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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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