Creating drugs that are tailored to the individual.

‘I have to enjoy where I am right now!’ This is the kind of super positive outlook that Nao Okino possesses. What prompted her interest in her current work of clinical development was her long-held interest in individualized medicine, in which treatments are tailored to the individual patient. ‘As a pharmacy student, I had a strong desire to pursue the genetic-level approach, which was one method for achieving individualize medicine.’ The reason behind this lay with Okino’s family. ‘My mother is extremely sensitive to medicines and finds that marketed pharmaceuticals have an excessive effect on her. This prompted me to want to plan and consider medicines that are tailored to the individual from the development stage.’

‘I am happy to have been able to work on the same drug since I joined the company,’ says Okino. The drug she is assigned to is a therapeutic agent for diabetes. ‘I have been involved since the Phase 1 trials and I feel as though I have trod the path of the drug’s development process along with it.’ There are expectations that this drug that Okino is working on will have a new mechanism of action and it is attracting a great deal of attention in the diabetes domain. ‘Because it depends on blood glucose concentrations to stimulate insulin secretion, this drug offers a new mechanism in which insulin is secreted only when blood glucose levels are high.’ As she talks, Okino’s eyes are shining in her excitement about the process by which a new drug develops.

‘Is the trial really ending?’

In her work on clinical trials, Okino feels happiest when she hears the doctors praising the drug as good and effective. Of course, the outcomes of the treatment are evident from the data. However, Okino says that hearing what the doctors and patients really think is a special joy. ‘We don’t meet the patients directly. Even so, when I hear that the patients were happy with the treatment or that patients who have seen their own data sound disappointed at the prospect of the trial ending, saying that they want to keep going, it makes me think that we have to develop the drug quickly and get it approved.’ Being able to create a drug that many people are waiting for anxiously must be the ultimate happiness for a clinical developer.

‘In clinical trials, as well as developing outstanding drugs, we also need to give a lot of thought to how they can be used safely,’ says Okino. The mission of clinical development is not only the development of drugs, but also the proper acquisition of safety information, such as adverse drug reactions. ‘When patients are actually administered a drug and an adverse reaction emerges, we do worry. Data on adverse drug reactions is critical information for clinical development, but it is hard on the patients. The therapeutic agent for diabetes that we are developing at the moment sometimes has vomiting as an adverse reaction, so it is important that we identify how that vomiting presents and in what kind of patients from the development stage. To do this, we consult with the doctors and proceed with the trial while considering follow-ups with the patients. That task of obtaining information about adverse drug reactions for the sake of the many patients who are out there, waiting for this drug to be developed, is a constant battle with that kind of dilemma.’

A little treat.

As Okino says, the sense of achievement and excitement that wells up when a task has been successfully completed is irreplaceable. When she encounters those moments of excitement, she gives herself “a little treat.” ‘In clinical development, our work comes in large and distinct waves, so when those waves peak and broken the back of a task, of course, we get excited. At times like that, I usually buy a slice of cake and eat it by myself or treat myself to a slightly fancy dinner. Recently, when I had finished submitting a notification of clinical trial plan, I bought a lot of cake and took it home to my parents’ house. I reported to my parents, “I did it!”‘ They both understand how tough my job is, so they welcome me warmly.’

Ever since she was small, Okino was praised as being a child who took in the situation around her and did what needed to be done. In the workplace, the word is that she “has a loud, clear voice.” ‘One thing that made me happy recently was when a senior colleague said that I had shin in Japanese. I’m embarrassed to say this myself, but this colleague said that what they meant by that word, shin, was three-fold - conviction, backbone, and new. I was so happy. Next, I want to increase that shin to the further meanings of sincerity and heart. I feel every day that it is important that I act with sincerity and heart to gain people’s trust.’ In her goal to be the ultimate professional, someone who others can entrust with a task with peace of mind, and who can be relied on when it comes to the crunch, Okino keeps pressing forward in her bright, cheerful way.

*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.