Overview
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Ensuring of a “Healthy Life Span” for the public is a growth strategy for the Japanese government, and actions for further vitalization of medical-related industries have begun. The “Headquarters for Healthcare Policy” and “Japan Agency for Medical Research and Development (AMED)” were established as centers of research and development, and the Pharmaceutical Affairs Law was amended to the Pharmaceutical and Medical Device Act (PMD Act). Research and development of drugs and medical devices in Japan is being supported in both tangible and intangible ways. The number of new and approved drugs available for the first time in Japan has significantly increased.
Japan’s strong capabilities in basic research have been appreciated for some time; however, this proficiency for basic research has not been fully reflected through translational medicine into clinical advances. There is still room for significant improvement. In addition, Japan has a leading position in postmarketing safety evaluation and the variety of measures that can be applied to new drugs which will be used first in Japan. In these ways, Japan’s role is changing significantly.
The themes of the 2013 and 2014 DIA Japan Annual Meetings were “Revolutionary Drug Development from Japan: The Role Academia, Regulators, and Industry should Play in the Discovery and Fostering of Innovative Drugs” and “The Dawn of Medical Innovation that Transcends Boundaries,” respectively, where the foundations of research and development were actively debated and discussed. This year, “Medicine Development” is selected as the theme to discuss how to achieve actual results, building on those previous discussions. Medicine Development means continuously generating data on benefits and risks of drugs, medical devices, and regenerative medicines, etc., from development through postmarketing, to enhance value. The value of products used in medical care means the added value which is provided to patients. We have to
recognize the change in paradigm from the conventional company-centered medicine development to patient-focused medicine development. Innovation is not generated only by industry, government and academia, but by the entire society by enhancing a quadripartite partnership including patients. In this era, innovation driven by the country of Japan, and also by each and every individual in the country, will deliver significant results in medicine development, and bring us to the next horizon. We invite you to join us in fruitful discussions to explore this new territory.
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Program Committee
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Akihisa Harada, MD, PhD President
Pfizer Japan Inc., Japan -
Satoshi Saeki, MSc Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan -
Tsuyoshi Ando, PhD Review Director, Office of Vaccines and Blood Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Hideki Hanaoka, MD, PhD Professor and Head of Clinical Research Center and Vice Director
Chiba University, Japan -
Yasuhiro Honsho Associate Director, Safety & Risk Management Department
Daiichi Sankyo Co., Ltd., Japan -
Yoichi M. Ito, PhD Director
Hokkaido University Hospital, Institute of Health Science Innovation, Japan -
Kazuhiro Kanmuri, PhD Vice President, Product Development and Clinical Operations
Ascent Development Services Inc, Japan -
Kazuhiro Keitoku Director, Head of Global Patient Safety, Japan
BeiGene Japan, Japan -
Hiroshi Kosaku, MSc Senior Corporate Officer, Non-clinical CRO Business, Bio-CDMO Business
CMIC HOLDINGS, Japan -
Rei Maeda Consultant
Independent Consultant for Drug PV, Japan -
Shogo Nakamori, MBA, MSc, RPh Senior Vice President & Managing Director, DIA Japan, Korea, and Singapore
DIA, Japan -
Junichi Nishino, MSc, RPh Head, Regulatory Affairs Department
Otsuka Pharmaceutical Co., Ltd., Japan -
Mitsuhiro Okamoto, RPh Associate Director, HR Development, Development Management Dept
Takeda Pharmaceutical Company Limited, Japan -
Junko Onaka Group Manager, Labeling Group, Regulatory Compliance Dept, RA Div.
Janssen Pharmaceutical K.K., Japan -
Yukie Sano Office of Generic Drugs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Takashi Sato, MSc, PMP
PM Orchestra Takashi Sato, Japan -
Miwa Tamada Manager, New Drug RA Department, Regulatory Affairs
GlaxoSmithKline K.K., Japan -
Rick Tsai, DMD, MD Head of Medical Affairs, Exective Officer
MSD K.K., Japan -
Yoichi Yamamoto, MD, PhD Academic Clinical Research Center, Department of Medical Innovation/ Professor
Osaka University Hospital, Japan -
Sanae Yasuda, PhD Senior Director, Clinical Pharmacology, Medicine Development Center
Japan -
Hidenobu Yoshida Group Manager, Japan Development, Japan Data & Statistical Sciences Group
AbbVie GK, Japan -
Shingo Hasetoh Director, Development Intelligence
Pfizer Japan Inc., Japan -
Junko Sato, PhD Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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