Wednesday, August 31, 2011

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

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

Oct 25 2011 8:00AM - Oct 26 2011 4:00PM
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Comparative Effectiveness/Health Technology Assess,Pharmacology,Nonclinical,Medical Communications,Quality Assurance/Quality Control,Regulatory Affairs,Statistics,Clinical Data Management/ eClinical

Overview:
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 Identification 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

Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Frank R. Lichtenberg, PhD, Courtney C. Brown Professor of Business, Columbia University and Stephen J. Ruberg, PhD, Distinguished Research Fellow, Scientific Leader, Advanced Analytics, Eli Lilly & Company, Global Statistical Sciences, will be Keynote Speakers.


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 effectively realize the benefits of tailored therapeutics

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

Event Code:
11028

Learn more here.

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