Preclinical and Translational Vaccine Development Support for HIV and Other Candidate Agents: Scientific, Quality and Regulatory Support Services

这项合同计划将为NIAID提供广泛而灵活的能力，这些能力是为艾滋病毒和其他候选药物提供前景看好的疫苗和相关产品的临床前和转化性开发支持所必需的。该合同将为工艺和产品开发、小规模生产、临床前试验和文件编制的所有阶段提供所需的支持和服务，从而为第一阶段、第二阶段和第三阶段的临床试验提交研究新药(IND)。这些能力将使NIAID能够迅速有效地解决发展和生产差距。

This contract program will provide NIAID with a broad and flexible range of capabilities that are required for preclinical and translational development support for promising vaccines and related products for HIV and other candidate agents. This contract will provide the support and services needed for all stages of process and product development, small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submissions for Phase I, II, and III clinical testing. These capabilities will allow NIAID to rapidly and efficiently address development and production gaps.