Pediatric Oncology In Vivo Testing Program Coordinating Center

儿科肿瘤体内测试项目协调中心

基本信息

批准号：
10474488
负责人：
CAROL J BULT
金额：
$ 83.02万
依托单位：
JACKSON LABORATORY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-25 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10474488
关键词：
Address Adult Antineoplastic Agents Bioinformatics Biological Models Cancer Model Cancer Patient Child Childhood Clinical Clinical Trials Collaborations Communication Communities Complement Data Data Analyses Data Security Database Management Systems Databases Decision Making Development Engineering Ensure FDA approved Foundations Generations Genomics Goals International Laboratories Leadership Logistics Malignant Childhood Neoplasm Malignant Neoplasms Methods Molecular Target New Agents Online Systems Pediatric Oncology Performance Pharmacologic Substance Pharmacology Preclinical Testing Process Program Evaluation Property Protocols documentation Publications Recording of previous events Research Research Personnel Resource Development Resource Informatics Resources Secure Site Standardization Statutes and Laws System Systems Analysis Testing The Jackson Laboratory Therapeutic Agents Time Vision base cancer genomics cancer therapy cloud based cohesion data integrity data management data portal efficacy evaluation experience genomics cloud human cancer mouse model improved outcome in vivo in vivo Model in vivo evaluation member metadata standards model development new therapeutic target novel therapeutics patient derived xenograft model pediatric patients precision medicine preclinical study programs public-private partnership software systems success targeted cancer therapy targeted treatment technical report user-friendly web page

项目摘要

PROJECT SUMMARY The overarching goal of NCI's Pediatric In Vivo Testing Program (Ped-In Vivo-TP) is to improve outcomes of pediatric cancer patients and to satisfy the requirements of the Research to Accelerate Cures and Equity (RACE) for Children Act to assess the efficacy of targeted anti-cancer agents developed for adults in pediatric contexts. To coordinate the activities of the new Ped-In Vivo-TP initiative, we have assembled a team of investigators from The Jackson Laboratory (JAX) and Seven Bridges Genomics (SB) with unique combined expertise and experience with in vivo cancer models, scalable cloud-based data management and analysis systems, informatics resource development, and multi-site project coordination. Combining the complementary strengths of JAX and SB provides the ideal foundation for a coordinating center to maximize the short- and long-term impacts of the Pediatric In Vivo Testing Program for advancing the application of precision medicine in pediatric oncology. We will manage a comprehensive and cohesive testing program to advance precision medicine in pediatric oncology through effective public-private partnerships among pharmaceutical companies, regulatory agencies, funders, and research organizations. We will achieve this goal through the following aims: Aim 1: Establish and maintain the Pediatric In Vivo Testing Coordinating Center (PIVOT CC) to provide administrative and logistical support for diverse stakeholders in the Pediatric in Vivo Testing Program consortium. We will draw on our team's combined decades of experience with multi-site program management, cancer model development, standardized testing of in vivo cancer models, data management and analysis, and informatics resource development to ensure timely decision making, conformance to standard protocols, resource tracking, and effective communications within the Ped-In Vivo-TP. Aim 2: Provide data management, statistical, and bioinformatics support to ensure data security and integrity. We will leverage existing protocols and software systems at JAX and SB to identify relevant in vivo cancer models and to collect, analyze, and securely manage data generated from testing centers within the consortium. We will perform statistical and bioinformatic analyses on consortium data to reliably inform the evaluation of the efficacy of novel therapeutic agents in a pediatric oncology setting. We will develop a public- facing data portal for sharing of data and methods with the broader scientific community. Aim 3: Provide scientific coordination to maintain an efficient and effective preclinical testing pipeline. We will draw from the extensive experience of our team with in vivo pharmacology and coordination of similar consortia to manage and coordinate the testing of agents by the Ped-In Vivo-TP centers at all stages of the process, from the identification of relevant in vivo models to the generation of final technical reports and publication of results. We will develop, record, and track performance metrics for the consortium to inform the evaluation of the program's success and impact.

项目摘要 NCI的体内测试计划（PED-IN Vivo-TP）的总体目标是改善结果小儿癌患者并满足研究的要求加速治疗和股权（儿童种族）评估针对成年人在儿科开发的有针对性抗癌药的功效的行为上下文。为了协调新的PED-IN Vivo-TP计划的活动，我们聚集了一个团队杰克逊实验室（JAX）和七个桥梁基因组学（SB）的研究人员具有独特的合并体内癌症模型，基于云的数据管理和分析的专业知识和经验系统，信息学资源开发和多站点项目协调。结合补充 JAX和SB的优势为协调中心提供了理想的基础，以最大程度地提高短和短暂的基础小儿体内测试计划的长期影响用于推进精密医学的应用在小儿肿瘤学中。我们将管理一项全面和凝聚力的测试计划，以提高精度通过制药公司之间有效的公私伙伴关系，小儿肿瘤学医学，监管机构，资助者和研究组织。我们将通过以下目标实现这一目标：目标1：建立并维护体内测试协调中心（Pivot CC）的小儿在体内测试计划中为各种利益相关者提供的行政和后勤支持财团。我们将利用团队在多站点计划中的数十年经验管理，癌症模型开发，体内癌症模型的标准化测试，数据管理和分析和信息学资源开发，以确保及时决策，符合标准协议，资源跟踪和PED-IN Vivo-TP中的有效通信。目标2：提供数据管理，统计和生物信息学支持，以确保数据安全和完整性。我们将利用JAX和SB的现有协议和软件系统来识别体内癌症模型并收集，分析和安全管理从测试中心生成的数据财团。我们将对财团数据进行统计和生物信息分析，以可靠地告知评估新型治疗剂在儿科肿瘤学环境中的功效。我们将开发一个公共面对数据门户，用于与更广泛的科学界共享数据和方法。目标3：提供科学协调以保持有效有效的临床前测试管道。我们会画从我们团队在体内药理学和类似财团协调的丰富经验中在过程的各个阶段，通过PED-IN VIVO-TP中心来管理和协调代理的测试将相关的体内模型识别为生成最终技术报告和结果发布。我们将为财团开发，记录和跟踪绩效指标，以告知评估计划的成功和影响。