20-year Astellas veteran Mark Dekker - now back in his home country of the Netherlands and overseeing the Benelux cluster having primarily developed his career in emerging European markets - outlines the strategic significance of the cluster to the company. Benelux is both a source and recipient of cutting-edge biopharmaceutical innovation for Astellas today, although Dekker highlights some of the access issues that need to be ironed out for this positioning to be maintained moving forward.

 

Approaching 20 years with Astellas, a large part of your career was spent in the dynamic but challenging contexts of emerging markets. What attracted you to return home to the Netherlands in 2020 and what have your first impressions been?

Despite being Dutch, I had never actually worked in my home country market during my many years with Astellas; my experience having primarily been built up in finance and general management positions in countries like Romania and Turkey. The speed of change in these emerging markets, the impact that increasing patient access to medicines and healthcare have there, as well as the need for agility and adaptability, prepared me well for operating in potentially more mature and stable environments. I took up the position as General Manager for the Netherlands in July 2020 before this was expanded to include the entire Benelux region in October 2021.

My experience of the market situation in Benelux has thus far been broadly positive, with a reasonable level of predictability, overall high levels of access to medicines and innovation, and the expectations for companies clearly laid out. This should help ensure these systems’ long-term sustainability, although with an ageing population and increased demands on healthcare there is understandably mounting pressure on affordability and thus still work to be done – especially in the Netherlands – on ensuring that the pharma industry is recognized by all stakeholders as a partner in keeping healthcare sustainable and accessible for all in the long term. Additionally, the democratic and collaborative nature of Dutch healthcare whereby many different stakeholders have a say in reimbursement decisions is generally a positive, but it can slow down the process and ultimately prevent patients from having rapid access to new medicines.

 

What was the rationale behind Astellas consolidating its Dutch and Belgian affiliates in 2021 and what have been some of the opportunities and challenges of managing the entire Benelux cluster?

Given the evolution of Astellas’ portfolio in line with our Corporate Strategic Plan 2021 (CSP2021), whereby we aim to launch more products that meet an unmet need and sometimes serve smaller patient populations, it made sense to consolidate the two affiliates to pool resources and knowledge. We are now fully organized, working and thinking as one Benelux organization but with specialized resources in each country where necessary and feasible. This gives us the ability to develop both country-specific approaches as well as engage in co-creation and collaboration between the two countries; the best of both worlds.

Additionally, this consolidation is helping to maximise the impact of our existing portfolio, where there are still significant growth opportunities. Moreover, it is creating a massive opportunity for two experienced and well-established affiliates to learn from each other and inject new energy into our operations. While there are of course some differences between Belgian and Dutch people, this is far outweighed by what we have in common. We are a lot more alike than we think!

 

How important are mid-sized European markets like Benelux to Astellas and what impact is the company’s new strategy, described as “aggressive” by CEO Naoki Okamura, having on performance thus far?

Mid-sized markets, like those of Benelux, are of huge importance to Astellas in Europe. The Mid-Sized Markets cluster has seen very strong performance in recent years, with numbers close to those of the continent’s leading markets, such as Germany. The Benelux affiliate is the biggest contributor to this cluster, thus emphasizing its importance. Growth here is being driven both by our existing portfolio – which continues to bring value to patients and remains a stable source of revenue for the firm – as well as new therapies, some of which tackle smaller patient populations and less prevalent but no less important unmet medical needs in new therapeutic areas, but also in some cases have the potential to reach wider patient groups. These new products in oncology as well as upcoming launches also in areas like women’s health and nephrology represent both a continuation of our existing operations as well as new frontiers.

 

How challenging and exciting is it to be working in a company in growth mode and which is making several strategic external collaborations and acquisitions?

It is an extremely exciting time to be working for Astellas! The company has adopted a ‘Focus Area’ approach to its R&D whereby we examine combinations of biology, modalities, and technologies and apply them to a broad range of diseases with high unmet needs. This allows us to explore innovation from multiple angles and accelerate the pace of discovery and development. Our primary focuses include regenerative medicine and blindness, genetic regulation, immuno-oncology, mitochondria biology, and targeted protein degradation.

On a Benelux level, we have responsibility for laying the groundwork for the later adoption of these innovations, which could come to be completely new options for patients. We also have a role to play in bolstering the reputation of Astellas as a reliable partner for new modalities like one-off gene therapies in the eyes of the region’s authorities and other stakeholders. This process, in turn, should foster the Benelux cluster’s positioning within the company as a good place in which to launch our most cutting-edge innovations and thus ensure access to these possibly groundbreaking therapies for patients across Benelux.

 

Can you tell us a little about your experience, particularly in Belgium, with the company’s oncology portfolio, which is one of the core pillars of Astellas’ strategy?

Astellas currently has three oncology products on the market in Belgium, and our experiences have, thus far, been extremely good. Although oncology was a relatively new therapeutic area for the company, we brought a strong heritage in urology, which provided a good bridge for our prostate cancer therapy in terms of expertise, credibility, and reliability. Belgian healthcare practitioners (HCPs) tend to be open to trying new approaches and using the options available to them, meaning that we have built good buy-in and relationships with them.

