Day One, Tuesday 23rd March 2010, London, UK
09:00 Registration and refreshments
09:30 Chair’s opening remarks
Eddie Blair
Director
Integrated Medicines
09:40 Biomarkers in translational medicine
• Introduction
• Bio-sampling
• Lessons learned “Biomarkers discovery and clinical protocols’’
• Case study - functional studies and study design
• Summary
Hassan Rahmoune
Head of Translational Medicine & Discovery Biomarkers
University of Cambridge / Psynova
10:20 Providing integrated protein biomarker solutions for clinical trials
Christian Rohlff
CEO
Oxford BioTherapeutics
11:00 Morning refreshment & networking session
11:20 The application of biomedical informatics to biomarker development in the clinical setting
• Background to Biomedical Informatics in clinical drug development
• Modeling and Simulation for personalised Healthcare
• Integrating modelling and simulation into a clinical program
• Support for biomarker discovery, development and validation via data mining
• Case studies for both efficacy and safety
James Weatherall
Global Lead, Biomedical Informatics
AstraZeneca
12:00 Protein array technologies for biomarker discovery
• How to design a biomarker discovery study.
• Technology requirements for discovering biomarkers
• Types of protein arrays and their use in biomarker discovery
• Development and use of ProtoArrays
Niro Ramachandran
R&D Manager
Life Technologies
12:40 Lunch
13:40 Combining open platform and targeted approaches for protein biomarker discovery and development
• Analytical requirements for plasma protein biomarker discovery
• Study design and technology considerations for discovery and verification stages
• Bridging the gap between discovery and clinical implementation
• Case study: discovery and validation of novel plasma protein biomarkers for the diagnosis and management of heart failure
Huw Davies
Director, Business Development
Pronota
14:20 How biomarkers and pharmaceuticals interact as personalised medicines to create value for patients?
• Diagnostic value as leverage in companion diagnostic relationships
• Relative value of predictive and prognostic markers
• The role of stakeholder perceptions in the value proposition
• The cash value and market for companion pharmaceuticals and diagnostics
Eddie Blair
Director
Integrated Medicines
15:00 Afternoon refreshments & networking session
15:20 Integrating your biomarker into drug development: The importance of the EMEA/FDA qualification procedures
• Use of biomarkers from the pre-clinical and clinical drug development process; Case studies
• The importance of seeking agency input on the validity of your biomarker
• New biomarker qualification procedures in Europe and the US
• Why does going through the qualification procedure make sense?
Patricia Hurley
Head of Project Management & Head of Biomarkers Division
ERA Consulting UK
16:00 Chair’s closing remarks
16:10 Networking drinks
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