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[V2-S2] ICH E14: Update on Current Status and Future Directions of Cardiac Safety Assessment
Session Chair(s)
Boaz Mendzelevski, MD
Consultant Cardiologist
Cardiac Safety Consultants Ltd., United Kingdom
Drug-induced QT prolongation may lead to cardiac arrhythmia and sudden cardiac death, and has resulted in the withdrawal and non-approval of several drugs. The regulatory response to concerns regarding the cardiac safety of new drugs also led to the development of the ICH S7B (non-clinical) and ICH E14 (clinical) guidelines. The hallmark of the ICH E14 guideline is the Thorough QT (TQT) study. Recently, an early phase Intensive QT (IQT) clinical assessment, using exposure response (ER) modeling as its primary analysis, was advocated as an alternative to the TQT study and is currently under regulatory discussions. In a separate initiative, presently under development, the US FDA proposed a platform of non-clinical investigations, the ‘Comprehensive Pro-arrhythmia In vitro Assay’ (CiPA), as a replacement for the above guidelines. This session will provide an introduction to cardiac safety and an overview of the current and future clinical research and regulatory landscape in Japan and globally.
Speaker(s)
Drug-induced QT Prolongation: From Ion Channels and Cardiac Arrhythmia to Regulatory Guidance
Atsushi Sugiyama, MD, PhD
Toho University Faculty of Medicine, Japan
Professor and Chairman, Department of Pharmacology
The ICH E14 Guideline: Overview of its Status in Japan and Future Directions
Kaori Shinagawa, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist for Clinical Medicine, Office of New Drug II
QT Assessment in Clinical Drug Development: Are We There Yet?
Boaz Mendzelevski, MD
Cardiac Safety Consultants Ltd., United Kingdom
Consultant Cardiologist
Yuji Kumagai, MD, PhD
Kitasato University Hospital, Japan
Professor, Kitasato Clinical Research Center
Koki Nakamura, MD, PhD
Takeda Pharmaceutical Company Limited, Japan
Vice President, CVM Marketing, Japan Pharma Business Unit
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