The ICH E-14 Thorough QT study is essentially mandated for drug approval. However these studies are expensive and are usually performed late in Phase II or in Phase III, after many subjects have been exposed to an undefined repolarization risk. Furthermore, using the E-14 approach, a Sponsor will not learn of a drug’s QT liability until after a large expenditure of money and personnel effort.
A better assessment of QT liability can be achieved early in the drug development cycle, at lower cost to the Sponsor and lower risk to the subject. The strategy to achieve these goals will be discussed by the experts in this webinar.
Dr. Jay Mason, Chief Medical Officer, Spaulding Clinical Research
Jay W. Mason, M.D., is a world-renowned cardiac drug safety expert with 35+ years of experience in cardiac care and research. He graduated from Princeton and obtained his MD degree from the University of Pennsylvania. He also trained in Medicine and Cardiovascular Diseases at Stanford University where he was a member of the faculty from 1975-83. He was Chief of Cardiology at the University of Utah from 1983-99 (where he still serves as a faculty member) and served as Chairman of the Department of Medicine at the University of Kentucky from 1999-2003.
Dr. Mason’s clinical, teaching and research emphasis is in cardiac arrhythmias and electrophysiology. He has authored over 400 publications and has served on the National Research Review Committees for the NIH and the American Heart Association. He has also served on several editorial boards, including the American Journal of Cardiology, Circulation, Annals of Internal Medicine, American Journal of Medicine, and the Journal of the American College of Cardiology.
Dr. Charles Benson, Eli Lilly and Company and E14 Implementation Working Group Member
Dr. Benson is a Medical Fellow with Eli Lilly & Co. He received a B.S. from Massachusetts Institute of Technology (M.I.T.) before attending Indiana University, where he received a M.D. and a Ph.D., the latter in Physiology and Biophysics. He then completed a residency in Internal Medicine at the Scripps Clinic, La Jolla, California.
Dr. Benson joined Eli Lilly and Company in 2000 and has focused on early phase drug development and clinical pharmacology for the majority of his career. He is recognized for his leadership and expertise in quantitative approaches to early drug development, including work on advancing the field of prediction of arrhythmias through the measurement of the QT interval. He is currently a member of the IQ QTc Working Group, the OQT—Optimizing TQT Studies Through PK-PD working group, and ICH E14 Implementation Working Group, as well as other efforts to further our understanding of measurement of the QT interval.
Daniel Selness, Sr. VP and GM of Clinical Research, Spaulding Clinical Research
Daniel Selness is a research executive with over 19 years of experience in operational management of clinical research, with 15 years focused on Phase I trials, from both the Phase I unit and the Pharmaceutical Sponsor standpoint.
Who Should Attend?
Senior level executives involved in Early Clinical Development for Bio/Pharmaceutical companies. This presentation will especially benefit those working in Phase I, Phase II or cardiac safety.
Spaulding Clinical Research, LLC (www.spauldingclinical.com) provides Clinical Pharmacology, Cardiac Core Lab clinical research services, and is a medical device manufacturer. Spaulding Clinical operates a 155-bed clinical pharmacology unit with 96-beds of telemetry in West Bend, Wisconsin, USA. The facility is paperless, with a Phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core ECG Laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services with state-of-the-art technologies, including the proprietary Spaulding Model 1000iQ Electrocardiograph, expert cardiologists and project managers.