Biospecimen, Pathology, and Immune Monitoring

点击翻译按钮获取中文摘要

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.