1-SOW-Formulation-June-2023_v2.pdf

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

STATEMENT OF WORK(SOW)

(SERVICES)

GENERAL INFORMATION

Title of Project:

Development of formulation strategy for one lead compound to support preclinical and IND-enabling studies for the Early Translation Branch at NCATS.

Statement of Need and Purpose:

This requisition is to develop a formulation strategy for one lead molecule to support preclinical and IND-enabling studies. The contractor will need to:

• Provide preliminary screening of physicochemical properties relevant to formulation (solubility, DSC, TGA, DVS, pKa, LogD, chemical stability, crystallization propensity, etc.).

• Investigate the feasibility of generating a suitable formulation strategy for clinical evaluation.

The strategy requires crystallization and micronization of free base, salt screening the addition of solubilizers such as cyclodextrins, and propensity to form amorphous solids.

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. The Early Translational Branch (ETB) is tasked with identifying and developing novel small molecule leads for improving human health.

In pursuit of this goal, the Center has a strong internal trans-disciplinary team of scientists who continually discover novel small molecules to modulate molecular targets to identify novel treatment strategies. As such, discovering lead molecules that could serve as starting points for therapeutic development for patients is a key part of discovery. Formulation of small molecule lead compounds is an important part of the discovery process and key to advancing a molecule for the treatment of patients. As such right formulation condition is essential for toxicity and IND studies.

Period of Performance:

The Period of Performance (PoP) is 12 weeks from the contract award and receipt of the materials.

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:

N/A

LEVEL OF EFFORT:

N/A

GOVERNMENT RESPONSIBILITIES

The government will not furnish the property, facilities, workspace, computers, or other equipment. The contractor will not use federal facilities. The government will have the responsibility to review and approve the final report. The government will have the responsibility to provide sufficient quantities of the test compound to the contractor to accomplish the necessary work.

DELIVERY OR DELIVERABLES

A written report on the result of study in the form of email or electronic document

REPORTING REQUIREMENTS

The vendor shall provide the result of study to NCATS through a written report by email.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

N/A

Information System Security Plan:

N/A

Data Rights:

All data and materials produced, used and analyzed is sole property of the government. The right to all data belongs to NCATS and the contractor must keep all the data and information confidential.

Section 508—Electronic and Information Technology Standards:

The contractor will not be involved in EIT Standards.

Publications and Publicity:

The result of study will not be published by the vendor.

Confidentiality of Information:

Any information provided to the contractor by NCATS or collected by the contractor on behalf of NCATS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract.