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[Session 3] Industry’s Perspective for Drug Development Using Asia MRCT
Session Chair(s)
Yoshiko Komuro, PhD
Inspection Director, Office of Non-Clinical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Koichi Miyazaki, PhD
Senior Director, Group IV, Oncology Clinical Development Department
Daiichi Sankyo Co., Ltd., Japan
Pharmaceutical companies elaborate a new compound clinical development plan to efficiently confirm safety, efficacy and patient benefit as well as to accelerate the process of bringing the new drug to market as early as possible. Although MRCTs were established as one option for efficient drug development, ethnic factors are an important consideration when planning MRCTs. As a result, East Asian MRCT have recently been attracting close attention because of the small racial and ethnic differences in the region. For successful drug development, it is critically important to anticipate the latest trends in advance. In this session, experienced speakers will describe various development strategies and visions which will be of great benefit as you work to deliver innovative drugs to patients in Asia.
Speaker(s)
Experiences in Asia MRCT and Future Prospects
Satoshi Miki
UCB Japan Co., Ltd., Japan
Senior Advisor
Industry Perspective on Development by Using Asia MRCT
Shun Jin, MBA
Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore
Head, Regulatory Affairs, APMA
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