I want to help solve problems that I became aware of during my hospital practicum.

Mayu Tomita has been interested in the field of personalized healthcare since her university days. While researching methods for predicting drug efficacy in her undergraduate pharmacology studies, Tomita developed a strong awareness of the importance of personalized medicine when she was undertaking a practicum at a hospital pharmacy. ‘I had many opportunities to interact with cancer patients. In actual medical settings, treatment is first conducted with standard anticancer drugs, and then, when they no longer work, they move onto the next treatment. This approach, however, places a great deal of mental, physical, and financial strain on patients and leads to higher medical costs. I thought that this problem could be solved if drugs could be delivered to individual patients in a tailor-made way from the early stages of treatment. This thought planted in my mind a desire to contribute to personalized medicine in the future.’

With that in mind, Tomita became interested in post-marketing drug development research while searching for post-graduation employment. To deliver to each individual patient the drugs that best suit them, we first need to clarify what kind of patients a particular drug works for and why, before providing medical settings with that knowledge. This is the purpose of post-marketing drug development research and matched exactly with what Tomita wanted to do. ‘In particular, Chugai Pharmaceutical had already clearly declared that it would promote personalized medicine by the time I started my job search, and I had been paying it close attention. When I visited Chugai Pharmaceutical’s research laboratory, a researcher who was involved in post-marketing drug development research told me that they were working to bridge the gap between drug discovery and clinical trials. I felt that I would be able to take on the challenge of rewarding work here, so I applied to Chugai Pharmaceutical.’

The quest for evidence that cannot be obtained from clinical studies

“Post-marketing drug development research” refers to the efforts to offer scientific evidence for events that were observed or that could not be predicted in clinical studies, to develop or “nurture” drugs to make them easier for patients and healthcare professionals to use, safer, and more effective after they have been brought to market. After joining Chugai Pharmaceutical, Tomita was assigned to the Product Research Department, where she is currently involved in non-clinical studies involving an anticancer drug under development. ‘This anticancer drug is in the late stage of clinical development and is under evaluation for patient safety and efficacy, but clinical trials alone are not enough to reveal the complete picture of the drug. My role is to collect non-clinical evidence that cannot be obtained from clinical trials, asking the question “What kind of treatment effects will this drug have on patients with these characteristics?” I then compile the results into articles to impart that knowledge to medical settings.’

Tomita’s specific job is to shed light on questions such as whether combination therapy with a novel anticancer drug can overcome resistance to existing treatments that may have occurred in patients, and if so, by what mechanisms, through experiments using cells and animals. ‘I conduct my studies based on ongoing discussions with my boss and senior colleagues about whether or not the experimental models I have devised are suitable. I always keep in mind the question of whether or not the data I want to obtain from the experiment will really be of value to patients and healthcare professionals. I work on my research not to simply conduct experiments that satisfy my own interest as a researcher, but with patients and healthcare professionals in mind.’

Contributing to medical settings on an “understanding” basis rather than a knowledge basis.

Tomita approaches her work with a repeated cycle of trial and error, constantly considering what kinds of experiments she should conduct on what kinds of themes. ‘I am not yet at the stage where I can deliver my research results to the wider world, but it always makes me happy when my research results are well received at project team meetings, with comments such as that my data will be useful to confirm the efficacy of the drug in patients in the clinical study.’ Tomita says that post-marketing drug development research can contribute to medical settings on an “understanding” basis rather than a knowledge basis. ‘Even if the mechanisms of a drug are not well understood, that drug can still be used if its treatment efficacy can be recognized in clinical trials. On the other hand, if the mechanisms and characteristics of the drug are clarified and the drug is used on patients with an understanding of why this drug works on patients with particular characteristics, more appropriate treatment can be delivered to patients. I gain a strong sense of reward in my research in that respect.’

Answering the question of why a certain drug works on patients with particular characteristics will lead to the kind of personalized medicine that Tomita decided she wanted to make a reality before she joined the company. For this reason, Tomita wants to understand actual clinical research from the perspective of non-clinical research. ‘To promote personalized medicine, the non-clinical research approach, such as precisely identifying the actions of individual molecules and cells in the bodies of patients with various characteristics, is essential. Through involvement in non-clinical post-marketing drug development research, I want to be an employee who is able to contribute to personalized medicine by identifying evidence that will truly be of value in actual clinical trials. I believe that I can become that kind of person at Chugai Pharmaceutical, where each and every person participates actively with a “patient-centric” approach.’

*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.