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Network Core Research Lab

网络核心研究实验室

基本信息

批准号：
8099897
负责人：
RONALD T. MITSUYASU
金额：
$ 41.79万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-01 至 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8099897
关键词：
Animal Testing Area Biological Assay Biological Markers Budgets Cell Culture Techniques Clinical Clinical Pharmacology Clinical Trials Complementary DNA Conceptions DNA Detection Diagnosis Equipment Gene Targeting Group Meetings HIV Highly Active Antiretroviral Therapy Human Papillomavirus Human Resources International Laboratories Laboratory Research Location Malignant Neoplasms Modeling Pathologist Pathology Pathway interactions Performance Pharmaceutical Preparations Pharmacology Process Proteins Protocols documentation Publications Quality Control Regulation Reporting Research Research Personnel Sampling Serum Markers Solid Neoplasm Specimen Specimen Handling Time Validation Viral Work abstracting base chemotherapy design medical specialties member novel novel virus organizational structure pre-clinical quality assurance therapy development tumor virology working group

项目摘要

1. Organizational structure. The CRLs comprise five independent units led by the director of CRLs, Dr. D. Dittmer. Each CRL has unique expertise, capabilities, and responsibilities. All CRL leaders are members of the laboratory working group (LWG), and are involved with protocol design as well as assay performance. 2. Management and oversight plan for various CRLs. Each CRL reports twice annually to the full AMC as part of the AMC group meetings. Specifically, each CRL reports; (1) number of publications and abstracts to which the laboratory contributed, (ii) compliance with all applicable standards and regulations, and (iii) number of samples received and assays completed (these are captured by the enhanced Global Trace¿). Figure 4 depicts the organizational structure. The CRL director reports to the chair of the LWG and to the EC. The five CRLs report to the CRL director, who is responsible for oversight. Each CRL is responsible for scientific specialties that may be part of the same laboratory, or may require expertise and equipment that is only available at a separate location. (!) The pathology core (Path) is directed by Dr. Cesarman. It is responsible for central pathology for hematologic and solid tumors. The central Path core draws on a number of hemato-, dermato- and tumor-type-specific pathologists to make diagnoses, (ii) The virology core (Vir) is directed by Dr. Ambinder and is responsible for DNA isolation from all AMC specimens, as well as herpesvirus1-8 viral copy number quantification, non-standard HIV assays, and detection of novel viruses, as needed. Since HPV assays require strain typing rather than copy number quantification, those assays are done by Dr. Palefsky's group, (iii) The pharmacology (Pharm) core is directed by Dr. Rudeck. It Is responsible for clinical pharmacology of HAART and chemotherapeutic drugs. Since HAART-chemotherapy interactions have emerged as a key concern in therapy development, the Pharm core and the new pharmacology committee have separate budgets. (iv)The biomarker core is directed by Dr. Dittmer. It is responsible for unified processing of AMC specimens to yield material that is suitable for multiple downstream assays (DNA, amplifiable cDNA, proteins). The current standard for AMC trials encompasses multiplexed serum marker quantitation (systemic), and targeted gene arrays based on real-time QPCR (tumor), e.g. for viral or pathway-specific profiling. We expect a particular assay will change depending on trial needs, but that specimen processing and quality assurance/quality control (QA/QC) will remain as standardized as possible, (v) The preclinical core is directed by Dr. Dittmer and conducts cell culture and animal testing on AIDS-malignancy-specific models under ABSL-2 and ABSL-3.

1. 组织结构。CRLs由五个独立单位组成，由CRLs主任D. Dittmer博士领导。每个CRL都具有独特的专业知识、功能和职责。所有CRL负责人都是实验室工作组（LWG）的成员，并参与方案设计和分析性能。