PACT

协议

基本信息

批准号：
8429229
负责人：
MYRIAM ARANDA
金额：
$ 187.71万
依托单位：
BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
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/8429229
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 Institutional Review Boards 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 Personnel Sampling Services Shipping Ships Site Visit Societies Testing Therapeutic Studies TimeLine Training Translational Research United States National Institutes of Health Work Writing authority base cytokine design interest manufacturing facility 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).

国家心脏，肺和血液研究所（NHLBI）正在计划为细胞疗法生产援助（PACT）计划的竞争续签，以生产和测试新型体细胞（生物）细胞疗法。该计划最多将资助美国六个在美国的地理分散的细胞处理设施（CPF）和1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临床试验研究设计，以及在心脏，肺部，肺部，血液细胞治疗研究领域开发新型细胞疗法所必需的行政和调节专业知识。 CC将是该计划计划的组织和监管方面的监视器和协调员。将建立PACT CPF，以服务于研究人员为与细胞疗法和细胞疗法产品制造商有关的转化研究中心。这些CPF将根据其满足请求的能力来评估和优先考虑服务请求。 PACT CPF将从NHLBI获得资金，用于为需要制造支持的学术界和行业的研究人员制造蜂窝治疗产品。将收到，评估，评估的临床等级产品和转化研究的产品请求，并将其分配给CPF进行制造。该细胞产品主要用于美国产品中的临床用途，CPF只能在研究新药（IND）下释放临床用途。