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[V5-S4] Recent Efforts for Realizing Personalized Medicine by Industry, Government and Academia
Session Chair(s)
Norisuke Kawai, PhD
Senior Director, Head of Clinical Research, Pfizer R&D Japan G.K., Japan
To facilitate the development of personalized medicine, pharmaceutical companies, academic institutions, and regulatory agencies promote research and development in different ways. Pharmaceutical companies accelerate the evaluation of the relationship between the investigational drug and many biomarkers in the early phase of drug development and subsequently utilize this information in the later phases. Academic institutions endeavor to exploit novel adaptive designs, such as the umbrella design, to efficiently establish standard therapies. The Japan Agency for Medical Research and Development sponsors academic research in this field in collaboration with the pharmaceutical industry. This session will discuss the recent efforts of, and collaborations between, the government, industry, and academia in the field of personalized medicine.
Speaker(s)
Hideharu Yamamoto, PhD
Chairperson Data Science Expert Committee Drug Evaluation Committee, Chugai Pharmaceutical Co., Ltd., Japan
Challenges Faced Conducting Interim Biomarker Exploration in a PoC Study
Akihiro Hirakawa, PhD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
Utilization of Novel Trial Design for Personalized Medicine
Yoshinori Makino, PhD
Head of office,, National Cancer Center Hospital, Japan
AMED Efforts to the Realization of Personalized Medicine