Yuji has 15 years of experience in the pharmaceutical industry, during which he has continuously worked at Taiho Pharmaceutical Co., Ltd. At Taiho, he has been primarily involved in CMC-related tasks, including the development of analytical methods for drug products. He has successfully managed around ten approval applications for injectable and solid oral dosage forms, several of which were global products submitted in Japan, the U.S., Europe, and Asia.

Additionally, he has collaborated with both domestic and international CMOs to set up and technical transfer analytical methods. This experience has allowed him to deepen his understanding of different cultures and regulations, enabling him to lead multinational projects to success.

Recently, Yuji transferred to Taiho drug substance team where he leads the development of analytical methods and setting specifications for APIs for global development. This has further broadened his career, reinforcing the importance of analytical technology in ensuring product quality and safety.

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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