Task X14: Evaluation of Ebola Vaccines

传染病疫苗和其他生物制品的评估和测试服务 (ETS) 合同提供各种产品开发服务，从早期可行性研究到提交生物制品许可申请 (BLA) 和/或研究性新药 (IND) 申请所需的活动。任务领域包括：1) 行政管理和技术支持，包括培训和研讨会，以及质量监督和管理（现场考察、关键阶段审核和最终研究报告审核），2) 免疫测定的开发、鉴定和验证，3) 免疫原性和功效测试，4) 非临床和临床样本测试，以及 5) 安全/毒理学研究。这些服务将促进新候选疫苗和生物制剂（由 CBER 监管）的开发和引进，以对抗潜在的生物恐怖主义和新出现和重新出现的传染病。

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.