Statement of Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Proteomic markers of cognition and brain structure in chronic kidney disease

Statement of Need and Purpose:

The purpose of this requirement is to utilize a discovery-based proteomics platform in archived plasma samples collected in the BRINK (Brain IN Kidney Disease) study to identify circulating plasma proteins and protein networks that influence the trajectory of cognitive function and brain volume in patients with chronic kidney disease.

Background Information and Objective:

Chronic kidney diseases pose an increasing public health burden, especially on older adults.

Kidney dysfunction and its downstream effects are known to affect brain structure and function, increase risk for cognitive impairment, and promote neurodegenerative diseases. Although the degree of kidney dysfunction can influence the extent of cognitive impairment, with this information alone it is difficult to predict which patients with kidney disease will experience cognitive decline and which will remain cognitively stable.

Using plasma specimens from the BRINK (Brain IN Kidney Disease) study, the present study aims to apply large-scale proteomics to available plasma specimens to identify a set of proteins and protein networks in blood that are associated with longitudinal changes in cogntion and MRI measures of brain structure in individuals with chronic kidney disease. We expect that this analysis will yield a novel set of plasma protein panels that can be used to identify individuals at greatest risk for becoming Aβ-positive in the coming years. Furthermore, examinaition of the cognition- and MRI-related proteins in individuals with kidney disease will allow us to better understand the biological changes that place one at risk for cognitive decline in the context of kidney dysfunction.

Period of Performance:

The period of performance for this contract will be within 6 months of receipt of samples.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor shall –

Perform discovery-based proteomic assays on approximately 40 human plasma samples to identify molecular pathways that accelerate cognitive decline. The contractor shall use the aptamer-based assay to measure levels of approximately 7,000 proteins including cytokines, growth factors, receptors, proteases, protease inhibitors, kinases, structural proteins, and hormones known to be important in human diseases. The assay should require approximately 100 microliters of plasma or serum and allow hundreds of assays to be run in parallel 96-well plates. The contractor shall use a modified aptamer-based reagent comprised of synthetic single-stranded DNA sequences with protein-like appendages that bind to specific target proteins. The single-stranded DNA SOMAmer reagent should then be quantifiable by hybridization to a custom DNA microarray containing probes complementary to the SOMAmer sequences.

LEVEL OF EFFORT:

Senior researcher or technical researcher.

GOVERNMENT RESPONSIBILITIES

The government shall provide adequate quantities of archived plasma samples to the contractor to enable the performance of the proteomic assays detailed above.

DELIVERY OR DELIVERABLES

The contractor shall provide an electronic copy of spreadsheet or database files incuding quantitative measurement of all proteins assayed in the provided plasma samples and relevant quality control metrics (including specimen usage, assay coefficients of variation, assay success/failure rates, normalization process) as well as an electronic copy of a report summarizing the laboratory methods and technical specifications used, both to be delivered within 6 months of receipt of the samples by the contractor.

REPORTING REQUIREMENTS

The contractor shall submit via e-mail as PDF or a MS Word document a progress report during the contract period. The progress report shall include tasks completed and a list of tasks to be completed, inclusive of timeframe. This report shall also describe any problems that arose and state the resolution or provide an explanation if a solution was not identified.

OTHER CONSIDERATIONS

Key Personnel:

The key personnel requirements for the senior researcher are as follows:

• A Masters or PhD in a laboratory science field

• Extensive experience in high throughput lab methods.

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW.

Confidentiality of Information:

The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.