Atsushi Kitamura is head of Japan Clinical Development Quality at Pfizer Japan R&D. His responsibility is leading Quality Management System (QMS) including process management, risk management and inspection readiness for clinical development. Moreover, He has been leading Patient Engagement activities for Pfizer Japan and DIA Patient Engagement Community. Regarding Decentralized Clinical Trial (DCT), he has presented more than 5 presentations related DCT topic including DIA Japan annual meeting.

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.

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.

Yukiko Nishimura is President and founder of NPO ASrid (Advocacy Service for Rare and Intractable Diseases’ multi-stakeholders in Japan). Working as an intermediary organization, ASrid is committed to providing valuable services/systems for connecting and creating multiple stakeholders related to its field. ASrid has established an MOU on research promotion and drug development with JPA (Japan Patients Association), the largest NANBYO (rare and intractable diseases) patient association in Japan. It has also collaborated with Pediatric NANBYO Supporting network, the largest pediatric rare diseases network in Japan.

I was diagnosed with cancer in the summer of 2004, when I was in my 30’s, AYA generation. I subsequently utilized my personal experience with cancer and my social skills to start up a support-group. We are currently focusing our efforts on enlightening people and spreading awareness about survivorship. Since then, I have continued my activities, appealing for an independent livelihood and self-supporting lifestyle for patients living with the disease and their families. 2008-, President : CSR project, Non-profit organization, 2016-, Commissioner : Japan Federation of Cancer Patient Groups

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.

Hiroki is Executive Director of Japan Chronic Disease Self-Management Association (J-CDSMA). He lives with hemophilia and was infected with HIV via the administration of unheated blood products (during the “HIV-tainted blood scandal”). After graduating from Waseda University School of Social Sciences, he has worked for the J-CDSMA since its establishment in 2005, and in 2007 he completed the Chronic Disease Self-Management Master Training at Stanford Patient Education Research Center. He is currently serving as a Board Member for the Social Welfare Corporation Habataki Welfare Project, an Auditor for the Japanese Network of People Living with HIV/AIDS (JaNP+), and a Steering Committee Member of the Society of Intractable Disease Centers.

Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects (RA strategy & operation). He has been global project manager for nearly 20 years (in JPN & US) and the head of PM office in Daiichi Sankyo Japan for 3 years. He has been an active volunteer to both DIA global and Japan, playing session chair roles in global annual meeting more than 10 times, and was the vice-chair for 13th DIA Japan Annnual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.

Nobuko Ushirozawa, RN, has run, and also managed research clinical trials, for two decades. She also has the experience of promoting clinical trials at the national level, when she was seconded to serve as the assistant director of the Office of Clinical Trial Promotion at the Ministry of Health, Labour and Welfare. She currently also administers clinical reseach at the National Cancer Center of Japan, as assistant chief of the Research Administration Section, Center for Research Administration and Support, and as head of the Clinical Trial Administration Section, to which she is doubly appointed to.