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[V3-S6] Drug Developments for Rare Cancer and Fraction Areas
Session Chair(s)
Akihiro Hirakawa, PhD
Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University, Japan
In rare cancer and fraction areas, phase 2 trials are conducted as pivotal trials, but their regulatory requirements differ depending on the target disease, standard treatment, and so on. It is important to organize the basic ideas of clinical development in rare cancer and fraction areas and make it easier to establish a path for drug approval. In this session, we will focus on the industry-academia cooperation to make development more efficient along with the clarification of regulatory requirements. The basic idea of clinical development in these area are organized.
Speaker(s)
Collaborative Challenge for Drug Development in Rare Cancer Field
Kan Yonemori, MD, PhD
National Cancer Center Hospital, Japan
Director, Department of Medical Oncology
The Current Status and the Issue of Drug Development for Rare Cancer and Rare Fraction Area from the Pharmaceutical Industry Perspective
Miki Harumiya, MPharm
Novartis Pharma K.K., Japan
Japan Development, Solid Tumor Clinical Development Dept.
PMDA Perspective: Rare Cancer Review - Now and Future
Noriyuki Komiyama, MSc
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Pharmacovigilance II