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139th National Cancer Advisory Board

FY 2006 budget. In the Senate, the Appropriations Subcommittee added $200 M to the NIH request and specifies $4.799 for the NCI, $9 M more than the FY 2006 budget.

Roadmap Trans-NIH Strategic Initiative Drive. Dr. Niederhuber reported that Dr. Elias Zerhouni, Director, NIH, and NIH leadership have begun planning for a new cohort of Roadmap initiatives to begin in FY 2008. He explained that the Roadmap fund comprises about 1.7 percent of the FY 2008 budget across the NIH, and that an agreement has been reached that growth of the fund would not exceed 1 to 1.1 percent of the NIH budget as long as flat or negative budgets continue to be enacted. In Phase 2 of the planning process, which occurred during July and August, five consultation meetings were held to solicit ideas for initiatives from the extramural community. The goal at these meetings was to identify scientific priorities that would be enabling for biomedical research across diseases. During August, ideas for initiatives were also solicited from Institute and Center (IC) Directors and program officers in the OD, NIH. In Phase 3 of the process, the identified initiatives will be brought to the larger stakeholder community via a Web-based Request for Information (RFI) to be released in October. The process of reviewing and prioritizing the proposed initiatives will continue through fall, and Dr. Zerhouni will select up to five to be developed into concepts in December. Roadmap development teams will than conduct pre-RFA activities to produce initiative-focused science and business plan packages between January and May 2007. A final review of the proposed initiatives will be conducted in May by IC Directors and the Advisory Council to the NIH Director, with final selections to be made by Dr. Zerhouni, also in May.

Oncology Biomarkers Qualification Initiative (OBQI). Dr. Niederhuber presented an update on the OBQI, which began in February 2006 and was developed collaboratively by the NCI, Food and Drug Administration (FDA), and Center for Medicare and Medicaid Services (CMS). NCI’s contribution to the initiative is to develop biomarker technologies and validation protocols to improve detection, diagnosis, treatment, and prevention of cancer. The FDA responsibility will be to develop guidance for the use of the biomarkers to facilitate cancer drug development, and the CMS task will be to make informed decisions about reimbursement for new or existing cancer treatment regimens based on biomarker-guided knowledge. Members were reminded that the OBQI was developed to implement the biomarker discovery and development objective of the NCI/FDA Interagency Oncology Task Force (IOTF). The IOTF was established in 2003 to enhance efficiency of clinical research and scientific evaluation of new cancer treatments. Other IOTF objectives were to establish joint training and fellowships, utilize the Cancer Bioinformatics Grid (caBIGTM) to support standardized and organized clinical trials data reporting and to support electronic filing to speed regulatory review, and address specific regulatory barriers impeding cancer drug development. The two initial OBQI projects are studies of FDG-positron emission tomography (PET) as a biomarker. The first project is studying the efficacy of FDG-PET as a predictor of tumor response and patient survival in lymphoma; the second is a Phase II study of FDG-PET as a predictive marker of tumor response and patient outcome in non-small cell lung cancer. Dr. Niederhuber noted that the OBQI also represents a first step in the effort to develop a biomarkers consortium that will be a public-private partnership involving the NIH, FDA, CMS, pharmaceutical and biotechnology companies, and the NIH Foundation. The consortium will work through individual projects, and the FDG-PET studies will be the lead projects. An announcement about the consortium is expected in October.

Scientific Updates. Dr. Niederhuber called attention to the recently published advances in immunotherapy made intramurally in the Surgery Branch, CCR, by Dr. Steven Rosenberg, Chief, and colleagues. Gene therapy has been shown to enhance adoptive cell transfer, which, until now, had been shown to mediate a 50 percent objective response only in patients with advanced melanoma and only in those who have a population of tumor reactive lymphocytes. The Rosenberg group has developed a method to transfect T-lymphocytes retrovirally with T-cell receptors that recognize cancer antigens. With

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