2nd DIA Patient Engagement Webinar: Industry-Government-Academic-Patient Collaboration in Drug Development - Current Status & Issues
Keiko Katsui, PhD
- Deputy Director / AMED Program Officer, Divison of Genomic Medicine
- Japan Agency for Medical Research and Development (AMED), Japan
Dr. Keiko Katsui is a Deputy Manager at Department of Research Infrastructure, Japan Agency for Medical Research and Development (AMED). As a member of Group for Research and Analysis, Dr. Katsui is responsible for the survey of patient and public involvement (PPI) in clinical research. Dr. Katsui makes a special study of Biomedical Ethics, Japanese History of Medicine and Pedagogy. Dr. Katsui holds a PhD in Medicine from Juntendo University in 2017, MA in Education from the University of Tokyo in 2009, and is also the recipient of the 17th Academic Encouragement Prize of Japanese Society for the History of Medicine in 2011.
- Department Head, Trial Monitoring, Japan Development, Global Development Ops.
- Novartis Pharma K.K., Japan
Eri Sekine is Regional Head of Trial Monitoring Japan for Novartis Pharma K.K. In this position, Ms. Sekine is responsible for study management and site monitoring of clinical trials and post-marketing surveillance conducted in Japan. Ms. Sekine has worked for more than three decades in the pharmaceutical industry, in positions responsible for biostatistics, statistical programming, data management, project management, training, and other operational areas. She received the DIA Japan Outstanding Service Award in 2012.
- Clinical Development
- Chugai Pharmaceutical Co., Ltd., Japan
- NPO ASrid, Japan
Kenichi Nakamura, DrMed
- Division Chief, Research Management Division
- National Cancer Center Hospital, Japan
- Vice Chair
- NPO GISTERS, Japan
Junko Sato, PhD
- Director, Office of International Programs
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She also worked in U.S. FDA as a guest reviewer from 2002-2003, and in EMA as the Japan Liaison Officer from 2012-2014. She is actively involved in many academic societies, and contribute them as counselor, committee member, and a board member.