In terms of the reimbursement negotiations for this oncology portfolio, our experience is that when NIHDI recognises the added therapeutic value or benefit of a treatment, they will find a way to get it to patients. This has been the case for our therapies in refractory acute myeloid leukaemia (AML) and metastatic bladder cancer, which achieved reimbursement in 2021 and 2023 respectively. However, there is room for improvement in terms of adequately valuing what innovations like these offer patients and the overall healthcare system, as there can sometimes be a one-sided focused on costs without fully recognizing the value that innovation can bring. Not all innovative medicines make it to the market and the patient in Belgium and, as a consequence, the gap between approval and availability is 534 days on average, far behind Germany (133 days) and the Netherlands (294 days). The authorities are aware of these concerns and there is hope that NIHDI’s new medicines roadmap can go some way towards addressing these and ensure higher and faster access to innovation for Belgian patients, by moving the country further towards a value-based healthcare system.

 

Globally, Astellas invests almost 20 percent of its turnover into R&D. Given Benelux’s strong scientific fundamentals and infrastructure, are you advocating for more investment into R&D and clinical trials in your countries despite them sitting outside of the company’s established research hubs in Japan and the US?

The Netherlands is a major (bio)pharmaceutical innovation hub, particularly for biotech, and we strongly advocate its position as ‘Boston by the North Sea.’ Belgium in turn is a country with a strong historic pharma presence and economic footprint, and today stands as one of Europe’s leading countries for clinical trials. It also is home to several biotech clusters that have been successful in bringing new therapies to market. Within Astellas, we are always keen to play up these fundamentals, as well as the consistent positioning of Benelux as the heartland of European pharma – the Netherlands hosts the European Medicines Agency (EMA) and Belgium the European Union (EU) as well as our European industry association, the European Federation of Pharmaceutical Industries and Associations (EFPIA) – to highlight our countries’ attractiveness and hopefully attract further investment here.

An excellent illustration of Benelux’s global significance to the company and its potential for future innovation investments is provided by Astellas’ upcoming women’s health product. The product was developed at the Free University of Brussels before being spun off into a local biotech called Ogeda and acquired by Astellas in 2017. Having already obtained FDA approval, the product is now being launched in the US and will hopefully soon be launched in many further countries including Belgium. Our expectation is that it will be a game-changer in women’s health, and it is internally perceived as one of the most important contributors to CSP21, and all of that fully based on Belgian research. That is why we proudly label this product as ‘invented in Belgium’!

That notwithstanding, there are challenges to and concerns about the competitiveness and positioning of Europe – with Belgium at its heart – as a global innovation hub. These include the slated reform of the EU pharmaceutical legislation which could further decrease Europe’s competitiveness versus innovation hotspots in the US and Asia.

 

Does Astellas currently engage in clinical trials in Belgium?

We do run clinical trials in Belgium and believe the country to possess excellent fundamentals in this respect. However, as mentioned previously, in a context in which European competitiveness is slipping, this requires continuous lobbying and advocacy work. Given Astellas’ historic footprint in Japan and the US, a compelling case is needed to continue to situate research elsewhere, including in Belgium. In many instances, we are able to make such a case, but it can be challenging at times.

 

Where are the growth expectations for Astellas Benelux and which areas would you like to see more resources allocated to?

We continue investing to tap into the growth opportunities present in the Benelux cluster. This is especially true for Belgium, where we see that there is a still increasing number of patients that will benefit from our existing products. Further to that, we of course also prioritize allocation of resources to our recent and upcoming launches of therapies that meet new unmet needs and demands. We have no doubts about committing our resources and funds to Belgium in this manner, as we are confident of the environment of broad alignment between authorities, HCPs, and innovative companies like Astellas on how to progress.

 

Astellas’ former Global Chief Medical Officer Bernie Zeiher has written in PharmaBoardroom about the importance of the ‘patient-defined value’ of medicines to truly meet patient needs. How does Astellas engage with patient representatives in Belgium to better serve patients?

Patient-centricity has long been more than a buzzword for Astellas and today forms a core part of the development, clinical trials, and commercialisation of our medicines. A lot of work has been expended on implementing patient-centricity throughout all our processes and every year we hold a ‘Patient Centricity Month’ to bring the patient voice forward even more prominently.

We continuously engage with patient associations in all our therapeutic areas, and the fact that many of the European-level groups have their headquarters in Belgium allows us to stay at the cutting edge of patient-centricity trends and developments. It is truly part of our DNA.

 

How do you attract talent to Astellas?

While we must admit that a battle for key profiles does exist within the Benelux pharma sector, there are a lot of talented and highly educated people here with drive, commitment, an entrepreneurial spirit, and good levels of English as well as other languages.

As Astellas, we have a certain level of modesty in terms of our achievements, possibly due to our Japanese heritage, but I can safely say that the affiliate has built up a good reputation and a lot of visibility in the areas we are active in over the last few years. Moreover, our people have a true sense of inclusion and belonging, with a strong culture of collaboration and learning, taking pride in the work they do to bring life-changing breakthroughs to patients, which helps us attract the right level of people.

Looking forward, the company’s entry into new modalities and therapeutic areas places it at the forefront of healthcare change, which is a fantastic transformation to be a part of and a key attractor for top-tier talent.

 

Do you have a closing message for our international audience on behalf of Astellas?

Astellas – both globally and in Benelux – aims to be a cutting-edge and value-driven life sciences innovator to realize its vision of turning innovative science into value for patients. We are working to create innovative drugs for diseases with high unmet medical need by identifying unique combinations of biology and therapeutic modalities/technology from multiple perspectives. There is therefore a lot to be excited about as we push forward on these new frontiers in the coming years.