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

Date(s) And Time(s):
Oct 25 2011 8:00AM - Oct 26 2011 4:00PM

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

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

Learning Objectives:

At the conclusion of this workshop, participants should be able to:
• Define a common understanding of what a tailored therapeutic is, and is not, and of the terminology used in the field
• Explain successful and unsuccessful case studies illustrating the benefits and pitfalls of tailored therapeutics in drug development and for regulatory applications
• Describe the role and scope of tailored therapeutics in decision making at various stages of the drug development, e.g. patient population selection, clinical trial and program design choices, supporting information for regulatory application, including posthoc examinations of subgroups versus a priori design hypotheses
• Explain the value of collaborative multi-disciplinary interactions as a centerpiece to eff ectively realize the benefi ts of tailored therapeutics

Target Audience:
• Biostatistics
• Clinical research
• Molecular profiling/Genomics
• Clinical pharmacology
• Medical information
• Compliance
• Quality assurance/control
• Data analysis
• Regulatory affairs
• Drug safety and pharmacovigilance
• Risk management

Event Code:

Contact Information:

Event Information: Contact Constance Burnett at the DIA offi ce by telephone 215.293.5800, fax 215.442.6199 or email Constance.Burnett@diahome.org.