PACT

协议

基本信息

批准号：
8163689
负责人：
ADRIAN Philip GEE
金额：
$ 254.19万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-01-15 至 2015-01-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8163689
关键词：
Academia Adverse event Animal Welfare Antibodies Area Biocompatible Materials Biological Blood Cell Therapy Cell physiology Cells Center for Translational Science Activities Clinical Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Consult Contractor Contracts Data Databases Development Educational Activities Educational workshop Ensure Evaluation Event Funding Heart Industry Infusion procedures Institution Investigational Drugs Laboratories Laboratory Animals Lung Maintenance Manuals Manufacturer Name Manuscripts Monitor National Heart, Lung, and Blood Institute Office for Human Research Protections Performance Phase Procedures Process Production Protocols documentation Publications Quality Control Reagent Recombinant Proteins Regulation Reporting Research Design Research Ethics Committees Research Personnel Sampling Services Shipping Ships Site Visit Societies Testing Therapeutic Studies TimeLine Training Translational Research Work Writing authority base cytokine design interest material transfer agreement meetings member novel operation preclinical study programs quality assurance translational study

项目摘要

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).

美国国家心肺血液研究所 (NHLBI) 正在计划对细胞疗法生产援助 (PACT) 计划进行竞争性更新，以生产和测试新型体细胞（生物）细胞疗法。该计划将资助美国多达六个地理上分散的细胞处理设施 (CPF) 和一个协调中心 (CC)，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必要的管理和监管专业知识在心脏、肺和血液细胞治疗研究领域开发新型细胞疗法。 CC 将担任 PACT 计划组织和监管方面的监督者和协调者。 PACT CPF 的建立将作为细胞疗法相关转化研究的绩效中心和细胞疗法产品制造商为研究人员提供服务。这些 CPF 将根据其满足请求的能力来评估服务请求并确定优先级。 PACT CPF 将获得 NHLBI 的资助，为需要制造支持的学术界和工业界的研究人员生产细胞治疗产品。将接收、评估临床级产品和转化研究的产品请求，如果获得批准，则分配给 CPF 进行制造。这些细胞产品主要用于美国境内的临床使用。CPF 可能仅根据研究性新药 (IND) 发布用于临床使用的产品。