D. Attachment 1 - Statement of Work.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Develop manufacturable tablet formulation of CD206 compound NCGC00413972, N-(3-(2-oxopyrrolidin- 1-yl)propyl)-4-(6-phenylimidazo[1,5-a]pyrazin-3-yl)benzamide, for use in dog sarcoma clinical studies.

Statement of Need and Purpose:

These studies are needed to evaluate our leading compound, NCGC00413972, for its efficacy against sarcoma in dogs. These results will help us determine the efficacy of our compound and its possible use in humans.

Background Information and Objective:

Design manufacturable tablet formulations using milled NCGC72 will be designed to provide tablet strength of 1000 x 50mg and 500 x 100mg strength. This will be done at a feasibility scale of several grams of drug (i.e. ~ 1/50 scale). Milling of NCGC72 will be optimized, followed by optimized mixing with a platform tableting formulation (e.g. CombiLac), obtaining adequate flow properties for tableting, identify appropriate compression parameters to provide adequate hardness, but still have desired dissolution, all with appropriate dose homogeneity to meet product release criteria at several dosage strengths. As a precursor to this, analytical assays for drug product (the tablet) will have to validated for potency, impurities and batch release.

Similarly, a dissolution method will be developed.

These tablets will contain our leading compound, NCGC00413972, to evaluate its efficacy against sarcomas and these studies will help determine the properties of the tablets and their ability to deliver the compound by dissolution.

Period of Performance:

Up to 6 months ARO depending on the clinical results.

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:

NCATS will supply the compound, NCGC00413972, within 14 days of the award. The vendor will make the tablets at 1000 x 50mg and 500 x 100mg strength.

LEVEL OF EFFORT:

Scientists at NCATS will obtain the amount of NCGC00413972 required to run the studies. KU will make the tablets at the required dosage strength

GOVERNMENT RESPONSIBILITIES

The government will pay for the services provided by the contractor. The Contractor will pay its scientists to prepare the tablets at the required dosage strengths.

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

DELIVERY OR DELIVERABLES

1000 x 50mg and 500 x 100mg strength tablets of NCGC00413972 at most 6 months after approval of order.

REPORTING REQUIREMENTS

The contractor will ship the required tablets to any other facility approved by NCATS for the studies to be carried out.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

To be be determined at the time of award Information System Security Plan:

N/A Data Rights:

All data collected will be the property of NCATS/NCI Section 508—Electronic and Information Technology Standards:

N/A Publications and Publicity:

N/A

Confidentiality of Information:

Results of the studies are the confidential property of NCATS/NCI