Translational and Clinical Sciences Research Program (Project-007)

项目总结/摘要 转化和临床科学项目使南加州大学诺里斯分校的发现能够转化为临床 通过开展与我们的患者群体相关的创新试验。成员具有不同的专业知识， 参与临床研究并高度参与。通过跨方案指导丰富领导能力 该委员会利用基因组学、生物标志物、生物成像和药物开发方面的专业知识， 与疾病和专题小组定期举行会议，以确保转化和临床研究在 跨学科和协调的方式。新的目标是从基础科学研究计划中选择的， 在专注于开发新疗法的合作团队的支持和加速下， 诊断和生物标志物以及执行临床试验。成员积极参与内部和内部 利用南加州大学诺里斯共享资源和临床资源的专业知识进行计划性研究。优先 主题是新的目标，使用药物缀合物增强抗体的功效，免疫治疗剂， 细胞疗法和表观遗传靶点。我们已经确定并验证了肿瘤相关靶点， 已经首先在人类研究中采用的药物，开发了伴随成像剂，并启动了 多项高优先级研究者发起的试验。几个新的目标已经选定并通过 已经或即将进入临床的不同阶段的翻译。伴随的生物标志物和 成像探针也已被开发用于若干目标并被集成到试验中。多次高冲击 已经进行了试验，包括在USC Norris发现和开发的首次人类新型药物， 积极的II期试验已经进入III期。USC Norris PI曾担任首席研究员， 几项多中心III期NCTN试验。该计划的61名成员来自6所学校和21个 部门他们有1600万美元的总资金（直接成本），其中31%来自NCI，25%来自其他NIH 13%来自其他同行评审的资金来源。该方案富有成效， 项目期间出版了1，030份出版物，其中27%是计划内出版物，31%是跨计划出版物， 42%是计划性的，42%是机构间的。

Project Summary/Abstract The Translational and Clinical Sciences Program enables USC Norris discoveries to be translated to the clinic by conducting innovative trials relevant to our patient population. Members have diverse expertise from basic to clinical investigation and are highly engaged. Leadership is enriched by an inter-programmatic Steering Committee, which leverages expertise in genomics, biomarkers, bio-imaging and drug development, and regular meetings with disease and thematic teams to ensure that translational and clinical research occurs in an interdisciplinary and coordinated manner. New targets are selected from basic science Research Programs, with translation supported and accelerated by collaborative teams focused on developing novel therapeutics, diagnostics and biomarkers and on executing clinical trials. Members actively participate in intra- and inter- programmatic research using the expertise of USC Norris Shared Resources and clinical resources. Priority themes are novel targets, enhanced efficacy of antibodies using drug conjugates, immunotherapeutics, and cell therapies, and epigenetic targets. We have identified and validated tumor-associated targets, developed agents that have been taken to first in human studies, developed companion imaging agents, and initiated multiple high priority investigator initiated trials. Several novel targets have been chosen and moved through different stages of translation that are already or soon to be in the clinic. Accompanying biomarkers and imaging probes have also been developed for several targets and integrated into trials. Multiple high-impact trials have been conducted, including first in human novel agents discovered and developed at USC Norris and positive Phase II trials that have moved to Phase III. USC Norris PIs have served as lead investigators for several multicenter Phase III NCTN trials. The Program's 61 members come from six schools and 21 departments. They have $16M in total funding (direct costs) of which 31% is from NCI, 25% is from other NIH sources, and 13% from other peer-reviewed funding sources. The Program has been highly productive with 1,030 publications during the project period, of which 27% were intra-programmatic, 31% were inter- programmatic and 42% were inter-institutional.