Network Core Research Lab

网络核心研究实验室

• 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
• 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

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。该中心由五个独立的小组组成，由中心主任邓兆棠博士领导。迪特默每个CRL都具有独特的专业知识、能力和职责。所有CRL负责人都是实验室工作组（LWG）的成员，并参与方案设计和试验性能。 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每年向全体AMC报告两次。具体而言，每个CRL报告：（1）实验室贡献的出版物和摘要的数量，（ii）符合所有适用的标准和法规，以及（iii）收到的样本数量和完成的分析（这些由增强的Global Trace捕获）。 图4描述了组织结构。CRL主任向LWG主席和EC报告。这五个CRL向负责监督的CRL主管报告。 每个CRL负责可能属于同一实验室的科学专业，或者可能需要仅在单独地点提供的专业知识和设备。(!)病理学核心（Path）由Cesarman博士指导。它负责血液和实体肿瘤的中心病理学。中央路径核心吸引了一些血液，皮肤和肿瘤类型的特定病理学家， 病毒学核心（Vir）由Ambinder博士指导，负责从所有AMC标本中分离DNA，以及疱疹病毒1 -8病毒拷贝数定量、非标准HIV检测和检测新病毒（如需要）。由于HPV检测需要菌株分型而不是拷贝数定量，这些检测由Palefsky博士的小组完成。（iii）药理学（Pharm）核心由Rudeck博士指导。负责HAART和化疗药物的临床药理学 毒品由于HAART-化疗相互作用已成为治疗开发中的一个关键问题，因此Pharm核心和新的药理学委员会有单独的预算。（iv）生物标志物核心由Dittmer博士指导。它负责AMC标本的统一处理，以产生适用于多种下游检测（DNA、可扩增cDNA、蛋白质）的材料。AMC试验的当前标准包括多重血清标志物定量（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。我们预计特定的检测方法将根据试验需求而变化，但样本处理和质量保证/质量控制（QA/QC）将尽可能保持标准化，（v）临床前核心由Dittmer博士指导，并在ABSL-2和ABSL-3下对艾滋病恶性肿瘤特异性模型进行细胞培养和动物试验。