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[V8-S2] Update on Current Status and Future Directions of Proarrhythmic Risk Assessment
Session Chair(s)
Kaori Shinagawa, MD, PhD
Senior Scientist for Clinical Medicine, Office of New Drug II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Proarrhythmic potential remains a major concern during drug development and in 2005, ICH adopted the ICH-S7B (non-clinical) and ICH-E14 (clinical) guidelines outlining the evaluation of the potential to delay ventricular repolarization. In late 2015, E14 Q&A was revised to allow the use of concentration response modeling applied to data from early phase clinical studies as an acceptable alternative to the Thorough QT/QTc Study. For more efficient and more specific proarrhythmic risk assessment, further research on clinical and non-clinical methodologies, such as novel ECG biomarkers, and use of human stem cell-derived cardiomyocytes (hSC-CMs) has been progressing. This session will provide an overview of current and future research in non-clinical and clinical proarrhythmic risk assessment, and points to consider for Japanese implementation of concentration response modeling for QT analysis. Speakers and panelists from academia, industry and regulatory agency will also discuss future perspectives of proarrhythmic risk assessment in drug development.
Speaker(s)
Potential of in Vitro TQT Study Using iPS Cell Technology
Tadahiro Shinozawa, PhD
Takeda Pharmaceutical Company Limited, Japan
Associate Director, Drug Safety Research Lab, Regenerative Medicine Unit
Role of Early Phase Clinical Trials on Proarrhythmic Risk Evaluation
Hiroyuki Fukase, MD, PhD
Clinical Research Hospital Tokyo, Japan
Director, Clinical Research Center
Assessment of QT prolongation Risk Using Concentration Response Modeling - the Clinical Perspective -
Kaori Shinagawa, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist for Clinical Medicine, Office of New Drug II
Assessment of QT prolongation Risk Using Concentration Response Modeling - Viewpoint of Model Analysis -
Yoshinori Ochiai, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Advanced Evaluation with Electronic Data /Office of New Drug
Yasunari Kanda, PhD
National Institute of Health Sciences, Japan
Head of Division of Pharmacology
Yuji Kumagai, MD, PhD
Kitasato University Hospital, Japan
Professor, Kitasato Clinical Research Center
Atsushi Sugiyama, MD, PhD
Toho University Faculty of Medicine, Japan
Professor and Chairman, Department of Pharmacology