Conference on Phase I Clinical Trials Summit

Conference on Phase I Clinical Trials Summit Bharatbook

Conference on Phase I Clinical Trials Summit Bharatbook.com announces the inclusion of latest conference on "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 (http://www.bharatbook.com/detail.asp?id=136318&rt=Conference-on-Phase-I-Clinical-Trials-Summit. html) 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 file:///C|/Documents%20and%20Settings/user29/Deskto...e%20on%20Phase%20I%20Clinical%20Trials%20Summit.htm (1 of 6)7/27/2010 11:40:36 AM

Conference on Phase I Clinical Trials Summit Bharatbook

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

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Conference on Phase I Clinical Trials Summit Bharatbook

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

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Conference on Phase I Clinical Trials Summit Bharatbook

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 file:///C|/Documents%20and%20Settings/user29/Deskto...e%20on%20Phase%20I%20Clinical%20Trials%20Summit.htm (4 of 6)7/27/2010 11:40:36 AM

Conference on Phase I Clinical Trials Summit Bharatbook

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 For more information kindly visit http://www.bharatbook.com/detail.asp?id=136318&rt=Conference-on-Phase-I-Clinical-Trials-Summit. html OR Contact us at 207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.

Phone : +91 22 2757 8668 / 2757 9438 Fax : +91 22 2757 9131 E-mail : info@bharatbook.com Website : www.bharatbook.com Follow us on twitter: http://twitter.com/3bbharatbook Please visit our blog at http://bharatbookseo.blogsome.com file:///C|/Documents%20and%20Settings/user29/Deskto...e%20on%20Phase%20I%20Clinical%20Trials%20Summit.htm (5 of 6)7/27/2010 11:40:36 AM

Conference on Phase I Clinical Trials Summit Bharatbook

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