D 75N95020Q00145_SOW.pdf

STATEMENT OF WORK

(SOW)

GENERAL INFORMATION

Title of Project:

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

Statement of Need and Purpose:

The NCATS' Therapeutic Development Branch (TDB) requires regulatory and operational support for a pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA). This pre-IND application meeting is for the preclinical development of QGRFT, which may have therapeutic value as a preventative against SARS-CoV-2, the causative agent of the current COVID-19 pandemic.

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 make them more attractive for adoption by outside business partners. The TDB is collaborating with research partners from the University of Louisville Research Foundation (ULRF) to develop Q-Griffithsin (QGRFT) as a preventative therapeutic against SARS-CoV-2 Infection in humans.

The objective of this acquisition is to obtain regulatory expertise and operational support for a pre-IND meeting with the FDA, which will inform the further pre-clinical development of QGRFT to combat the novel coronavirus (COVID-19) pandemic. This meeting with be requested under the FDA’s Coronavirus Treatment Acceleration Program (CTAP). The TDB does not currently have in-house regulatory expertise to support the technical requirements of pre-IND meeting activities and a contractor with this experience is required.

Period of Performance:

The period of performance is 12 months, anticipated to be June 2020 through June 2021. Due to the urgency of supporting efforts related to COVID-19, the contractor must begin work on the below requirements immediately upon contract execution.

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

RFQ No. 75N95020Q00145 provided by the Government as needed to perform the Specific Requirements listed below. The below requirements must be completed in accordance with applicable FDA requirements and standard practices, including but not limited to, documents in eCTD format when needed, submission to the FDA via the electronic submission gateway (ESG), the use of meta data and leaf titles. The contractor will be required to communicate directly with the FDA, and work collaboratively with NCATS and NCATS’ collaborators at ULRF in the performance of these requirements. The contractor shall maintain documents and communications with the FDA in accordance with applicable life-cycle management guidelines.

Specific Requirements:

1. Prepare and develop the pre-IND meeting request and questions for the FDA. The contractor will conduct research, gather data, participate in discussions, and seek reviews as needed.

2. Prepare Phase 1 Clinical Trial Outline (CTO) and Schedule of Visits.

3. Prepare the pre-IND meeting package. The contractor will template, write, review, and finalize the meeting request and package.

4. Submit the pre-IND package to the FDA.

5. Participate in FDA telephone conference.

6. Process the FDA’s response. The contractor will prepare rebuttals and written responses to the FDA’s comments and questions.

7. Engage in follow-up communications with the FDA as needed.

Deliverables:

The contractor shall provide copies of all work product to NCATS and ULRF. This includes but is not limited to documents, Phase 1 Clinical Trial Outline (CTO), Schedule of Visits, questions, responses, and the meeting request.

OTHER CONSIDERATIONS

Travel:

This requirement does not involve travel.

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. All data furnished by ULRF will be owned exclusively by ULRF and will be considered confidential information, not to be used or disclosed except as specified to perform the requirements and submit the deliverables of this Statement of Work.

RFQ No. 75N95020Q00145

SCOPE OF WORK