The Clinical and Administrative Core (Core D) is designed to: 1) Facilitate interactions between Projects and Cores; 2) Provide administrative support for: a) GTRP applications and interactions (Clinical Grade Vector manufacture, Biodistribution & Toxicology Studies); and b) manage IND submissions (Project 1, and perhaps Project 2). Organizational and Administrative Structure. The Principal Investigator of the proposed Program, Dr. H. Kirk Hammond, will be responsible for all operations and policy decisions of the program. He will report to and be assisted by several Program Committees including: a) Local Advisory Committee. This Committee will be comprised of the Project Leaders of all the research components (Drs. Hammond, Roth, and Dillmann). The committee will meet quarterly to identify and solve problems related to general programmatic issues and evaluate progress toward the program's goals; b) External Advisory Committee. This Committee consists of three basic and clinical research investigators with expertise directly relevant to gene transfer, cardiovascular physiology and heart failure. The committee will meet in La Jolla annually to confer with the Principal Investigator and the participating investigators in the program. These clinicians and scientists will play an important advisory role in the implementation, oversight, and data assessment in the overall Program; c) Data and Safety Monitoring Board (DSMB). The NHLBI DSMB will assess any clinical trials that are initiated in the tenure of the proposed renewal Program, as mandated by the NIH. The day-to-day operations of the program including program development and oversight will be coordinated through Dr. Hammond. The local site administrative personnel will include an experienced and senior program Administrative Assistant (Ms. Eileen D'Souza).
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