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

IGF::OT::IGF 任务顺序

• 批准号: 10685239
• 负责人: CAROL E GREEN
• 金额: $ 8.08万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10685239
• 关键词: Animal Welfare; Area; Award; Biological Products; Chemistry; Client; Contractor; Contracts; Dosage Forms; Equipment; Formulation; 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 and Toxicology; Principal Investigator; Production; Regulation; Request for Proposals; Resources; Science; Scientist; Services; Testing; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; Work; base; bench to bedside; design; experience; flexibility; good laboratory practice; 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 NHLBI-HV-10-13 提案请求 (RFP)，SRI International (SRI) 建议充当灵活且反应灵敏的资源承包商，用于生产和测试新型非生物和小分子疗法，以支持美国国家心肺血液研究所 (NHLBI) 的科学走向研究转化和治疗 (SMARTT) 计划旨在治疗心肺和血液疾病。该合同的总体目标是支持转化研究，并作为美国食品和药物管理局 (FDA) 定义的现行良好生产规范 (cGMP) 生产设施为非生物和小分子治疗产品提供服务。非生物制品和小分子生产设施 (PF) 将根据其满足请求的能力来评估服务请求并确定优先顺序。 SRI 对 RFP 中规定的合同条款一视同仁，并准备充分响应工作说明书的所有规定。