Biospecimen, Pathology, and Immune Monitoring

生物医学、病理学和免疫监测核心(核心D)将提供领导和专业知识 需要支持与每个项目相关的临床前研究和预期临床试验 在组成这一孢子申请的四个项目中。《核心》由罗杰·麦克伦登博士和 肯特·温霍尔德。麦克伦登博士将监督所有预制材料的采购、准备、注解和沉积 四个项目中每一个项目的临床和临床标本都输入了Biosecimen储存库。此外，Dr。 麦克伦登将监督特定研究所指定的生物标本的病理分析。 包括这四个项目中的每一个。他将直接与所有项目负责人以及指定的员工进行互动 关于Core D的持续支持，他将确保所有程序的执行都符合 标准操作程序(SOP)以及临床实验室改进建立的指南 修正案(CLIA)、美国病理学家学会(CAP)和其他实体。温霍尔德博士将监督所有 对每个孢子项目的临床前和临床免疫监测方面的支持，并将 完全负责保证及时的分析和尽可能高的数据质量。他会定期 直接与四个孢子项目的项目负责人和工作人员互动，以建立和 在项目和核心D.伊丽莎白·里普博士之间保持关键的沟通渠道，其负责人 职责将包括执行所有临床前免疫监测研究以及指导 已建立的孢子间免疫监测联盟正在进行的活动将在这些方面帮助他 活动。珍妮特·斯塔茨女士也将协助温霍尔德医生，她将管理所有的临床免疫 利用已建立的SOP和正式验证的化验来监测符合良好临床的工作 实验室操作规范(GCLP)指南。

The Biospecimen, Pathology, and Immune Monitoring Core (Core D) will provide the leadership and expertise required to support both the pre-clinical studies and the anticipated clinical trials that are associated with each of the four Projects comprising this SPORE application. The Core is co-directed by Drs. Roger McLendon and Kent Weinhold. Dr. McLendon will oversee the procurement, preparation, annotation, and deposition of all pre- clinical and clinical specimens from each of the four Projects into the Biospecimen repository. Additionally, Dr. McLendon will oversee the designated pathologic analyses of biospecimens, dictated by the specific studies comprising each of the four Projects. He will interact directly with all Project Leaders as well as designated staff regarding ongoing support by Core D. He will assure that all procedures are performed in compliance with Standard Operating Procedures (SOPs) as well as guidelines established by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and other entities. Dr. Weinhold will oversee all aspects of the pre-clinical and clinical immune monitoring support for each of the SPORE Projects, and will be solely responsible for assurance of timely analyses and the highest possible data quality. He will regularly interact directly with Project Leaders and Staff of each of the four SPORE Projects in order to establish and maintain critical lines of communication between the Projects and Core D. Dr. Elizabeth Reap, whose principal responsibilities will include the performance of all pre-clinical immune monitoring studies as well as directing the ongoing activities of the established Inter-SPORE Immune Monitoring Consortium, will assist him in these activities. Also assisting Dr. Weinhold will be Ms. Janet Staats who will manage all of the clinical immune monitoring efforts utilizing established SOPs and formally validated assays in compliance with Good Clinical Laboratory Practices (GCLP) guidelines.