In 2019, the Japanese Pharmacological Society launches a certification system of pharmacology educators. Many members of this society are now involved in student education as well as researches in clinical and basic science. We need talented teachers with excellent educational ability so that current and future students can receive high standards of pharmacology education. In order to nurture and support superior pharmacology educators, we have established this certification system for pharmacology educators. In this article, I will explain the implementation guidelines of this system, including its purpose, application procedure, and approval requirements.

Medicine is the science and practice of the diagnosis, treatment, and prevention of a various kind of mental and physical disorders. About 150 year ago, Japan was opened to an influx of foreigners and foreign influence that went far beyond anything the Japanese had imagined. Meiji government decided to adopt German medicine in 1869. Even after that time, Japanese educational system appears to be influenced by western countries, especially United States. This is symbolized by JACME (Japan Accreditation Council for Medical Education), aiming to strengthen and advance medical education in Japan from an international standpoint. This movement was partly because ECFMG (Education Commission for Foreign Medical Graduates) that issues a certificate for post-graduate clinical training in US to graduates of non-US medical schools, made an announcement that only graduates from medical schools accredited based on the global standards would be eligible for taking the ECFMG examination after 2023. Knowing our own place, by combining basic and clinical point of views, it is now time for us to try to make every effort to review our own pharmacological education system in Japan.

About 12 years ago, a 6-year course was started in the Faculty of Pharmacy, and now more than 90% of the students enrolled in the school of Pharmacy belong to the 6-year course. However, as the new educational system progresses, some issues have been pointed out, and it is necessary to proceed with the correction in the future. As the environment surrounding pharmaceutical education changes, it is necessary for the pharmacology education to evolve in accordance with the trend. While the development of therapeutic agents based on the pathogenesis of pathophysiology shows the spread, there are still a number of drugs that have not yet been elucidated, and the importance of pharmacology is increasing as a discipline to educate them systematically. In addition, it is also important to understand how medicine is used in clinical practice and what side effects should be expected from a pharmacological viewpoint. For this purpose, it is necessary for a pharmacologist to grasp the trend of drug therapy in clinical practice and learn it from the viewpoint of pharmacology by students. As a future task, it is necessary to strengthen cooperation with other fields, especially pharmacotherapeutics, and to make appropriate cooperation with human resources who can feed back the latest drug treatment on actual clinical sites to university education. In addition, it is an urgent task to increase the number of students entering the doctoral program. Currently, there is concern that it will lead to the depletion of the human resources who have a degree and a pharmacist license, and urgent measures are necessary.

The installation of nursing colleges/universities has rapidly increased from the late 1990s, there are 263 institutions in Japan as of 2018. Pharmacology and clinical pharmacology education in undergraduate and postgraduate nursing colleges/universities is highly important, in addition, the education of clinical pharmacology in the training courses of Certified Nurse Specialist, Certified Nurse and Nurse designated procedures is positioned as compulsory subject. Whereas, the lack of human resources involved in pharmacology education due to the rapid increase of nursing colleges/universities cannot be denied. Comprehensive pharmacology education in nursing based on the “Patient-oriented Pharmacology” is effective against the improvement of quality of pharmacotherapy and patient satisfaction. It is important to provide an opportunity to learn comprehensive education program of nursing pharmacology as a mutual cooperation between both fields of nursing sciences and pharmacology.

Primary cilium is a membrane-protruding immotile sensory organelle. It had been supposed that the cilium was a static organelle for long periods. However, recent studies have uncovered that the cilium is dynamically organized organelle in a cell cycle-dependent manner; it is formed during G₀/G₁ phase and resorbed when the cells enter cell division cycle. Despite the primary cilium is very short and its surface area is extremely small, the cilium possesses a few kinds of G protein-coupled receptors, growth factor receptors and ion channels. Therefore, it can function as a signaling receptor for selective bioactive ligands and mechanical stresses. Dysregulation of the ciliary dynamics is linked with hereditary disorders, so called “ciliopathy”, with clinical manifestations of microcephaly, polycystic kidney, situs inversus, polydactyly, and so on. No effective medical treatment for the ciliopathies has been available. Increasing evidences about the molecular mechanisms of ciliary dynamics and ciliary functions have revealed that enormous number of molecules regulate a cycle of ciliogenesis, cilium-derived signaling, ciliary resorption and elimination. However, it is a fact that research progress is far inferior to the full disclosure of the molecular mechanisms. Further studies are required to clarify the pathogenesis of the cilipathies. Moreover, efficient medical treatments are expected to be developed by pharmacological approaches.

To accelerate drug discovery and development, improve R&D efficiency and facilitate scientific decision making, quantitative systems pharmacology (QSP) is increasingly being utilized in the pharmaceutical and biotech industry. QSP approach has emerged as a central technology in innovative framework based on “learn and confirm” cycle, which is currently called as model-informed drug discovery and development (MID3). QSP approach is supporting the rational decision in drug discovery and development from exploratory research to late-stage clinical development, and enables selection/validation of novel target molecules, identification of mechanism-of-action of pharmacological/toxicological compounds, prioritization of pharmaceutical candidates, facilitating translational research, optimization of clinical trials, and others. In this review paper, I explained summary and effectiveness of QSP approach by showing two our case-studies related to identification of mechanism-of-action of compounds. These are 1: differentiation of thrombin inhibitors and 2: endocrine disrupting compounds, they have been good practices in my experiences of applying QSP at pharmaceutical company.

Elobixibat is a novel small-molecule that acts as an inhibitor of the ileal bile acid transporter (IBAT), and used for chronic constipation in Japan. Elobixibat selectively inhibited IBAT in vitro, and dose-dependently inhibited the absorption of bile acids in vivo. Also, elobixibat dose-dependently increased wet fecal weight in a rat loperamide-induced constipation model. The drug-drug interaction study suggested that elobixibat may have a clinically slight inhibitory effect on P-glycoprotein. In a phase II study with chronic constipation, the recommended dosage for oral administration of elobixibat once daily was estimated to be 10 mg. In a phase 3 study with chronic constipation, the superiority of the elobixibat 10 mg group to the placebo group was demonstrated in the change from baseline (ie, the last week of the 2-week run-in period) in the frequency of spontaneous bowel movements per week during the first week of treatment set as the primary endpoint. In a long-term study in which elobixibat was administered to patients with chronic constipation for 52 weeks, the ameliorating effects of elobixibat on constipation were observed from the first week of treatment and maintained well until week 52. In addition, the safety/tolerability of elobixibat administered once daily for 52 weeks was considered to be acceptable. Therefore, elobixibat has a mechanism of action that differs from any of the existing therapeutic agents for constipation and is expected to become one of the new treatment options for chronic constipation.