New Approaches to Assessing Cardiac Drug Safety: Updates on ICH E14 and Moving Beyond Thorough QT Testing
Sponsored by: Covance
- Clinical Development
Date: 25 July
Time: 11AM EST
All small molecules with systemic bioavailability must conduct a study to assess that drug’s proarrhythmic liability during clinical development, usually before Phase III. Updated guidance from the International Conference on Harmonisation (ICH) now allows for specific Phase I data as a reasonable substitute for a Thorough-QT (TQT) dedicated trial. This presentation explores those options, the challenges, considerations and savings to both development costs and time.
Please join us for an interactive webinar with Dr. Plehn, Dr. Kleiman and Angela Hassman, to understand the ICH E14 updates including:
• The ICH E14 modifications
• New Option in Study Design
• How to potentially avoid a dedicated TQT trial
• What type of assets might qualify
• How this new guidance can be applied to your Phase I studies
Register now to learn how to be strategically prepared.
Jonathan F. Plehn MD, FACC,
Vice President, Cardiovascular Medicine, Covance Inc.; Clinical Professor of Medicine, Drexel University School of Medicine
Dr. Jonathan Plehn is Vice President of Cardiovascular Medicine at Covance Inc., a large contract research organization and Clinical Professor of Medicine at the Drexel University School of Medicine. Before joining the industry Dr. Plehn was director of heart failure programs at the National Heart, Lung and Blood Institute, National Naval Medical Center and the George Washington University Medical Center. His early work at the Framingham Heart Study involved epidemiologic assessment of diastolic heart failure and risk prediction. He has participated in the design, oversight and execution of trials ranging from pre-clinical studies to large cardiovascular outcomes trials. He has published over 140 articles, chapters and abstracts and is on the editorial board for the Journal of Cardiac Failure.
Robert Kleiman, MD,
Chief Medical Officer and Vice President, Global Cardiology
Dr. Robert Kleiman is a board certified cardiologist and cardiac electrophysiologist who has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman completed his training at the University of Pennsylvania and was a member of a cardiology practice for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer and Vice President, Global Cardiology. His responsibilities include oversight of ERT’s cardiology services, consulting with external clients and managing overall satisfaction of ERT’s global customers, including all aspects of ERT’s solutions.
Angela Hassman, BS,
Senior Clinic Director
Angela Hassman has more than 10 years of Phase I Clinical Operations experience with Covance. As Clinic Director, she is oversees all aspects of clinical study conduct and also provides feasibility and operational support to the commercial team. Prior to coming to Covance in 2006, Angela spent several years as a biochemist in drug discovery research for two large pharma companies. She holds a Bachelor’s degree in Biology from the University of Indianapolis.
Key Learning Objectives
- Learn more about the ICH E14 modifications
- Discover new options in study design
- Understand how to potentially avoid a dedicated TQT trial
- Identify how to apply this new guidance to your Phase I studies
- Clinical pharmacology operations
- Cardiovascular specialists
- Medical director