DIA/FDA Tailored Therapeutics: Practical Issues and Methodologies in Selecting the Right Patients

Venue: Bethesda North Marriott Hotel & Conference Center

Location: North Bethesda, Maryland, United States

Event Date/Time: Oct 25, 2011 End Date/Time: Oct 26, 2011
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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

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