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Someone who works on establishing a quality-oriented culture within the company for the sake of patients

Shuhei Tokiwa

Quality & Regulatory
Compliance Unit
Quality Initiative Dept.
Since 2019

Interest in the “Quality & Regulatory Compliance” position that involves working with many people

Shuhei Tokiwa studied pharmacy at university and was considering a career as a hospital pharmacist as well when he was looking for post-graduation employment. However, having sensed during his hospital practicums that there are still diseases that cannot be cured by drugs, he wanted to play a part in changing that situation, and he decided to apply to pharmaceutical companies. He was particularly drawn to Chugai Pharmaceutical, because he felt that, with its advanced research and development capabilities, it has the potential for significant growth in the future due to its strategic alliance with Roche. He also found Chugai Pharmaceutical’s position of “Quality & Regulatory Compliance” appealing. ‘During my job search, I was initially interested in research and development and considered various companies, but after learning that Chugai Pharmaceutical was recruiting for the specialist position of “Quality & Regulatory Compliance,” it piqued my interest, so I looked into it and I felt this was the job for me.’

The “Quality & Regulatory Compliance” position is one that ensures the reliability of various information about the company’s drugs, including their quality, efficacy, and safety. ‘At Chugai Pharmaceutical’s company information session, they explained that this position of “Quality & Regulatory Compliance” involved working in cooperation with various departments of the company. Interacting with many people expands my world and allows me to have more impact. It seemed like it would be a very interesting job, so that is what I applied for.’ After becoming a member of Chugai Pharmaceutical’s Quality & Regulatory Compliance Unit, Tokiwa was assigned to the Global QA Strategic Planning & Promotion Group in the Quality Initiative Department.

Establishing mechanisms to improve the quality of clinical development

Tokiwa’s main current mission is to assist with the quality of operations of the Clinical Development Division from the Quality & Regulatory Compliance Unit side, viewing that quality as Chugai Pharmaceutical’s quality. ‘In clinical development settings, clinical studies are conducted with the aim of sending drugs out into the world as pharmaceuticals, including patient trials and approval applications made to the regulatory authority. I am working to create mechanisms to improve the quality of clinical development to enhance the reliability of this process. This includes, for example, establishing an environment in which standard operating procedures (SOP) can be prepared to conduct the work without errors, and, if an event occurs in the process that affects the safety of subjects, the root cause will be investigated, and action will be taken to prevent problems in the future.’ This position requires a broad knowledge of clinical development, so Tokiwa has been striving constantly to acquire that knowledge since joining the company.

In drug approval applications, Tokiwa is also involved in the management of responses to compliance reviews by regulatory authorities to determine whether the drug meets the criteria set by the authorities. This work gives him many opportunities to collaborate with Roche. ‘We conduct clinical trials on a global scale for the development of drugs. For drug applications in Japan based on Roche’s clinical trial data, we need to communicate to Roche the PMDA’s and Chugai’s intentions and ask them to prepare the data accordingly. In the approval application phase, we communicate with Roche regularly as we proceed with the compliance review. Although my English was poor when I joined the company, it has gradually improved as a result of frequent participation in these global meetings and by working very hard to communicate in English.’

Making digital technologies another powerful weapon for quality & regulatory compliance

Chugai Pharmaceutical is currently striving to transform the pharmaceutical business with digital technology. Tokiwa is also involved in this moves from the standpoint of quality & regulatory compliance. ‘I am my department’s representative in the Chugai Digital Academy, an in-house initiative to foster digital human resources, where I have received training in data science. Based on the knowledge and insights I have gained at this academy, I am taking on more and more new challenges. Today, real-world data (data relating to patients’ health status collected from daily clinical practice) is attracting attention, and there is a growing movement to use it in the development of drugs. On the other hand, the question is how to evaluate the reliability of this kind of big data, and I have been assigned to lead a task team to consider methods for evaluating that reliability.’ In this way, Chugai Pharmaceutical offers an environment in which junior employees are given a variety of opportunities to grow significantly. Tokiwa sees this as a distinctive feature of the company.

Tokiwa is also planning and introducing robotic process automation (RPA) to improve the quality of operations within the unit and in the other divisions with which he works. There are many opportunities for Tokiwa to make his ideas a reality as long as it is an initiative that will contribute to quality & regulatory compliance. Those ideas have a huge impact on the company and change the way the business is operated for the better. The gratitude and feedback that he obtains from many employees as a result are what motivates Tokiwa. His next goal is to foster an even more quality-oriented culture within the company. ‘Being conscious of the quality of development work on a daily basis will allow us to avoid unnecessary problems and to accelerate the development of drugs. In doing so, we can deliver our drugs to patients more quickly. I will always keep that essential point in mind and work to ensure quality & regulatory compliance.’

*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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