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The 6^th Annual Phase I Clinical Trials Conference Day 2: Conference schedule, 15^th June 2005

Time	Stream A	Stream B
9:00	Registration and coffee
9:30	Opening remarks from the chairs
	Stream A – Biomarkers I	Stream B – Biomarkers II
9:40	Evaluating Human Microdosing: results from the CREAM trial Dr Willem Jan Drijfhout Chief Scientific Officer, Pharma Bio Research	Showcasing Recent Work on “Wet Biomarkers”
10:20	Case Study: Biomarker Modulation in Rheumatoid Arthritis Dr Stefan Simianer Therapeutic Area Director, Rheumatology, Boehringer Ingelheim Canada	Early Phase clinical trials: Re-evaluating the boundaries between Phase I & II Dr Jörg Täubel Managing Director, Richmond Pharmacology Ltd
11:00	Networking coffee break
	Stream A – Imaging	Stream B – Cardiac Safety
11:20	The Value of Imaging? Ensuring Return On Investment with Novel Imaging Technologies Dr Bill Vennart Site Head, Clinical Technology, Pfizer Global R&D	Examining the detail of the ICH E14 Step 3 Document on Cardiovascular Safety Assessment: Due April 2005 Dr Rashmi Shah Pharmaceutical Industry Consultant, Formerly EMEA/MHRA EMEA Rapporteur
12:00	An Imaging Modality to Translate Biomarkers into Reality; fMRI Dr Liqun Wang Global Head, Imaging, Novartis Pharmaceuticals	Latest Considerations and Successful Approaches to the Design of a Thorough QT Study Dr Jean-Louis Pinquier Head, Clinical Discovery & Human Pharmacology, Sanofi-Aventis France
12:40	Lunch
14:10	Novel Technology: AstraZeneca on Hyperspectral Scanning Dr Paul Newbold Research Scientist, Experimental Medicine, AstraZeneca R&D	Novel Approaches to Data Analysis and Presentation for Regulatory Approval Dr Boaz Mendzelevski Director, Covance Central Diagnostics
14:50	Latest Advances and Applications for Positron-Emission Tomography (PET) in Specific Therapeutic Areas Professor Bengt Langstrom Invited Chief Scientific Officer, Imanet	The Genetic Background of Pro-Arrhythmia and Long QT Syndrome
15:30	Networking coffee break
16:00	Deciding Whether to Outsource Imaging in Early Development	Beyond the QT Interval: Broader Aspects of Cardiac Safety Compliance Dr Borje Darpo Vice President Late Strategy Leader, Daiichi Medical Research
16:40	Discussion session: Beyond the QT Interval: What are Industry and Regulatory Commitments to Continuing Cardiac Safety Assessment in all Necessary Forms into the Post-Approval Phase?
18:00	Closing remarks from the Chairs
18:10	End of day two

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Richmond Pharmacology
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2005
6th Annual Phase I Clinical Trials Conference
Day 2: Conference

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