Drug phenotypic screening SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Phenotypic screening of candidate drugs to treat Alzheimer’s Disease

Statement of Need and Purpose:

There is currently a pressing need to identify effective treatments for Alzheimer’s disease (AD).

With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, it is critical to test novel methods of discovering disease-modifying AD treatments. As part of an ongoing study called the Drug Repurposing for Effective Alzheimer’s Medicines (DREAM) study, the NIA IRP is testing whether exposure to commonly prescribed, FDA-approved drugs will be associated with protection against AD. DREAM will test approximately 20 drugs that we have nominated as ‘candidate AD treatments.’

Background Information and Objective:

Research in the NIA IRP has identified several FDA approved drugs that may target metabolic abnormalities associated with AD and be of utility as effective disease-modifying treatments.

Repurposing of approved drugs for AD is a promising approach that can accelerate the development of novel AD treatments. As art of the DREAM study, we will perform pharmacoepidemiologic analyses of approximately 20 FDA approved drugs to test whether older individuals exposed to these ‘candidate AD treatments’ are at ower risk of AD. In parallel with these analyses, we wish to test whether these drugs also ameliorate pathological changes associated with AD at the cellular level.

Period of Performance:

September 30, 2020 – September 29, 2021

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:

The main objective of the requirement is but not limited to the following:

1. Perform cell culture based phenotypic screening of 20 FDA approved drugs to test their potential utility as treatments for Alzheimer’s disease (AD)

2. Perform statistical analysis to derive dose-response profiles for each drug in the phenotypic screening assays.

3. The phenotypic screening will be performed to test the following read-outs:

i) β-amyloid1-42 (Aβ) toxicity

ii) Aβ clearance

iii) Aβ seretion

iv) Tau aggregation

v) Tau phosphorylation

vi) Neuroinflamamtion

vii) Neurite outgrowth

Specific Requirements:

LEVEL OF EFFORT:

Senior researcher 960 labor hours for period of performance

GOVERNMENT RESPONSIBILITIES

Provide a list of FDA-approved drugs i.e. ‘candidate AD treatments’ to the contractor to enable the performance of the phenotypic screening assays detailed above.

DELIVERY OR DELIVERABLES

Electronic copy of excel spreadsheet incuding results of the drug phenotypic screening assays to be delivered within 364 calendar says of receipt of the list of ‘candidate AD treatments’ by the contractor. The timely submission of this deliverable is essential to successful completing this requirement.

REPORTING REQUIREMENTS

The contractor is required to provide written progress reports every 2 months for the contract period 9/30/20 through 9/29/21. The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period.

This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation.

Reports should be as follows;

• WORD document detailing all the technical aspects of the experimental methodology used including coefficients of variation (CV) of the assays, dose-response results, success/failure of the drug(s) in each phenotypic screen.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

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