Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics

描述（由申请人提供）：作为两个作为先前UOl地点合作的NCI指定的综合癌症中心，威斯康星州大学Carbone癌症中心（UWCCC）和新泽西罗格斯癌症研究所（CINJ）已证明具有领导力、强大的基础设施和合作进行临床试验的良好记录。因此，UWCCC和CINJ成立了威斯康星州和新泽西精准实验治疗联盟（WIN-Alliance），其使命是在多学科和多机构模型中开发和评估创新的早期实验治疗临床试验。科学优势包括生物标志物开发的翻译重点;药物基因组学评估;基因组评估和治疗;临床和组织成像;以及系统生物学。从理论上讲，我们已经成立了工作组，利用中心共享资源的科学专业知识和基础设施优势，优先考虑ET-CTN的工作。WIN-Alliance独有的特定利基包括UWCCC强大的PK/PD工作，已经为CTEP/U 01临床试验增加了价值; UWCCC和CINJ的互补成像优势;使用罗格斯大学细胞和DNA库（RUCDR）进行基因组分析;以及CINJ与高级研究所西蒙斯系统生物学中心的关系。在过去的五年中，UWCCC和CINJ在所有治疗试验中累积了超过4，000名患者，为NCI-CTEP开发了67个中心科学驱动的提案，并为UOl支持的研究累积了目标100名患者/年的平均值。具体目标是：1）开发和执行新的ET-CTN赞助的抗癌药物的早期临床试验; 2）利用和协同中心的研究和核心计划领域，将实验室的科学发现转化为临床试验; 3）开发综合和整体的 该研究的主要目的是：（1）研究基因组学、药物基因组学、药代动力学和药效学生物标志物;（2）开发临床和组织成像的完整和综合的新方法;（3）培养和发展转化研究中的年轻研究人员。 相关性：该申请将合并两个强大的先前I期（UOl）研究中心，以创建威斯康星州和新泽西精密实验治疗联盟（WIN-Alliance）。该小组作为一个协同、多学科和多机构的模式，将开发和评估创新的早期实验性治疗临床试验，以改善临床结果。

DESCRIPTION (provided by applicant): As two NCI-designated comprehensive cancer centers that were collaborative as prior UOl sites, the University of Wisconsin Carbone Cancer Center (UWCCC) and Rutgers Cancer Institute of New Jersey (CINJ) have proven leadership, a robust infrastructure, and a strong record of conducting clinical trials collaboratively. UWCCC and CINJ have, therefore, formed the Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics (WIN-Alliance) with a mission to develop and evaluate innovative early phase experimental therapeutic clinical trials in a multi-disciplinary and multi-institutiona model. Scientific strengths include a translational emphasis with biomarker development; pharmacogenomic assessment; genomic assessment and treatment; clinical and tissue imaging; and systems biology. Organizationally, we have formed working groups that leverage scientific expertise and infrastructural strengths from center shared resources to prioritize ET-CTN efforts. Specific niches unique to the WIN-Alliance include strong PK/PD efforts at UWCCC already adding value to CTEP/U01 clinical trials; complementary imaging strengths at UWCCC and CINJ; genomic analysis using the Rutgers University Cell and DNA Repository (RUCDR); and CINJ's relationship with the Institute for Advanced Study's Simons Center for Systems Biology. Over the past five-years UWCCC and CINJ accrued over 4,000 patients on all therapeutic trials, developed 67 center science driven proposals to NCI-CTEP, and accrued a mean of the targeted 100 patients/yr to the UOl supported studies. The specific aims are to: 1) develop and perform early clinical trials with new ET-CTN sponsored anti-cancer agents; 2) leverage and synergize with center programmatic areas of research and cores to translate scientific discoveries from the laboratory into clinical trials; 3) develop integrated and integral genomic, pharmacogenomics, pharmacokinetic, and pharmacodynamic biomarkers; 4) develop integral and integrated novel approaches to clinical and tissue imaging; and, 5) train and develop young investigators in translational research. RELEVANCE: This application will merge two strong prior Phase I (UOl) sites to create the Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics (WIN-Alliance). This group, as a synergistic, multidisciplinary and multi-institutional model, will develop and evaluate innovative, early phase experimental therapeutic clinical trials to improve clinical outcomes.