[S19] "Drug discovery" and "health care" of biopharnaceuticals: Considerations in future development and clinical usage of biopharmaceuticals

Thu. Mar 26, 2020 4:15 PM - 6:15 PM [Room W] Annex Hall 2 (1F)

Organizers: Akiko Ishii-Watabe (NIHS), Atsushi Yonezawa (Dep Clin Pharmacol Therap, Kyoto Univ Hosp, Grad Sch Pharm Sci, Kyoto Univ)

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.

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4:15 PM - 4:39 PM

[S19-1] Introduction to “neobiologics”, a new modality of protein drugs developed by using "LassoGraft Technology"

Emiko Mihara¹, Nozomi Nakamura¹, Hidenori Hirai², Hiroaki Suga³, ○Junichi Takagi¹ (1. Inst. Protein Res., Osaka Univ., 2. MiraBiologics Inc., 3. Grad. Sch. Science, Univ. Tokyo)

4:39 PM - 5:03 PM

[S19-2] Development of a modified therapeutic enzyme for Hunter syndrome using a Blood-Brain Barrier penetrating technology

○Hiroyuki Sonoda¹ (1. JCR Pharmaceuticals)

5:03 PM - 5:27 PM

[S19-3] Human resource development method for biopharmaceutical development / manufacturing and its international development at BCRET

○Kazuhisa Uchida¹ (1. BCRET)

5:27 PM - 5:51 PM

[S19-4] Regulatory science research for facilitating development and ensuring quality and safety of biopharmaceuticals

○Akiko Ishii-Watabe¹ (1. NIHS)

5:51 PM - 6:15 PM

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

○Atsushi Yonezawa^1,2, Kazuo Matsubara² (1. Graduate School of Pharmaceutical Sciences, Kyoto University, 2. Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital)