PACT

美国国家心脏、肺和血液研究所（NHLBI）计划竞争性更新细胞疗法生产援助（PACT）项目，用于生产和测试新型体细胞（生物）细胞疗法。该项目将资助位于美国的六个地理位置分散的细胞处理设施（cpf）和一个协调中心（CC），这些中心有能力提供咨询、制造、临床前研究和早期临床试验研究设计，以及在心脏、肺和血液细胞治疗研究领域开发新型细胞疗法所需的管理和监管专业知识。协调委员会将监督和协调PACT计划的组织和管理方面的工作。PACT cpf将作为细胞治疗相关转化研究的研究人员和细胞治疗产品制造商的绩效中心而成立。这些cpf将根据满足请求的能力评估服务请求并确定优先级。PACT CPFs将从NHLBI获得资金，为学术界和工业界需要生产支持的研究人员生产细胞治疗产品。临床级产品和转化研究的产品申请将被接收、评估，如果批准，将分配给CPF进行生产。细胞产品主要用于美国境内的临床使用。CPF仅可在新药研究（IND）下发布产品用于临床使用。

The National Heart, Lung, and Blood Institute (NHLBI) is planning a competitive renewal for the Production Assistance for Cellular Therapies (PACT) program for the production and testing of novel somatic (biological) cell therapies. This program will fund up to six geographically dispersed Cell Processing Facilities (CPFs) and one Coordinating Center (CC) in the U.S. with the capacity to provide consulting, manufacturing, preclinical study and early phase clinical trial study design, and administrative and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung and blood cellular therapy research. The CC will be the monitor and coordinator for organizational and regulatory aspects of the PACT Program. The PACT CPFs will be established to serve investigators as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. These CPFs will evaluate and prioritize requests for service based on their ability to fulfill the request. PACT CPFs will receive funding from the NHLBI to manufacture cellular therapy products for investigators from academia and industry needing manufacturing support. Product requests for clinical grade products and translational research will be received, evaluated, and, if approved, assigned to a CPF for manufacture. The cellular products are primarily intended for clinical use within the U.S. Products may be released by the CPF for clinical use only under an Investigational New Drug (IND).