D.1 SOW 021221.pdf

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

Statement of Work for Services (SOW)

General Information:

Title of Project:

Assay Development for AlphaLISA needed for COVID-19 research in NCATS TDB.

Statement of Need and Purpose:

National Center for Advancing Translational Sciences (NCATS) Therapeutic Development Branch (TDB) program is requesting to measure SARS CoV-2 antiviral effect of remdesivir and the development of assay for AlphaLISA in biosafety level 3 (BSL-3) conditions.

Background Information and Objective:

The current pandemic of SARS-CoV-2 requires the emergency response of NCATS to develop high-throughput cell-based assays for drug screening (HTS). The research conducted will target the infection and replication of the virus in various cell types that are clinically relevant.

Moreover, NCATS is investigating the effect and toxicity of various compounds to cell-based assays against SARS-CoV-2. Specifically, the program is requesting to test the antiviral effect of remdesivir in VeroE6 cells using AlphaLISA assay.

NCATS does not have a BSL-3 facility and therefore must procure this service from a contractor able to fulfill the requirement.

Period of Performance:

The period of performance shall be 3 (three) months from the receipt of order (ARO) including the receipt of the assay-ready plates by the vendor.

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 vendor shall set up the assay to do the testing. Testing shall be conducted in a high-throughput, 384-well plate format. NCATS is requesting the test in 30 plates.

• NCATS will ship vendor duplicate sets of assay ready plates (ARP) containing compounds.

• Vendor shall dispense media, cells, and SARS-CoV-2 virus into one set of ARP to run in vitro infection assay.

• After incubation, vendor will measure viability by ATP content.

• Vendor shall dispense media and cells to second set of ARP to run cytotox assay using ATP content.

• Vendor shall return raw data and control plate data to NCATS for analysis.

Specific Requirements:

The scope of this work will be divided into two different tasks:

Task 1 - Measure SARS CoV-2 antiviral effect of remdesivir (non-GLP)

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

• Measure SARS CoV-2 antiviral effect of remdesivir with and without 24 hour pre-incubation in VeroE6 cells using AlphaLisa assay for nucleocapsid and spike proteins

• Compound will be tested in 10-point dose response with parallel cytotoxicity evaluation

Task 2 - Assay Development for AlphaLISA (non-GLP)

• Determine optimal virus dilution, time course and assay volume to measure SARS-CoV- 2 nucleocapsid and spike proteins by AlphaLISA in 384-well plates using A549 cells expressing ACE-2. Measure EC50 values of reference compounds (chloroquine, hydroxychloroquine, remdesivir, calpain inhibitor IV) in 10-point dose response in both assays using optimized conditions. Measure cytotoxic effects of compounds in a parallel A549 cell viability assay.

• Development will be conducted under biosafety level 3 (BSL-3) conditions.

Government Responsibilities

1. Provide assay-ready plates.

2. Perform data analysis.

Delivery or Deliverables

1. Raw data files and a calculated data report for references compounds shall be provided as the final report.

2. Control plates shall also be returned to NCATS.