Shared Resource 13: Pharmaco Analytical (PhASR)

项目摘要--药学分析共享资源(PHaSR) PHaSR为CCC成员提供药代动力学(PK)和药效学(PD)研究方面的专业知识， 包括生物分析服务，以准确量化药物、代谢物和内源性生物分子 支持实验性癌症治疗的临床前和临床发展的生物样本。这 支持还包括用于表征PK/PD的实验设计、数据分析、建模和模拟 临床前抗癌治疗进展的关系及最佳剂量方案的模拟 和临床发展阶段。PHaSR之前在分析共享资源中被评为杰出 组。没有发现任何弱点，但建议PHaSR计划预期的增长 为了未来的需求。PHaSR的具体目标是：1)开发和验证新的分析方法，以量化药物和 生物样品中的代谢物；2)量化生物基质中的药物和代谢物水平，并进行 PK/PD研究，用于纳入临床前和临床决策；以及3)提供PK/PD方面的专业知识 研究设计和数据解释，以支持提交早期1期和2期临床方案、拨款和 出版物。在当前的5年筹资周期中，PHaSR支持了所有五个OSCCC中的67名调查人员 研究计划和全国儿童医院，并支持52种出版物(8种具有10个影响因子) 和11个NCI补助金，包括1个K22、1个K24、2个P01、2个P50、4个R01和1个UM1。PHaSR未来的服务将 解决OSUCCC在翻译基因组学、免疫肿瘤学和癌症工程方面的战略优先事项。 鉴于OSUCCC的招聘情况强劲，对服务和新技术的需求将会增加。PHaSR 将在产能达到之前扩大其工作人员、仪器设备和服务。最新技术和新技术 订单将加强我们对小批量样品的准确和灵敏的测量，重点是 开发准确量化免疫疗法和其他生物制品的分析方法，并增加统计分析 在细胞、肿瘤、器官或全身水平上为PK/PD关系建模服务。年度预算 PHaSR是612,272美元，而CCSG的请求是94,171美元。因此，PHaSR利用广泛的 机构支持，仅从CCSG基金寻求15.4%的支持。

PROJECT SUMMARY – PHARMACOANALYTICAL SHARED RESOURCE (PhASR) PhASR provides CCC members with expertise in pharmacokinetic (PK) and pharmacodynamic (PD) studies, including bioanalytical services to accurately quantify drugs, metabolites, and endogenous biomolecules in biological samples to support pre-clinical and clinical development of experimental cancer therapies. This support also includes experimental design, data analysis, modeling and simulation for characterizing PK/PD relationships and simulating optimal dose regimens for the advancement of anti-cancer therapies in pre-clinical and clinical development stages. PhASR was previously rated as Outstanding in the Analytical Shared Resource Group. There were no weaknesses noted, but it was recommended that PhASR plan for anticipated increases for future demand. PhASR’s Specific Aims are to: 1) develop and validate new assays to quantify drugs and metabolites in biological specimens; 2) quantify drug and metabolite levels in biological matrices, and conduct PK/PD studies for incorporation into pre-clinical and clinical decision-making; and 3) provide expertise in PK/PD study design and data interpretation to support submission of early phase 1 and 2 clinical protocols, grants, and publications. During the current 5-year funding cycle, PhASR supported 67 investigators in all five OUSCCC research programs and Nationwide Children’s Hospital, and supported 52 publications (8 with >10 impact factor) and 11 NCI grants, including 1 K22, 1 K24, 2 P01s, 2 P50s, 4 R01s, and 1 UM1. PhASR future services will address OSUCCC strategic priorities in translational genomics, immuno-oncology and cancer engineering. Given the robust OSUCCC recruitment, demand for services and new technologies will increase. The PhASR will expand its staff, instrumentation and services before capacity is reached. Recent and new technologies on order will enhance our efforts for accurate and sensitive measurements in samples of small quantity, focus on development of assays to accurately quantify immunotherapies and other biologics and increase statistical modeling services for PK/PD relationships at the cellular, tumor, organ, or whole body levels. The annual budget of the PhASR is $612,272 yet the CCSG request is $94,171. As such, the PhASR leverages extensive institutional support and seeks only 15.4% support from CCSG funds.