Cancer Vaccine Clinical Trials Workshop

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8:00am – 8:30am	Introductory Remarks Ulrich Keilholz, MD • Charité CBF, Berlin, Germany Axel Hoos, MD, PhD –Bristol-Myers Squibb, Wallingford, CT
8:30am – 10:30am	Development of Cancer Vaccines: Industry & Academic Perspectives
8:30am – 8:55am	Dendritic Cell Based Vaccine Development Robert Hershberg, MD, PhD -Dendreon Corporation, Seattle, WA
8:55am – 9:20am	Registration-directed Development of a Combination Approach: Anti-CTLA4 and a Melanoma Peptide Vaccine Geoffrey Nichol, MD -Medarex Inc, Bloomsbury, NJ
9:20am – 9:45am	Autologous and Allogeneic Gene-transfected Tumor Cell Vaccines Kristen Hege, MD –Cell Genesys, South San Francisco, CA
9:45am – 10:10am	Multi-Peptide Vaccines Craig Slingluff, Jr., MD –University of Virginia, Charlottesville, VA
10:10am – 10:35am	WT1 Vaccines for Patients with Acute Myeloid Leukemia Carmen Scheibenbogen, MD -Charité, CBF, Berlin, Germany
10:45am - 12:30pm	Summary of Issues and Goals Presentation of Workstream Manuscripts
	Workstream 1: Clinical Endpoints to Support Efficacy Peter Bross, MD –Food and Drug Administration, Rockville, MD Hans Loibner, PhD -HL Bioscience Research GmbH, Vienna, Austria Giorgio Parmiani, MD -Istituto Nazionale Tumori, Milan, Italy Workstream 2: Design Methodologies for Cancer Vaccine Trials Alexander Eggermont, MD, PhD -Erasmus University Medical Center, Rotterdam, Netherlands Steven Hirschfeld, MD, PhD -Food and Drug Administration, Rockville, MD Axel Hoos, MD, PhD –Bristol-Myers Squibb, Wallingford, CT Workstream 3: Technical Challenges in Cancer Vaccine Clinical Trials Kristen Hege, MD –Cell Genesys, South San Francisco, CA Walter Urba, MD, PhD -Earle A. Chiles Research Institute, Portland, OR Keith Wonnacott, PhD -Food and Drug Administration, Rockville, MD Workstream 4: Enabling Technologies and Combinations of Investigational Agents Ke Liu, PhD - Food and Drug Administration, Rockville, MD Geoffrey Nichol, MD –Medarex, Bloomsbury, NJ Mario Sznol, MD –Yale University, New Haven, CT
1:30pm - 2:45pm	State of the Field Presentations
1:30pm – 1:55pm	Measuring Residual Tumor Burden Jerald Radich, MD -Fred Hutchinson Cancer Research Center, Seattle, WA
1:55pm – 2:20pm	Cancer Biometrics - Results of the 2003 iSBTc Workshop Theresa Whiteside, PhD –University of Pittsburgh Cancer Institute, Pittsburgh, PA
2:20pm – 2:45pm	Bayesian Designs for Early Drug Development Trials Stephen George, PhD – Duke University, Durham, NC
2:45pm - 3:15pm	FDA Special Lecture (Group Session)
	FDA Perspective on the Preclinical Development of Cancer Vaccines Richard McFarland, MD, PhD –Food and Drug Administration, Rockville, MD
3:30pm - 5:30pm	Workstream Discussion Reports/Open Audience Discussion (Group Session)
	Workstream 1: Clinical Endpoints to Support Efficacy Peter Bross, MD ~ Hans Loibner, PhD ~ Giorgio Parmiani, MD Workstream 2: Design Methodologies for Cancer Vaccine Trials Alexander Eggermont, MD, PhD ~ Steven Hirschfeld, MD, PhD ~ Axel Hoos, MD, PhD Workstream 3: Technical Challenges in Cancer Vaccine Clinical Trials Kristen Hege, MD ~ Walter Urba, MD, PhD ~ Keith Wonnacott, PhD Workstream 4: Enabling Technologies and Combinations of Investigational Agents Ke Liu, PhD ~ Geoffrey Nichol, MD ~ Mario Sznol, MD

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