Conference on Phase I Clinical Trials Summit

Conference on Phase I Clinical Trials Summit
Strategies for improving Phase I trial design, management and execution
To be held at 28th – 29th October 2010, BSG Conference Centre, London, UK

Key Speakers

Dr. Eckhard von Keutz, Senior Vice President Head Global Early Development, Bayer Schering Pharma
Dr. Walter Janssens Coordinator Early Phase Development, FAGG/AFMPS
Corina Dota ECG Centre Manager, Medical Science Sweden, AstraZeneca
Dr. Fatiha Sadallah, Principal Scientifi c Manager, Innovative Medicines Initiative (IMI)
Dr. Andrea Laslop, Head of Institute Science and Information, AGES PharmMed
Rob Nichols, Director of Commercial Development, Phase Forward Europe
Dr. Finbarr Cotter Prof of Haematology, Medical Oncology, Barts and the London School of Medicine
Robert Blakie, Director, ERA Consulting
Dr. Assem S. el Baghdady, Director, Alpha Beta Pharma
Dr. Jennifer J. Wheler, Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer
Medicine, The University of Texas M. D. Anderson Cancer Center
Professor Atholl Johnston, Professor of Clinical Pharmacology, Barts and the London School of Medicine and
Dentistry, Queen Mary University of London
Dr. Dominic Williams, MRC Centre for Drug Safety Science, The University of Liverpool

Who should attend?

Vice/Presidents, Directors, Heads of:
• Clinical Operations • Clinical Research
• Clinical Development
• Exploratory Development
• Strategic Drug Development
• Clinical Trial Design
• Clinical Pharmacology / Pharmacometrics
• Quality Assurance / Quality Control • Pharmacokinetics/ Pharmacodynamics
• Project Management
• Regulatory Affairs
• Scientifi c Relations
• Statistical Methodology

Day 1
Phase I Clinical Trials Summit
Thursday 28th October 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 The use of biomarkers early in clinical development
• Biomarkers as go/no-go in early clinical development
• Do biomarkers worth the cost or the time?
• Can we use biomarkers in late clinical development too?
• What role do biomarkers play in the clinic?
Dr. Assem S. el Baghdady
Director, Alpha Beta Pharma
Formerly Medical Director R&D, Norgine

10:20 Exploring translatability from phase I to phase IIb
• Clarify different concepts of biomarkers
• Speed up the transition from Phase I to Phase IIb
• Integrative assessment of available data
• Designing biomarker studies efficiently for informative decision making in clinical development
• Illustrative example in diabetes
Dr. Arne Ring
Team Leader Biostatistics Phase I/IIa
Boehringer Ingelheim Pharma

11:00 Morning refreshments

11:20 Regulatory experience with exploratory clinical trials
• Critical issues in the trial application
- preclinical
- quality issues
- protocol related
• Experience in Belgium with exploratory clinical trials
Dr. Walter Janssens
Coordinator Early Phase Development
FAGG/AFMPS

12:00 Phase I clinical trials: beside to bench
Dr. Jennifer J. Wheler
Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine
The University of Texas M. D. Anderson Cancer Center

12:40 Networking lunch

13:40 Reducing the cost of clinical QT studies
• Relationship between the electrocardiographic precision and the study size
• Electrocardiographic methods to increase measurement precision
• Design implications for crossover and parallel studies
• Advantages of continuous ECG acquisition
• Optimum combinations of computerised and manual readings to reduce the cost of ECG analysis
Marek Malik
Professor of Cardiac Electrophysiology, Head, Noninvasive Electrocardiology
St. George’s, University of London

14:20 Evaluating the efficiency of design methods and implementing early clinical trials with novel therapeutics
• Determine dose and schedule
• Discuss continual reassessment methods
• Study specific target patient populations

15:00 Afternoon refreshments

15:20 Study design for Leukaemia therapy
• What does we mean by Phase I studies in the context of Leukaemia
• What are the goals
• How do we design the study
• How to we record and evaluate the trial
• What are added value studies
Dr. Finbarr Cotter
Prof of Haematology, Medical Oncology
Barts and the London School of Medicine

16:00 Update on ICH guidelines
• Review the guidelines
• Discuss the risk benefit
• Examine the regulatory requirements

16:40 Closing remarks from the chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
Phase I Clinical Trials Summit
Friday 29th October 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Preparing phase I clinical trials
• Early clinical trials methodology
• Principles of laboratory methodologies
• Reviewing preclinical data
Professor Atholl Johnston
Professor of Clinical Pharmacology, Barts and the London
School of Medicine and Dentistry
Queen Mary University of London

10:20 Understanding the importance of preclinical
studies for clinical success
• What has changed?
• What is necessary?
• Opportunities for better investigations
• Opportunities for cross-functional cooperation
Dr. Eckhard von Keutz
Senior Vice President, Head, Global Early Development
Bayer Schering Pharma

11:00 Morning refreshments

11:20 Clinical trials data management in phase I

12:00 The case for automating phase I clinical trials
• Understand the unique challenges for phase I clinical units and how these can be addressed by improved use of automated
solutions
• Appreciate the breadth of available solutions suitable for phase I
• Understand the key issue areas to consider when planning a
smooth implementation
Rob Nichols
Director, Commercial Development
Phase Forward Europe

12:40 Networking lunch

13:40 Translational medicine in Europe: Role of the innovative medicines initiative :IMI
• Public-private partnership in the health sector
• Building on strengths and tackling weaknesses in the EU
• IMI first two calls for proposals
Dr. Fatiha Sadallah
Principal Scientific Manager
Innovative Medicines Initiative (IMI)

14:20 Presentation to be announced
Dr. Andrea Laslop
Head of Institute Science and Information
AGES PharmMed

15:00 Afternoon refreshments

15:20 Cardiovascular risk profiling in early clinical development
• Role of preclinical testing for cardiovascular safety profiling
• What can be achieved in the early phase 1 studies?
• What are the technologies at hand to ensure quality and cost efficiencies in early clinical development
Corina Dota
ECG Centre Manager, Medical Science Sweden
AstraZeneca

16.00 Mechanism-based markers of murine drug-induced liver injury
• Paracetamol as a tool for translational hepatotoxicity
• Use of keratin-18 as a serum marker of apoptosis
• Use of High Mobility Group box-1 as a serum marker of necrosis
• Fed and fasted animal models in pre-clinical development
Dr. Dominic Williams
MRC Centre for Drug Safety Science, Dept.
Pharmacology & Therapeutics
The University of Liverpool

16:40 Chair’s closing remarks

16:50 End of conference

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