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: 10397464
• 负责人: MARK MIDDLETON
• 金额: $ 1.14万
• 依托单位: STARKS ASSOCIATES, INC.
• 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/10397464
• 关键词: Acquired Immunodeficiency Syndrome; Animals; Area; Basic Science; Clinical Research; Clinical Trials; Collaborations; Communities; Complex; Contracts; Development; Devices; Extramural Activities; HIV; HIV/TB; Hepatitis B; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; In Vitro; Investigation; Investigational New Drug Application; Investigator-Initiated Research; Licensure; Mycobacterium tuberculosis; National Institute of Allergy and Infectious Disease; Private Sector; Quality Control; Research; Resources; Services; Testing; Therapeutic; Therapeutic Agents; United States Food and Drug Administration; Work; infectious disease treatment; 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.

HIV治疗药物的临床前服务：这些不确定交付/不确定数量合同的目的是为外部科学界提供研究材料和临床前产品开发支持，以支持研究者发起的研究或与私营部门或学术伙伴合作产生的候选产品。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。这些服务还可用于支持产品发现和开发，从而向食品和药物管理局（FDA）提交研究性新药申请（IND），研究性器械豁免（IDE）和/或新药申请（NDA）。NIAID艾滋病司将主要利用这些合同更快速有效地填补关键的开发和资源缺口，并将有希望的产品推向临床试验。这些合同的重点将是开发人类免疫缺陷病毒（HIV）、乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和结核分枝杆菌（MTB）复合物的治疗产品，以及存储库服务。