Throughout this proposal, we have emphasized the need to move research findings into the clinic. The new Shared Resource and Methodology dispussed below will provide important new areas of expertise needed by our investigators on both sides of the clinical interface. In order to link the developing shared resources with our Cancer Center members, we propose to use CCSG pilot project support specifically for projects that utilize the new shared resources. 7.5.2.1 TRANSLATIONAL METHODOLOGY PILOT FUNDING! In order to fully utilize the capabilities of the Translational Methodology, we will create a new mechanism for pilot support designed to move a project through from discovery to drug scale-up. Support for a single project funded at $100,000 per year for one year will help ensure that new cancer therapeutics are using this methodology. 7.5.2.2 CLINICAL PHARMACOLOGY PILOT SUPPORT New therapies may fail for many reasons. We are beginning to understand how pharmacokinetics affect benefit and toxicity of many new drugs. Many clinical studies frequently do not incorporate pharmacokinetic, pharmaCodynamic, or pharmacogenetic evaluation into their trial design because of cost. In this pilot mechanism, we will offer support for these types of studies in investigator-initiated clinical trials. The purpose of this mechanism of pilot support is not meant to fund the entire clinical trial Instead, this pilot funding will serve as a supplement to ongoing clinical trials. A total amount of $50,000 per year is committed to this program from CCSG funds. There will be no uniform date for application for this mechanism given the nature of clinical investigation. Instead, this mechanism will be promoted to the Cancer Center membership, and a review of each proposal will be initiated by the Clinical Research Leadership committee and Drs. Jacobson and Kirstein. If the study is deemed to be of sufficient merit, then it will be funded and funds will be expended on a first-come, first-served basis. Other meritorious trials can be supported by philanthropic funds if they are proposed after the CCSG support is committed. In addition to these specific mechanisms, the existing pilot project support will be maintained (TTURC, Women's Cancer, Brainstorm, Population Science, Sarcoma). The CCSG will support some of these mechanisms and may be supplemented with philanthropic support. 7.5.2.3 ONGOING SUPPORT OF EXISTING AWARD MECHANISMS We propose to continue to bur annual Brainstorm awards to promote interprogrammatic research, as well as specific awards in the areas of population sciences and translational research. Although the majority of these awards will be funded through philanthropic support, we have budgeted $200,000 in CCSG support.
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