Task V01: Administrative Support for Evaluation and Testing Services (ETS) for Vaccines and other Biologics for Infectious Diseases

任务 V01：疫苗和其他传染病生物制剂评估和测试服务 (ETS) 的行政支持

• 批准号: 10223850
• 负责人: THOMAS RUDGE
• 金额: $ 14.59万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-12 至 2021-09-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10223850
• 关键词: Area; Biological; Clinical; Communicable Diseases; Contracts; Development; Educational workshop; Feasibility Studies; Immunology procedure; Investigational New Drug Application; Licensing; Office of Administrative Management; Reporting; Safety; Sampling; Services; Site Visit; Testing; Toxicology; Training; Vaccines; Validation; efficacy testing; evaluation/testing; immunogenicity; novel vaccines; product development; testing services; vaccine candidate

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 a wide array of infectious diseases.

传染病疫苗和其他生物制品的评估和测试服务（ETS）合同提供了从早期可行性研究到提交生物许可申请（BLA）和/或研究性新药（IND）申请所需的活动的各种产品开发服务。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（研究中心访视、关键阶段稽查和最终研究报告稽查），2）免疫测定的开发、确认和验证，3）免疫原性和有效性检测，4）非临床和临床样本检测，以及5）安全性/毒理学研究。这些服务将促进开发和引进新的候选疫苗和生物制剂（由CBER监管），以预防各种传染病。