant editing services using CRISPR-Cas9 method. Species: Human, Cell Line: PGP1, Type of Knock In: SNV/codon change, Edit In: Protein Coding Sequence. The planned period of performance is 1-year from date of award.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice and may submit a capability statement, which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement.

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. 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. All respondents must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses to this notice shall be submitted electronically by 5:00 PM Eastern Standard Time, on May, 8th, 2024 to jacob.balenson@nih.gov and shall include pre-solicitation # 75N94024Q00083 in the subject line.

http://www.sam.gov/ mailto:jacob.balenson@nih.gov