D_Attachment 1 - Statement of Work (Services)_final.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Biochemical, Biophysical, and in vivo Testing of Compounds

Statement of Need and Purpose:

The purpose of this requirement is to obtain biochemical, biophysical, and in vivo testing services of 100 compounds in support for a drug discovery campaign to develop a novel therapeutic effective in Alzheimer’s Disease and Related dementias (AD/RD). The scope of this project shall be protein biochemistry, biophysical assays, in vivo microscopy, flow cytometry, proteomics, and cryoEM.

Background Information and Objective:

The National Institutes of Health (NIH) is the steward of medical and behavioral research for the Nation. Its mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

The mission of the National Institute of Neurological Disorders and Stroke (NINDS) is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. The NINDS Division of Intramural Research (DIR) has a drug discovery campaign to develop a novel therapeutic effective in Alzheimer’s Disease and Related dementias (AD/RD).

Having identified potential small-molecules, the government seeks to characterize these compound-protein interactions by a series of biochemical, biophysical and cellular assays including Protein Purification, Thermal Unfolding, Intrinsic Trptophan Fluorescence, Surface Plasmon Resonance, CryoEM, flow cytometry, microscopy and mass spectrometry.

To this end, NINDS has engaged in a drug discovery screen to find small-molecules capable of redirecting autophagy, a cellular debris removal system, using autophagy related protein KIAA0203 for a potential avenue of treatment for AR/RDs. To determine which of the compounds is to be carried forward in the therapeutic development plan, the government seeks data on the potency of identified compounds.

Period of Performance:

The period of performance shall include one 12-month base period effective at time of award anticipated to begin on:

Base Period: 4/29/2024 – 4/28/2025

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 test 100 compounds to perform assays and analyze proteomics data with biochemical, biophysical techniques and in vivo testing in cell culture models. Specifically:

1. To produce recombinant proteins used in each assay. Each compound shall be initially tested with Intrinsic Tryptophan Fluorescence and thermal unfolding. Potent compound (those with lower than 10 μM KD) compounds will be tested using SPR. Where applicable the government can request further analysis on these compounds using in vivo flow cytometry, confocal microscopy, and proteomics. Highly potent compounds shall be anlyzed for binding mode via CryoEM and structural data shall be reported.

LEVEL OF EFFORT:

It is anticipated that one (1) 70% (FTE) scientist is needed to perform assays and one (1) FTE at 10% effort is needed to analyze the proteomics data for the completion of the testing services required over a 12-month base period.

GOVERNMENT RESPONSIBILITIES

The Government will provide the compounds to the contractor for testing shortly after the issuance of the resultant purchase order.

DELIVERY OR DELIVERABLES

The Contractor shall provide bimonthly progress reports and a final report. Progress reports shall include the number of compounds that have been tested and when testing of new compounds is anticipated. The progress reports shall include a description of any problems encountered and whether these issues were resolved. The final report shall include the results and date of the testing of 100 compounds at the conclusion of the services.

REPORTING REQUIREMENTS

The Contractor shall submit the bimonthly progress reports and the final report through email to the Contracting Officer’s Representative (COR) and the NINDS technical point of contact to be specified at time of award. Results of each test shall also be reported bimonthly during meetings scheduled by NINDS and the Contractor.

OTHER CONSIDERATIONS

Travel:

Not applicable.

Key Personnel:

Not applicable.

Information System Security Plan:

Not Applicable.

Data Rights:

All data will be considered confidential and the property of the government.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

Data will not be published by the contractor without permission from the government and the contractor will not have any influence or reference in, or on any publication produced as a result of this requirement.

Confidentiality of Information:

Data will be kept confidential.