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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

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

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S23] What Patient Registries Bring to Rare Disease Medicine Development

Session Chair(s)

Harumasa  Nakamura, MD, PhD

Harumasa Nakamura, MD, PhD

Director of Department of Clinical Research Support,

National Center of Neurology and Psychiatry, Japan

In drug development for rare diseases, the small number of target patients often makes it difficult to collect the number of patients required to verify the drug’s effectiveness in a clinical trial. Therefore, pharmaceutical companies often do not encourage drug development for rare diseases. But in recent years, development of patient registries [for rare diseases?] has been vigorously promoted. This session will introduce practical use of, and current utilization problems with, patient registries for drug development from different expert points of view.

Speaker(s)

Yoko  Aoi, PhD

Current Situation and Future Perspectives of Review and Scientific Consultation about Orphan Drugs

Yoko Aoi, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Review Director, Office of New Drug V

Yoshihisa  Yamano, MD, PhD

The Role of Patient Registry in the Drug Development of HTLV-1-Associated Myelopathy

Yoshihisa Yamano, MD, PhD

Institute of Medical Science St. Marianna University Graduate School of Medicine, Japan

Professor, Department of Neurology

Hiroshi  Nagabukuro, PhD

Patient Registry Study in Novel Drug Development for Intractable Vascular Malformations

Hiroshi Nagabukuro, PhD

ARTham Therapeutics, Inc, Japan

COO / CSO

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