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.组织架构。CRLS由五个独立的单位组成，由CRLS主任D.Dittmer博士领导。每个CRL都有独特的专业知识、能力和职责。所有CRL负责人都是实验室工作组(LWG)的成员，并参与方案设计和分析性能。 2.各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AMC全体成员报告两次。具体地说，每个CRL报告：(1)实验室贡献的出版物和摘要的数量，(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化验的数量(这些由增强的全球跟踪收集)。图4描述了组织结构。CRL主任向LWG主席和欧盟委员会汇报工作。五个CRL向CRL主任报告，CRL主任负责监督。每个CRL负责的科学专业可能是同一实验室的一部分，或者可能需要只有在不同地点才能获得的专业知识和设备。(！)病理学核心(PATH)由Cesarman博士指导。它负责血液和实体肿瘤的中枢病理。中心通路核心利用了许多针对血液、皮肤和肿瘤类型的特定病理学家来制作 (Ii)病毒学核心(VIR)由Ambinder博士领导，负责从所有AMC样本中分离DNA，并根据需要进行疱疹病毒1-8拷贝数量化、非标准艾滋病毒检测和新病毒检测。由于HPV检测需要菌株分型，而不是拷贝数量化，所以这些检测是由Palefsky博士的团队完成的，(Iii)药理学(药学)核心由Rudeck博士指导。负责HAART的临床药理和化疗 毒品。由于HAART-化疗的相互作用已经成为治疗开发中的一个关键问题，制药核心和新的药理学委员会有单独的预算。(4)生物标志物核心由Dittmer博士指导。它负责AMC样本的统一处理，以产生适合于多种下游分析(DNA、可扩增的cDNA、蛋白质)的材料。AMC试验的当前标准包括多路血清标记物定量(系统)，以及基于实时定量聚合酶链式反应(肿瘤)的靶向基因阵列，例如用于病毒或路径特异性分析。我们预计特定的化验方法将根据试验需要而变化，但标本处理和质量保证/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，根据ABSL-2和ABSL-3对艾滋病-恶性肿瘤特异性模型进行细胞培养和动物测试。