Pharmacogenomics in Drug Development and Regulatory Decision Making - Apr 11-13, 2005 Bethesda, MD

Pharmacogenomics in Drug Development and Regulatory Decision Making
Apr 11-13, 2005 Bethesda, MD
Marriott Bethesda Hotel
Learning Objectives of this Conference are:
Recognize the role of pharmacogenomics in FDA?s critical path initiative to enable efficient and successful drug development.
Describe clinical study designs for proof of concept, and Phase II and Phase III trials that leverage pharmaco-genomics for greater efficiency and informativeness.
Explain the current and future potential impact of pharmacogenomics on revolutionizing oncology trials.
Identify areas of possible harmonization of pharmaco-genomics guidance among regulatory agencies in
Europe, Japan and US.
Describe challenges and strategies to bridge pharmaco-genomics information from drug development research to adoption into clinical practice.
Assess the impact of the FDA draft genomic data submission guidance on voluntary pharmacogenomic
submissions.
Discuss the retrospective clinical validation study designs of genomic biomarkers.
Discuss prospective clinical validation of genomic biomarkers for decision making.
Describe the creation of a diagnostic test during or after drug development for clinical practice.
Recognize international approaches to use pharmaco-genomics for regulatory decision making during
clinical development.