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Tokyo Big Sight

2025 年 10 月 19 日 10:00 上午 - 2025 年 10 月 19 日 1:00 下午

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

#SC04 : (Life Cycle Management) Let's Talk about Post-Marketing Utilization of RWD. Are We Really Doing What We Want to Do?

Instructors

Kasumi  Daidoji, PhD, RPh

Kasumi Daidoji, PhD, RPh

Associate Director, Clinical Planning & Development Dept., Medical Headquarters, Eisai Company, Ltd., Japan

Kasumi Daidoji is an Associate Director of Clinical Planning and Development Department, Medical HQs at Eisai Co., Ltd. After graduating from the master course at faculty of pharmaceutical sciences, Tokyo University of Science, she joined Eisai. She has over 20 years’ experience in statistical analysis of clinical trials, observational studies and pharmacovigilance. Now she is mainly responsible for pharmacoepidemiologic research and post-marketing database study using large-scale hospital administrative database / health insurance claims database. In addition, she supports Student Activities in DIA Japan this year.

Toshifumi  Sugitani, PhD, MBA

Toshifumi Sugitani, PhD, MBA

Senior Lead, Real World Evidence and Evidence Excellence, Novartis Pharma K.K., Japan

Dr. Toshifumi Sugitani is currently a Director of RWE at Syneos Health Japan. He has a PhD in Biostatistics. Toshi’s area of expertise span across statistical methodologies in confirmatory clinical trial designs (e.g., Graphical approaches, Adaptive designs), dose-response studies (e.g, MCP-Mod), observational studies, real-world studies and evidence generation using large healthcare databases in Japan (e.g, MDV, JMDC, C-CAT), patient-preference studies, and marketing science for sales data in pharma industry in Japan. He is the lead or co-author of more than 20 peer-reviewed publications in statistics or medical journals. He received a Research Encouragement Award from the Biometric Society of Japan in 2020.

Takaaki  Konishi, MD, PhD

Takaaki Konishi, MD, PhD

Head, Clinical Information Section, Division of Health Services Research, Natonal Cancer Center, Institute for Cancer Control, Japan

Dr. Takaaki Konishi is the Section Head of the Division of Health Services Research at the National Cancer Center Institute for Cancer Control. He leads health services research utilizing real-world databases at the National Cancer Center. Drawing on ten years of clinical experience in surgery, Dr. Konishi earned a PhD in clinical epidemiology and health economics, focusing on surgical and oncological fields, using nationwide real-world data at the University of Tokyo. During his secondment to the Ministry of Health, Labour and Welfare, he contributed to the operation of the National Database of Health Insurance Claims (NDB) untill June 2025, including efforts to accelerate data provision and expand the scope of available information.

Yuya  Kimura, MD, MPH

Yuya Kimura, MD, MPH

Assistant Professor, Department of Health Services Research, University of Tokyo, Japan

Dr. Kimura is a Project Assistant Professor at the University of Tokyo's Graduate School of Medicine (https://researchmap.jp/yuya-kimura). With a background as a physician specializing in respiratory medicine and allergies, Dr. Kimura conducts research using medical big data, primarily focusing on diseases in these areas. Dr. Kimura has experience using various types of medical big data and has recently been concentrating on research using the National Database of Health Insurance Claims (NDB), which covers 99% of all the medical institutions in Japan.

Tomoaki  Hasegawa

Tomoaki Hasegawa

Senior Reviewer, Division of Pharmacoepidemiology, Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Tomoaki Hasegawa is a reviewer in Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA). In recent years, he has been engaged in designing and conducting pharmacoepidemiological studies for post-market safety evaluation of pharmaceuticals, utilizing real-world data in Japan. Before that, he has an experience in reviewing marketing authorization applications of medical devices and developing a medical database system (i.e., MID-NET®).

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