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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

基本信息

批准号：
10397469
负责人：
JAMES TALTON
金额：
$ 1.72万
依托单位：
ALCHEM LABORATORIES CORPORATION
依托单位国家：
美国
项目类别：
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/10397469
关键词：
Acquired Immunodeficiency Syndrome Address Animals Antiviral Agents Area Basic Science Cells Clinical Clinical Research Clinical Trials Collaborations Communities Complex Contracts Development Devices Dosage Forms Evaluation Extramural Activities Formulation Gene Expression HIV HIV/TB Hepatitis B Hepatitis B Virus Hepatitis C Hepatitis C virus In Vitro Infection 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 in vitro testing infectious disease treatment meetings novel therapeutics pre-clinical product development quality assurance repository research clinical testing research study screening therapeutic development

项目摘要

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校外科学界提供研究材料和临床前产品开发支持，这些产品来自制药商发起的研究或与私营部门或学术合作伙伴的合作。工作范围包括从基础研究和初步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，从而向美国食品药品监督管理局（FDA）提交新药临床试验申请（IND）、试验用器械豁免（IDE）和/或新药申请（NDA）。NIAID艾滋病司将主要利用这些合同更快、更有效地填补关键的开发和资源缺口，并将有前途的产品推向临床测试。这些合同的重点将是开发人类免疫缺陷病毒（HIV）、B肝炎病毒（HBV）、丙型肝炎病毒（HCV）和结核分枝杆菌（MTB）复合体的治疗产品，以及储存服务。