Meet our speakers
Chief Scientific Officer, Global Product Safety,
Eli Lilly & Co
Dr. Beasley’s internship was in the Department of Psychiatry, Yale University and he completed his training in psychiatry at the University of Cincinnati in 1987. He immediately joined Eli Lilly and Company in the area of clinical development of psychiatric medications. He was responsible for Prozac from the time of its US launch through 1991 working extensively on the topic of the potential for SSRI medications to induce suicidality. During this period of time he was also responsible for the development program for atomxetine as an antidepressant (program terminated) during which he developed a particular interest in placebo response and trial design. From 1991 through 2001 he was responsible for the development of Zyprexa as a treatment for schizophrenia. From 2001 through 2002 he served as Medical Director for Cialis. Since 2003 he has served as a consultant across all therapeutic areas in both experimental design and safety, initially from a position in the Neuroscience area and since 2004 in Global Patient Safety. He has particular interest in three areas of safety: suicide; hepatic dysfunction; and delay in ventricular repolarization and the design of “Trough QT Studies”.
During his 20 years in industry with Lilly he has authored over 80 peer reviewed publications. He is an inventor on eight patents of Lilly products. He has extensive experience interacting with multiple divisions of the FDA, European regulatory authorities, and Japanese regulatory authorities. He is a member of AOA, the American Psychiatric Association, the American Society for Clinical Psychopharmacology, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the American Federation for Clinical Research. He is also a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom and the American Academy of Pharmaceutical Physicians.
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Dr Alexander Breidenbach, Global Coordinator, Safety Pharmacology,
F. Hoffmann - La Roche Ltd
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ECG Centre Manager, Medical Science Sweden,
AstraZeneca
M.D. with 11 years of clinical research and management experience in the field of safety biomarkers of pro-arrhythmia, digital ECGs and use of computerised systems in dECG analysis at AstraZeneca in Sweden. Currently provides scientific expertise and leadership for the AstraZeneca ECG Centre in Molndal, Sweden and is co-chair of AstraZeneca´s QT/Arrhythmia Review Group.
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Preclinical Cardiosafety Expert,
Novartis Pharma AG
Bérengère Dumotier completed her PhD in 1999 in the University Hospital in Lille, France (CHU, laboratory of Pharmacology, Pr. B. Dupuis). She was hired in Novartis Pharma AG in 1999 and established an in vitro cardiac safety laboratory in Preclinical Safety Department. She is currently leading a research program focusing on electrophysiological signature for torsadogenic drugs.
Since 2005, she is a preclinical cardio-safety expert responsible for the global assessment of the preclinical cardiosafety data within the Cardiac Advisory Team. She gives expert statements to project teams and the integrated Safety Assessment group with regard to cardiac safety issues. She is a core member of the safety pharmacology steering committee. She also contributes to the global co-ordination of the cardiosafety pharmacology activities in Novartis, including relationship with clinical cardiovascular assessment group and participates to the development of a computerized based system of heart model.
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Group Head Biostatistics, Cardiovascular,
Novartis Pharma AG
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Senior Group Leader, Integrative Pharmacology,
Abbot Laboratories
Gary Gintant is Senior Group Leader in the Dept. of Integrative Pharmacology, Global Pharmaceutical Research and Development, Abbott Laboratories, where he heads the Early Preclinical Studies Group. He is actively involved in various cardiac risk assessment / QT interval committees (including the ILSI/HESI Cardiovascular Risk Assessment Committee and Abbott QT Working Group) and has served on various NIH study sections and as advisor to the National Institutes for Drug Abuse regarding cardiac toxicity. Gary also reviews for numerous cardiovascular journals, and is a member of the Editorial Advisory Board for JPET. Research interests are centered on cardiac electrophysiology, ion channels, arrhythmias, and cardiovascular pharmacology, with numerous publications. He gained his M.A., M.Phil. and Ph.D. degrees from Columbia University (College of Physicians and Surgeons) and was a member of the Depts. of Cardiology and Pharmacology at Wayne State University School of Medicine prior to joining Abbott. Gary is a member of the Safety Pharmacology Society, Biophysical Society, a Fellow of the American Heart Association, and an Associate Research Fellow of the Volwiler Society.
