NIAID PRECLINICAL DEVELOPMENT SUPPORT - Production of Clade B, B.63521Δ11 gp120 Env Protein

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. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Activities include: -Process Development and Production of candidate HIV vaccines, microbicides or non-vaccines HIV prevention modalities -Safety, Immunogenicity and Spectrum of Activity Testing of candidate HIV vaccines, microbicides or non-vaccines 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.