Bethesda North Marriott Hotel & Conference Center, North Bethesda, MD, USA
Oct 25 2011 8:00AM - Oct 26 2011 4:00PM
This multi-disciplinary conference provides an opportunity to increase awareness,
communicate shared experiences, and clarify terminology regarding tailored therapeutics across the stages of drug development, including:
• Topics of response guided therapy
• Biomarkers
• Diagnostic tests
• Clinical trial operational and regulatory issues
• Personalized medicine FEATURED TOPICS
Applications and case studies will cover multiple therapeutic areas
• Hepatitis, Oncology, Cardio-Renal, HIV, Pediatrics, Psychiatrics and Other
Potential Applications
• Genotyping for Tailored Therapeutics
• Subgroup Identification When Biomarkers Are Unknown
– Exploratory Approaches
• Subgroup Identification With Some Possible Biomarkers
– Assessing a Small Set of Biomarkers
• Subgroup Identifi cation When Biomarkers Are Well Known
– Assessing the Clinical Utility of Biomarkers
• Biomarker Guided Patient Selection Genomic Controlled Trials
• Biomarker-integrated Approaches to Tailored Therapeutics
– Medical, Clinical and Design Aspects of the I-SPY-2 Trial
– Statistical Design and Results of the BATTLE Trial
• Key Principles for Incorporating Predictive Diagnostic Tests in Drug Development
• Response-Adaptive Randomization Tailored Therapy Studies
• Use of a Composite Endpoint for an Enrichment Design
Event Code:
11028
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