NHLBI CATALYZE PROGRAM - PRECLINICAL SERVICES COMPONENT - ADMINISTRATIVE SERVICES

本服务合同旨在支持持续的临床前开发研究、拨款后支持，或通过催化临床前(CatPC)计划公开征集和授予程序支持从头开始的临床前研究。CatPC的主要目的是提供服务，促进和加快心、肺、血液和睡眠(HLBS)疾病的预防、诊断和/或治疗(HLBS)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和批准其他催化资助计划的技术进步进入，也可以直接向CatPC申请，以支持计划范围内的技术开发活动。对于成功的申请，CatPC将填补在产品定义阶段进行的末期优化和预期临床研究启动后的监管批准申请之间的空白。因此，CatPC将是催化计划的关键和必需的部分，以提供从发现到第一次人体试验的连续转换管道。

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.