Vaccines and Related Biological Products Advisory Committee (VRBPAC) Consultant Services

Seeking consultant services of a service provider with extensive experience with FDA Advisory Committee, in particular Vaccines and Related Biological Products Advisory Committee (VRBPAC) as well as support and strengths in the areas noted below DVC is seeking interested parties for the following: 1.0 Support the development of a VRBPAC briefing document and associated presentation slides (including back-up slides). 2.0 Coordinate the VRBPAC meeting preparation activities. 3.0 Must have the contacts and specialized expertise in Medical Countermeasures that will enable them to recruit the experts needed to support the team with speakers and mock panelists. 4.0 Ability and knowledge to provide technology with unique AdComm-optimized tools that include a secure portal enabling team collaboration and version control, as well as the technology to provide at Mock meetings and the AdComm as well as a slide library and slide recall system. 5.0 Ad hoc consulting services (optional) may be required to respond to FDA requests for information outside of the scope of a VRBPAC meeting. The scope is divided into a series of Milestones that include support for: 1 Milestone 1: VRBPAC Meeting Support Prior to BLA Review for rF1V From: Subcontract To: Award March 2018 2 Milestone 2 : VRBPAC Meeting Support During the BLA Review for rF1V From: January 2020 To: June 2021 3 Milestone 3: VRBPAC Meeting Support During the BLA Review for rBV A/B From: January 2020 To: June 2021 4 Milestone 4: Ad-Hoc Consulting Support From: Subcontract Award To: June 2021 Requested responses due by Friday, July 8, 2016 Additional Background The FDA may convene a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Animal Rule strategy and/or pivotal nonclinical and clinical study protocols prior to the conduct of label-supporting studies and/or to review pivotal nonclinical and clinical study data following submission of a Biologics License Application (BLA) for rF1V and/or rBV A/B. However, it is less likely that a VRBPAC meeting would be convened for rBV A/B prior to the Phase 3 clinical trial. DVC would seek consultation services as part of preparing for VRBPAC meetings to prepare for a critical meeting that may be convened by the FDA. A successful outcome at a VRBPAC meeting is directly linked to program performance. Preparing for a successful VRBPAC meeting as efficiently as possible will minimize the cost and schedule implications of holding a meeting prior to conduct of the pivotal and Phase 3 studies. Preparing for a successful VRBPAC meeting during the BLA review will support first cycle BLA review/approval.