Stream 1: APPLICATION OF BIOMARKERS IN EARLY DEVELOPMENT (OR)
last modified: 10 May '10
12.55
Opening remarks from Dr Jochen Theis, Principal Physician & Principal Consultant, InHeCon
13.00
Biomarkers in drug development
• How biomarkers can be used to determine Proof of Mechanism
• Translational biomarkers
• Biomarkers to enable increased efficacy and decreased adverse events
Biomarker Expert, Roche
13.30
Biomarkers as an efficacy endpoint in clinical development
• Need for biomarkers to guide dose selection
• Need for biomarkers to enhance benefit-risk assessment
• Biomarkers for internal decision making vs regulatory purposes
• Biomarker qualification
Clinical Program Director, UCB Group, Schwarz BioSciences GmbH
14.00
Validating biomarkers for effective clinical development
• The desired properties of biomarkers and how these can be assessed
• Using pre-clinical data from in-vitro systems and samples from undosed volunteers to increase the robustness of biomarkers in the clinic
• The implications of these inputs for the design of the clinical programme
Technical Lead Statistician, AstraZeneca
14.30
Early development standards for global drug development
• FDA Critical Path Initiatives pertaining to clinical trial design – biomarkers and streamlining clinical trial designs
• Key variables in early clinical trials on which national reviewing agencies may differ
• The role of pre-IND consultation and scientific advice
• Case study
Director of Regulatory Affairs, Americas, Chiltern International
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last modified: 10 May '10
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