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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。

基本信息

批准号：
10295144
负责人：
CHRISTOPHER J KEMP
金额：
$ 12.77万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-12-12 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10295144
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

项目摘要

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.

项目总结/文摘