Being the first to witness he birth of a new drug.

Masataka Hirota himself participated in a clinical trial when he was in junior high school. ‘That new drug was extremely effective, and I became extremely interested in medicines and their mysteries.’ In graduate school, he researched mechanisms of action of therapeutic drugs and decided that he wanted to work for a pharmaceutical company after graduation. Chugai Pharmaceutical has concluded a strategic alliance with Roche and has maintained independent management in Japan. He was attracted to the environment in which the company was able to create new original pharmaceuticals itself, while sharing the leading-edge knowledge that Roche has accumulated on a global scale. ‘Chugai Pharmaceutical was the only Japanese pharmaceutical company with this kind of business model, so that aspect had great appeal for me.’

Hirota has been working in regulatory affairs since he first joined the company. Regulatory affairs mainly involves preparing applications for the approval of pharmaceuticals and responding to the review process. ‘I had initially wanted a position in clinical development, but at a Chugai Pharmaceutical company information session, someone working in regulatory affairs said, "In this job, we can be the first to witness the birth of new drugs," and I was very drawn by those words. It struck me that it would be very rewarding to do a job that played a leading role in sending new drugs out into the world. Another reason I chose this job category was that, because regulatory affairs involves dealings with a wide range of divisions, my own horizons would also be broadened.’

No precedents. No role models.

The work involved in regulatory affairs has broadened significantly in recent years. As well as submitting approval applications to the regulatory authority and responding to the review process, it also involves joining a project from the research phase and discussing the issues with the people in basic research and clinical development to draw up an efficient development strategy. They consider clinical trials to verify the safety and efficacy of the product from an early stage and to obtain the information needed for the application. To facilitate consensus building with the regulatory authorities in Japan and other countries and deliver the new drug to patients as quickly as possible, the regulatory affairs staff play a central role in developing strategies for the entire process, right up to the approval of the new drug. The most interesting thing about the job of regulatory affairs, according to Hirota, is that ‘we build roads where there were no roads before.’

‘For example, regenerative medicine has been receiving a lot of attention lately. Our company is also engaged in this research, but when it comes to such a cutting-edge field as regenerative medicine, no guidelines or expertise has yet been built for its development. So, what we in regulatory affairs must do is consider the appropriateness, efficacy, and safety of manufacturing methods and quality control and come up with a development strategy.’ For new domains, they must gather information that will form the basis of guidelines and verify it from various angles. ‘With absolutely no precedents, we pool our wisdom and clear a variety of hurdles before sending out new innovative drugs. It is the ultimate to be able to lead that process oneself.’

Next stop, the global arena.

Lately, the scope of Hirota’s work has broadened even further. He is involved in new drug development aimed at the global market and works on dealing with overseas authorities in Europe, Asia, and other regions. ‘To negotiate with overseas authorities, you need to have a proper understanding of the state of medical practice, legislation, and other factors in that country, so the difficulty of the job is of a completely different dimension. However, overseas expansion is one of Chugai Pharmaceutical’s key themes going forward. I want to be of service expanding Chugai Pharmaceutical’s innovative drugs globally. For this reason, I want to gain experience in regulatory affairs at Roche. Several people are sent to Roche on temporary assignment every year from my department, so I would love to go there too if have the chance.’

In regulatory affairs, there are many difficult times such as when approval applications and the review process do not go well in our dealings with the regulatory authority. However, at such times, Hirota always goes back to that starting point of “for the sake of the patients.” ‘As we work, without realizing it, we tend to place boundaries around our ways of thinking. However, I have realized that, if I place limits on the possibilities, the timing of delivery of our drugs to patients will become more and more delayed. Even if I think something is impossible, I will take the challenge and do what can be done. As my career has progressed, that feeling has become even stronger.’ With a strong sense of mission in his heart, Hirota continues today to confront many different challenges.

*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.