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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.

Speaker(s)

Tomoko  Okudaira

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

Tomoko Okudaira

  • Deputy Review Director, Office of New Drug II
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Shinobu  Shimizu, PhD

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

Shinobu Shimizu, PhD

  • Associate Professor, Department of Advanced Medicine
  • Nagoya Univeresity Hospital, Japan
Yumiko  Tomoyasu, DDS, PhD

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

Yumiko Tomoyasu, DDS, PhD

  • Deputy Manager, Office of Promotion Coordination
  • Japan Agency for Medical Research and Development (AMED), Japan
Michiyo  Oshima, MBA

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

Michiyo Oshima, MBA

  • Senior Director, Japan Portfolio & Project Management Development Japan
  • Pfizer R&D Japan, Japan