KEYNOTE ADDRESS: Where we are Now: Development, Approval and Commercialization of CDx in Oncology
Dr Richard Buller, Vice President, Translational Oncology, Pfizer
Companion Diagnostics: FDA Policies on Oversight
Dr Elizabeth Mansfield, Director, Personalized Medicine, FDA
Deciding when a Targeted Drug is Ready to Leave Phase I: An Academic Perspective
Developing a Successful Strategy for Targeted Therapy Development in Oncology: Key Considerations
Dr Steve Coats, Senior Director R&D, MedImmune
Case Study: Identifying a Predictive Biomarker of Response to Imetelstat, a Telomerase Inhibitor
Dr Katia Bassett, Scientist II, Translational Oncology, Geron
From Research Lab to a Validated Biomarker Assay that Improves Therapy: What the Researcher Needs to Consider
Dr Barbara Conley, Associate Director, Cancer Diagnosis Program, NCI
Identification of Response Biomarkers and Development of Clinical Assays for Patient Stratification: A Case Study
Identification of Stratification Biomarkers for Cancer Management
Dr Richard Kennedy, VP Experimental Medicine, Almac
Molecular Pathology in Decision Making for Clinical Drug Development
Dr Shethah Morgan, Senior Research Clinical Scientist, Clinical Biomarker Group, AstraZeneca
Evolving from a Biomarker to a Companion Diagnostic
Enabling Reliable Mutational Profiling of Clinical Samples: COLD-PCR Technology and Application to Highly Sensitive Sequencing
Pioneering Partnerships: Business Models for Successful Companion Diagnostic Co Development
Richard Watts, Senior Director, Companion Diagnostic Partnerships, QIAGEN
Molecular Diagnostics: Challenges, Opportunities, Vision and Longevity
Dr Jon Burrows, Executive Vice President, R&D, Expression Pathology
Evolving Applications of Oncology Clinical Trial Specimens and Externaln Biorepositories for Biomarker and Diagnostic Development
Dr John Bloom, President, Bloom Consulting Services and Special Government Employee, FDA
Acquiring and Using your own Clinical Trial Specimens for Biomarker Identification
Dr Diane Leong, Global Scientific and Business Strategy, Biosample Operations, Genentech
Biospecimen Challenges in Developing and Validating Molecular Diagnostic Assays
Next Generation Sequencing of Cancer-Associated Genes in FFPE Tumor DNA
Dr Gary Latham, Director, Diagnostic Research & Technology Development, Asuragen
Successful MDx Development: Tissue is the Issue
Dr Anne-Marie Martin, Senior Director Clinical Development and Clinical Biomarkers, Oncology, GSK
Aligning the Development, Regulatory and Commercial Strategies for a Companion Diagnostic
Reimbursement for Personalized Medicine Diagnostics: Current Limitations and Evolving Strategies
Kristin Pothier, Partner, Health Advances
Gary Gustavsen, Associate, Health Advances