Presenters
Atsushi Kitamura, MS
Director, Clinical Development Quality, Pfizer R&D Japan, Japan
Since 2020, Mr. Atsushi Kitamura has served as the community lead for the DIA Patient Engagement Community. Mr. Kitamura has also coordinated with other industry groups leading Patient Engagement or DCT activities to invigorate the DIA Japan annual meetings, DIA Patient Engagement workshops, and Patient Engagement information exchange meetings. Mr. Kitamura began his career in clinical development at Nippon Kayaku, Oncology division. He then moved to a global CRO and later to Wyeth Research. Currently, he works at Pfizer R&D Japan as the GCP Quality Head. In this role, Mr. Kitamura promotes GCP renovation, encourages input from multiple stakeholders including patients, and contributes to the clinical trial ecosystem.
Eri Sekine
Executive Vice President Data Business and Quality, CMIC Co., Ltd, Japan
Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business (including Clinical Data Management, Biostatistics, Statistical Analysis, Pharmacovigilance, Real World Data, Evidence Genration) and Quality. 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.
Mika Ikeda
Manager, Global Project Management Department, Daiichi Sankyo, Inc, United States
Keiko Katsui, PhD
Manager, Division of Biomedical Ethics and Social Co-Creation, Japan Agency for Medical Research and Development (AMED), Japan
Dr. Keiko Katsui is a Deputy Director of Group for 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, PhD, MSc
Director, Advocacy Service for Rare and Intractable Diseases, Japan
Yukiko Nishimura is the President and Founder of NPO ASrid (Advocacy Service for Rare and Intractable Diseases’ Multi-stakeholders in Japan), an organization dedicated to connecting stakeholders in the rare disease community. She has over 18 years of experience working with patients, families, healthcare professionals, industry, and policymakers in the fields of rare diseases and orphan drugs. Since 2021, she has served as a Board Director of APARDO (Asia Pacific Alliance for Rare Disease Organizations). Her previous roles include positions at the Japan Patients Association, The University of Tokyo, Kyoto University, and MEXT. She holds BSc and MSc degrees from Meiji University and completed graduate studies at The University of Tokyo.
Naomi Sakurai
President, CSR-Project, NPO, Japan
Diagnosed with breast cancer in 2004 while in her 30s, she founded a patient support group based on her own experience as a cancer survivor. Since then, she has focused on advocacy, education, and raising awareness of cancer survivorship, while promoting independent living and social participation for people affected by cancer and their families. Licensed Social Worker, Licensed Psychiatric Social Worker, and Professional Engineer. Recipient of the JCI Japan Director's Special Award (2007), Avon HELLO TOMORROW Award (2008), and Best Survey Award, University of Tokyo (2009).
Junko Sato, PhD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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 Takeda
Executive Director, Japan Chronic Diseases Self-Management Association, Japan
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 Tsukamoto, PhD, MSc
Head is Therapeutic Area Strategies , Daiichi Sankyo, United States
Atsushi is the Corporate Officer and Head of Therapeutic Area Strategy in Daiichi Sankyo, to manage multiple therapeutic area strategy. Prior to that, he was VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. 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 Annual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.
Nobuko Ushirozawa, RN
Chief, Research Admin. Div. Center for Research Admin and Support, National Cancer Center, Japan
Ms. Nobuko Ushirozawa is the Chief of the Research Administration Division at the National Cancer Center Japan (NCC). She oversees research fund management, ensures human reserch protection through the Research Ethics Committee, and supports industry-academia collaboration, enhancing NCC’s research promotion system. Starting her career as a nurse at a university hospital, Ushirozawa has spent 25 years supporting clinical research in various roles, including clinical research coordinator and establishing support organizations for investigator-initiated clinical trials. She also worked at the Ministry of Health, Labour and Welfare, promoting policies to revitalize clinical trials.
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