Pre-Conference Symposia  •  Sunday, August 9  •  2:00-5:00pm

2:00-5:00pm (SC1) CIRCULATING TUMOR CELLS AS SURROGATE ENDPOINTS IN CLINICAL TRIALS

2:00 CTCs

Richard J. Cote, M.D., FRCPath, Professor and Chairman, Pathology; Director, Biomedical Nanoscience Institute, University of Miami, Miller School of Medicine

2:30 Circulating Tumor Cells as Biomarkers in Castration-Resistant Prostate Cancer

Howard I. Scher, M.D., D. Wayne Calloway Chair in Urologic Oncology, Chief, Genitourinary Oncology Service, Department of Medicine, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center

Recent trials using an FDA-cleared assay show that CTC number is a biomarker of prognosis and more predictive than posttherapy changes in PSA, raising the possibility that posttherapy changes in CTCs might represent an intermediate endpoint of treatment efficacy. The question of whether CTC counts are potential surrogates for survival is currently being addressed in the context of a phase 3 registration trial. Also under study are biologic profi ling of these tumors to explore the relationship between specifi c alterations in androgen receptor signaling and the response to novel agents targeting these alterations.

3:00 CTC and DTC as Surrogate Endpoints in Clinical Trials

Stephan Braun, M.D., Ph.D., Senior Medical Advisor Oncology, Amgen Austria GmbH

• Background on DTC and CTC in breast cancer
• Impact of DTC and CTC on clinical trials
• Perspectives

3:30 Networking Refreshment Break

4:00 Micrometastases and Cancer Stem Cells: on Lethal Seeds and Supportive Soil

Marija Balić, Ph.D., Division of Oncology, Department of Internal Medicine, Medical University of Graz

This talk will address the correlation of micrometastases and cancer stem cells and development of needed novel protocols for detection and characterization of DTC/CTC. The first clinical evidence on association of disseminated tumor cells with the putative breast cancer stem cell phenotype was published in Clin Can Res Okt 2006. Based on this data, novel protocols have been evaluated and established to enhance the sensitivity for DTC detection and enable the characterization of these cells according to the phenotype. In addition, the talk will provide the review of the current and important literature on interaction of DTC/CTC with the host (incl. bone and immune system).

4:30 Q&A with Speakers

5:00 Close of Symposium

2:00-5:00pm (SC2) REALITY CHECK ON COMPANION DIAGNOSTICS

• Landscape of the companion diagnostic space today
• Types of companion diagnostics tests
• Clinical areas for companion diagnostic tests
• Potential new companion diagnostic tests that will impact the market
• Three fundamental steps in companion diagnostics
• Impact on healthcare improvement and healthcare cost reduction
• Where is the revenue coming from?
• Who are the key players?
• Where are the gaps?