BACKGROUND
FOCUS AREAS
More than 6 years of expertise in CMC-RA in the Pharmaceutical industry and more than 10 years of expertise in the bioscience research field, especially in stem cell biology.
Global CMC-RA strategies
As a senior manager in Regulatory Science of Eliquent Japan, Shinichi is in charge of supporting J-IND, -JNDA and lifecycle management of client’s products.
Shinichi is responsible and leads the support for J-IND, JNDA, and lifecycle management of clients’ products to maximize clients’ value and to solve drug loss and drug rugs in Japan.
6 years of expertise in CMC-RA in the Pharmaceutical industry especially biological and regenerative medicines and more than 10 years of expertise in the bioscience research, Shinichi empowers Regulatory Science of Eliquent Japan to expand capabilities of regulatory science. Shinichi served as postdoctoral fellow in academic institute including Linkoping university in Sweden and Hospital for Special Surgery in the US and served in lead roles as CMC expert in biotech company and global pharmaceutical company, including Healios K.K. and Takeda Pharmaceutical Company limited.
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Education:
Bachelor of Science. – Seikei University
Master of Science. – The University of Tokyo
Ph.D. – The University of Tokyo -
Expertise
Linkoping University (Sweden) – Senior Research Engineer
NH foods (Japan) – Research Fellow
Hospital for Special Surgery (US) – Postdoctoral fellow
Healios K.K. – CMC expert
Takeda Pharmaceutical Company Ltd. – CMC RA staff
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