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.
The Administrative Core (Core A) will oversee the interactions between the Leaders of the Projects and Core B, the Advanced Proteomic Phenotyping Core (APP), and act as liaison with our external partners, the NIH, the FDA, and SRI, a company often contracted by NIH, that will carry out preclinical studies in the rats, and pharmacokinetic and immunogenicity studies for the Phase I and II clinical trials. The Core will also coordinate meetings and conference calls with our commercial partner, Proteo. and with the Internal and External Advisory Boards. The Core will coordinate educational activities of the trainees, and assist with updating of animal and clinical protocols, and will facilitate the preparation of publications, presentations and progress reports.
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