NIAID PRECLINICAL DEVELOPMENT SUPPORT - PRODUCTION OF HCMV-TR3∆PP71 HIVGAG FOR CLINICAL TRIALS

这份合同将为NIAID提供广泛和灵活的非传统、前瞻性和面向开发的能力，当有前景的产品从研究人员发起的研究中出现时，为这些产品提供临床前开发支持。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。承包商应协助NIAID工作人员为小规模生产、临床前测试和文件提供所需的所有支持，以提交第一、第二和第三阶段临床测试的研究用新药(IND)。 活动包括： -艾滋病毒候选疫苗、杀微生物剂或非疫苗艾滋病毒预防方式的进程开发和生产 -符合FDA相关指南的候选艾滋病毒疫苗、杀微生物剂或非疫苗艾滋病毒预防方式的安全性、免疫原性和活性测试谱 -监管文件-获取并汇编非临床数据、研究人员手册和/或最终产品试验方案，以提交给CBER或CDER、FDA(用于IND申请)或其他非美国监管机构。

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.