Newsletter Volume 40, Number 6, 2025
Introduction
We have only a few days left in this year. What kind of year was it for you this year? In my work as a hospital pharmacist, I have become keenly aware of the “2025 problem. The baby boomers will be elderly in the latter half of their lives, and their medical and nursing care needs will increase rapidly, but it will not be easy to secure personnel for all of the various professions. Under such circumstances, we feel that there is an ever-increasing need to reduce adverse events and maximize therapeutic effects with limited resources. We believe that optimizing drug therapy for each patient through appropriate dosage and administration design based on pharmacokinetics will play an important role in achieving this goal. We hope that this newsletter will provide an opportunity to discuss the role and potential of pharmacokinetics with basic and clinical researchers as well as industry. We hope you will continue to read this newsletter. (T.H.)
Topics
Pharmacokinetic Society of Japan Newsletter: Regulatory Science Information
The Newsletter Committee reports on regulatory science information in the field of pharmacokinetics, including the latest trends in guidelines and regulatory harmonization activities at ICH. … ( To be continued at the NL website )
NEW POWER working on kinetic research
Seeing the Invisible” A View from Pharmacokinetic Research
Pharmacokinetics and Safety Research Department, Ono Pharmaceutical Co.
Bio-DMPK and Systems Pharmacology Group
Seitaro Otsu
It is a pleasure to meet you all. My name is Seitaro Otsu and I am with the Pharmacokinetics and Safety Research Department of Ono Pharmaceutical Co. I would like to express my sincere gratitude to the editorial board members and all those involved for this valuable opportunity to write for the newsletter of the Japanese Pharmacokinetics Society.
Seeing the invisible” – this is the theme I have been pursuing in my research, and it is the source of my excitement. Whether it is peering into a microscope and unlocking the secrets of the microscopic world, or touching a heritage site or building and tracing its past history, exploring the unknown and understanding the unknowable is always exciting to me. … ( To be continued at the NL website )
Research on the Pharmacokinetics of Modified Antibodies
No. 2: FcRn binding-enhancing modified antibodies
DMPKG, Biopharmaceutical Research Department, Research Division, Chugai Pharmaceutical Co.
Shunsuke Yamada
Kenta Haratani
Hello! In the previous issue, we reported on “Basics of Antibody Pharmacokinetics”. In this second issue, I would like to introduce “FcRn binding-enhancing modified antibodies”. In this article, I would like to describe the history of research on half-life extension by FcRn binding enhancement modification, examples of half-life extension effects in crab-eating macaques and humans, and how to predict the pharmacokinetics of antibodies in humans from animal models.
Antibodies are known to have a long half-life due to their high molecular weight (approximately 150 kDa), which makes them difficult to undergo glomerular filtration, and a recycling mechanism mediated by the neonatal Fc receptor (FcRn). After the antibody is taken up by vascular endothelial cells, it binds to FcRn in the acidic environment of endosomes. This binding avoids transport to lysosomes and protects them from degradation by proteolytic enzymes. … ( To be continued at NL website / Members only )
Comments from the Award Winners
On receiving the Drug Discovery Contribution and Encouragement Award
Translational Research Division, Chugai Pharmaceutical Co.
Miho Nagayasu
I would like to express my sincere gratitude for receiving the prestigious Drug Discovery Contribution and Encouragement Award from the Japanese Society for Pharmacokinetics and Pharmacodynamics. I would like to express my sincere gratitude to Dr. Masao Kato, President of the Japanese Society of Pharmacokinetics, the members of the selection committee, and Dr. Ryoichi Saito, Research Division, Chugai Pharmaceutical Co.
I have been engaged in non-clinical pharmacokinetic research mainly on antibody drugs. With your kind permission, I would like to introduce my research on “Development of a novel antibody evaluation platform and its contribution to the discovery of next-generation antibody drugs”. … ( To be continued at the NL website )
Receiving the Drug Discovery Contribution and Encouragement Award
Takeda Pharmaceutical Company Limited Pharmacokinetics Research Laboratories
Miyu Nakayama
I am honored to receive the Drug Discovery Contribution and Encouragement Award from the Japanese Society for Pharmacokinetics and Pharmacodynamics for my research entitled “Development of Evaluation Platform for Biodistribution of Novel Medical Modalities”. I am honored to receive such a prestigious award. I would like to express my sincere gratitude to the members of the selection committee, to all the people involved in the Japanese Pharmacokinetics Society, and to Dr. Shunsuke Yamamoto (now at Chugai Pharmaceutical Co., Ltd.) for recommending me for this award.
With the remarkable progress of science and technology in recent years, “medical modalities” have diversified to include not only small molecule drugs but also biologics, nucleic acid drugs, gene therapy drugs, and cell therapy drugs. However, the pharmacokinetic evaluation basis has not yet been established for these new medical modalities, and their pharmacokinetic properties remain to be elucidated. In this study, we have established three new bases for evaluation of biodistribution to solve the above-mentioned problems and to promote the creation of new medical modalities. … ( To be continued at the NL website )
Receiving the Encouragement Award
Nagasaki University Graduate School of Biomedical Sciences (Pharmaceutical Sciences)
Hidefumi Mukai
I am very honored to receive the Encouragement Award for my research entitled “PET-based Pharmacokinetic Study of New Modality and its Application to Development of Diagnostic Imaging Drugs and Drug Delivery System (DDS). I am very honored and at the same time, I feel very humbled. I am deeply grateful to Professor Shigeru Kawakami of Nagasaki University Graduate School for his recommendation, Professor Mitsuru Hashida of Kyoto University, and Professor Emeritus Yasuyoshi Watanabe of RIKEN (Professor Emeritus of Kobe University Graduate School and Osaka Public University) for their guidance and support. I would also like to express my deepest gratitude to the members of the selection committee and to all the professors who have been involved in the selection process. I would like to give a brief introduction of my research activities. ( To be continued at the NL website )
Receiving the Kitagawa Award for Drug Discovery
T. N. Technos Corporation CTO/CRO Division
Hideki Hirabayashi
I am honored to receive the prestigious Kitagawa Award for Contributions to Drug Discovery from the Japanese Society for Pharmacokinetics and Pharmacodynamics for “Research on Advanced Application of Pharmacokinetics in the Discovery of Novel Drugs”. I would like to express my sincere gratitude to everyone who has supported me and made it possible for me to receive such a great award. I would like to express my sincere gratitude to Dr. Kenji Tabata, formerly of Astellas Pharma Inc. who made an effort to recommend me for this award, Dr. Masao Kato, President of the Japanese Pharmacokinetics Society, who accepted the chairmanship of the lecture, the members of the Board of Directors and the selection committee, and all of my professors. I would also like to express my deepest gratitude to my colleagues at Fujisawa Pharmaceutical Industries Ltd, Astellas Pharma Inc. and Takeda Pharmaceutical Company Limited, with whom I have worked on this project. … ( To be continued at the NL website )