IGF::OT::IGF NIAID PRECLINICAL DEVELOPMENT SUPPORT - SUPPORT FOR PRODUCTION AND TESTING OF ADC6-HIV GP140 AND ADC7-HIV GP140

IGF::OT::IGF NIAID 临床前开发支持 - 支持 ADC6-HIV GP140 和 ADC7-HIV GP140 的生产和测试

• 批准号: 9361940
• 负责人: PHILLIP ISHIKAWA
• 金额: $ 317.9万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-30 至 2020-01-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9361940
• 关键词: AIDS prevention; Adenovirus Vector; Contracts; Data; Development; Documentation; Guidelines; HIV; HIV vaccine; Investigational Drugs; Investigational New Drug Application; Investigator-Initiated Research; Modality; National Institute of Allergy and Infectious Disease; Pamphlets; Phase; Preclinical Testing; Process; Production; Protocols documentation; Research Personnel; Safety; Testing; authority; flexibility; immunogenicity; microbicide; pre-clinical; research clinical testing; research study; vector vaccine

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. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. In particular this project will support the production and testing of AdC6-HIV gp140 and AdC7-HIV gp140 adenoviral vector vaccines.

该合同将为NIAID提供广泛而灵活的非传统，主动和以开发为导向的能力，为有前途的产品提供临床前开发支持，当这些产品从制药商发起的研究中出现时。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。活动包括但不限于小规模生产、临床前试验和文件编制，以提交研究性新药（IND）进行I、II和III期临床试验。 特别是，该项目将支持AdC 6-HIV gp 140和AdC 7-HIV gp 140腺病毒载体疫苗的生产和测试。