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Personalized therapy of biological medicines -TDM of monoclonal antibodies-

Biopharmaceuticals such as therapeutic antibodies are expected to show efficacy not achieved by conventional small molecule drugs, and have continued to evolve as drugs that meet unmet medical needs. Japan had been behind in the development of therapeutic antibodies, however, new trends are emerging in product development, training for manufacturing and quality control, and research in personalized medicinal treatment, because the expansion of products and their indications became them more important in clinical field. Recent topics include the increase in the products originated in Japan, and establishment of the Biologics Research Training Center. With the diversification of products, pioneering results on personalized medicine, which will be important in this field, are being obtained. In addition, standardization of fundamental technologies is also progressing in regulatory science research that links advanced technologies with drug development and implementation in post-approval phase. In this symposium, development of innovative biopharmaceuticals, education of human resource for manufacturing and quality control, regulatory science, and clinical research for personalized medicine are presented.Then the latest trends related to development and clinical implementation of biopharnaceuticals that can be expected to contribute from Japan to other countries including Asia in a new era will be discussed.

"Drug discovery" and "health care" of biopharnaceuticals: Considerations in future development and clinical usage of biopharmaceuticals

The 140th Annual Meeting of the Pharmaceutical Society of Japan (Kyoto)

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[S19-5]Personalized therapy of biological medicines -TDM of monoclonal antibodies-

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