To provide research and development services supporting process development and pilot plot production of promising candidate malaria vaccines into well-characterized malaria vaccine products suitable for evaluation in clinical studies. The contractor will optimize the NIAID-selected immunogens and delivery systems with a focus on helping NIAID bring as many potential vaccines through the IND process as possible. The contractor will perform all core functions ? overall project management, regulatory supportg for compiling documentation needed for submission of an IND and/or Master file, technology transfer, data management and security, and ad hoc advisory group meeting support. The contractor will identify, recruit, select and manage teams of subcontractors for process development;pilot lot production;and receipt, storage, shipping and inventory functions.
