ATTACHMENT D-BotPlague_InitialTaskOrderPWS.docx

Task Order Performance Work Statement Regulatory and Quality Assessment on DynPort Vaccine Inc. (DVC) 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 rBV A/B investigational vaccine and plague (rF1V) investigational vaccine are developed by DVC, and 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 need for regulatory and cGMP manufacturing expertise to provide consultation/interpretation and evaluation of the DVC pre-EUA draft packages for emergency use of the new Drug Products of rBV A/B and plague vaccines to ensure the regulatory approach taken 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.

The purpose of this task is to evaluate and provide a regulatory and quality risk assessment of the DVC rBV A/B and plague vaccine development efforts to the Senior Director Medical Regulatory (IDIQ Task 2). The regulatory and quality risk assessment will be focused on the following: 1) assurance the approach and any relevant drafted documents are informed by all previous Food and Drug Agency feedback on both vaccines, 2) scientific and regulatory evaluation of newly manufactured Drug Products, and 3) 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 rBV A/B and plague vaccines (IDIQ Task 1). 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 conduct the regulatory and quality risk assessment.

1. Kick-off Meeting:

a. The contractor shall attend a kick-off meeting with the Government to discuss and ensure common understanding of the purpose and scope of the regulatory and quality assessment.

2. Execute Review and provide Report:

a. Upon receipt and review of materials and attendance in relevant meetings, the contractor will prepare and submit to the Government written comments, and a report identifying actual or potential regulatory risks and risk mitigation strategies and recommendations to inform the Senior Director Medical Regulatory. The contractor may, at any time during their review request additional information or request clarification from the Government; the contractor will have access to the appropriate JPEO-CBRND technical and regulatory subject matter expert(s) for this effort. It is expected that the contractor schedule periodic meetings with the Senior Director Medical Regulatory and the ONE-RAQA to discuss task progress. It is also expected that the contractor perform a site visit to DVC’s Drug Products manufacturer for an in-depth review of manufacturing changes and batch record review of newly manufactured Drug Products (IDIQ Task 3).

3. Review Meeting: The contractor will participate in a meeting with the JPEO-CBRND team to discuss details of their report and provide recommendations to the Senior Director Medical Regulatory. The report will be finalized after this meeting and submitted to the ONE-RAQA Leadership Team as a final deliverable.

III. DELIVERABLES

The deliverables are –

1. The contractor shall attend the Government kick-off meeting via teleconference.

2. The contractor shall provide written analysis with substantiated references supporting identified risks and recommendations on the following; 1) assurance the regulatory approach and any relevant drafted documents are informed by all previous Food and Drug Agency feedback on both vaccines, 2) scientific and regulatory evaluation of newly manufactured Drug Products, and 3) regulatory evaluation and recommendations to assist in the generation of the DVC pre-EUA draft packages for emergency use of the new Drug Products of rBV A/B and plague vaccines.

3. The contractor shall meet with the Government, via teleconference, to review and discuss the written comments and/or reports.

4. The contractor shall finalize the report after meeting with the Government.

5. 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.