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[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
Center for Clinical Research and Development, National Center for Child Health and Development, 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
Director of Personnel Coordination, Office of General Affairs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Significance of R&D Strategic Document through Regulatory Consultation and Review Process in PMDA
Shinobu Shimizu, PHD
Associate Professor, Department of Advanced Medicine, Nagoya Univeresity Hospital, Japan
Significance and Examples of TPP and R&D Strategic Documents in Academia
Yumiko Tomoyasu, DDS, PHD
Deputy Manager, Office of Promotion Coordination, Japan Agency for Medical Research and Development (AMED), Japan
AMED R&D Management Based on Stage Gate and Drug Development Strategy
Michiyo Ohshima, MBA
Senior Director, Head of Japan Portfolio and Project Management, Pfizer R&D GK, Japan
Significance and Examples of TPP and R&D Strategic Documents in a Pharmaceutical Company