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[V4-S3] The Next Generation Drug Development for Personalized Health Care
Session Chair(s)
Hideharu Yamamoto, PhD
Chairperson Data Science Expert Committee Drug Evaluation Committee, Chugai Pharmaceutical Co., Ltd., Japan
All medicines, both on the market and under research/development, can be precision medicine, when the adequate usage information for each individual is enhanced. Recently, supplying the information for the personalization of medical products has become a duty of the pharmaceutical industry. So far, most pharmaceutical companies’ commitments to such activities have not resulted in much progress. In this session, we will introduce a research outcome of approved precision medicines in Japan and discuss novel drug development strategy with clinical study design that fits in with today’s society.
Speaker(s)
Shinichi Tsuchiwata, MS
Manager, Clinical Pharmacology, Pfizer R&D Japan G.K., Japan
Applied Drug Development for Personalized Medicine
Akihiro Hirakawa, PhD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
Gene Finding for Patient Selection in Academic Researches
Hiroyuki Sato, PhD
Reviewer, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Recent Advances in Clinical Trial Design for Personalized Medicine – Regulatory Perspective
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