Essential Core Activities: NIAID Preclinical Development Support

必要的核心活动：NIAID 临床前开发支持

• 批准号: 9731261
• 负责人: THOMAS VANCOTT
• 金额: $ 35.14万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-29 至 2019-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9731261
• 关键词: AIDS prevention; Contractor; Development; Documentation; HIV vaccine; Investigational Drugs; Investigator-Initiated Research; Modality; National Institute of Allergy and Infectious Disease; Phase; Preclinical Testing; Process; Production; Support Contracts; flexibility; microbicide; preclinical development; research clinical testing; research study

NIAID Preclinical Development Support: 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. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing

NIAID 临床前开发支持：该合同将为 NIAID 提供广泛且灵活的非传统、主动和以开发为导向的能力，以便在研究者发起的研究中出现有前景的产品时，为此类产品提供临床前开发支持。这些能力将使 NIAID 能够更快速、更有效地缩小开发和生产差距。承包商应协助 NIAID 工作人员提供小规模生产、临床前测试和文件记录所需的所有支持，从而提交研究性新药 (IND) 以进行 I、II 和 III 期临床测试