D CSS_75N95025Q00040.pdf

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Transcriptomics Sequencing and analysis in Liver Spheroids

(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 75N95025Q00040 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;

and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

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 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 Insphero Inc, 74 Zorion Street, STE A, Brunswick, Maine 040141 for Transcriptomics Sequencing and analysis in Liver Spheroids

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 through Federal Acquisition Circular (FAC) Number 2024-05 with effective date April 22, 2024.

(iv) The associated NAICS code is 325414: Biological Product (Except Diagnostic) Manufacturing and the small business size standard is 1250 employees. There are no set-aside restrictions for this requirement.

(v) This requirement is for the following services:

Transcriptomics Sequencing and Analysis in Liver Spheroids

The National Center for Advancing Translational Sciences (NCATS) focuses on treating rare diseases. A significant emphasis of NCATS is the rapid development of effective therapies for patients diagnosed with these conditions. Although each condition is individually rare, cumulative rare diseases lead to considerable morbidity and mortality among the American population. NCATS is directly addressing this problem by discovering new technologies and other approaches, such as ASO therapies, that could significantly accelerate developing and deploying solutions that all translational researchers can use.

There are over 7,000 different rare diseases that affect 350 million globally and about 35 million people in the U.S. Sadly, about half of these rare diseases have onset in childhood, and the vast majority (~95%) have no FDA-approved treatment. Most rare diseases have a known single gene cause, making them potentially amenable to oligonucleotide therapeutics like ASOs. ASOs are short strands of modified RNA and DNA that bind to target RNA and can act by modulating splicing, inhibiting translation, or inducing mRNA degradation. ASOs are increasingly being deployed as individualized medicines as they are rapidly customizable, relatively easy to deliver, and inexpensive to manufacture. Although there is a growing number of clinical examples and safety data for ASOs, there is a need to reduce the cost and development timelines to test these therapies in more patients with rapidly progressing life-threatening diseases faster without compromising safety.

Antisense oligonucleotides comprise 16 to 20 nucleotide bases, often with chemical modifications of the phosphate backbone. It is thought that the sequence and backbone chemistry of the ASOs determine whether administering a particular ASO molecule will lead to liver toxicity. However, the broader development of high-affinity gapmer ASOs for rare diseases has been hampered by hepatotoxicity. An unanswered question is whether the 3D liver microtissues can accurately predict the hepatotoxicity of ASOs. The project is designed to answer this question.

The objective of this contract is to generate proof-of-concept data for evaluating the ability of the 3D liver microtissue platform to predict the hepatoxicity of individual ASOs.

If successful, this will represent a new means to screen ASOs for this type of toxicity that is cheaper, faster, and has high throughput. NCATS is seeking technical support to evaluate the safety and acute liver toxicity of candidate ASOs by checking the gene expression. The results from these studies, in conjunction with existing cell-based assays, will help better predict the safety of future candidate ASOs intended for clinical use.

NCATS is seeking technical support to evaluate the safety and acute liver toxicity of candidate ASOs by checking the gene expression. The results from these studies, in conjunction with existing cell-based assays, will help better predict the safety of future candidate ASOs intended for clinical use.

(vi) SPECIFIC REQUIREMENTS:

This contract aims to determine if the 3D Insight liver spheroids developed by InSphero can predict the hepatic cytotoxicity of ASOs. The studies are designed to characterize the efficiency of the assays. These studies will use a set of 8 ASOs known to be hepatotoxic in humans or rodents (hepatotoxic ASOs) and a group of ASOs that show no hepatotoxicity in humans or rodents (safe ASOs). This project will generate proof-of-concept data.

The contractor will test each ASOs on multi-donor human liver spheroids.

WP2: Transcriptomics – Sequencing and analysis 8 ASOs, 2 concentrations, 2 time points (2 & 7), n=7, including MALAT1

Work package 1 – Low-input bulk RNA Transcriptomic sequencing

Goal • Investigative toxicology study of the therapeutic compound.

3D InSightTM Liver model • Human 3D InSight™ liver microtissues Test groups • Test compound: 8

• Test concentrations:

o IC10ATP o 0.1-fold of IC10ATP

• Timepoints:

o 2 days o 7 days

• Biological replicates: 7

• Vehicle control: PBS

Compound procurement By client

• All compounds

General Protocol • Medium: BSA-free 3D Insight™ LiMM Tox

• 7 days compound treatment with compound application on day 0, 2 & 4.

• Sample preparation for RNA sequencing at selected timepoints Measurements • Low input bulk RNA sequencing

LEVEL OF EFFORT:

PhD level scientists with knowledge and training in ASOs shall run the tests.

GOVERNMENT RESPONSIBILITIES

The Government will provide the 50 candidate ASOs to the Contractor for evaluation

DELIVERY OR DELIVERABLES:

The contractor will provide a report of the extracted RNAs in the assay results for each animal and each measured time point.

REPORTING REQUIREMENTS

The vendor shall send a full report with raw data and explanations at the end of the project.

DATA RIGHTS:

All this information and dat will be kept confidential.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, with the anticipated period of performance of 8 weeks after receipt of order (ARO). Perormance shall be FOB Destination and shall be delivered to 9800 Medical Center Drive, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal Holidays).

(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 (Aug 2020)

• FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders –

Representation and Disclosures (Dec 2023)

• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial

Services (Sep 2023)

• FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Feb 2024)

• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

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:

(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 (Aug

2020)

• FAR 52.212-4, Contract Terms and Conditions-Commercial Products and

Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached.

The following provisions and clauses apply to this acquisition and are attached in full text:

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Oct 2018)

• NIH Invoice and Payment Provisions (2/2014)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions below and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services- Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (Feb 2024)

• FAR 52.222-48 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014).

• NIH Invoice and Payment Provisions

(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].

The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(x) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2024), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi) 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. The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. 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 attached in full text

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) 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 Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an http://www.sam.gov/ active registration in the System for Award Management (SAM) www.sam.gov.

All questions must be received by 3:00PM., Eastern Daylight/Standard Time, on November 19, 2024, and reference Solicitation Number 75N95025Q00039 Questions may be submitted electronically to Chandani Hangilipola, Contract Specialist, at chandani.hangilipola@nih.gov

All quotations must be received by 3:00 PM, Eastern Daylight/ Standard Time, on November 22, 2024 and reference Solicitation Number 75N95025Q00039 Responses must be submitted electronically to Chandani Hangilipola, Contract Specialist at chandani.hangilipola@nih.gov

Fax responses will not be accepted.

http://www.sam.gov/ mailto:chandani.hangilipola@nih.gov mailto:chandani.hangilipola@nih.gov

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).