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Published by: SMI Publishing, Ltd
Published: Jan. 22, 2007
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Danshi Li, Senior Research Investigator, Bristol-Myers Squibb.
- Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca.
- 9.10 YOU DON'T GIVE DRUGS TO NORMAL PEOPLE!
- Electrocardiography in drug safety evaluation
- The difficulties in extrapolating safety data from a healthy animal model to a diseased person
- Is there an animal surrogate that is most likely to predict a toxic event in man?
- What parameters should we examine in pharmacology or toxicology safety studies?
- Interrogation of properties of the cardiovascular system that predict toxic events in persons: are QT and systemic arterial pressure enough?
- Are the regulatory agencies held to the same standard as the pharmaceutical industry?
- How many safe and effective drugs are kept off of the market because of aberrant preclinical signals?
- Robert Hamlin, Scientific Director, Q Test Labs.
- 9.50 CARDIAC SAFETY SURVEILLANCE AND RISK MANAGEMENT
- How do you ensure that your drug has no adverse cardiac effects?
- Designing efficient protocols
- Efficient time points
- Sample collection
- Reproducibility
- Reviewing all data from all stages of the study
- Adverse reporting strategies
- Site training and monitoring
- Dhiraj Narula, Clinical Cardiac Electrrophysiology, Medical Director, Quintiles.
- 10.30 Morning Coffee
- 11.00 CLINICAL LABORATORY ASSESSMENT
- Cardiac sympathetic innervation and function
- Physiological, pharmacologic, neurochemical, and neuroimaging approaches for assessing cardiac sympathetic innervation and function
- Compensatory cardiac sympathetic stimulation in heart failure
- Prognostic significance of abnormal cardiac sympathetic neuroimaging
- Cardiac toxicity of high catecholamine levels
- Drugs affecting adrenoceptor occupation in the heart
- Concepts of scientific integrative medicine, as applied to cardiac safety
- David Goldstein, Chief, Clinical Neurocardiology Section, CNP, DIR, NINDS, National Institutes of Health.
- 11.40 LATEST RESEARCH INTO THE MECHANISM OF CARDIAC ARRHYTHMIAS
- The hERG channel
- The role of the hERG gene in cardiac safety studies
- Mechanism of hERG channel leading to long QT syndrome
- Drug interaction with the HERG channel
- Drugs and HERG channel protein trafficking
- New research in cardiac safety testing
- Craig January, Chief Medical Officer, Cellular Dynamics International.
- 12.20 Networking Lunch
- 1.50 VALIDATING AND IMPROVING PRECLINICAL ARRHYTHMIA MODELS
- Traditional and novel models employed in cardiac safety studies
- What arrhythmia models are currently used? - discussing the porcine and rabbit hearts and others
- Limitations and advantages
- Assessing QT liability and TdP potentials
- Sensitivity and specificity
- Do these models provide a high predictive value?
- Potential models and future directions
- Latest research and results
- Wilhelm Haverkamp, Consultant Cardiology, Head of EP Lab, Charite University.
- 2.30 PANEL DISCUSSION
- Practical approaches to Cardiac Safety
- An overview of in vivo models
- Traditional and novel methodologies and technologies
- Limitations and application in cardiac safety evaluation
- Overcoming common and not so common pitfalls
- Robert Hamlin, Scientific Director, Q Test Labs.
- Michael Markert, Lab Head, Pharmacology, Boehringer-Ingelheim.
- Boaz Mendzelevski, Director, Cardiology, Cardiac Safety Services, Covance.
- Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca.
- 3.10 Afternoon Tea
- 3.40 ECG MEASUREMENT
- RR AND QT interval evaluation
- QT interval measurement
- QT/RR relationship
- QT/RR hysteresis and its implications
- Sample size and cost of thorough QT/QTc studies
- Marek Malik, Chairman, St Paul's Cardiac Electrophysiology.
- 4.20 ECG ACQUISITION AND ORGANISATION OF ECG DATA-POINTS
- Early clinical studies and thorough QT/QTc studies
- Possible recorders and recording technology
- Advantages of long-term ECG acquisition
- Definition to data-points and time-points
- Noise in the electrocardiograms and selection of samples for measurement
- Implications for QTc variability
- Marek Malik, Chairman, St Paul's Cardiac Electrophysiology.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca.
- 9.10 PROTOCOL DESIGN
- Designing the protocol for a Thorough QT Study
- Choosing the optimum design
- How many replicates to use
- Consideration of baseline measurements
- How many timepoints to choose
- Calculation of sample size
- Kalyan Ghosh, Director, Merck & Co Inc.
