An Academic-Industry Partnership to Advance Functional Genomics for Personalized Oncology.

学术与行业合作，推进个性化肿瘤学的功能基因组学。

• 批准号: 10049232
• 负责人: CHRISTOPHER J KEMP
• 金额: $ 60万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-12 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10049232
• 关键词: Acute Myelocytic Leukemia; Address; Adoption; Antineoplastic Agents; Benchmarking; Biological Assay; CLIA certified; Cancer Center; Cancer Patient; Cells; Certification; Clinic; Clinical; Clinical Data; Clinical Oncology; Clinical Research; Clinical Trials; Community Hospitals; Computational Biology; Cultured Tumor Cells; DNA sequencing; Data; Data Set; Databases; Decision Making; Designer Drugs; Drug Combinations; Drug Industry; Drug Screening; Drug resistance; Economics; Feedback; Fred Hutchinson Cancer Research Center; Generations; Genetic; Genomics; Goals; Grant; Health Care Costs; Health Sciences; Individual; Institution; Leukemic Cell; Libraries; Link; Liquid substance; Malignant Neoplasms; Medicine; Methodology; Mission; NCI Center for Cancer Research; Observational Study; Oregon; Organoids; Outcome; Patient-Focused Outcomes; Patients; Performance; Pharmaceutical Preparations; Phase I Clinical Trials; Precision therapeutics; Predictive Value; Procedures; Process; Quality Control; Recommendation; Reporting; Reproducibility; Research; Research Personnel; Sampling; Services; Site; Solid Neoplasm; Standardization; System; Technology; Testing; Therapeutic; Tumor-Derived; Universities; Validation; Work; base; cancer care; cancer genomics; care providers; clinical care; clinical efficacy; clinical research site; clinically relevant; data integration; drug development; drug sensitivity; drug testing; effective therapy; experience; flexibility; functional genomics; genomic data; genomic platform; high throughput screening; improved; industry partner; insight; inter-institutional; machine learning method; malignant breast neoplasm; method development; neoplastic cell; novel; novel drug combination; patient derived xenograft model; patient response; precision medicine; precision medicine clinical trials; precision oncology; predicting response; predictive test; prospective; response; screening; software development; standard of care; success; tumor; tumor DNA; user-friendly

PROJECT SUMMARY/ABSTRACT Oregon Health & Science University and the Fred Hutchinson Cancer Research Center have worked over the past decade to develop ex vivo drug profiling to guide a rationale decision-making in assigning drugs to cancer patients, thereby improving patient outcomes and reducing healthcare costs. A number of recent breakthroughs, many developed through our partnership, have dramatically improved on nearly all aspects of ex vivo drug testing. Our work to date has led to numerous compassionate-use cases as well as new investigator initiated clinical trials. Recognizing the broad utility for a clinic-friendly ex vivo drug sensitivity platform, we set up a commercial entity, SEngine Precision Medicine, whose mission is to provide functional testing of patient derived tumor cells for research, clinical studies, and drug development. Here we seek to move beyond proof of concept in the assay toward wider adoption by cancer research centers, community hospitals, and individual users. We will benchmark the assay’s predictive performance in both “N of 1” settings and in prospective observational studies, and use this baseline performance to drive the development of methods to further improve its predictive value. We will continue to optimize drug selection by integrating ex vivo drug testing with patient specific genomic profiling and clinical data. In parallel, we will develop a reporting system, based upon requirements analysis, for potential end users such as clinicians and academic research centers. OHSU will provide expertise in precision medicine for AML, functional testing of primary leukemia cells, and clinical trials and will assist with assay optimization. FHCRC will provide expertise in functional testing of cells derived from solid tumors, focusing first on breast cancer, cancer genomics, and clinical trials; and will assist with assay optimization and benchmarking. SEngine will develop CLIA certified assays, optimize sample analysis workflows, and develop a reporting system for end users. All three sites will work together to demonstrate inter-institutional proficiency of the assays. At least five additional academic centers have agreed to provide patient derived tumor cells for this project and we anticipate this number will increase during the granting period. The partnering institutions will also provide essential feedback for our performance and reporting system. Our end goals for this project are to produce a refined functional genomic platform based on ex vivo drug screens, a user-friendly reporting interface, and adoption of the technology in the clinical care decision-making process.

项目概要/摘要 俄勒冈健康与科学大学和 Fred Hutchinson 癌症研究中心致力于 过去十年开发离体药物分析以指导将药物分配给癌症的合理决策 患者，从而改善患者的治疗效果并降低医疗成本。 通过我们的合作伙伴关系开发的许多药物在离体药物的几乎所有方面都得到了显着改善 迄今为止，我们的工作已经产生了许多同情使用案例，并启动了新的调查员。 认识到临床友好的离体药物敏感性平台的广泛实用性，我们建立了一个临床试验。 商业实体 SEngine Precision Medicine，其使命是提供源自患者的功能测试 在这里，我们寻求超越概念验证。 争取癌症研究中心、社区医院和个人用户更广泛地采用。 将在“N of 1”设置和前瞻性观察中对测定的预测性能进行基准测试 研究，并利用该基线性能来推动方法的开发，以进一步提高其预测能力 我们将通过将离体药物测试与患者特异性基因组相结合来继续优化药物选择。 同时，我们将根据需求分析开发一个报告系统。 潜在的最终用户，例如人群和学术研究中心，将提供精确度方面的专业知识。 AML 药物、原发性白血病细胞的功能测试和临床试验，并将协助分析 FHCRC 将提供实体瘤细胞功能测试方面的专业知识，首先重点关注。 乳腺癌、癌症基因组学和临床试验；并将协助分析优化和基准测试。 SEngine 将开发 CLIA 认证的检测方法、优化样品分析工作流程并开发报告系统 所有三个站点将共同努力证明机构间的检测能力。 至少另外五个学术中心已同意为该项目提供患者来源的肿瘤细胞，我们 预计在资助期间这一数字将会增加，合作机构也将提供。 我们的绩效和报告系统的基本反馈是我们该项目的最终目标。 基于离体药物筛选的精细功能基因组平台、用户友好的报告界面以及 在临床护理决策过程中采用该技术。