Yasunori started his industrial career in 2009 at Kyorin Pharmaceutical Co., Ltd. During his early years at Kyorin, he made significant contributions to the process development department, engaging in process research, clinical API manufacturing, external manufacturing management, and supporting the launch of new drugs. In 2017, he transitioned to Taiho Pharmaceutical Co. Ltd. as a key member of the process development department, leading the development and commercialization of robust and sustainable processes for numerous small molecule API. His areas of expertise include process chemistry, quality engineering and statistics. Throughout his career, he has been dedicated to improving the efficiency and sustainability of API manufacturing processes. His work involves not only optimizing chemical routes for APIs production, but also ensuring that these processes meet stringent quality and regulatory standards. He is passionate about applying advanced statistical methods and quality engineering principles to solve complex challenges in APIs development and manufacturing.

Presentation Title: Observations and Challenges in Global Registration of a New Anti-Cancer Drug.

Abstract: Taiho Pharmaceutical Company, part of the Otsuka Group of Companies, is a mid-sized pharmaceutical company headquartered in Tokyo. The company is expanding its Global reach through a developing pipeline of innovative oncology products. Lytgobi® (Futibatinib), which is the subject of this presentation, is the first product that Taiho has marketed in the 3 major territories of the USA, Japan, and EU.

Our presentation will reflect on some observations and challenges we faced in achieving this global resignation. The first part will focus on the control of two Critical Quality Attributes in the drug substance, namely related substances and particle size distribution. In the second part we will show how we responded to different agency questions for the dissolution method of the drug product.

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