solicitation.pdf

SOLICITATION

(1) Action Code: Solicitation

(2) Date: 07/28/2021

(3) Year: 2021

(4) Contracting Office Zip Code: 20892

(5) Classification Code: AN12

(6) Contracting Office Address:

6705 Rockledge Drive Rockledge I Bethesda, MD 20892

(7) Subject/Title: Professional Service-Validate gene expression, autoantibodies, and somascan analyte detection assay results on patient samples

(8) Proposed Solicitation Number: 75N92021Q0086

(9) Closing Response Date: 08/02/2021

(10) Contact Point(s): Elizabeth Francois, Contract Specialist

(11) Contract Award and Solicitation Number: TBD

(12) Contract Award Dollar Amount: TBD

(13) Contract Line Item Number(s): TBD

(14) Contractor Award Date: TBD

(15) Contractor Name: TBD

(16) Description:

(i) This is a 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 75N92021Q0086 and the solicitation is issued as a request for quotation (RFQ).

(iii) The solicitation document, the incorporated provisions, and clauses are those in effect through Federal Acquisition Circular 2021-06 effective 07/12/2021.

(iv) This solicitation is not set aside. The associated NAICS code is 812990, Other Professional Services, small business size $8 Million. This acquisition is being conducted in accordance with the procedures of FAR Part 12.

(v) It is anticipated that there will be four (4) contract line items listing the required services.

(vi) The requested requirements are listed in the attached Statement of Work.

(vii) This is a sole source requirement to Dr. Perez Riveros for Professional Services.

A Notice of intent to solicit and award for sole source was posted on 07/20/2021.

(viii) Period of Performance:

Base Year: August 5, 2021 – August 4, 2022 Option Year 1: August 5, 2022 – August 4, 2023 Option Year 2: August 5, 2023 – August 4, 2024 Option Year 3: August 5, 2024 – August 4, 2025

(ix) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

• The contractor is preferred to have a PhD in Biomedical Science and understanding of molecular biology, histology, PBMCs culture and analysis, NGS, SomaScan data processing, and Sjogren’s Syndrome and signaling pathway analysis.

• The contractor should have extensive experience in the area of gene expression analysis, and histological analysis of salivary glands as well as establishing short term primary cultures of salivary glands, PBMCs and an experience in signal transduction in the salivary gland.

• The contractor should have a background in industry for management of clinical data and immunology/ autoimmunity viral biology in SG. Experience in industry is beneficial.

• The Contractor should have a demonstrated record of publications in peer reviewed scientific journals.

The offeror shall provide the following:

• Provide cost estimate, broken down into hourly compensation, and option period.

• Provide most recent resume narrating capabilities to meet the additional requirements as stated.

• Provide a CV stating the relatable experience and education background necessary to complete the tasks as stated under the statement of work.

(x) FAR clause 52.212-2, Evaluation – Commercial Items is applicable to this acquisition.

(xi) Please include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, with all offers.

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(xii) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xiii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition:

• 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L.

115-232).

• 52.217-9, Option to Extend the Term of the Contract (Mar 2000)

• 52.222-3, Convict Labor (June 2003) (E.O. 11755)

• 52.222-21, Prohibition of Segregated Facilities (APR 2015)

• 52.222-26, Equal Opportunity (APR 2015) (E.O. 11246)

• 52.222-36, Equal Opportunity for Workers with Disabilities (JUL

2014) (29 U.S.C. 793)

• 52.222-50, Combating Trafficking in Persons (MAR 2015). (22

U.S.C. chapter 78 and E.O. 13627)

• 52.222-53, Exemption from Application of the Service Contract

Labor Standards to Contracts for Certain Services- Requirements

• 52.223-18, Encouraging Contractor Policies to Ban Text

Messaging While Driving (AUG 2011) (E.O. 13513)

• 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008)

• 52.232-33, Payment by Electronic Funds Transfer—System for

Award Management (JUL 2013) (31 U.S.C. 3332)

(xiv) Additional Contract Requirements: None

(xv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable.

(xvi) Offers shall be submitted via the FedConnect web portal (www.fedconnect.net). The due date for receipt of offers is 12:00 PM Eastern Time on 08/02/2021.

(xvii) Point of Contact:

Elizabeth Francois, Contract Specialist www.fedconnect.net solicitation 75N92021Q0086

(17) Place of Contract Performance:

Salivary Disorder Unit lab space

NIH/NIDCR

10 Center Dr.

Bethesda, MD 20892

(18) Set-aside Status: None http://www.fedconnect.net/ http://www.fedconnect.net/

STATEMENT OF WORK

Program Office:

IC:NIDCR

Project Officer: Blake M. Warner, DDS, PhD, MPH

Background:

Potential mechanisms of immune dysregulation in Sjogren’s Syndrome, pathogenic inflammation and resultant tissue dysfunction and destruction (e.g., salivary glands) are a core research aim of the Salivary

Disorders Unit. Sjogren’s Syndrome is the second most common autoimmune disease in the United

States and affects 1-4 million individuals. Presently, no effective therapy exists for Sjogren’s Syndrome beyond supportive care or the alleviation of localized or systemic symptoms. Although the pathogenesis is not well understood, most data support an imbalanced interaction of the immune system with specific organ systems (e.g., the salivary glands) as a principal underlying mechanism. One pathway implicated in the immune imbalanced reported in Sjogren’s Syndrome is the cGAS-STING pathway. STING regulates the immune response to microbial and self-DNA by activating the expression of type I interferons and other inflammatory cytokines. The activation of STING is mediated by cyclic dinucleotides (cAMP, cGMP and cGAMP) produced by DNA sensors (such as cGAS and DDX41) from cytosolic DNA. Recent evidence from analysis of patient samples has demonstrated a robust type I interferon response in a subset of individuals diagnosed with a range of chronic autoimmune disorders including Sjogren’s

Syndrome.

