医薬品の国際的な研究開発業務に15年以上携っている経験をもとにお話ができます

2019 to present, Tokyo, Japan
Global market analysis to create a global development strategy with global market insights.
Global epidemiology, competitive intelligent analysis, pricing strategy, market access in non-oncology therapeutic area.
Belong to ISPOR and AMCP

2017 to 2019, NJ in the U.S.
Engaged to conduct global business analysis and build development strategy for clinical candidates in early development stage.
Dedicated to both business/marketing function and R&D function, created sophisticated global development strategies at early development stage.
Experienced therapeutic area; women health, infection, gastroenterology, metabolic disorders, respiratory

2015 to 2017, Tokyo, Japan
Translation research, conduct Phase 1 or first entry in human studies globally.
IND in S. Korea to begin Phase 1, first entry in human study.
Competed the Phase 1, SAD and MAD studies with healthy men and moved to Phase 2 development in S. Korea.
Released Phase 1 and Phase 2 results at medical conferences and with manuscript.
Generated global development strategy and built protocols for each clinical study

2008 to 2015, Tokyo, Japan
Clinical develop function.
Japanese development program and success to launch a new biologic agent.
Support worldwide filling of a medicine, which worldwide sales over USD 2 billion in rheumatology.
A Japanese clinical functional leader at a top 5 global pharmaceutical company, worked in a CNS program, complete a bridging study in Japan and entry to a global Phase 2 study
Prepare to initiate global Phase 3 studies including Japan and east Asian countries, input Japanese healthcare system, PMDA and HAs in S. Korea requirement on study design; endpoint, Bio-STAT, comparator.

2005 to 2008, Shizuoka, Japan
Basic researcher in a safety assessment function, to complete required safety packages in order to transfer preclinical candidates into clinical trial stage, Phase 1. Dedicated to assessment with cardiovascular risk associated ICH-S7B.

■その他
地域: アメリカ法人、東京本社、研究所
役割: 基礎研究員からキャリアをスタートして、日本及び海外における臨床開発、世界市場の分析とその結果を開発戦略へ応用する戦略的業務
規模: 世界年間売り上げ2,000億円超の医薬品開発を経験