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Tokyo Big Sight

2017 年 11 月 12 日 9:30 上午 - 2017 年 11 月 14 日 5:30 下午

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

14th DIA Japan Annual Meeting 2017

[V3-S6] Drug Developments for Rare Cancer and Fraction Areas

Session Chair(s)

Akihiro  Hirakawa, PhD

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)

Kan  Yonemori, MD, PhD

Collaborative Challenge for Drug Development in Rare Cancer Field

Kan Yonemori, MD, PhD

National Cancer Center Hospital, Japan

Director, Department of Medical Oncology

Miki  Harumiya, MPharm

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.

Noriyuki  Komiyama, MSc

PMDA Perspective: Rare Cancer Review - Now and Future

Noriyuki Komiyama, MSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Office of Pharmacovigilance II

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