Research experience leads to a desire to contribute to patients.

The impetus for Shinichi Matsuda’s strong interest in Chugai Pharmaceutical came from the research he was conducting at university. He specialized in clinical testing in the Faculty of Health Sciences in the School of Medicine at his university, where he engaged in research to elucidate the causes of rheumatoid arthritis and the development of treatment methods. ‘The professor who guided my research, who is a specialist in rheumatoid arthritis, taught me not only the enjoyment and skills of research, but also many different ways of thinking. What I particularly empathized with was his strong commitment to devoting all of his abilities to the challenge of finding a treatment for rheumatoid arthritis, and his conviction that, if he could shed light on the causes of this disease, a difficult problem that is yet to be solved, he would be able to help patients all over the world. Around the time I started thinking that if I, too, worked hard, I could contribute to that treatment, Chugai Pharmaceutical launched a groundbreaking antibody drug for rheumatoid arthritis onto the market. At the time, I had been attending meetings of the College of Rheumatology, and when I saw that this new drug was significantly more effective than conventional rheumatoid drugs, I began to feel drawn to Chugai Pharmaceutical as a company that could develop that kind of drug.’

As Matsuda was gathering information for his job search, he learned about Chugai Pharmaceutical’s focus on safety. ‘I listened to a talk by an employee who was working there at a company information session, and I learned that safety was taking on increasing importance worldwide and that it was an area of rapid change. I sensed the significance of this job of safety, which contributes to patients’ peace of mind, not because of the drug’s efficacy, but from the aspect of adverse drug reactions, and this prompted me to apply to join the company.’

Creating new value based on epidemiology.

The role of the safety division is to promote the appropriate use of drugs by gathering information about adverse drug reactions, analyzing the frequency and risk factors of such adverse reactions, and providing safety information to healthcare practitioners. Matsuda’s first job on joining the company was to analyze the causal relationship between the company’s drugs and their adverse reactions, based on the adverse drug reaction reports of individual patients. While engaging in this important job with a sense of purpose on the one hand, on the other hand, Matsuda felt that there was a limit to what could be achieved with this approach alone. ‘With only the adverse drug reaction information for individual patients, it is often difficult to determine whether those reactions were truly due to the drug or whether they just happened to occur coincidentally. For example, say a person developed a stomachache after taking a drug. That stomachache might be an adverse reaction to the drug, but what if that person would have developed a stomachache even if they had not taken the drug? In that case, we could assume that it was not the fault of the drug, but the fact remains that no data exists for the case of not taking the drug, so we simply do not know.’

In the course of exploring new methods, Matsuda learned of the existence of an academic discipline known as “epidemiology.” Epidemiology is a discipline that analyzes large-scale data not from individuals but from groups, to reveal the causes of diseases and adverse drug reactions. Multiple examples of its use have been reported overseas. Around that time, a new group specializing in epidemiology was to be formed in the safety division. Matsuda put himself forward to become a member of that group and was selected. Chugai Pharmaceutical was the first of Japan’s pharmaceutical companies to set up its own specialist epidemiology department. ‘In the beginning, every day was a process of trial and error. The members of the group had many discussions. It was tough, but, more than that, it was so interesting to create something from scratch by ourselves.’

Toward the goal of contributing to people’s health.

If epidemiological analysis of adverse drug reaction information can be used to reveal the characteristics of patients who are more susceptible to adverse reactions and the trends in the timing of their occurrence, specific action can be taken, such as recommending regular testing for the early detection of those reactions. ‘What is important is that epidemiology exists precisely because it is there for the benefit of people. Every day, we think about data analysis that will contribute to patients. It is not easy, but the ability to contribute to people’s health is a major attraction of studying epidemiology.’ Four years have now passed since the group’s establishment and it has built up a strong track record. Through in-house projects, Matsuda has established signal detection mechanisms, which detect the early signs of unknown adverse drug reactions, based on adverse drug reaction information. Concurrently with those efforts, he has presented his findings at international academic conferences and in scholarly articles. ‘To improve safety initiatives even further, it is important to disseminate information globally and obtain input based on discussions.’

What are Matsuda’s current feelings about the significance of engaging in epidemiology?‘We are focusing on the possibility that, through epidemiological analysis of large-scale data, we will make early discoveries of beneficial knowledge that has not existed until now and save many patients with that information. In epidemiology, hypothesis construction and analysis design are extremely important, but these are not things that can necessarily be achieved with specialist epidemiological capabilities alone. They require the cooperation of members with a variety of specializations, including medicine and pharmacy, statistics, and pharmaceutical regulations. Since working in epidemiology, I myself have had many more opportunities to engage with other people within the company and from outside. I need to keep trying hard myself in different ways toward my goal of contributing to people’s health.’ In various situations, Matsuda continues in his fight to discover new wisdom that will contribute to the health of people all over the world.

*The contents of this article, and the divisions that the people featured in this article belonged to and the names of those divisions are current as of the time of the interview.