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:

Measurement of global plasma metabolites and targeted short chain fatty acids in the Baltimore Longitudinal Study on Aging (BLSA) samples.

Statement of Need and Purpose:

The purpose of this requirement is to assess over 1000 plasma metabolites including a targeted panel for short chain fatty acids using a high throughput mass spectrometry. The plasma metabolite profiles will be used to identify biomarkers of brain aging.

Background Information and Objective:

Alzheimer’s disease (AD), the most common form of dementia, is a progressive neurodegenerative disease with devastating impact to the patients, their families and healthcare system. AD is pathologically characterized by the accumulation of amyloid plaques and development of hyperphosphorylated tau neurofibrillary tangles. However, attempts to prevcent or improve AD symptoms based on targeting these pathology characteristics has not been so far effective. Thus, identification of novel treatment targets for AD prevention and cure are needed. In recent years, there has been increased interest in the role of the gut microbiome on brain health. The gut has bidirectional communication with the brain through several mechanisms. The gut microbiome can directly synthesize neurotransmitter such as GABA, dopamine and norepinephrine, and indirectly control the synthesis of serotonin through metabolism of tryptophan. The gut microbiome produces a wide range of metabolites such as short chain fatty acids (SCFA) and secondary bile acids that modulate the enterocytes to synthesize gut hormones such CKK, PYY and GLP-1. These metabolites can also stimulate immune cells such as the macrophages to trigger an inflammatory response. Inflammation can also be triggered directly by bacterial structural component such as membrane-bound lipopolysaccharide (LPS). While several pathways that establish the gut-brain axis have been describe, the full mechanisms for this connection are yet to be discovered. To gain insight into possible mechanisms by which microbiome characteristics and metabolic activity may impact AD, comprehensive characterization plasma metabolites is needed. In prior study through collaboration with Johns Hopkins University, fecal metabolites were measured using Metabolon’s global metabolite panel and short chain fatty acids. The objective of this proposal is to measure metabolites using the same assays in plasma samples collected from participants of the BLSA study.

Period of Performance:

12 months

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 plasma metabolomic profiling including tools and reagents to run the global metabolomic and targeted SCFA panels. The contractor will provide a data report that includes rationale and objective, methods used to generate the data, and any technical information that will be needed to perform downstream analyses. The contractor shall provide raw data as well as any processed data on the abundance of the metabolites including data on over 1000 metabolites as well as SCFA.

GOVERNMENT RESPONSIBILITIES

The government will provide adequate quantities of archived plasma samples (total of 1840 samples) to the contractor to enable the performance of plasma metabolite profiling detailed above.

DELIVERY OR DELIVERABLES

The contractor shall provide an electronic copy of spreadsheet or database files including the abundance of metabolites assessed. The contractor shall also provide written documentation to describe any quality control and process of the data generated along with the codes that were used to conduct each of the QC and processing procedure.

REPORTING REQUIREMENTS

The contractor shall provide data reports and results from the metabolomic assessments for the 1840 samples sent to the contractor. During the contracting period, the contractor shall provide reports should there should be any problems that arise 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.

Publications and Publicity:

The government will perform data analysis. The contractor will not write or publish articles from the of data produced as a result of the requirements 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.