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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S48] How Should We Set Up Our R&D Strategy and Target Product Profile? Key Learning from Real Cases

Session Chair(s)

Kotone  Matsuyama, RPh

Kotone Matsuyama, RPh

Professor, Department of Health Policy and Management

Nippon Medical School, Japan

How can we make the best choice when making decisions throughout different phases of clinical development? The Target Product Profile (TPP) is a strategic document to refine new market values for the pharmaceuticals development, and serves as a compass for developing development strategy. Based on the TPP to be developed, it is very important to maximize the value of the developmental target in the clinical practice and to carry out the earliest development by putting it into a viable clinical development plan. In this session, we would like to approach development strategy and its key points through the real cases of TPP and clinical development plans in companies and academia.


Tomoko  Okudaira

Significance of R&D Strategic Document through Regulatory Consultation and Review Process in PMDA

Tomoko Okudaira

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Review Director, Office of New Drug III

Shinobu  Shimizu, PhD

Significance and Examples of TPP and R&D Strategic Documents in Academia

Shinobu Shimizu, PhD

Nagoya Univeresity Hospital, Japan

Associate Professor, Department of Advanced Medicine

Yumiko  Tomoyasu, DDS, PhD

AMED R&D Management Based on Stage Gate and Drug Development Strategy

Yumiko Tomoyasu, DDS, PhD

Japan Agency for Medical Research and Development (AMED), Japan

Deputy Manager, Office of Promotion Coordination

Michiyo  Ohshima, MBA

Significance and Examples of TPP and R&D Strategic Documents in a Pharmaceutical Company

Michiyo Ohshima, MBA

Pfizer R&D GK, Japan

Senior Director, Head of Japan Portfolio and Project Management

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