Attachment_SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Plasma tau as a biomarker and risk factor for pathogenic brain changes in non-demented adults

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 Baltimore Longitudinal Study of Aging (BLSA) to identify molecular pathways that accelerate pathological phosphorylation of tau in individuals at risk for Alzheimer’s Disease (AD).

Background Information and Objective:

Given the putative role of tau phosphorylation, destabilization, and aggregation in Alzheimer’s disease pathogenesis, understanding the biological processes that promote pathological tau formation is essential. The association between amyloid-beta (Aß ) and early p-tau accumulation has been established, supporting the theory that amyloidosis can lead to hyperphosphorylation of pathogenic tau isoforms. In addition, evidence that peripheral inflammatory/immune and hemostatic/vascular processes may act as molecular drivers of tau pathology has recently emerged. Using available data from the Baltimore Longitudinal Study of Aging (BLSA), we have the unique opportunity to apply a proteome-wide discovery approach to identify peripherally-acting molecular drivers of tau progression. In doing so, we will learn about the systemic biological processes that may influence tau progression. Results will point to new therapeutic avenues for slowing pathogenic tau in those at risk for Alzheimer’s disease. To further understand the peripheral processes that may accelerate pathological tau formation within the brain, we will use stored plasma from approximately 1800 participants to conduct a comprehensive proteomic measurement using an aptamer-based assays and examine whether baseline expression of circulating plasma proteins and identified protein networks predict longitudinal increases in plasma p-tau181, PET-defined tau neurofibrillary tangles (NFTs), and cognitive decline.

Period of Performance:

The period of performance for this contract will be 6 months after 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 1800 human plasma samples from the BLSA cohort to identify molecular pathways that accelerate pathological phosphorylation of tau in individuals at risk for AD. 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 hundres of assays to be run in apreallel 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

Travel:

N/A

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.

Information System Security Plan:

N/A

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.”

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.

Publications and Publicity:

N/A

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.