B. AP SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Assess cytochrome P450 (CYP450) enzymes induction potential of 2 test articles (TA)

Statement of Need and Purpose:

Assess CYP450 induction potential using study designs in compliance with FDA recommendations of 2 test articles (TA) for: CYP1A2 (AhR mediated), CYP2B6 (CAR mediated) and CYP3A4 (PXR mediated). CYP2C may be evaluated as a follow-up assay when positive results for CYP3A4.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose 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, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

To support drug development for Mitragynine and its major metabolite 7-hydroxymitragynine, the CYP450 induction potential of the test articles for major human CYP450 needs to be assessed.

Period of Performance:

Four months after awarded.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualif ied personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

1. The CYP450 induction potential for mitragynine and 7-OH-mitragynine will be assessed for CYP1A2 (AhR mediated), CYP2B6 (CAR mediated) and CYP3A4 (PXR mediated).

2. TAs are tested for CYP450 induction at three concentrations.

3. All conditions are performed in triplicate, and mean data are calculated.

4. Controls/probe substrates will be used to validate the test system.

Specific Requirements:

LEVEL OF EFFORT:

Scientis who are capable to run the human CYP450 induction studies. The effort include to conduct in vitro cell based assays, data analysis and report writing.

GOVERNMENT RESPONSIBILITIES

NCATS will review study protocol, provide the test article, review experiment data, and review/approve study report.

DELIVERY OR DELIVERABLES

1. CYP450 induction studies protocol and experiment results

2. Final study reports

REPORTING REQUIREMENTS

Final report should include experiment protocol, study date and site, materials used, CYP450 induction results, data interpretations, and conclusions.

OTHER CONSIDERATIONS

Travel:

None

Key Personnel:

Cell biologist, CYP450 induction study expert

Information System Security Plan:

Vendor’s SOP on information system security

Data Rights:

NCATS owns the right on the study data for mitragynine and 7-OH-mitragynine.

Section 508—Electronic and Information Technology Standards:

Vendor’s SOP on the electronic and information technology standards.

Publications and Publicity:

No publication on this study is allowed without the permission from NCATS.

Confidentiality of Information:

All data generated from this study by the awarded vendor should not be released, disclosed, or published without the permission from NCATS.

ATTACHMENTS

1. Independent Government’s Cost Estimate.

2. Quote from quoted CROs.