NHLBI CATALYZE PROGRAM - PRECLINICAL SERVICES COMPONENT - ADMINISTRATIVE SERVICES

NHLBI 催化计划 - 临床前服务部分 - 行政服务

• 批准号: 10926792
• 负责人: DIANA SEVERYNSE-STEVENS
• 金额: $ 76.43万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10926792
• 关键词: Acceleration; Award; Clinical Research; Contract Services; Development; Diagnosis; Grant; Heart Diseases; Hematological Disease; Lung diseases; Maintenance; National Heart, Lung, and Blood Institute; Prevention; Process; Reporting; Secure; Services; Sleep Disorders; Technology; Work; falls; first-in-human; new technology; pre-clinical; preclinical development; preclinical study; programs; technology development; translational pipeline

This service contract is to support continued preclinical development studies post-grant support, or support de novo preclinical studies through the Catalyze Preclinical (CatPC) program open solicitation and award process. The primary purpose of the CatPC is to provide services to facilitate and accelerate the development of novel technologies for the prevention, diagnosis, and/or treatment of heart, lung, blood, and sleep (HLBS) disorders from late optimization through regulatory approval filing. Projects may enter via successful completion and approval for advancement of a technology from other Catalyze grant initiatives, or may apply directly to CatPC to support technology development activities that fall within the program scope. For successful applications, CatPC will fill the gap between end-stage optimization conducted during the product definition stage, and regulatory approval filing in anticipation of clinical study initiation. Thus, CatPC will be a critical and required portion of the Catalyze Program to provide a continuous translational pipeline from discovery to first-in-human trials.

本服务合同旨在通过Catalyze Preclinical（CatPC）项目公开征集和授予流程，支持持续的临床前开发研究（授予后支持），或支持从头开始的临床前研究。CatPC的主要目的是提供服务，以促进和加速用于预防、诊断和/或治疗心、肺、血液和睡眠（HLBS）疾病的新技术的开发，从后期优化到监管批准备案。 项目可以通过成功完成并批准其他Catalyze赠款计划的技术进步进入，也可以直接向CatPC申请，以支持属于计划范围的技术开发活动。对于成功的申请，CatPC将填补产品定义阶段进行的终期优化与预期临床研究启动的监管批准申报之间的差距。因此，CatPC将是Catalyze计划的关键和必需部分，以提供从发现到首次人体试验的连续转化管道。