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.

该服务合同旨在支持促进临床前发展研究后的授予后支持，或通过催化临床前（CATPC）计划开放招标和奖励过程来支持从头研究。 CATPC的主要目的是提供服务，以促进和加速新技术的发展，以预防，诊断和/或治疗心脏，肺，血液和睡眠（HLBS）疾病，从晚期优化到调节性批准文件。 项目可以通过成功完成和批准进入其他催化赠款计划的技术，或者可以直接应用于CATPC以支持属于计划范围内的技术开发活动。对于成功的应用，CATPC将填补产品定义阶段进行的终点优化之间的差距，以及预期临床研究开始的监管批准申请。因此，CATPC将是催化程序的关键且必需的部分，以提供从发现到首次人类试验的连续翻译管道。