Day One: Wednesday 19 May 2010
last modified: 10 May '10
Morning plenary
08.20
Opening remarks from Chair
Senior Vice President, Early Development Services, PRA International
08.30
The changing R&D process; the need to move from a linear model to highly interactive drug discovery and development
• Organisational models to support the interactive R&D concept
• Introduce novel methodologies
• Time to assess return on investment for biomarker strategies
Vice President Neuroscience & Ophthalmology Research & Development, Franchise Integrator, Merck Ltd
09.00
Keynote presentation: Organisational models for innovative research and development
• Informed decisions about new early development organisational models
• What are the ideal organisational models?
• Should the organisation be around functional capabilities?
Senior Vice President, Science Environment Development, GlaxoSmithKline EOOD
09.30
Speed networking and morning coffee
This is the revolutionary, exciting and non-pressurised way to meet fellow conference attendees and industry peers in one hour long session and it is a part of the formal conference agenda. As you ‘speed network’, the introductions you make will become the starting point for conversations and networking throughout the conference. This is where long-lasting and profitable business relationships begin. We strongly advise that you bring plenty of business cards and take advantage of this session to meet as may people as possible.10.30
New approaches in early clinical development
• Where we stand and where we are heading?
• Introducing the latest advanced approaches and technologies
• Cases / applications of combined approaches like IVMS BCS / IVIVC for efficient POC, FIM, and early clinical development
Principal Clinical Investigator, Medical Affairs and Clinical Development, GlaxoSmithKline EOOD
11.00
Using exploratory clinical trials in pharmaceutical discovery
• Summary of latest eCTA options as per ICH M3 (R2) 2009
• Regulatory and industry experience with eCTAs
• Impact of eCTAs on pharmaceutical pipeline attrition
Senior Director Safety Assessment, AstraZeneca
11.30
The fast track way to Proof of Concept – should you still use healthy volunteers if you can get patients?
• Fast track designs in practice
• Test tube approach vs. real clinical endpoints
• Increasing demand, where is the supply?
Senior Vice President, Early Development Services, PRA International
12.00
Lunch
12.55
Opening remarks from Dr Jochen Theis, Principal Physician & Principal Consultant, InHeCon
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last modified: 10 May '10
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