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Episode 4:
Nilima Patel, Kyowa Hakko Kirin Pharma *1

The name of Kyowa Hakko Kirin Pharma, Inc. changed to Kyowa Kirin Pharmaceutical Development, Inc. in April 2016.

Working in safety, reaction speed is absolutely critical. We are always alert and monitoring for serious adverse event (SAE) reports, acting upon them according to the detailed procedures that we have in place to ensure that all necessary actions are taken in the shortest possible amount of time. And monitoring and safety management has to be carried out for every single product going through clinical trials or released to the market. Safety never ends – it continues throughout the life of the product. As long as a patient is using a product, safety data has to be collected and monitored.

The Drug Safety Surveillance team at Kyowa Hakko Kirin Pharma, Inc. (KKP) supports the clinical team and the regulatory team, processing safety data and presenting it at safety review team meetings. Without safety, the clinical trials would be unable to move forward, so it is a key element. The authorities not only want to see efficacy, but that the product is going to be safe when it goes to market.

As a Senior Drug Safety Manager, my responsibilities include maintaining the consistency of safety assessments, ensuring regulatory compliance, analyzing data for trends on a periodic basis, and assisting in performing risk-benefit evaluations to ensure patient safety on our products in every stage from clinical trial to post-marketing within and outside Japan. We also maintain the safety management plans for protocols for which KKP is responsible for SAE processing.

Prior to joining KKP, I was working in safety for prescription and consumer products. I love the dedication and passion of the staff at Kyowa Hakko Kirin (KHK) that brings to market life-saving and life changing products while still maintaining a great work-life balance. This is truly a rare combination that the company possesses.

I am sure that we have all at some point in our lives been touched by a friend or a family member that has had to endure and suffer a life-threating disease, and KHK is a company that is trying to ease the suffering of all of the countless lives that have been affected by debilitating diseases such as cancer or Parkinson’s disease. Last fall a run was organized in support of patients with Parkinson’s disease in Princeton NJ. It was a fun-filled event which was attended by many people including some of my colleagues, our families and friends. It brought many smiles, along with awareness about the disease which is equally important. I think that this is a perfect reflection of the “Commitment to Life” in which it says “Don’t just make medicine. Make people smile, bring light to their lives.” I carry the “Commitment to Life” with me at all times in both my heart and my mind.

Another area in which the passion of KKP staff is seen would be in the will to change the way things are done, to improve processes. When I joined we were still building up the safety team and striving to change the way things had been done in the past, refining and streamlining processes. I felt that the whole team, not only safety but also clinical and regulatory, were on the same page throughout the endeavor.

This is in part thanks to the efforts being made to increase global project communication and transparency. Our president at KKP, Jeffrey Humphrey, has played a major role in this, being closely involved in planning and promoting transparency of what people are working on, reinforcing the feeling that we are all working together toward a common goal. We have also seen the establishment of the One Drug Development Organization (ODDO) bringing together all the worldwide locations to make sure everyone is in step, with our goals aligned, and trying to reach the same endpoint. There are monthly newsletters and town-hall meetings where information is shared, as well as global meetings to ensure everyone is well informed and working in concert in different locations. It is always nice to be kept informed, rather than working without a full understanding of what our colleagues are doing and how their work impacts the entire company or how we can effectively work together.

In safety, we are working to improve our mutual understanding through initiatives such as the global safety review team meetings held each quarter between safety groups in Japan and in Princeton to jointly analyze safety data instead of looking at our respective data in silos. This is a very important step to get an overall picture of the safety data in order to obtain an accurate analysis. We also have regular meetings with the group in the UK to share progress updates on our work.

The passion of the staff is also seen in terms of the mutual support in the company and within individual teams. The fact that I can enjoy such a rewarding career while also raising two children is really important to me. Having a husband that takes care of his fair share of the household responsibilities is also an important aspect that helps to relieve some of the pressure, but the company also allows the flexibility therefore I know that I can handle any unforeseen situation when necessary.

The North American pharmaceutical market is very competitive, but KHK's approach is a strong pipeline where we are dedicated and focused on life-saving and life-changing treatments in broader but targeted therapeutic areas. This is one reason why I believe that KHK will not only succeed but also be very competitive in this market in the future. I feel that KHK is a company like no other out there, thinking about patients first, targeting disease states for relatively small numbers of patients with no treatment available to them. That is the key to our approach of specialization.

Our priority milestones are to obtaining approval for our two main products and successfully launching them in the US and Europe, which I'm very confident that we will accomplish in the very near future. We are well on our way in getting there - it will take hard work and patience, but we have very knowledgeable and experienced team members working diligently to help us reach that goal.

The future looks very bright for KKP with our unique research and pipeline -and I am confident we will but we will reach our goals.


The name of Kyowa Hakko Kirin Pharma, Inc. changed to Kyowa Kirin Pharmaceutical Development, Inc. in April 2016.

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