NIAID Preclinical Development Support - HIV-1 Envelope Protein Production

NIAID 临床前开发支持 - HIV-1 包膜蛋白生产

• 批准号: 9553424
• 负责人: PHILLIP ISHIKAWA
• 金额: $ 18.18万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-29 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9553424
• 关键词: AIDS prevention; Clinical Trials; Contracts; Development; Documentation; Guidelines; HIV vaccine; HIV-1; Human; 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; cGMP production; env Gene Products; flexibility; immunogenicity; microbicide; preclinical development; research clinical testing; research study

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. This will support cGMP production of HIV-1 Env protein for use in human clinical trials.

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。 这将支持cGMP生产用于人类临床试验的HIV-1 Env蛋白。