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CRLS主任D. Dittmer博士领导的五个独立单位。每个CRL都有独特的专业知识，能力和责任。所有CRL领导者都是实验室工作组（LWG）的成员，并且参与了协议设计和测定性能。 2。各种CRL的管理和监督计划。作为AMC小组会议的一部分，每个CRL每年两次向完整的AMC报告。具体而言，每个CRL报告；（1）实验室贡献的出版物和摘要数量，（ii）遵守所有适用的标准和法规，以及（iii）收到的样本和完成的样品数量（这些样品由增强的全球跟踪捕获）。图4描述了组织结构。 CRL董事向LWG和EC的主席报告。五个CRL向负责监督的CRL董事报告。每个CRL负责可能是同一实验室一部分的科学专业，或者可能需要仅在单独位置可用的专业知识和设备。（！）病理核心（路径）由Cesarman博士指导。它负责血液学和实体瘤的中心病理。中心路径核心借鉴了许多血液，皮肤病和肿瘤特异性病理学家诊断，（ii）病毒学核心（VIR）由Ambinder博士指导，负责与所有AMC标本的DNA隔离，以及疱疹病毒1-8病毒拷贝数定量，非标准HIV分析和对新病毒的检测。由于HPV分析需要应变键入而不是拷贝数定量，因此这些测定是由Palefsky博士组完成的，（iii）药理学（Pharm）核心由Rudeck博士指导。它负责HAART和化学治疗的临床药理学毒品。由于HAART化学疗法的相互作用已成为治疗开发的关键问题，因此药物核心和新药理学委员会具有单独的预算。（iv）生物标志物核心由Dittmer博士指导。它负责统一的AMC样品处理，以产生适合多个下游测定的材料（DNA，可扩增的cDNA，蛋白质）。 AMC试验的当前标准包括多路复用序列标记定量（全身性）和基于实时QPCR（肿瘤）的靶向基因阵列，例如用于病毒或途径特异性分析。我们预计，特定的测定法会根据试验需求而发生变化，但是标本处理和质量保证/质量控制（QA/QC）将保持尽可能的标准化，（v）临床前核心由Dittmer博士指导，并在ABSL-2和ABSL-2和ABSL-3下对AIDS-MALIGNANCY特定模型进行细胞培养和动物测试。