Shunsuke Iwano, Ph.D.
Head of Regulatory Affairs Practice – Japan
BACKGROUND
FOCUS AREAS
More than 15 years of experience in research and development in the pharmaceutical industry, including more than a decade of experience in the early/late phase of clinical development and roles implementing business in Japan in collaboration with global members.
- Clinical development strategy in Japan
- Regulatory science in Japan
Shunsuke Iwano leads ELIQUENT’s regulatory affairs practice across Japan and the Asia Pacific region. He supports biopharmaceutical companies in clinical development and regulatory submissions in Japan, driven by a deep commitment to addressing the country’s drug loss challenges.
Shunsuke began his career in academia, conducting basic research as an Assistant Professor at the Graduate School of Pharmaceutical Sciences, Hokkaido University, where he also earned his Ph.D. in Pharmaceutical Sciences. He continued his academic work as a Lecturer at the Faculty of Pharmacy, Takasaki University of Health and Welfare before transitioning to industry.
At Toray Industries, Inc., Shunsuke contributed to drug discovery efforts as a pharmacokinetics researcher, helping secure several promising development compounds. He later joined Novartis Pharma K.K., where he played a key role in global early-stage clinical development, leveraging his pharmacokinetic expertise.
Shunsuke advanced to AbbVie G.K., where he led late-stage clinical development projects, serving as a clinical development representative, project leader, and eventually head of clinical development. His career then took him to Sanofi K.K., where he gained valuable management experience within a global organization. There, he was instrumental in shaping regulatory strategy for the Asia Pacific region and represented the region in a global initiative focused on organizational transformation.
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EDUCATION:
- Bachelor of Pharmaceutical Sciences, Hokkaido University
- Master of Pharmaceutical Sciences, Hokkaido University
- Doctor of Pharmaceutical Sciences, Hokkaido University
CERTIFICATIONS:
- Pharmacist
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PROFESSIONAL EXPERIENCE:
- Head of Regulatory Strategy and Excellence at Sanofi, JPAC GRA
- Head of Clinical Development at AbbVie Japan
- PK scientist at Novartis Japan
AREAS OF EXPERTISE:
- Clinical development and regulatory science in Japan
- Pharmacokinetics and clinical pharmacology