Message from President

My name is Takashi Yoshinaga of Eisai Co., Ltd. and I have been appointed as the fourth JSPS President. I would like to offer a few words upon assuming office.

The JSPS was established in December 2009, and this year marks its 12th year. As shown in our website, our mission is "to contribute to the development of superior pharmaceutical products through the inheritance and innovation of safety pharmacology" and we aim to contribute to the creation of new drugs by sharing information and exchanging personnel on safety pharmacology knowledge, technological development, and application examples.

We believe that safety pharmacology is a discipline that integrates best practices in pharmacology, physiology, and toxicology, and seeks extrapolation between clinical and non-clinical settings. Our responsibility as safety pharmacologists is to ensure the safety of healthy adults and patients participating in clinical trials. In order to fulfill this responsibility, we have held not only annual meetings but also various information and technical exchange meetings as a part of our activities with our members. In the area of cardiovascular system, iSmart*1 has conducted proarrhythmic risk prediction using ion channel data and in silico models and discussed with CiPA*2, and activities using human iPS cell-derived cardiomyocytes have proposed a proarrhythmic risk classification method in collaboration with JiCSA*3, as well as J-ICET*4 and CiPA*5 are also involved in this project. In addition, J-ICET*4 has revealed useful findings on the extrapolation of telemetry studies using non-rodents to humans. In the area of the central nervous system, JESICE*5 conducted practical and classroom training on the observation of general symptoms and evaluation of emotional behavior of representative drugs using rodents in order to improve the level of techniques and evaluation and to facilitate eye contact among researchers and institutions.

Extrapolation between clinical and non-clinical settings is a challenging goal, and there are still issues to be resolved. In the respiratory system, there are no complex evaluations outside of the menu of studies that meet the requirements of the guidelines, and research efforts at an advanced level for organs other than the core battery have not yet been reached. In terms of drug modalities, further data accumulation is needed to establish appropriate evaluation methods and endpoints for new modalities such as nucleic acid drugs, macromolecular drugs, and antibody drugs, and sufficient discussion from a scientific perspective based on data is important.

We will continue to actively engage in activities with an awareness of extrapolation between clinical and non-clinical aspects this year and beyond. In addition to the dissemination of information from the research group, we have established the "Forum" and "JSPS Community" to promote information sharing and discussion among members by utilizing the website more than ever before. Although the 11th Annual Meeting was held via the web to avoid the influence of the spread of COVID-19 infection, a great number of people accessed the site and had lively discussions. This fact suggests that the web is an effective tool and that it is possible to share and discuss useful information by setting appropriate opportunities. We hope that you will continue to actively use the JSPS website.

The difficulty of creating new drugs is increasing, and investment in the field of safety pharmacology is shrinking due to changes in the business model in response to changes in global economic conditions and declining research funding from public institutions. It is precisely because we are in an era in which the limitations of research activities by individual organizations and individuals are being felt more strongly than ever, that the importance of group activities such as this study group is growing. It is essential to maintain cooperation among industry, government, and academia, as well as international collaboration at the academic level. We would like to ask our members for their continued participation and cooperation.

*1: Investigation of in silico/in vitro model for arrhythmogenic risk prediction
*2: Comprehensive in vitro proarrhythmia assay
*3: Japan iPS cardiac safety assessment
*4: Japan activity for improvement of cardiovascular evaluation by telemetry system
*5: Japan activity for encouragement, succession and improvement of CNS evaluation

April 2020

Takashi Yoshinaga
President, Japanese Safety Pharmacology Society
Eisai Co.,Ltd.
Advanced Biosignaling Safety Evaluation Department