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Director Pharmacology RDP/GP,
Nycomed Gmbh
Guido Hanauer currently works in the research unit of Nycomed GmbH as Director of Pharmacology. He studied Veterinary Medicine at the University of Giessen, Germany, as well as at the University of Illinois, Urbana, Il. He gained his DVM and PhD degrees from University of Giessen and his board certification in Pharmacology and Toxicology in 1991. After his PhD he joined Byk Gulden, Konstanz, as Laboratory Head in Safety Pharmacology. Thereafter, he was a member of the Department of Inflam-mation research as well as of the Department of Gastroenterology. Guido worked in different development groups, i.e. for Pantoprazole (Protonix®) or Phase I to Phase III products in the field of gastroenterology and inflammation. In 1992 he was appointed group leader in the field of Gastroenterology and Animal welfare. In 1999 he was appointed Head of Safety Pharmacology and set up a group of scientist working in electrophysiology, receptor-pharmacology and in vivo experiments in different species. After the take over of Nycomed he is responsible as Director of Pharmacology for the transfer of the pharmacology unit from Konstanz to Hamburg, where a new center of excellence for in vivo research has been set up. Guido has a list of 40 publications and presentations and is member of several scientific societies.
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Principal Scientist, Safety Pharmacology,
Roche
Henry Holzgrefe. Wissenschaftliche Expert. Currently, Group Head of Cardiovascular Safety Pharmacology for F. Hoffmann-La Roche in Basel, Switzerland, responsible for the preclinical in vivo assessment of potential cardiovascular liabilities for novel therapeutic compounds. Over twenty-seven years of international drug-development experience within the pharmaceutical industry. Member of the Board of Directors of the Safety Pharmacology Society. Lifelong research interests have been focused in the field of cardiovascular physiology, with recent emphasis on the accurate detection and quantification of the QT interval. His novel findings regarding the nature of the QT interval and its accurate assessment have been the subject of 3 separate publications during the past year.
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Professor Mitchell Krucoff MD FACC, Professor Medicine / Cardiology,
Duke University Medical Center, Chairman, Cardiac Safety Research Constorium
In 1988 Dr. Krucoff joined the cardiology faculty at Duke University Medical Center where he remains to this date. He is currently fully tenured as a Professor of Medicine/Cardiology, member of the Duke Senior Interventional Cardiology Staff and Director of the Cardiovascular Devices Unit at the Duke Clinical Research Institute (DCRI). Dr. Krucoff served for as Director of the Cardiovascular Laboratories at the Durham VA Medical Center for 12 years. He is a special government employee of the United States FDA, and served as a member of the Circulatory Devices Panel, Center for Devices and Radiological Health at FDA, for 6 years. Dr. Krucoff is the founder and Director DCRI eECG Core Laboratories, the largest academic electronic ECG Core Laboratory in the world. In exploring new healing paradigms complementary to modern high tech medical practices Dr. Krucoff has served on the Board of Directors of the Sri Satya Sai Institute of Higher Medical Sciences in Puttaparthi, India since 1990. He is past Editor In Chief of Larry Dossey’s Alternative Therapies in Health and Medicine, is currently Senior Editor of the peer review Journal of Alternative and Complementary Medicine, and recently published the book Integrative Cardiology from McGraw Hill. Areas of clinical and research activities and publications include strategies of elective and acute coronary revascularization, high risk revascularization, diagnosis and interventions in acute coronary syndromes, silent and symptomatic myocardial ischemia and complementary therapies and spirituality applications in high tech cardiovascular care.
