NIAID Preclinical Development Support - Production of Research Cell Lines

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This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. -Process Development and Production of candidate HIV vaccines, microbicides or non-vaccine HIV prevention modalities -Safety, Immunogenicity and Spectrum of Activity Testing of candidate HIV vaccines, microbicides or non-vaccine HIV prevention modalities consistent with relevant FDA guidelines -Regulatory Documentation-obtain and compile non-clinical data, Investigator's Brochure, and/or final product trail protocol appropriate for submission to CBER or CDER, FDA (for an IND application) or other non-US regulatory authorities.