VPES Olink JOFOC 11Jul22 PDF redact.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Immune responses during COVID-19 and clinical vaccine development and testing

I . Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value)

The purpose of this request is the purchase of proprietary biologics from Olink Proteomics assay kits that are capable of measuring 96 different immune and inflammatory protein mediators in nasal, serum, and pulmonary tissue samples from animal model and human studies developing and testing universal influenza vaccine candidates.

These studies are part of previous and on-going studies examining immune responses in vaccination and influenza viral challenge human studies.

A. Type of action. Check the appropriate box:

☒ New requirement ☐ Follow-on

• Name of the previous contractor(s): ________________________________

• Sequence number(s), if available: ____________________________________

• Was the initial and any subsequent awards competed? ☐ Yes ☐ No

B. AMBIS Sequence number for this requirement: _2136021__________

C. Total estimated dollar value of the requirement (including options, if applicable):

D. Period of performance, inclusive of options: from July 10, 2022 to September 30, 2022

E. Project Background

The Viral Pathogenesis and Evolution Section (VPES) within Laboratory of Infectious Diseases (LID) conducts research directed toward the development of universal influenza and SARS-CoV-2 vaccines. VPES engages in a wide range of research activities that extends from clinical virology to molecular characterization of influenza viruses that can cause severe disease in people and animals models to the development of novel vaccines and antiviral drugs. The VPES also studies immune responses and disease during human influenza viral challenge at the NIH CC.

Scientists in the section employ high-throughput genomic, proteomic and machine learning computational approaches to elucidate pathogenesis of viral diseases, understand the responses to infection and development of severe disease, as well as determine the molecular correlates of vaccine protection in animals and humans.

Project Description To characterize immune responses in vaccinated and unvaccinated mice and people before, during, and following influenza viral challenge. These include the identification of diagnostic and predictive biomarkers for vaccine efficacy, viral infection, vaccine-induced memory responses, length of viral shedding, symptom severity, and progression of disease, as part of the mission of the VPES to understand develop a broadly neutralizing universal influenza vaccine.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☐ 41 USC 253(c)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source ☒ 41 USC 501 a n d F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition

☐ An urgent and compelling need exists, and following the procedures would result in unacceptable delays

☒ Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or

☐ In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 253(c)(2) a n d F A R P a r t 6 . 3 0 2 - 2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) a n d F A R P a r t 6 . 3 0 2 - 3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services ☐ 41 USC 253(c)(4) a n d F A R P a r t 6 . 3 0 2 - 4 : International agreement ☐ 41 USC 253(c)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute ☐ 41 USC 253(c)(6) a n d F A R P a r t 6 . 3 0 2 - 6 : National security ☐ 41 USC 253(c)(7) a n d F A R P a r t 6 . 3 0 2 - 7 : Public interest

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s)

Olink Proteomics 65 Grove St.

Watertown, MA 02472 617-393-3933

B. Describe why only the requested supply/service will meet the government’s needs

This project will measure the concentration of 96 multi-plexed cytokines and chemokines in nasal secretions and serum collected from unvaccinated and vaccinated mice and humans before, during, and following viral challenge.

The goal of these long-term, longitudinal studies is to develop and test universal influenza vaccines. This is a continuation of previous and current animal and human studies using these kits, and it is essential for project continuity project that we use these proprietary biologics from Olink Proteomics. Further, in 2020 VPES purchased Olink proteomic reagents for $230,000 and to ensure project continuity, Olink is the only contractor capable of providing these proprietary biomolecule reagents.

C. Describe why only the proposed contractor is capable of providing the requested supply/service

Olink Proteomics has developed a ground-breaking, proprietary technology to make highly sensitive, precise, and accurate multiplexed protein concentration measurements in diverse sample types. Their proprietary Poximity Extension Assay (PEA) technology that enables high-throughput, multiplex immunoassays that measure 92 proteins across 96 samples simultaneously using only one microliter of serum, plasma, nasal secretions, or almost any other type of biological sample. Moreover, the PEA technology allows for simultaneous measurement of a proteins with extremely high sensitivity and a >6-log linear concentration range, thus allowing for accurate and precise measurements of both very low and very high concentration cytokine and chemokine proteins in a single assay.

D. Actions to increase Competition(if applicable or reason why not)

E. Market Research. (if applicable or reason why not)

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The price is determined to be fair and reasonable based on (provide a narrative describing how the determination was made and the rational for the determination): (AMOB) A. Synopsis if required.

B. Response to Synopsis.

C. Price reasonableness determination.

VI. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date