Dreams of doing work that will save lives
from pharmaceutical perspectives.

In July 2018, after more than ten years in development, Chugai Pharmaceutical finally obtained approval from the regulatory authority for a therapeutic agent for malignant lymphoma. ‘It is thanks to the efforts of many that we are finally able to deliver this drug into the hands of patients. Thank you very much.’ Eisuke Ueda made this speech on behalf of the team. There were tears from the team members who had worked together on this project. ‘The path to approval of a new drug can be described as a long journey. Clinical trials pass through many steps as they progress from Phase 1 through to Phase 3. When we received the notification of approval, I was overwhelmed with a deep sense of relief and achievement that we had reached our goal without dropping the baton that our predecessors had handed to us.’ One factor that prompted Ueda to join Chugai Pharmaceutical was that he had relatives who suffered from cancer and rheumatism.

‘Although they were mentally fit, their bodies did not move well. They should have been able to live longer lives, but they have left behind grieving families. Witnessing this, I started to wonder if there was something that I could do, and I decided that I wanted to do a job that saves lives from pharmaceutical perspectives.’ Ueda applied to Chugai Pharmaceutical because of the company’s specific focus on development in the cancer and rheumatism fields and the excellence of its antibody drug technologies. Chugai Pharmaceutical creates new therapeutic agents and is expected to grow further through its strategic alliance with Roche. Ueda believes that he too would be able to grow in such an environment. With this recent approval, one of the dreams that he had when he first joined the company has come true.

Expanding the possibilities of drugs
and patients with a strong will.

The clinical development division to which Ueda belongs is broadly divided into four departments, Clinical Science & Strategy, Clinical Study Management, Biometrics, and Clinical Operation. ‘The Clinical Science & Strategy Department prepares the protocol for a clinical trial and the Clinical Study Management Department conducts the trial according to that protocol. The Clinical Science & Strategy Department then compiles the necessary materials for the approval application, based on the evidence obtained from the clinical trial.’ A protocol is a detailed plan that compiles the purpose of and grounds for the trial, its statistical settings, and how to administer the test drug to what type of patients. ‘The Clinical Science & Strategy Department is mainly in charge of the initial and final stages of the clinical trial, while the Clinical Study Management Department is in charge of implementation of the trial. However, we also respond to inquiries from medical institutions, such as whether or not the setting of the clinical trial is appropriate and whether or not a certain patient is eligible for the trial. As such, both departments regularly coordinate with each other, exchanging opinions along the way.’ Even after the trials results have come through and the approval application has been submitted, the regulatory authority will have various queries. They may ask questions such as “On what points do you think the drug is effective for this patient?” and “Why did this adverse drug reaction occur?” We will build a logical, fact-based response and explain in a way that will satisfy their concerns. It is tough work, but it is also a rewarding part of the job, which comes with a sense of responsibility.’

Chugai Pharmaceutical started developing the newly approved therapeutic agent for malignant lymphoma before Ueda joined the company. ‘For this clinical condition, a competitor’s drug had held the top position among standard therapies (therapeutic agents recommended at that point in time as the best based on scientific evidence) for many years. No other drug had emerged that produced better results.’ Ueda joined the clinical development team in the middle of the process known as Phase 3, in which efficacy and safety are verified. ’The massive volumes of past data showed that the drug had a better therapeutic effect than the competitor’s drug I just mentioned. When it finally entered that final phase, Phase 3, I took over the role of anchor.’ If he were to fail, more than 10 years of hard work would have come to nothing. ‘I felt the weight of my responsibility, but at the same time, I also felt a fighting spirit that “we absolutely must deliver this new drug to patients” begin to grow in my heart. The results were better than those of the competitor’s product, and they were able to deliver more effective drugs to patients. That was also a moment when he felt rewarded for his work.

Dreams of one day developing a therapeutic agent that will cure cancer completely.

Ueda says, ‘If I can be of help to others, I do not care how busy I am.’ He says that the part of the process of designing a research protocol and the trial-and-error approach toward how to observe the results of a clinical trial and how to interpret them gives him a sense of enjoyment that has much in common with his research in university. On the other hand, his passion and ability to concentrate on the pursuit of things is incomparably stronger than when he was a student. ‘If I think of the patients waiting out there beyond my work, I cannot give up easily. We had also aimed to shorten the administration time to relieve the physical burden on the patients, but after repeated negotiations, we had to pass on this idea when we submitted the application for approval. I have long wondered if that was the right call, and we are considering conducting another clinical trial.’

This job requires many things, but ultimately, Ueda believes, “passion” is the most important. ‘We will continue to develop drugs that can extend patients’ lives, and, one day, I hope to be involved in the development of a drug that will cure cancer completely. Creating a world where there no-one needs to suffer because of illness. That is my ultimate dream.’

*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.