Core--Administration, Biostatistics, Data Management

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This program will interface clinical and tissue culture studies that will exploit dendritic cells in the induction of strong immunity to melanoma. An administrative core will carry out functions that interface with the 3 subprojects and with the cores for cell production and for immunologic monitoring. The administrative core will include administrative assistants in Dallas and New York who will function to: (1) Ship patient samples and sera that are to be assayed in the cores and in the interactive experimental aims; (2) To arrange joint meetings between the investigators and external advisors in New York and Dallas; (3) Prepare protocol submissions and annual renewals to the institutional review boards; (4) Arrange contacts and prepare reports to the NCI; (5) Procure and maintain informed consents for therapies, blood, and tissue sampling; (6) Help to prepare, submit, and track manuscripts; (7) Enter and maintain a shared reference data base; (8) Monitor budgets; (9) Manage personnel including immigration, stipends, benefits and housing; (10) Coordinate equipment maintenance and repair. The administrative core will support centralized biostatistics and data management personnel in New York, and Dallas. A Contract has been signed between Baylor Research Institute and biostatistical firm, Statistics Collaborative, to address all the biostatistics matter needed at BUR. The president of the company, Janet Wittes, PhD, is a respected Biostatistician who will serve as a collaborator to the Program Project. This group has had a major input in the design of the trials proposed in this revised application. A five person external advisory committee has agreed to serve the program and includes outstanding investigators in the fields of dendritic cells, immunotherapy of human melanoma, biology of Regulatory T cells, and immunotherapy of human myeloma.