IGF::OT::IGF TASK ORDER #001 PERFORMANCE AREA 1 MANAGEMENT AND OPERATIONS SUPPORT

IGF::OT::IGF 任务顺序

• 批准号: 10910830
• 负责人: CAROL E GREEN
• 金额: $ 8.15万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-13 至 2024-09-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10910830
• 关键词: Animal Welfare; Award; Biological Products; Chemistry; Client; Contractor; Contracts; Dosage Forms; Equipment; Formulation; Good Manufacturing Process; Heart Diseases; Hematological Disease; International; Laboratory Animals; Lung diseases; Modernization; National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Drug Abuse; National Institute of Mental Health; National Institute of Neurological Disorders and Stroke; Office for Human Research Protections; Pharmacologic Substance; Pharmacology; Principal Investigator; Production; Qualifying; Regulation; Request for Proposals; Resources; Science; Scientist; Services; Testing; Toxicology; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; Work; bench to bedside; design; experience; flexibility; good laboratory practice; manufacture; member; novel; novel therapeutics; operation; programs; research and development; response; screening; small molecule; small molecule therapeutics

In response to Request for Proposal (RFP) NHLBI-HV-10-13, SRI International (SRI) proposes to act as a flexible and responsive resource contractor for the production and testing of novel non-biologic and small molecule therapeutics in support of the National Heart, Lung, and Blood Institute's (NHLBI) Science Moving towards Research Translation and Therapy (SMARTT) program to treat heart, lung, and blood diseases. The overall objective of this contract is to support translational research and provide services as a U.S. Food and Drug Administration (FDA)- defined current good manufacturing practice (cGMP) production facility for non-biological and small molecule therapy products. The Non-Biologics and Small Molecules Production Facility (PF) will evaluate and prioritize requests for service based on its ability to fulfill the requests. SRI takes no exceptions to the contract terms stated in the RFP and is prepared to be fully responsive to all the provisions of the statement of work.

为了响应征求建议书（RFP）NHLBI-HV-10-13，SRI International（SRI）提议作为一个灵活和响应的资源承包商，用于生产和测试新型非生物和小分子治疗药物，以支持国家心脏，肺和血液研究所（NHLBI）的科学转向研究转化和治疗（SMARTT）计划，以治疗心脏，肺和血液疾病。该合同的总体目标是支持转化研究，并作为美国食品药品监督管理局（FDA）定义的非生物和小分子治疗产品的现行良好生产规范（cGMP）生产设施提供服务。非生物制剂和小分子生产设施（PF）将根据其满足服务请求的能力对服务请求进行评估和优先排序。SRI对RFP中规定的合同条款没有任何例外，并准备充分响应工作说明书的所有规定。