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Medical Safety Assessment, Global Pharmaciovigilance and Epidemiology,
Bristol-Myers Squibb Pharmaceutical Research Institute
Dr. Danshi Li has a PhD degree from cardiac electrophysiology and a degree of medicine (MD). She is currently an Associate Medical Director in Cardiovascular/Metabolics group at Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb Pharmaceutical Company. She has 5-year medical practice experience in the field of cardiology, 7-year experience in cardiovascular safety pharmacology, and 10-year’s research experience in the field of cardiovascular diseases from academia and industry. Her scientific career has been dedicated to cardiac arrhythmias, cardiac ischemia and other cardiac diseases, with emphasis on cardiac electrophysiologic functions, such as ion channel functions, cardiac depolarization, repolarization and conduction. Her scientific interests include acquired and inherited long QT syndrome, atrial fibrillation, and drug safety evaluation. She has published more than 30 articles in top journals of cardiology including Circulation and Circulation Research. She has been invited as a guest speaker at American Heart Association Annual Scientific Session (AHA) and at annual conference of cardiac electrophysiology of European Society of Cardiology (Europace). She is currently a member of Heart Rhythm Society and a reviewer of the Heart Rhythm Journal. She is also a member of American Heart Association and American Cardiac Electrophysiology Society.
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Director of Clinical Pharmacology,
AstraZeneca
Dr. Jianguo (James) Li earned a B.Sc. degree in mathematics and statistics first but later he changed his career pursuit to clinical pharmacology and clinical pharmacokinetics and earned M.Sc. and PhD degrees in Pharmacokinetics. Before joining the pharmaceutical industry, he worked as a post-doctoral fellow at the Center for Drug Development Science, Georgetown University Medical Center with professor Carl Peck (the former Director of Center for Drug Evaluation and Research, US Food and Drug Administration), and Dr. Joga Gobbburu (the current Director of the FDA Pharmacometrics) on the use of population PK/PD modeling and clinical trial simulation to help drug development. Dr. Li worked as a Senior Research Investigator at the Department of Clinical Pharmacokinetics, Pfizer Global R&D, USA, an Associate Director of Clinical Pharmacology, AstraZeneca R&D, USA, and a Director of Strategic Modeling and Simulation, Bristol-Myer Squibb Co. Dr. Li is currently a Director of Clinical Pharmacology & DMPK of AstraZeneca in Wilmington, USA. He has been conducting research on the use of population PK/PD modeling and clinical trial simulation approaches to estimate individual correction factor, characterize the relationship between QT/QTc interval
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Director, Cardiovascular Therapeutic Area,
Quintiles Transnational Corp.
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Professor of Cardiac Electrophysiology,
University of London
Marek Malik is presently Professor of Cardiac Electrophysiology at the University of London, Head of Non-invasive Electrophysiology Unit at St. George's, and Chairman of St Paul's Cardiac Electrophysiology in London. His research interests include electrocardiography and computerised ECG processing, acquired long QT syndrome and assessment of drug-induced changes in cardiac repolarisation including the drug-induced QTc changes. Among others, he is a Fellow of American College of Cardiology, European Society of Cardiology, and Heart Rhythm Society. In his field, he authored 11 monographs and textbooks, and more than 350 articles in peer-review journals. He also served on a number of academic task forces.
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Senior Consultant Early Clinical Development,
SGS Life Sciences
Alain Mignot is currently Senior Consultant to Early Clinical Development at SGS Life Science Services. He holds a Ph.D (Pharm.) in Medicinal Chemistry from the University of Paris XI, France. During his 20 year professional career in a leading CRO he acquired diverse skills and competencies in clinical research and drug development with emphasis on human pharmacology of new compounds.
As a Senior Consultant, Dr Mignot provides scientific and regulatory advice on analysing preclinical package to support exploratory and conventional Phase 1 and 2 clinical studies including the risk assessment approach. He also provides advice on investigational medicinal product dossiers and investigator brochures. To date he authored or contributed to more than 85 publications.
