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.
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