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[V4-S6] How Should a Collaboration between Academia & Industry be Promoted for an Efficient Medicine/Medical Device Development
Session Chair(s)
Hiroi Kasai
Associate Professor, Tohoku University Hospital, Japan
A strategic collaboration such as an investigator initiated clinical trial (IICT) for registration between academia and industry is the key to success to develop medicine/medical device more efficiently. Actually, there are successful cases of the strategic collaboration led to regulatory approval with IICT collaboration. There is the one advanced example of the three-way collaboration for a combination product consisting of medicine and medical device. In this session, an ideal collaboration model will be discussed from various points of view, academia, industry, and PMDA plays as the Japan NDA review.
Speaker(s)
Point of Consider to Collaborate with Industry on Investigator Initiated Clinical Trial for Registration - Academia’s Standpoint -
Manabu Muto, MD, PhD
Professor, Department of Therapeutic Oncology, Graduate School of Medicine, Graduate School of Medicine, Kyoto University, Japan
A Better Academia-Industry Collaboration Aiming for Regulatory Approval - The Experience of Cooperation with Investigator Initiated Clinical Trials -
Izumi Okugaito
Department Manager, Prescription Products Development Department, Zenyaku Kogyo Co., Ltd., Japan
Effective Coordination Between Academia and Industry from the Reviewer Side
Ken Hatogai, MD, PhD
Guset Scientist, Medicine, The University of Chicago, United States
Fumiaki Kobayashi, PhD
President, CTD inc., Japan
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