Core A: Administrative Core

行政核心(核心A)由方案主任拉比诺维奇博士领导，将监督 项目领导与高级蛋白质组学表型核心B之间的互动 (应用程序)。核心将每月组织两个小时的计划参与者的TPPG会议，即项目 领导、合作者和顾问、生物统计学家、博士后研究员、研究助理和护士 协调人。每周，一个项目或核心领导将负责科学议程。 行政核心将在最后半小时内提出任何监管或程序问题。核心意志 还与内部咨询委员会每两年举行一次会议，并与外部咨询委员会举行年度会议 顾问委员会。中心将协调受训人员的教育活动，包括为受训人员 获得培训方案(K12、T32)和博士后事务办公室提供的相关资源 斯坦福大学。行政核心将与项目3负责人扎马尼安博士和数据公司密切合作 协调中心，帮助组织I期和II期临床试验，包括协调与 第二阶段临床试验的其他现场主任，以及与医疗监督员--医疗监督员--的沟通 和项目经理。核心将作为项目负责人和Proteo(我们的商业 合作伙伴和IND赞助商)以及项目3负责人和SRI国际之间关于180天GLP 大鼠试验和I、II期临床试验的药代动力学和免疫原性研究。这个 CORE还将促进与NIH Smartt计划的互动，以获得在提交IND和 在启动第二阶段临床试验之前，准备与FDA的快速通道会议。行政部门 CORE还将担任项目负责人、Proteo和FDA之间的联络人。核心将协助 准备和更新动物和临床方案，并获得IRB批准。核心意志 协助编写出版物、演示文稿和进度报告。

The Administrative Core (Core A), headed by the Program Director Dr. Rabinovitch, will oversee the interactions between the Leaders of the Projects and Core B, the Advanced Proteomic Phenotyping Core (APP). The Core will organize monthly two-hour TPPG meetings of the program participants, i.e., project leaders, collaborators and consultants, biostatisticians, postdoctoral fellows, research associates and nurse coordinators. Each week, one of the Projects or Core Leaders will be responsible for the scientific agenda. The Administrative Core will present any regulatory or procedural issues in the last half hour. The Core will also organize a bi-annual meeting with the Internal Advisory Board and an annual meeting with the External Advisory Board. The Core will coordinate educational activities of the trainees, including facilitation of trainee's access to relevant resources offered by training programs (K12, T32) and the Office of Postdoctoral Affairs at Stanford. The Administrative Core will work closely with Project 3 leader, Dr. Zamanian, and the Data Coordinating Center to help organize the Phase I and II clinical trials, including coordination of meetings with the other site directors for the Phase II clinical trial, and communication with the DSMB, the Medical Monitors and Program Managers. The Core will act as liaison between the project leaders and Proteo (our commercial partner and IND Sponsor) and between the Project 3 Leader and SRI international, regarding the 180 day GLP study in the rats and the pharmacokinetic and immunogenicity studies in the Phase I and II clinical trials. The Core will also facilitate interaction with the NIH SMARTT program, for regulatory help in filing the IND and in preparing for the fast track meeting with the FDA prior to initiating the Phase II clinical trial. The Administrative Core will also act as liaison between the Project Leaders, Proteo and the FDA. The Core will assist with preparation and updating of animal and clinical protocols, and with obtaining IRB approvals. The Core will facilitate the preparation of publications, presentations and progress reports.