Dr. Keiko Katsui is a Deputy Director of Research Integrity and Social Co-Creation at Japan Agency for Medical Research and Development (AMED). In this position, Dr. Katsui is responsible for general managing all activities related to “Social Co-Creation”, such as Ethical, Legal and Social Issues, Patient and Public Involvement, Diversity and Inclusion, and Sustainable Development Goals across AMED’s R&D programs. Dr.Katsui has over 10 years’ experience in researches and teaching Biomedical Ethics and History of Medicine. Dr. Katsui holds a PhD in Medicine and is also the youngest ever recipient of the Academic Encouragement Award of Japanese Society for the History of Medicine for 2011.

Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes Clinical Data Management, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing Management and Quality Management. Eri Sekine has over 30 years' experience in various functions in clinical development. For DIA, Eri Sekine is a member of DIA Advisory Council of Japan, and involving DIA Communities (Clinical Operations, Patient Engagement) and DIA Student Group.

Shun completed his Ph.D in Health Science at Tokyo University. Shun joined NPO ASrid (Advocacy Service for Rare and Intractable Diseases' stakeholders in Japan) as a researcher. He has conducted a number of studies in rare and intractable diseases field such as QOL of patients and families, management of patient groups, and ELSI (Ethical, Legal and Social Issues) of patient participation in medical research.

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 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.

GIST / Sarcoma Patients and Family Association, Vice Chair of NPO GISTERS In 2004, my husband was 38 years old and suffered from GIST originating from the small intestine. After becoming resistant to domestically approved drugs, he tried clinical trials and off-label use drugs, but my husband passed away in 2010. NPO GISTERS is engaged in patient support activities such as requesting early approval of drugs, operating SNS and holding seminars. Auditor of the Japan Federation of Cancer Patient Groups Kenji Sakurai Shoten Co., Ltd. (Food wholesaler, Choshi City, Chiba Prefecture) President and CEO