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This 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

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Danshi Li

Danshi Li, Senior Research Investigator, Bristol-Myers Squibb

Philip Sager

Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca

9:10 YOU DON'T GIVE DRUGS TO NORMAL PEOPLE!

Robert Hamlin

Robert Hamlin, Scientific Director, Q Test Labs

·                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?

9:50 CARDIAC SAFETY SURVEILLANCE AND RISK MANAGEMENT

Dhiraj Narula

Dhiraj Narula, Clinical Cardiac Electrrophysiology, Medical Director, Quintiles

·                Designing efficient protocols
o         Efficient time points
o         Sample collection
o         Reproducibility
·                Reviewing all data from all stages of the study
·                Adverse reporting strategies
·                Site training and monitoring

10:30 Morning Coffee

11:00 CLINICAL LABORATORY ASSESSMENT

David Goldstein

David Goldstein, Chief, Clinical Neurocardiology Section, CNP, DIR, NINDS, National Institutes of Health

·                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

11:40 LATEST RESEARCH INTO THE MECHANISM OF CARDIAC ARRHYTHMIAS

Craig January

Craig January, Chief Medical Officer, Cellular Dynamics International

·                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

12:20 Networking Lunch

13:50 VALIDATING AND IMPROVING PRECLINICAL ARRHYTHMIA MODELS

Wilhelm Haverkamp

Wilhelm Haverkamp, Consultant Cardiology, Head of EP Lab, Charite University

·                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

14:30 PANEL DISCUSSION

·                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
Michael Markert

Michael Markert, Lab Head, Pharmacology, Boehringer-Ingelheim

Philip Sager

Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca

Robert Hamlin

Robert Hamlin, Scientific Director, Q Test Labs

Boaz Mendzelevski

Boaz Mendzelevski, Director, Cardiology, Cardiac Safety Services, Covance

15:10 Afternoon Tea

15:40 ECG MEASUREMENT

Marek Malik

Marek Malik, Chairman, St Paul's Cardiac Electrophysiology

·                QT interval measurement
·                QT/RR relationship
·                QT/RR hysteresis and its implications
·                Sample size and cost of thorough QT/QTc studies

16:20 ECG ACQUISITION AND ORGANISATION OF ECG DATA-POINTS

Marek Malik

Marek Malik, Chairman, St Paul's Cardiac Electrophysiology

·                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

17:00 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Philip Sager

Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca

9:10 PROTOCOL DESIGN

Kalyan Ghosh

Kalyan Ghosh, Director, Merck & Co Inc

·                Choosing the optimum design
·                How many replicates to use
·                Consideration of baseline measurements
·                How many timepoints to choose
·                Calculation of sample size

9:50 CARDIAC SAFETY OUTSOURCING

  • Assessing the financial implications of the regulatory guidelines
  • Current approaches to cardiac safety outsourcing
  • Bridging the information gap
  • Looking ahead 
  • Danshi Li

    Danshi Li, Senior Research Investigator, Bristol-Myers Squibb

    John Sulola

    John Sulola, Director, Macto Consulting Limited

    10:30 Morning Coffee

    11:00 THE USE OF ELECTROCARDIOGRAMS (ECG'S) IN CLINICAL TRIALS

    Corina Dota

    Corina Dota, ECG Centre Manager, Medical Science Sweden, AstraZeneca

    ·                Standard vs. continuous 12-lead ECGs
    ·                Automated, semiautomated or manual measurements?
    ·                Ease of analysis and reliability

    11:40 REPOLARISED-BASED CARDIAC RISK ASSESSMENT

    Boaz Mendzelevski

    Boaz Mendzelevski, Director, Cardiology, Cardiac Safety Services, Covance

    ·                QT study design
    ·                The ICH-E14 draft QT guidance document
    ·                Regional variations and challenges
    ·                Identifying requirements and novel methods

    12:20 Networking Lunch

    13:50 A POSITIVE THOROUGH QT STUDY

    Philip Sager

    Philip Sager, Executive Director, Global QT Strategy Leader & Medical Science Director, Cardiovascular Development, AstraZeneca

    ·                Consequences of a positive TQT
    ·                Late stage development- implications and QT assessment
    ·                Labelling issues
    ·                Post-marketing issues
    ·                Post-marketing risk management strategies

    14:30 PRACTICAL CONSIDERATIONS FOR IMPLEMENTING E14 LEGISLATION IN CLINICAL TRIALS

    Malcolm Mitchell

    Malcolm Mitchell, Director, BioPharmaceuticals, Eli Lilly & Company

    ·          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

    15:10 Afternoon Tea

    15:40 ICH-57B GUIDANCE

    ·                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
    Klaus Olejniczak

    Klaus Olejniczak, Scientific Director, BfArM (Federal Institute for Drugs & Medical Devices)

    Gerd Bode

    Gerd Bode, ICH Topic Leader, BfArM (Federal Institute for Drugs & Medical Devices)

    16:20 EMPLOYING COMPUTER MODELS TO PREDICT CARDIAC SAFETY

    Jeffrey  Fox

    Jeffrey Fox, Vice President, Research, Gene Network Sciences

    ·                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?

    17:00 Chairman’s Closing Remarks and Close of Day One

    +

    Workshops

    Therapeutic Risk Assessment Strategies (AM)
    Workshop

    Therapeutic Risk Assessment Strategies (AM)

    The Hatton, at etc. venues
    24th January 2007
    London, United Kingdom

    Beyond E14: Practical Approaches to Cardiac Safety Evaluation
    Workshop

    Beyond E14: Practical Approaches to Cardiac Safety Evaluation

    The Hatton, at etc. venues
    24th January 2007
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

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    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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