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DIAmond Session: Patient-Engaged Drug Development in Japan, US, and Europe
Session Chair(s)
Yoshinobu Hirayama, PHD
Professor, College of Pharmaceutical Sciences, Ritsumeikan University, Japan
Kihito Takahashi
Head of R&D/Medical Affairs Hub Japan, Swedish Orphan Biovitrium (SOBI) Japan, Japan
In recent years, there have been active discussions to bring patient perspectives into drug development, evaluation, and so on. The US and Europe have already implemented initiatives for patient engagement and some outcomes are available. It is expected that patient engagement initiatives will be promoted in Japan as well. This session will share the backgrounds, goals, achievements, and challenges of these initiatives in the US and Europe, followed by discussion among experts from Japan, US, and Europe about the aims for patient-engaged drug development in Japan.
Speaker(s)
Theresa Mullin, PHD
Associate Center Director - CDER, FDA, United States
Informing Benefit-Risk Assessment With Patients’ Perspectives: FDA Patient-Focused Drug Development
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
Patient-Engaged Drug Development - EMA
Kazuhiko Mori, PHD, MSC
Business Manager, "Toyama, the Silicon Valley of Medicine" Creative Consortium Management Office, Japan
Patient-Engaged Drug Development in Japan
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