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TFT Halls & Rooms

Nov 06, 2013 9:00 AM - Nov 08, 2013 6:00 PM

TFT Building, 3-6-11 Ariake, , Koto-ku,, Tokyo, 135-8071 Japan

10th Annual Meeting DIA Japan 2013

Round Table 1: Drug Development in the Future

Session Chair(s)

Tatsuo  Kurokawa, DIAFellow, PhD

Tatsuo Kurokawa, DIAFellow, PhD

Director General

The Japan Biosimilar Association, Japan

How will medical products be developed in the future in an increasingly globalized world? Drug developments from the bridging strategy to global clinical trials have been changed and the variations of development are also increasing, it has been important business strategy how a company get a marketing authorization for pharmaceuticals in global strategy. In addition, the proportion of targeting strategy, which it is a world-class new trend drug therapy with companion diagnostics, antibody and orphan drugs etc., is greater. When we turn our eyes to the domestic situation, it is existed unique Japanese issue that expensive medicines are increasingly tight in the budget, including medical insurance. Under these circumstances, regulators and heads of R&D department will exchange their opinions about the future drug development, including how to develop drug in the future and how a way of thinking of Regulatory authorities change in the future etc.

Speaker(s)

Sandy  Milligan, JD, MD

Sandra Milliagan presentation

Sandy Milligan, JD, MD

Innovex Strategies, United States

Board of Director Member, Gossamer Bio; Principal

Haruhisa  Hirosaki

Haruhisa Hirosaki presentation

Haruhisa Hirosaki

Astellas Pharma Inc., Japan

Executive Vice President, Head of Japan-Asia Development, Global Development

Hiromichi  Shirasawa, MD

Hiromichi Shirasawa presentation

Hiromichi Shirasawa, MD

MSD K.K., Japan

Vice President and Executive Officer, Head of Japan Development

Dalvir  Gill, PhD

Dalvir Gill presentation

Dalvir Gill, PhD

TransCelerate BioPharma Inc., United States

Chief Executive Officer

Daisaku  Sato, PhD, MPharm, RPh

Daisaku Sato presentation

Daisaku Sato, PhD, MPharm, RPh

Ministry of Health, Labour and Welfare, Japan

Director, Compliance & Narcotics Division

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