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Head of Genetic and Reproduction Toxicology Unit,
Federal Institute for Drugs and Medical Devices (BfArM)
Klaus Olejniczak is a graduate in Veterinary Medicine. Since 1983, he has been working as a Scientific Director in the German Federal Institute for Drugs and Medical Devices (BfArM), and he is head for the “Geno – and Reproductive Toxicity” Unit. Since 1988 he has been a member of several expert groups, e.g. in the CHMP Safety Working Party. He acts as a toxicological expert for 'Certification of Suitability to the Monographs of the European Pharmacopoeia' and for WHO as Temporary Adviser for Preclinical Testing Strategy. At ICH, he serves as EU Topic Leader for several topics (e.g. Safety Pharmacology, CTD – Safety, and Non-clinical Anticancer Drug Development).
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Senior Principal Scientist,
AstraZeneca
Chris Pollard is a Senior Principal Scientist at AstraZeneca, he has responsibility for in vitro electrophysiology in Global Safety Assessment, and is based at Alderley Park in Cheshire. He has 25 years experience in electrophysiology, the last 18 years of which have been within the pharmaceutical industry (Fisons, Astra and AstraZeneca). His industrial career was initially focused on ion channel drug discovery in the context of respiratory and inflammatory diseases but more recently has changed emphasis to consider the safety implications of ion channel modulation.
He attained a first class honours degree in physiology at Sheffield University (1983) and remained in Sheffield to complete a PhD about the effect of anaesthetics on neuronal discharge patterns in the cerebral cortex. Before moving into the pharmaceutical industry, he did post-doctoral research at St George’s Hospital Medical School, London, investigating ionic currents in the visual part of the thalamus, and at Newcastle University Medical School studying defective chloride channel activity in cystic fibrosis.
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Phase I - Iia Statistics,
Boehringer Ingelheim Pharma GmbH
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Chief Medical Officer,
CardioDX, Inc
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Senior Scientific Advisor, Therapeutics Products Directorate,
Health Canada
Dr. Colette Strnadova is a senior scientific advisor with the Therapeutic Products Directorate of Health Canada. Her professional responsibilities include review of drug submissions undergoing the reconsideration process, ECG assessment study consultations, and regulatory guideline development. Dr. Strnadova served as the Health Canada representative on two International Conference on Harmonisation (ICH) guideline projects: the ICH S7B guideline, which deals with the assessment of the potential for delayed ventricular repolarization in safety pharmacology studies, and the ICH E14 guideline, which deals with the assessment of QT/QTc interval prolongation liability in clinical trials. Dr. Strnadova currently serves on the ICH E14 Implementation Working Group. She has also developed Health Canada guidance documents on the analysis and review of QT/QTc data and Product Monograph content for drugs with QT/QTc prolongation liability.
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Managing Director,
Richmond Pharmacology Ltd
Dr. Jörg Täubel FFPM MD, Managing Director at Richmond Pharmacology Ltd, has been involved in excess of 400 Phase I and early Phase IIa studies in patients and healthy volunteers, either as Chief-, Principal or Co-Investigator. His extensive experience in drug development includes the design, conduct, management and analysis of numerous QTc studies. Dr. Täubel and his cardiac team at Richmond Pharmacology conduct QTc studies in partnership with the Cardiologist, Professor A.J.Camm BSc, MD, FRCP, Head of the Department of Cardiac & Vascular Sciences at St George's University of London under one roof. Based on his successful track record in the design and conduct of QTc studies, Jörg will be chairing Day 2 which looks closely at various aspects of the industry’s need to conduct successful QTc studies.
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Reserve an exhibition stand at the Safety Pharmacology World Europe exhibition - book early to ensure optimum stand placement!
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Reserve a stand
For details contact
James Hopkins
+44 207 608 7038 |
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