Deeply impressed by Chugai Pharmaceutical’s quality assurance.

After graduate school, where she conducted research into polylactic acids (PLA)-based biomaterials, Kiriko Kato joined a foreign-owned medical device manufacturer. ‘That company had developed a polylactic acid (PLA)- based implant, and I decided to join that company because I believed that I could make use of my knowledge there. After joining the company, I was assigned to quality assurance of products sold in Japan, but because the product was developed by the headquarters in the United States, we were struggling to reflect feedback from Japanese users. This situation frustrated me, so I started thinking about looking for a new job. I wanted to work for a company that had its own factories that would allow me to be involved in the product lifecycle from end to end.’ With these intentions, Kato’s attention was drawn to Chugai Pharmaceutical as a potential new employer. She was attracted by the company from her unique perspective of having been involved in quality assurance.

‘As part of my job, I often check product recall information posted on the website of the Pharmaceuticals and Medical Devices Agency (PMDA). I saw a notice that Chugai Pharmaceutical had decided to recall a certain product because its cap was hard to open. I was interested in their stance of making this recall decision from the perspective of the drug’s usability, not its quality, efficacy, or safety.’ Chugai Pharmaceutical’s view of quality assurance also struck a strong chord with Kato during her recruitment interview. ‘At an interview with the head of the Quality Assurance Department, they told me that quality assurance should be entrusted to people who can make judgements on scientific grounds with a patients-first approach, and that business should never take precedence. I felt that I would be able to delve more deeply into my ideal of quality assurance, so I submitted my application to Chugai Pharmaceutical.’

Making new rules for medicine in Japan.

In her previous company, Kato worked in the quality assurance of medical devices in the orthopedic field. At Chugai Pharmaceutical, on the other hand, she was assigned to the quality assurance of drugs themselves. This was an unknown challenge for Kato, so in the beginning, there was a sense of uncertainty mixed in with her sense of anticipation. ‘My first assignment was a project related to the Pharmaceutical Quality System (PQS). My mission involved integrating Chugai Pharmaceutical’s and Roche’s respective systems to make them more efficient to operate. For the penetration of the PQS within the company, it was essential to collaborate with other divisions such as the Pharmaceutical Technology Division and Quality & Regulatory Compliance Unit. In this regard, I was able to deepen my understanding of how drugs are produced and about the required quality assurance.’ What she felt immediately after joining Chugai Pharmaceutical was how personable its people were. Everyone is generous toward their fellow team members and always quick to provide abundant support, even for the smallest request. This kind of corporate culture also encouraged Kato to participate actively and make her own mark.

Meanwhile, as well as operating the PQS, Kato was also given a new task, namely the launch of a new business. Chugai Pharmaceutical was working on the launch in Japan of a genomic mutation analysis program developed by Foundation Medicine (FMI), an American company in the Roche group, and Kato was entrusted with building a quality assurance system for the program. ‘This was a medical software program, and neither myself nor Chugai Pharmaceutical had any prior experience of this kind of product. Japan did not yet have the legislation for this kind of program, and it was still not clear whether it would classified as a diagnostic drug or a medical device. Based on our own interpretation gained by reading ordinances and notifications, we negotiated numerous times with the Ministry of Health, Labour and Welfare and the PMDA, and ultimately, the program was approved as a medical device. This assignment was akin to paving the way in as-yet unexplored territory, so it was quite difficult. However, it involved the challenge of working with the authorities to make new rules for the medical industry in Japan, and I felt a tremendous sense of achievement when we obtained the approval.’

Only new challenges await.

Since her third year at Chugai Pharmaceutical, Kato took on the role of Quality Product Leader (QPL) for an oncology drug that Chugai Pharmaceutical has licensed out to Roche. The manufacture of this drug has been outsourced to external contract manufacturing organizations (CMO) in the Unites States, Germany, Belgium, and other countries. Kato’s role involves various tasks, such as gathering information from the staff in charge of quality assurance at the individual CMOs, integrating and managing problems at each manufacturing site, and solving those problems through discussions with Roche. ‘In my third year at the company, I was given the responsible position of leader in charge of the quality assurance of a certain product through global collaboration. As Chugai Pharmaceutical demands a high level of quality assurance, we sometimes find it difficult to make external CMOs understand our thinking, but if we can overcome these hurdles, excellent drugs of better quality can be delivered to patients every day. Making such a situation happen as the norm is what gives me motivation as a staff in charge of quality assurance.’

Quality assurance roles tend to be thought of as establishing and operating systems for complying with laws and regulations, but for Chugai Pharmaceutical, it is not enough just to meet the legislated standards. Every department has a deep-rooted culture of thinking and acting from the essence of the question, “What should we do to improve quality even further?” Kato is delighted that she is able to demonstrate her abilities to the fullest in such an environment. She is also enthusiastic about engaging in new modalities that will emerge one after another in the future. ‘I am working primarily with small-molecule drugs at the moment, but I hope to gain experience in quality assurance of bio-drugs as well in the future. I also want to establish the kinds of quality assurance systems that will be needed for the realization of regenerative medicine and genomic medicine. At Chugai Pharmaceutical, the lack of precedents is not an acceptable excuse (laughs), so I want to contribute to the progress of medicine by taking on new challenges that come my way one after the other.’

* The contents of this article are correct as of the time of interview.