D1 SOW.pdf

STATEMENT OF WORK

(SOW)

GENERAL INFORMATION

Title of Project:

Regulatory Support for FDA IND Meeting: QGRFT for the Prevention of SARS-CoV-2 Infection.

This is a COVID-19 requirement.

Statement of Need and Purpose:

The NCATS Therapeutic Development Branch (TDB) collaborates with external research partners (collaborators) to develop novel treatments for diverse medical conditions. The purpose of this acquisition is to provide regulatory and operational support for the development of Q-

Griffithsin (Q-GRFT), which may have therapeutic value as a preventative against SARS-CoV-2, the causative agent of the current COVID-19 pandemic. The QGRFT project requires preparation and submission of a revised Investigational New Drug (IND) application with the US

Food and Drug Administration (FDA) to obtain clearance to extend clinical trials. Because TDB does not have in-house regulatory expertise to support the technical requirements of IND application activities, a contractor with this experience is required.

Background Information and Objective:

The National Center for Advancing Translational Sciences (NCATS) is a part of the National

Institutes of Health (NIH), with a mission 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 NCATS Therapeutic Development Branch (TDB) forms collaborative research partnerships with external investigators with the goal of “de-risking” therapeutic candidates and novel technologies to speed their development toward clinical evaluation. TDB is collaborating with research partners from the University of Louisville Research Foundation (ULRF) and the

University of Pittsburgh (UPitt) to develop QGRFT as a preventative therapeutic against SARS-

CoV-2 Infection in humans.

This requirement represents the continuity of the work from the pre-IND meeting with the FDA, which informed the further pre-clinical development of QGRFT to combat the novel coronavirus

(COVID-19) pandemic.

The objective of this acquisition is to provide regulatory expertise and operational support for the conversion of an existing IND package from ULRF to enable further trials at UPitt.

Period of Performance:

The period of performance is 12 months, anticipated to be August 2021 through August 2022.

Due to the urgency of supporting efforts related to COVID-19, the contractor must begin work on the below requirements immediately upon award, not later than 30 days from award date.

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 Specific Requirements listed below.

Specific Requirements:

1. Conversion and cross-referencing of the existing IND package for SARS-CoV-2. This will include, but not be limited to, templating, writing, reviewing and editing the necessary IND modules; and reviewing and cross-referencing to the existing IND where appropriate.

2. Compilation and submission of the revised IND package. This will include, but not be limited to, submitting revised documents to FDA through the UPitt electronic portal.

3. Maintenance of the IND submission for 1 year. This will include, but not be limited to, preparing, reviewing, and submitting additional data and reports, and responding to any FDA requests for information.

Deliverables:

The contractor shall provide copies of all work product to NCATS, ULRF and UPitt, upon request. This includes but is not limited to documents, such as the original IND package for

SARS-CoV-2 from ULRF; the revised IND package for UPitt; and any communications, data or information requested by and submitted to the FDA.

OTHER CONSIDERATIONS

Travel:

This requirement does not involve travel.

Data Rights:

Data will be furnished to the contractor by NCATS and the collaborators at ULRF and UPitt (the

Clients). All data furnished by the Clients (Client Data) will be owned exclusively by the Clients and will be considered confidential information, not to be used or disclosed except as specified in the requirements and deliverables of this SOW. The government will have unlimited rights pertaining to the use and disclosure of Client Data.

Publications and Publicity:

The contractor will not write or publish articles containing data obtained or produced as a result of the requirements of this Statement of Work.

Confidentiality of Information and Data:

The contractor will receive confidential, proprietary information and/or data from the

Government and its collaborators at ULRF and UPitt (the Clients). All such data will be owned exclusively by the Clients and will be considered confidential information, not to be used or disclosed by the contractor except as specified to perform the requirements and submit the deliverables of this Statement of Work.