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.
