Sponsor or Organizer: Cambridge Healthtech Institute

Description: 9:00 am - 12:00 pm Circulating Tumor Cells (CTCs) as Biomarkers and their use in Oncology Clinical Trial Design Short Course (SC5)* Chairperson: Leon Terstappen, M.D., Ph.D., Vice President of R&D, Immunicon

9:00 FDA-CDER Current Biomarker Qualification Process Map Federico M. Goodsaid, Ph.D., Genomics Group Office of Translational Science, FDA-CDER 9:30 Understanding of the Biology, Origin and Clinical Significance of CTCs John W. Park, M.D., Associate Professor, Medicine, University of California, San Francisco 10:00 Coffee Break 10:15 The Preclinical & Clinical Development of the Cellsearch Assay: Its Specifications and Clinical Relevance Leon Terstappen 10:45 Overview of Completed & Ongoing Prospective Clinical Trials that Employ CTCs Jeffrey B. Smerage, M.D., Ph.D., Clinical Assistant Professor, Department of Internal Medicine, University of Michigan 11:15 Incorporation of CTCs in a Phase I/II Clinical Trial of a Novel Prostate Cancer Agent David R. Shalinsky, Ph.D., Director, Drug Development, Pfizer Inc. 11:45 Discussion 12:00 End of Short Course

Dates: 02/28/2007

Location: San Francisco, CA, USA