ATTACHMENT D-BotPlagueRegAsmnt_InitialTaskOrderPWS_Revised.docx

Task Order Performance Work Statement Virtual Audit Process Development And Regulatory and Quality Assessment on DynPort Vaccine Inc. (DVC) Botulinum (rBV A/B ) Vaccine and Plague (rF1V) Vaccine

I. SCOPE/BACKGROUND

The JPEO-CBRND’s mission is to provide Research, Development, Acquisition Fielding and Life-Cycle Support of Chemical, Biological, Radiological and Nuclear Defense Equipment, Medical Counter Measures (MCM) and Installation and Force Protection Integrated Capabilities Supporting the National Strategies. The JPEO-CBRND One Network of Regulatory Affairs and Quality Assurance (ONE-RAQA) is seeking the development of a virtual audit process and virtual regulatory and quality assessments of the DVC Botulinum Vaccine and DVC Plague Vaccine that will inform feasibility for use in the event of a declared military emergency.

The DoD has contracted with DVC to develop a botulinum investigational vaccine and plague investigational vaccine. DVC is the regulatory Sponsor. These vaccine development efforts are intended for protection of the Joint Forces from exposure or potential exposure to Botulinum neurotoxins (BoNTs) serotypes A and B and pneumonic plague, respectively. Both vaccines have completed Phase 2 clinical trials. Prior to initiating Phase 3 clinical trials, both vaccines underwent Drug Product manufacturing changes to reduce particulates. There is a current contract with DVC to deliver GMP material under the new manufacturing processes. Due to funding constraints, both the botulinum and plague vaccine programs are going through a responsible close down of the contracts which will result in the delivery of three GMP lots of botlunim vaccine and three GMP lots of plague vaccines. The objective of the regulatory and quality assessment is at minimum to identify whether DVC’s regulatory approaches up to the point of contract close-out will meet legal and regulatory requirements for emergency use during a military emergency per the Federal Food, Drug and Cosmetics Act (FFDCA) and PL 115-92, as outlined in the Emergency Use Authorization guidance document.

The first objective of this task is to develop a virtual audit process that will support the conduct of virtual audits of the GMP DVC botulinum (rBV A/B) and separately the GMP DVC plague (rF1V) vaccines. The audit shall at minimum follow regulations and standards; 21 CFR parts 210 and 211, Current Good Manufacturing Practices, 21 CFR parts 600 and 610 Biological Products, 21 CFR Part 11, ISO 90001:2015 Quality Management System. In the development of the virtual audit process, the Government will ensure that all information necessary to accomplish this task will be made available to the contractor and consultants hired.

The second objective of this task is the conduct of virtual regulatory and quality risk assessments, one specific to the DVC botulinum (rBV A/B) and the other to address the plague (rF1V) vaccine development effort (IDIQ Task 2). In the conduct of these reviews, the Government will ensure that all information necessary to accomplish this task will be made available to the contractor and consultants hired to conduct the reviews, to include access to CBRN Medical personnel for interviews.

II. REQUIREMENT

The contractor shall provide expertise in identifying appropriate Subject Matter Experts to draft a virtual audit process and conduct virtual DVC botulinum and plague vaccine regulatory and quality risk assessments. There will be no travel associated with the conduct of the tasks within this Task Order.

1. Kick-off Meeting:

The contractor shall attend a virtual kick-off meeting with the Government to discuss and ensure common understanding of the purpose and scope of the development of the virtual audit process and the conduct of the regulatory and quality assessments.

2. Virtual Audit Process:

Upon receipt and review of materials and attendance in relevant meetings, the contractor shall prepare a virtual audit process to be used to conduct virtual audits of the DVC botulinum and DVC plague GMP material. Certified quality auditors shall develop a virtual audit process to include discussions, questions, and a review of DVC’s level of current Good Manufacturing Practices (cGMPs) compliance with respect to the six FDA systems: quality system, materials system, facilities and equipment systems, production system, packaging and labeling systems, and laboratory control system. The contractor shall include the audit report findings into the overall regulatory and quality assessments so the Government can understand whether DVC’s regulatory approach taken for the botulinum and plague vaccine will meet legal and regulatory requirements for emergency use during a military emergency per the Federal Food, Drug and Cosmetics Act (FFDCA) and PL 115-92, and as outlined in the Emergency Use Authorization guidance document.

3. Regulatory and Quality Assessments:

The Government requires regulatory and quality risk assessments for both the botulinum and plague vaccines which shall at minimum include the following: 1) a determination on whether the GMP material manufactured under the current contract could be used in the event of a declared military emergency under an emergency-use mechanism 2) confirmation that any relevant drafted documents are informed by all previous Food and Drug Agency feedback, 3) scientific and regulatory evaluation of newly manufactured Drug Products (information from virtual audits), and 4) regulatory and quality evaluation and identification of data/information gaps that are needed in the event DVC or another Sponsor pursues a regulatory strategy for emergency use of the new Drug Products of botulinum and plague vaccines. The written analysis shall include substantiated references supporting identified risks and recommendations. (IDIQ Task 1).

4. Review Meetings: It is expected that the contractor shall schedule periodic virtual meetings with the Senior Director Medical Regulatory and the ONE-RAQA to discuss the virtual audit process and the status of the regulatory and quality assessments of the DVC botulinum and plague task progress. (IDIQ Task 3).

III. DELIVERABLES

The deliverables are –

1. Minutes from the Contractor/Government kick-off meeting (conducted virtually)

2. Virtual Audit Process framework delivered no later than 1 month after contract award.

3. Virtual Audit Report delivered no later than 3 months after contract award.

4. Draft regulatory and quality assessment for the DVC botulinum vaccine no later than 5 months after contract award. Government will provide comments for incorporation no later than 10 days after receipt of draft assessment. The contractor shall meet with the Government, via teleconference, to review and discuss the written comments and/or reports.

5. Draft regulatory and quality assessment for the DVC plague vaccine no later than 5 months after contract award. Government will provide comments for incorporation no later than 10 days after receipt of draft assessment. The contractor shall meet with the Government, via teleconference, to review and discuss the written comments and/or reports.

6. Final regulatory and quality assessment for the DVC botulinum vaccine no later 14 days after final draft assessment.

7. Final regulatory and quality assessment for the DVC plague vaccine no later 14 days after final draft assessment.

8. The contractor shall provide monthly execution reports specific to this task during the task period of performance.

IV. REPORTS/DELIVERABLES

1. All written materials developed under this Task Order shall be emailed to: usarmy.detrick.dod-jpeo-cbrnd.list.one-raqa-leadership@mail.mil , attention to Ms. Carmen Maher, Senior Director, Medical Regulatory.