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Tokyo Big Sight

Nov 16, 2014 9:00 AM - Nov 18, 2014 6:30 PM

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

11th Annual Meeting DIA Japan 2014

[V3-S3] Lessons Learned of Adaptive Design from Case Example

Session Chair(s)

Yasuo  Ohashi, PhD

Yasuo Ohashi, PhD

Professor, Dept. of Integrated Science and Engineering for Sustainable Society

Chuo University, Japan

Speaker(s)

Zachary Kulkarni Skrivanek, PhD

An Adaptive, Seamless Phase 2/3 Study Incorporating a Clinical Utility Index

Zachary Kulkarni Skrivanek, PhD

Eli Lilly and Company, United States

Principal Research Scientist, Global Statistical Sciences

Shintaro  Hiro, PhD

Experience of Sample Size Re-estimation for Registration Studies in Japan

Shintaro Hiro, PhD

Pfizer R&D Japan, Japan

Manager, Data Science & Analytics Japan Lead, Clinical Statistics

Hiroyuki  Sato, PhD

A Regulatory Perspective on the Use of Adaptive Design in Drug Development

Hiroyuki Sato, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Reviewer, Office of New Drug V

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