NIAID-RFQ19-1975722_-_SOW_20190918.pdf

9/18/2019

NIAID-RFQ19-1973527

Statement of Work – Regulatory Operations Services for IND Applications

Background and Purpose:

The Vaccine Research Center (VRC) develops, manufactures, conduct clinical trials and sponsors Investigational New Drug applications (IND) for investigational vaccine and monoclonal antibody products with prophylactic and therapeutic indications for a number of pathogens including filovirus, flavivirus, influenza and HIV. Clinical development of these investigational products is managed by the VRC’s Clinical Trials Program (CTP) and is conducted in the intramural clinic at the NIH Clinical Center and/or via external collaborations and partnerships, both domestic and international. IND preparation and submission of documentation to support clinical evaluation of VRC products is managed by the VRC Office of Regulatory Science (ORS). These clinical trials yield valuable data pertaining to the safety, tolerability, and efficacy of VRC products in support of VRC’s translational research mission.

Scope:

The scope of this statement of work is to provide regulatory operations support services for Investigational New Drug (IND) or mater files applications sponsored by the Vaccine Research Center and regulatory support for international regulatory authorities, when needed. Regulatory activities ensure IND Sponsor compliance with applicable federal regulations including but not limited to 21 CFR parts 50, 56 and 312, 45 CFR 46 and related guidance. Make certain that data integrity is preserved.

Objective:

As the IND sponsor for these investigational products, many of which share platform technology, VRC requires integrated regulatory support across the different projects. This requires that the communications and submissions to the FDA and other regulatory agencies be carefully coordinated, consistent, and prioritized correctly. The submissions must be compliant with current applicable regulations and guidelines.

Contractor Requirements:

Contractor shall be experienced with FDA regulatory submissions of similar investigational products and clinical trials. VRC Office of Regulatory Science (ORS) has identified the following task areas as critical to this initiative:

• Task 1: Provide expert regulatory operations support in the preparation, compilation, publishing and filing of Investigational New Drug Application (IND) submissions in compliance with all applicable regulations and guidelines.

• Task 2: Technical writing, review, and high-level quality control.

• Task 3: Regulatory Intelligence support.

• Task 4: Document control support.

Task 1: Provide expert regulatory operations support in the preparation, compilation, publishing and filing of Investigational New Drug Application (IND) submissions in compliance with all applicable regulations and guidelines.

Contractor shall complete the following:

1.1.1. Provide Sponsor with general administrative support for regulatory operations

(i.e. maintaining current key contact information, submission timelines and deadlines and filing and tracking correspondence) according to ORS SOP.

1.1.2. Prepare cover letters, FDA forms, and other associated documents as required for new and existing VRC INDs.

1.1.3. Perform Quality Control (QC) review of IND submission documents.

1.1.4. Prepare regulatory documents in electronic common technical document (eCTD) compliant format and submit through a registered Electronic Submission Gateway (ESG) account for FDA submissions using sponsor approved software. Provide eCTD Word Starting Point Document templates for sponsor documents to ensure compliance with current industry standards.

1.1.5. Track key regulatory submission deadlines and create alerts and preparation timelines to ensure compliance.

1.1.6. Manage weekly or biweekly teleconference updates with Sponsor to discuss regulatory submission activities.

1.1.7. Provide support to organize and prepare minutes for meetings with regulatory authorities or collaborators, as needed.

Task 2: Technical writing, review, and quality control.

Contractor shall complete the following:

2.1 Develop (as needed) and format regulatory documents (including but not limited to

Investigator Brochures, Annual Reports, and response to FDA/other regulatory authorities’ comments) to ensure compliance.

2.2 Develop a regulatory document Style Guide, to be approved by the sponsor, that will ensure document consistency.

2.3 Draft/review Trial Master File (TMF) plans and Transfer of Regulatory Obligations (TORO’s) for clinical trials associated with INDs.

2.4 Provide bibliographies of supporting articles and other references as needed to support regulatory documents.

Task 3: Regulatory Intelligence support.

3.1 Provide regulatory expertise by monitoring, gathering and analyzing publicly available regulatory information and leveraging existing regulatory intelligence based upon prior experience to develop effective strategy and communications to support the Sponsor IND when needed.

3.2 Survey and identify relevant new and updated regulations and guidance to ensure compliance with current regulatory requirements.

Task 4: Document control support.

4.1 Use the NIAID eCTD system which meets 21 CFR Part 11 requirements to ensure the authenticity, security, and confidentiality of electronic records submitted, in electronic common technical document (eCTD) compliant format, through registered Electronic Submission Gateway (ESG) account for FDA submissions.

4.2 File relevant regulatory documents in the NIAID eCTD System to ensure the integrity of INDs and Master Files and completeness of the entire submission history. The use of external media will be limited to tracking work load, drafting submission documents and formatting documents per eCTD requirements.

Deliverables:

Contractor shall provide regulatory operations support for an average portfolio of 20 to 30 active INDs, with an average of 3 to 5 new INDs per year, 2 to 3 Pre-INDs per year and an average of 100 other submissions per year (including but not limited to protocol amendments, Annual Reports, CMC updates) to support all active VRC INDs. Deliverables shall be stored in the NIAID eCTD system. Teleconference and face to face (rare) meetings between the Contractor and VRC to track regulatory submission support shall occur.

Government Responsibilities:

VRC is responsible for filling IND regulatory documentation to the U.S. FDA in order to support clinical evaluation of VRC investigational products. These regulatory support activities will ensure IND Sponsor compliance with applicable federal regulations and guidelines.

Government Furnished Information/Materials:

VRC will provide regulatory documents to the Contractor for eCTD formatting, processing (i.e., prepare eCTD compliant PDF), final VRC review, publishing and submission to the FDA per established Standard Operating Procedures (SOPs).

Period of Performance:

Base of one (1) year, with the option to renew for three (3) years.

Inspection and Acceptance:

Contractor shall file receipts, acknowledgements and validation reports and ESG acknowledgements in the NIAID eCTD System to document successful FDA submissions. All work shall be inspected and approved by a Government official.