Samantha Kingdom, general manager of Amgen Poland, highlights her strategy to be a significant contributor within the Polish healthcare space, while delivering highly innovative products to significantly improve Polish patients’ lives. Furthermore, she highlights the strong commitment of Amgen Poland to remain at the forefront of the clinical trials landscape, the critical importance of the affiliate within the global operations, and the steps required for Poland to reach its full potential in terms of R&D and innovation.

Thus far, what have been the main challenges you have encountered during your time in Poland?

It has been incredibly challenging and rewarding at the same time. I came into Poland with only a little experience of the Polish environment, so I was only able to have a helicopter view of the situation. The challenges have not only been to form a proper business perspective, but also to adapt to the cultural and language differences.

In the business side of things, innovation is still not entirely rewarded in Poland and this remains a challenge for the Polish affiliate. When I took up the role, it was important to set a clear strategy in terms of what we aim to achieve, as we want to broaden the capabilities of our organisation.

We see a very positive future in R&D and biotechnology for Poland, and the current government has put forward a highly ambitious plan to grow these sectors. One main objective for Amgen Poland is to be an active player in the healthcare landscape and a major contributor as an integral part of bringing together key stakeholders in the industry to facilitate this positive biotech approach. Furthermore, we must also remain focused on expanding our current portfolio.

Could you share the affiliate’s evolution in the last two years?

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Many of our current products achieved reimbursement prior to 2012 and are towards the end of their life cycle. Therefore, due to pricing and competition challenges, we are witnessing a commercial decline of these molecules. In the meantime, the healthcare landscape has not allowed us to gain market access for our new innovative therapies yet.

Nevertheless, in recent years we are encouraged by the government´s push to reward innovation to a further extent, and now it is up to us to deliver our new innovative treatments in a manner that demonstrates their value, allowing them to be reimbursed and reach Polish patients. In this vein, Amgen Poland is very supportive of the government´s endeavour to raise healthcare spending.

Looking ahead, next year the future is bright and we will grow based on two clear factors. Firstly, the government has a strong intent to make innovative medicines more broadly available. Secondly, Amgen is building on its trusted heritage in biomanufacturing and is delivering a diverse biosimilar portfolio. We hope that the introduction of these biosimilars to save funds on one end, will allow us to penetrate the market with innovative products on the other end. It is an important time for Amgen Poland.

What have been the main challenges you have encountered in gaining reimbursement?

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It comes down to economic terms. For example, Blinatumomab®, is the first registered immunotherapy for patients with relapsed refractory acute lymphoblastic leukaemia. It is considered an orphan therapy due to the small number of patients it treats and the value it can bring to the patient is significant, though, it has a relatively high cost per patient. We have ongoing discussions with the Ministry of Health on how to implement an outcome based risk sharing agreement. This is a perfect situation to pioneer this approach in Poland and -hopefully – this active dialogue will lead to results down the line.

Additionally, we have some other very exciting products. Kyprolis®, for multiple myeloma, will drastically change the game within this specific therapeutic area in Poland. Also, Repatha® for the treatment of cardiovascular disease in cases that standard care is not sufficient. All these products are critical for patients and now we must actively engage key stakeholders, so they can see the value of such innovation.

Amgen Poland, in terms of patient numbers, is the company´s second largest clinical trials nation in the world. What makes Poland such a great place to conduct clinical trials?

There are three key factors that allow Amgen to be so successful in this R&D area within Poland. Firstly, Poland has world-class clinicians, physicians and scientific experts in many therapeutic fields. Secondly, our clinical trials team performs at an excellent standard. Thirdly, the nation allows access to a large number of patients. These three factors, coupled with our team´s ability to meet trial timeline and quality expectations, make Poland a great destination for Amgen’s clinical trials.

Nevertheless, it would assist our operations if the administrative processes were streamlined. At present, we predominantly run phase-3 trials, and we are very excited to soon commence a phase-1 study. Although, to continually run more phase-1 studies, it is imperative to make the administrative system simpler at a legislative level, which will in turn make the Polish environment even more favourable from our HQ´s perspective.

What is the strategic importance of Poland for Amgen regionally?

Critically important! We are a large hub that supplies a lot of critical data from our 34 ongoing clinical trials, in Poland. Furthermore, we are often a rescue destination; meaning, because we are excellent at recruiting patients and obtaining results, often if recruitment timelines are not met elsewhere, Poland will take on additional trials.

Attracting clinical trials from headquarters is a competitive process. How does Amgen Poland continue be a preferred destination for the company to invest?

First and foremost, our team must continue to perform operations at a high level. I must be actively communicating to Amgen global the amazing potential and untapped opportunities that exist in Poland.

Additionally, increasing our footprint in phase-1 trials is a significant step. Once HQ notices that these trials can be performed at the same quality and output as other countries, we will attract their attention even more. This is heavily related to Amgen Poland´s growing importance with key stakeholders and our role in the nation´s push for an improved R&D and biotechnology ecosystem.

In your career you have worked in Australia and Switzerland. How do you blend these differing cultures with the Polish approach?

Despite the differing cultures, for me being an outsider it has been important to be adaptable and flexible in my approach and appreciate the differences. I attempt to be open, transparent and approachable in all situations. I believe that creating a relaxed workplace that encourages curiosity is a great way to establish a harmonious team environment.

What are your objectives in the next two years?

Definitely, to have Blinatumomab® and Kyprolis® reimbursed. Furthermore, we want to introduce biosimilars and see Poland reinvesting the savings generated via these biosimilars into innovative drugs. Moreover, Amgen Poland must continue to be a significant contributor within the Polish healthcare ecosystem, so Polish patients are able to receive our life-changing therapies.