Purpose:

For this requirement, the contractor will develop assays for assessing cGAS-STING pathway activation in subject samples, patient derived primary cells, sera, and peripheral blood mononuclear cells from healthy donors and patients with Sjogren’s Syndrome. Assays will include, but are not limited to, tissue culture and

Western immunoblots for phospho-STING, phospho-TBK1, STING and TBK1, as well as, phosho-flow assays and flow cytometry analysis for immunophenotyping healthy volunteers and Sjogren’s Syndrome

PBMCs. In vitro, and if viable, in vivo assays testing STING antagonist compounds on patient-derived samples (primary cells, PBMCs) and in mouse models of SS are a logical and clinically relevant continuation of this research. These assays will elucidate the impact of STING antagonism of pathogenic cytokine signaling and the impact on inflammation in systemic and target organs of Sjogren’s Syndrome.

Additional assays will include bulk and single cell RNA sequencing and qRT-PCR/droplet digital PCR validation to evaluate expression of inflammatory cytokine signatures in target tissues (e.g., salivary glands) by cell type, and PBMCs, as well as measurement of serum cytokines using multiplex assays.

These studies are covered under protocols NCT01425892 and NCT02327884.

Scope of Work:

The Salivary Disorders Unit investigators propose that STING-mediated inflammation driven by cytoplasmic DNA is hypothesized to play a critical role in the pathogenesis of diseases such as Sjogren’s syndrome. The inhibition of STING and its downstream mediators could ameliorate the symptoms, protect targeted tissues (e.g., salivary and lacrimal glands), and potentially slow disease progression in a subset of

Sjogren’s syndrome patients demonstrating a significant type I interferon response.

In this requirement, the primary objective of this project is to validate gene expression, autoantibodies, and somascan analyte detection assay results on patient samples. This will initially require extensive review of the collected data followed by assay design, validation, and testing.

Minor salivary glands represent an accessible primary tissue for analysis of the effect of AQP1 expression on recovery of gland function. This analysis will identify biomarkers that can be used in the identification of mechanism of response as well as those patients who might benefit from this therapeutic approach.

Specific Tasks:

i. Measure STING pathway activation in cells/tissues of patients diagnosed with Sjogren’s syndrome compared to healthy controls, to do this we plan to assess activation of the STING pathway by immunoblotting and immunofluorescent confocal microscopy for phospho-STING, STING, phospho-

TBK1 and TBK1, phospho-IRF3 and IRF3, DDX41 in Sjogren’s syndrome patient-derived primary cells and tissues.

ii. To correlate with target activation, we will measure the presence of mitochondrial DNA in the plasma using ddPCR/qRT-PCR or detection of 2’,3’-cGAMP by LC-MS/MS. An general cytokine profile in plasma/serum evaluation of the cytokine levels will be performed using ELISAs/Somalogic/ and/or other multiplexed proteomics platforms. The expression of signature cytokine genes in peripheral blood cells and/or glandular tissue using qRT-PCR or RNA-sequencing.

Personnel Qualifications:

1) The contractor is preferred to have a PhD in Biomedical Science and understanding of molecular biology, histology, PBMCs culture and analysis, NGS, SomaScan data processing, and Sjogren’s

Syndrome and signaling pathway analysis.

2) The contractor should have extensive experience in the area of gene expression analysis, and histological analysis of salivary glands as well as establishing short term primary cultures of salivary glands, PBMCs and an experience in signal transduction in the salivary gland.

3) The contractor should have a background in industry for management of clinical data and immunology/ autoimmunity viral biology in SG. Experience in industry is beneficial.

4) The Contractor should have a demonstrated record of publications in peer reviewed scientific journals.

Evaluation of the Contractor:

During the period of this Professional Services Contract award, the tasks and data collected will be evaluated. If it is determined by the program staff that this project needs to be extended, NIDCR will discuss the options with the Contracting Official.

Deliverable Requirements:

• The Contractor’s work will be reviewed weekly for appropriate progress and accuracy of the data.

• Research data, including results obtained through the process, as well as other relevant patient data, will be collected and maintained on a daily basis in the lab on-site in Building 10. The completed final summary must be submitted within thirty days after one-year period ends

• The contractor may be required to present findings at scientific meetings on behalf of the Salivary

Disorders Unit. This deadline may be extended at the discretion of Dr. Blake M. Warner, Salivary

Disorder Unit, DIR, NIDCR by arrangement prior to the due date.

All reports may be submitted electronically to:

TBD

Place of Performance:

Salivary Disorder Unit lab space

NIH/NIDCR

10 Center Dr.

Bethesda, MD 20892

Period of Performance:

TBD