SOW_75N95021Q00119.pdf

Statement of Work (SOW)

A. GENERAL INFORMATION

1. Title of Project: Investigation of potential serum autoantibodies in Alzheimer’s disease (AD) participants from the Women's Health Initiative Memory Study (WHIMS) for whom their APOE e4 allele status does not increase risk.

2. Background Information Several studies have identified serum antibodies in AD patients that are directed against brain components associated with neurodegenerative diseases, such as Aβ fibrils and MOG protein. The contribution of such autoantibodies to disease initiation or progression remains unknown. In addition, the impact of the APOE e4 risk allele’s influence on the status of autoantibodies is unclear.

3. Purpose or Objective of the Requirement: To define the ‘universe’ of autoantibody specificities we will both use phage immunoprecipitation sequencing (PhIP-Seq) and the HuProt protein array to: 1) determine differences in autoreactivities over time within each individual, 2) identify shared auto-specificities that develop with age in different individuals, and 3) determine whether certain autoreactivities are restricted to those who go on to develop AD.

4. Type of Contract Contemplated:

The Government anticipates award of a firm fixed-price purchase order for this acquisition.

5. Period of Performance:

The Government anticipates period of performance of one (1) year from the date of award.

B. CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

Briefly, both PhiP-Seq, a means to query an array of more than 250,000 90-residue peptides spanning the human proteome as well as The HuProt™ human proteome microarray v4.0, which contains > 21,000 unique, newly resequenced and individually purified human proteins encompassing 16,793 genes, will be utilized to probe the sera of participants from the WHIMS study. The Contractor shall 1) determine differences in autoreactivities over time within each individual, 2) identify shared auto-specificities that develop with age in different individuals, and 3) determine whether certain autoreactivities are restricted to those who go on to develop AD.

C. GOVERNMENT RESPONSIBILITIES

Government will provide high quality WHIMS AD sera samples to the contractor for preparation of PhiP Sequencing. Government will deliver samples to the CDI Laboratories in good condition

D. DELIVERY OR DELIVERABLES

1) Determine differences in autoreactivities over time within each individual, 2) Identify shared auto-specificities that develop with age in different individuals, and 3) Determine whether certain autoreactivities are restricted to those who go on to develop AD.

E. CONTRACTOR EXPERIENCE REQUIREMENTS – KEY PERSONNEL

The Government requires that contractor have expertise and demonstrated experience in phage display and sequencing and to apply the latest data management technologies for this project. The JHMI Department of Pathology investigator, H. Benjamin Larman, Ph.D, routinely carries out these procedures for researchers. The Larman lab also previously published this work here:

PhIPSeq characterization of serum antibodies using oligonucleotideencoded peptidomes .Mohan D, Wansley DL, Sie BM, Noon MS, Baer AN, Laserson U, Larman HB. Nat Protoc. 2018 Sep;13 (9):1958-1978.

For these reasons the government is satisfied that this core facility meets the requirements for this project.

F. DATA RIGHTS

The NIA/IRP/LMBI shall have unlimited rights to and ownership of all deliverables provided under this contract, including generated mouse strains, 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.