- 9.50 CARDIAC SAFETY OUTSOURCING
- Fresh approaches and new challenges
- Assessing the financial implications of the regulatory guidelines
- Current approaches to cardiac safety outsourcing
- Bridging the information gap
- Looking ahead
- Danshi Li, Senior Research Investigator, Bristol-Myers Squibb.
- John Sulola, Director, Macto Consulting Limited.
- 10.30 Morning Coffee
- 11.00 THE USE OF ELECTROCARDIOGRAMS (ECG'S) IN CLINICAL TRIALS
- Standard vs. continuous 12-lead ECGs
- Automated, semiautomated or manual measurements?
- Ease of analysis and reliability
- Corina Dota, ECG Centre Manager, Medical Science Sweden, AstraZeneca.
- 11.40 REPOLARISED-BASED CARDIAC RISK ASSESSMENT
- QT prolongation
- QT study design
- The ICH-E14 draft QT guidance document
- Regional variations and challenges
- Identifying requirements and novel methods
- Boaz Mendzelevski, Director, Cardiology, Cardiac Safety Services, Covance.
- 12.20 Networking Lunch
- 1.50 A POSITIVE THOROUGH QT STUDY
- Later stage development, labelling implications and post-marketing implications
- Consequences of a positive TQT
- Late stage development- implications and QT assessment
- Labelling issues
- Post-marketing issues
- Post-marketing risk management strategies
- Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca.
- 2.30 PRACTICAL CONSIDERATIONS FOR IMPLEMENTING E14 LEGISLATION IN CLINICAL TRIALS
- An Eli Lilly case study
- What to look out for when designing a QT study
- Choosing an appropriate positive control
- Collating all previous data in preparation for the trial commencement
- Overcoming the common and not so common pitfalls in following E14
- How to ensure successful submission
- Malcolm Mitchell, Director, BioPharmaceuticals, Eli Lilly & Company.
- 3.10 Afternoon Tea
- 3.40 ICH-57B GUIDANCE
- Debating the role of non clinical data
- What does this guidance mean?
- Defining legislation and ‘best practice’
- What challenges are you now faced with and how can you overcome these?
- Future steps
- Gerd Bode, ICH Topic Leader, BfArM (Federal Institute for Drugs & Medical Devices).
- Klaus Olejniczak, Scientific Director, BfArM (Federal Institute for Drugs & Medical Devices).
- 4.20 EMPLOYING COMPUTER MODELS TO PREDICT CARDIAC SAFETY
- Novel strategies in drug development
- What experimental data is required?
- What animal models to use?
- How to integrate/translate results from multiple assays
- Software that simulates cardiac electrical activity
- Identifying and recording proarrhythmic markers
- Ion channels
- Action potentials
- Wave propagation
- QT prolongation
- How robust and reliable are predictions?
- Jeffrey Fox, Vice President, Research, Gene Network Sciences.
- 5.00 Chairman’s Closing Remarks and Close of Day Two
AbstractThis is the essential event for companies to enable them to work effectively within the heightened scrutiny from regulatory authorities safety measures employed in clinical trials.
Don’t miss the opportunity to make certain your clinical trials are meeting regulations. Join your peers as they discuss the new legislation, novel methods and technologies that monitor cardiac responses effectively, how to design development studies and clinical trials that meet safety requirements, whilst remaining cost effective
Listen to an international selection of speakers, including:
- Dr Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca & Clinical Professor of Medicine, UMDNJ-New Jersey School of Medicine
- Malcolm Mitchell, Director, BioPharmaceutics, Eli Lilly*
- Dr Kalyan Ghosh, Director, Clinical Biostatistics, Merck
- Dr Corina Dota, ECG Centre Manager, Medical Science Sweden, AstraZeneca
- Dr Michael Markert, Lab Head, Pharmacology, Boehringer-Ingelheim
- Dr David Goldstein, Chief, Clinical Neurocardiology Section, CNP,DIR,NINDS, National Institutes of Health (NIH)
- Dr Dhiraj Narula MD, MRCP UK, FACC, Medical Director, Quintiles ECG Services
- Dr Boaz Mendzelevski, Director, Cardiology, Cardiac Safety Services, Covance
- Dr Klaus Olejniczak, Scientific Director, Federal Institute for Drugs & Medical Devices (BfArM)
This conference will provide an excellent opportunity for you to discuss:
- THE RIGHT parameters to examine in pharmacology or toxicology safety studies
- PRECLINICAL PIPELINES combating aberrant preclinical signals that negatively impact upon a safe drug
- INTEGRATING the latest technologies and protocols that aid monitoring and diagnosis
- EFFECTIVE STUDY DESIGN that lowers risk and costs
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