ユーザーIDをお忘れですか? or パスワードをお忘れですか?

東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V3-S1] Utilize Know-How and Experiences of Medicine/Device Development Obtained through Investigator Initiated Clinical Trials for Forthcoming Japan Venture Promotion

Session Chair(s)

Fumiaki  Kobayashi, PhD

Fumiaki Kobayashi, PhD


CTD inc., Japan

Nowadays, about 50% of new therapeutics approved in US are originated by small bio-tech company and academia. In Japan, drug discovery and research work by academic organization have been expected to make up for the delay of venture promotion. “Investigator-initiated clinical trials for registration (IICT)” have been available since 2003 with the revision of the Pharmaceutical Affairs Law (at that time). So far, it has been approved by many drugs and medical devices developed by the IICTs, contributed as one effective approach to develop additional indications as an idea of drug repositioning. Recently, Japan government intensively promotes drug discovery, research and medicine development by venture companies and academic organizations. This session will provide a great opportunity to learn a way of project management to be applied into a translational medicine and early clinical development from the case examples from the investigator initiated clinical trials.


Yoshitaka  Miyakawa, MD

Exciting Scenes in Investigator-Initiated Clinical Trials

Yoshitaka Miyakawa, MD

Saitama Medical University Hospital, Japan

Professor, Thrombosis and Hemostasis Center

Toshiki  Saito, MD, PhD

Cost-Effective Management and Essential Component of Investigator-Initiated Drug Trial

Toshiki Saito, MD, PhD

National Hospital Organization Nagoya Medical Center, Japan

Director, Department of Regenerative Medicine, Clinical Research Center

Tetsuya  Orito

Our Knowledge for Clinical Operation of Investigator’s Initiative Registration Studies from CRO Point of View

Tetsuya Orito

DOT World Co., Ltd., Japan