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Someone who maintains a balance between risk and benefit.

Kumiko Maie

Drug Safety Div.
Pharmacovigilance Dept.
Since 2006

The potential of “safety”.

A pharmacy graduate, Kumiko Maie’s interest in Chugai Pharmaceutical was prompted by its full line-up of products, as well as its extensive development pipelines. ‘I thought that there would be a lot of future potential in such a company.’When she learned about the work of safety at a Chugai Pharmaceutical information session for potential employees, she developed a strong interest in that work. ‘There is a lot of talk about the efficacy of drugs and it is easy to imagine what that area looks like, but it seemed to me that the aspects of drug safety and the risk of adverse drug reactions were not discussed very much in public. I thought it would be interesting to specialize deeply in an area that were still in the shadows.’

This is how Maie ventured onto the path of safety. In her first year at the company, she was assigned to the Safety Data Management Department, where she was responsible for evaluating each piece of safety information collected from the medical institutions and reporting to the Ministry of Health, Labour and Welfare and other agencies. The following year, she was transferred to the Pharmacovigilance Department, where she comprehensively evaluates safety data and, based on the latest trends in medical care, proposes and implements risk management plans. Maie has a passionate heart and is always thinking seriously about how to balance the benefits and risks for the sake of the patients.

Nurturing a global perspective.

Her job in the Pharmacovigilance Department involves obtaining an overall picture of the accumulated data related to safety, and making comprehensive judgments, based on overseas data, literature, and other sources, about whether or not incidents that are occurring are adverse reactions to a drug. If she determines that there is a possible causal relationship with the drug, she develops countermeasures to minimize the risk. As well as these duties, given Chugai Pharmaceutical’s many co-developed products with Roche, she also has frequent dealings with overseas parties. ‘With these co-developed products, we have a division of roles, such that Roche will evaluate the overseas data and develop safety measures based on that evaluation, while we handle the data evaluation and safety measures in Japan and the Asian markets.’

They bring together each other’s data and make comprehensive judgments. ‘At Chugai Pharmaceutical, there are many opportunities for these kinds of global collaborations. Also, because almost all of Roche’s safety officers are physicians, they have extensive medical knowledge, and we also need to know about global regulations, so our own expertise also increases. We hold regular cross-border meetings, so we naturally cultivate an international perspective.’

Facing up to decisions about life.

‘Every day, I am aware of the difficulty of standing between benefit and risk. There are patients with comorbidities or who are pregnant, but who want to use our products. In fact, through the sales and marketing division, physicians often seek our advice about whether they should prescribe a certain product. At those times, after consulting with the life cycle team involved in the products overall and with our in-house medical doctors, we organize and present the information that will enable the patient to ultimately make their own decision. I see this as is one of my most important roles.’As a result of these efforts, Maie has received comments, through the physician, that the information she had provided had helped the patient to decide. ‘When I hear these comments, I definitely feel my work is worthwhile. Day-to-day, I am confronted with e-mails and data, but I know that there are patients beyond that. I need to provide accurate information for the sake of the patient. I try never to forget that.’

Since 2014, Maie has been responsible for managing the safety of investigational products. She sees her next challenge as obtaining accurate information about adverse drug reactions earlier in the clinical trial stage, so pharmaceuticals can be sent out into the world in an even more reassuring condition. ‘Every single piece of safety information helps to prevent adverse drug reactions and to prevent the aggravation of illness. This will help to expand the value of drugs. If we can establish adverse drug reaction management at an early stage, we can make the drug available to more patients. I believe that this is what will benefit the patients.’How to control adverse drug reactions and be of benefit to patients. Benefit and risk. Maie constantly finds herself trying to find a balance between the two.

*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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