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Someone with his eyes on social development issues as well as drug development.

Takatsugu Narikiyo

Clinical Development Div.
Clinical Study Management Dept.
Since 2006

Putting one’s own interests to use for others.

Takatsugu Narikiyo specialized in the molecular life sciences at graduate school. ‘Just before I decided on my future path, I saw a special on television about biotechnology and I thought, “This is a field that is going to benefit society.” In my research into gene sequences, I was searching for something that triggered basidiomycete growth, working under a professor who was seeking to identify the growth mechanisms of basidiomycetes.’ This research theme also tied into industries such as crop agriculture and aquaculture. ‘I always felt that, if I were to do anything, instead of just pursuing my own interests, I wanted to do something that would connect to and benefit other people.’

That same thought process applied when Narikiyo was choosing an employer. ‘There is a family history of cancer on both my parents’ sides, so I was drawn to Chugai Pharmaceutical, which is trying to create a cancer-resistant society. I applied for a position in Clinical Study Management because I thought it was a job that connected research and sales. It also involves a great deal of interaction with other people, so I thought that it would suit my personality.’ In fact, in his 13 years with the company, Narikiyo has been able to engage in the development of a number of drugs that have been era-changing and drugs that benefit people.

‘So glad to have found this drug.’

His work in Clinical Study Management has both inward- and outward-facing elements. ‘The outward-facing work involves controlling the monitors who deal with the physicians and nurses on the ground and ensuring that clinical trials proceed to plan. I check that the safety of the trial participants is being ensured, that the drugs are being administered according to the protocol (clinical trial plan), and that the data is being evaluated properly, and if anything unexpected happens, I give instructions for how to deal with it, always thinking first of the patients.’ To deliver innovative drugs to patients as quickly as possible, Chugai Pharmaceutical has a Life Cycle Management framework, in which the individual functions, such as research, production, clinical development, regulatory affairs, and pharmaceutical safety, are managed in an integrated manner for each project. ‘Controlling the progress of trials as the “link” between the almost ten internal departments is the inward-facing part of my work. If it does not work well, it can make it difficult to complete the trial and have an impact on the speed of approval.’ There is one assignment that Narikiyo will never forget. ‘At a time when Japan did not have a satisfactory therapeutic agent for melanoma (a type of skin cancer), we developed a drug in Japan that Roche had shown was efficacious overseas.’ There were only about 200 patients in need of this drug in Japan (as of 2011; Chugai Pharmaceutical data), so it would not be viable as a business. Nevertheless, Chugai Pharmaceutical made the decision to pursue it, believing it was needed to contribute to society.

‘The question was how much we could speed up the approval process once we had ensured the drug’s safety. We held repeated discussions within the company about how we could narrow down the cohort and doses to keep the clinical trials to a minimum.’ It was not just within the company. Narikiyo says that they shared their desire to bring an effective therapeutic agent for melanoma to Japan as quickly as possible with the regulatory authority and physicians, and they all worked together on the development. ‘As a result, we were able to deliver the drug to market with exceptional speed, opening up new possibilities for the treatment of melanoma.’ Narikiyo does not normally have direct contact with patients but heard what a certain patient said through the treatment coordinator. ‘A young woman who had deferred her university studies to undergo treatment had her life extended thanks to that drug. She was able to return to her studies and graduate. I heard that her family were so glad to have found that drug. I felt that this had made all of our efforts worthwhile.’

Extend the boundaries of work and solve social issues.

‘Could I help solve the problem of society in that healthy longevity is not the same as average longevity?’ ‘I want to help eliminate pediatric diseases and realize a world in which no parent needs to bury their child because of illness.’ Now in his 13th year with the company, Narikiyo has started to explore the possibility of going beyond his immediate work and stepping into broader domains through drug development or even beyond the boundaries of his occupation. ‘In clinical development, our main goal until now has been to contribute to patients by sending drugs out into the world. However, I think there are so many more things we can do, such as contributing to regional medicine or thinking about Japan’s overall healthcare.’

He gives the example of partnering with local communities to create channels for taking in the opinions of patients. Making use of the latest technology to change lifestyle habits might also help to raise the efficacy of drugs. There is even potential to conduct activities to support patients with intractable diseases and their families. ‘I hope to be able to contribute to society in a way that will make people think, “We’re so glad that Japan has Chugai Pharmaceutical.”’

*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.


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