10th Annual Phase I Clinical Trials
Olympia Conference Centre
Hammersmith Road
London, W14 8UX, UK
10th Annual Phase I Clinical Trials
Olympia Conference Centre
Hammersmith Road
London, W14 8UX

Schedule of Presentations:

Tuesday, February 10, 2009
08:00:00 Coffee and registration
08:50:00 Keynote sessions: A thorough update on key regulatory and industry challenges
08:50:00 Opening remarks from the Chair
09:00:00 A thorough analysis of the new ICH pre-clinical safety guidelines – how will these influence the registration and execution of Phase I trials? David Jones
09:40:00 Regulatory perspective on the pre-clinical data required for Phase I approval - gaining greater control though translational medicine Walter Janssens
10:20:00 Industry perspective: How to effectively deliver the preclinical data now required for regulatory submission Karen Cornelissen
10:50:00 Morning Tea
11:30:00 Assessing the potential for personalised medicine in Phase I – how to identify markers to enrich respondents Gordon Duff
11:30:00 Opening up new opportunities in exploratory innovation
12:10:00 How patients and biomarkers provide you Proof of Concept Willem Jan Drijfhout
12:40:00 Lunch
14:30:00 Perfecting trial design in exploratory clinical development Ian Wilding
14:30:00 Tools and techniques for accelerating exploratory development
14:30:00 An investigation into the potential benefits and challenges of using microdosing Stefano Persiani,
14:30:00 Optimising QT study design to reduce overall drug development costs Chair: Borje Darpo MD PhD, Pharmaceutical Consultant, formerly Vice President, Chief Medical Officer, Daiichi Medical Research, UK and USA Borje Darpo
14:30:00 Assessing QTc Data in Drug Submissions: A Regulatory Perspective Colette Strnadova
14:30:00 Comparing and contrasting European and FDA guidelines on risk mitigation in FIM studies Anthea Cromie
15:00:00 New thinking in overcoming FIM dosing challenges James Dow
15:00:00 Case study: An examination of limitations and potential of PK/PD modelling Johanna Mäkelä
15:00:00 Overcoming the Challenges of QT studies with Novel Oncology Compounds Gary A. Gintant
15:30:00 Optimum ECG data collection, measurement, and rate and hysteresis correction Marek , Malik
15:30:00 Successful strategies for handling statistical aspects of Phase I and Proof of Concept Georg Ferber,
15:30:00 Spotlight session
16:00:00 Afternoon Tea
16:00:00 Afternoon Tea
16:00:00 Afternoon Tea
16:40:00 Fast into man by accelerating CMC Ian Wilding
16:40:00 Implementing Statistical Analysis of a Thorough QT Trial: Feedback based on contributions from the Journal of Biopharmaceutical Statistics, industry and the FDA Georg Ferber,
16:40:00 Dealing with safety issues for new oligonucleotides – an investigator’s and Sponsor’s perspective
17:10:00 Assessing the Latest Research into Designing a Thorough QT Study Borje Darpo
17:10:00 Novartis case study on optimising clinical trial design Frank Bretz
17:10:00 Spotlight session
17:40:00 Tools for achieving proof of mechanism/principle quickly and safely Caroline Dive
17:40:00 Managing ventricular Arrhythmia in First-in-Man (FIM) Studies Adel Nada
17:40:00 Failing early and failing cheaply: Creating stop-go points for efficient compound attrition Paola Tocchetti,
18:10:00 End of conference day one
Wednesday, February 11, 2009
09:00:00 Opening remarks from the Chair
09:10:00 Getting to grips with the European Commissions’ Innovative Medicines Initiative Ian Ragan
09:50:00 MHRA perspective on the changing expectations for Phase I applications Andrew French
10:30:00 Morning Tea
11:10:00 Designing efficient Phase I studies Mario Tanguay
11:40:00 Robust strategies for ensuring Phase I GCP compliance Ernesto Vera-Sánchez,
12:00:00 New Presentation
12:00:00 New Presentation
12:20:00 European regulators panel discussion: what do clinicians need to prepare for when submitting Phase I applications Europe wide? Andrew French
12:40:00 Lunch
14:10:00 Operational strategies for improving Phase I Trials management
14:10:00 Practical challenges and key potential of executing Phase I trials in India Rasendrakumar Jha
14:10:00 Perfecting trial design in exploratory clinical development (cont.)
14:10:00 Safety Specifications and Risk Management of Medicines Saad Shakir
14:40:00 Optimising the effectiveness of ADME studies in exploratory development Stefano Persiani,
14:40:00 Achieving significant cost reduction through innovative Phase I outsourcing Susanne Kihlblom
15:10:00 Afternoon Tea
15:10:00 Afternoon Tea
15:50:00 Practical guide to running a successful trial for paediatric populations Assem S el Baghdady
15:50:00 New approaches for effectively managing complex Phase I trials Harsukh , Parmar
16:20:00 New directions for improving education and training for Phase I professionals Susanne Kihlblom
16:20:00 Selecting the correct starting dose for FIM antibody studies Peter Lloyd
17:00:00 Close of conference
3D Tissue Models
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