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

IGF::OT::IGF 任务顺序

基本信息

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
项目类别：
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

项目摘要

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.

为了回应提案请求（RFP）NHLBI-HV-10-13，SRI International（SRI）提议作为一种灵活而响应的资源承包商，用于生产和测试新型的非生物学和小分子疗法，以支持该疗法国家心脏，肺和血液研究所（NHLBI）科学迈向研究翻译和治疗（SMARTT）计划，以治疗心脏，肺和血液疾病。该合同的总体目的是支持转化研究，并作为美国食品药品监督管理局（FDA）提供服务 - 针对非生物和小分子治疗产品定义的当前良好制造实践（CGMP）生产设施。非生物学和小分子生产设施（PF）将根据其满足请求的能力评估和优先考虑服务请求。 SRI对RFP中规定的合同条款没有例外，并准备完全响应工作声明的所有规定。