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14th DIA Japan Annual Meeting 2017


[V8-S2] Update on Current Status and Future Directions of Proarrhythmic Risk Assessment

    Session Chair(s)
      Kaori  Shinagawa, MD, PhD

      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)
      Tadahiro  Shinozawa, PhD

      Potential of in Vitro TQT Study Using iPS Cell Technology

      Tadahiro Shinozawa, PhD

      • Associate Director, Drug Safety Research Lab, Regenerative Medicine Unit
      • Takeda Pharmaceutical Company Limited, Japan
      Hiroyuki  Fukase, MD, PhD

      Role of Early Phase Clinical Trials on Proarrhythmic Risk Evaluation

      Hiroyuki Fukase, MD, PhD

      • Director, Clinical Research Center
      • Clinical Research Hospital Tokyo, Japan
      Kaori  Shinagawa, MD, PhD

      Assessment of QT prolongation Risk Using Concentration Response Modeling - the Clinical Perspective -

      Kaori Shinagawa, MD, PhD

      • Senior Scientist for Clinical Medicine, Office of New Drug II
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Yoshinori  Ochiai, PhD

      Assessment of QT prolongation Risk Using Concentration Response Modeling - Viewpoint of Model Analysis -

      Yoshinori Ochiai, PhD

      • Reviewer, Advanced Review with Electronic Data Promotion Gr/Office of New Drug 1
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Yasunari  Kanda, PhD

      Yasunari Kanda, PhD

      • Head of Division of Pharmacology
      • National Institute of Health Sciences, Japan
      Yuji  Kumagai, MD, PhD

      Yuji Kumagai, MD, PhD

      • Director of Clinical Trial Center
      • Kitasato University Hospital, Japan
      Atsushi  Sugiyama, MD, PhD

      Atsushi Sugiyama, MD, PhD

      • Professor and Chairman, Department of Pharmacology
      • Toho University Faculty of Medicine, Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org