Preclinical Services for HIV Therapeutics: QA/QC Plan and Task Order Initiation Meeting

HIV 治疗的临床前服务：QA/QC 计划和任务订单启动会议

• 批准号: 10397467
• 负责人: JANICE ENDSLEY
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-15 至 2021-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10397467
• 关键词: Acquired Immunodeficiency Syndrome; Animal Model; Area; Basic Science; Clinical Trials; Collaborations; Communities; Complex; Contracts; Development; Devices; Extramural Activities; HIV; Hepatitis B Virus; Hepatitis C virus; Investigation; Investigational New Drug Application; Investigator-Initiated Research; Licensure; Mycobacterium Infections; Mycobacterium tuberculosis; National Institute of Allergy and Infectious Disease; Private Sector; Quality Control; Research; Resources; Services; Testing; Therapeutic; United States Food and Drug Administration; Work; improved; meetings; novel therapeutics; pre-clinical; product development; quality assurance; repository; research clinical testing; research study; therapeutic development

Preclinical Services for HIV Therapeutics: The purpose of these Indefinite Delivery/Indefinite Quantity contracts is to provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID Division of AIDS will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. The focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services.

艾滋病毒治疗学的临床前服务：这些无限期交付/无限期合同的目的是为校外科学界提供研究材料和研究材料和临床前产品开发支持候选产品，这些产品从研究人员发起的研究或与私营部门或学术伙伴或学术伙伴合作中脱颖而出。工作范围包括从基础研究和初始产品发现到临床试验和/或产品许可所需的活动的活动。这些服务还可以用于支持产品发现和开发，从而导致研究新药应用（IND），研究设备豁免（IDE）和/或新药应用（NDA）申请（NDA）提交给食品和药物管理局（FDA）。 NIAID的AIDS将主要使用这些合同来更快，更有效地填补关键的发展和资源差距，并将有希望的产品推向临床测试。这些合同的重点将是开发用于人类免疫缺陷病毒（HIV），乙型肝炎病毒（HBV），丙型肝炎病毒（HCV）和结核病结核病（MTB）复合体的治疗产品。