Roland Wandeler, general manager of Amgen Iberia, discusses the affiliate’s commitment to innovation, clinical trials, and the importance of providing both medicines and solutions in order to foster a more sustainable health ecosystem for the future of Spain.

You became general manager of Amgen Iberia in 2012, in the middle of a serious decline for the industry. As a company dependent on the sale of new products, how has Amgen been affected by these problems?
All of Spain was deeply affected by the economic crisis: every industry, every household, and every level of government. Governments were under extreme pressure to cut budgets, including healthcare. As a result, Amgen and the rest of the biopharmaceutical industry faced cuts in price and restrictions on access. However, we were able to manage through the crisis better than the market, and better than most other companies. In fact, while sales declined a bit for a couple of years, we actually managed to reach more patients than ever before. In addition, we have created new partnerships with health authorities and healthcare professionals, to identify new solutions to ensure our medicines get to patients, while creating savings in health budgets.
Did you have to take any measures to protect your product launch strategy?
We have changed a number of things at Amgen Iberia, including becoming more efficient in our operations and communicating much more with health authorities. One thing that has not changed, though, is the value proposition of our medicines. We’ve set the bar very high for innovation, and we target serious illnesses with high unmet medical needs. As a result, we have managed to gain approval and access for new medicines and new indications over the past three years.
Spain is still a challenging healthcare environment, with significant cost pressures. This could become an obstacle to innovation, unless government and companies can work together to find new ways to deliver both quality care and sustainable cost. But from our perspective, we have already had some successes in this regard, and we’re determined to keep finding more win-win solutions.
Communication with health authorities and HCPs is quite complicated in Spain given the country’s decentralized nature. How do you ensure that every community is aptly taken care of?
We understand the realities of government cost pressures, and the need to find ways to live within a given budget. The good news is that cost-effective and high-quality care is not contradictory. If you do it right, you can achieve both. It requires our team in each of the 17 regions to bring a passion to their work and look for ways to partner to bring our medicines and solutions to each region.
One example of these solutions is a program called PAR, aimed at patients with chronic kidney disease that are not yet on dialysis. In working closely with nephrologists, pharmacists, hospital managers and authorities in Spain, we are proud as Amgen to have partnered in developing a program that improves care for patients before they go on dialysis, ensuring compliance and correct medication access. This program might cost slightly more in terms of medications, but it may delay the onset of dialysis with its burden for patients, the healthcare system and budget. This is one example in which a good strategy increases the quality of care while ensuring cost saving.
Going to the heart of your question, now we have to do this 17 times. Does this make life easier? Of course not. In a cost-cutting environment, the national government, regions and hospitals are under tremendous pressure to create new ideas to contain costs while still delivering high quality care, which makes the market unpredictable. Much of this containment happens in the short-term, meaning that we are at the risk of saving today in areas that will cost us more tomorrow. Spain has had a great healthcare system in the past, and the biopharmaceutical industry and government need to understand each other and be partners while maintaining sustainability to restore its quality.
In March, Amgen launched a web platform to facilitate the detection of RAS mutations in metastatic colorectal cancer. How has this fared in Spain so far?
We are proud to not only have brought a market-leading medicine for metastatic colorectal cancer to the Spanish market, but also helped to pair it with a biomarker test that selects these patients in a better way. The whole point of our web platform is to ensure that our medicine is used with patients who will be able to benefit – and that health resources are used as efficiently and effectively as possible. Our initiative allows oncologists to order tests for patients and track their progress in the test, to use as an input into their diagnostic pathway. The RAS platform has been implemented together with HCPs and the authorities. Amgen actually pays for this test to ensure patients are treated more effectively, demonstrating our commitment to bringing value to the healthcare system in Spain.
How active is Amgen Spain in participating in clinical trials?
This is one of the key strengths that we have at Amgen Spain. In 2013, we invested €19 million in clinical development and research – a very high figure for a company of Amgen’s size. Within Amgen, we are proud to be one of the leading contributors to our clinical development in Europe. It speaks to the high quality of research, talent and infrastructure in clinics and research labs in Spain. Last year this subsidiary conducted almost 90 clinical trials with innovative medicines, many of them in early phase and on a large scale, involving almost 700 hospitals. We are proud not only of the number but of the quality of this research and engagement of partnership.
What breakthroughs are you expecting in the Spanish pipeline?
We are very excited about our pipeline. Amgen had eight Phase III readouts in the first part of this year. The company will continue to bring important innovation to the market; for instance, we are providing a new mechanism that delivers a new order of magnitude and efficacy to lower LDL cholesterol levels for patients that cannot be treated effectively with existing medicines. In psoriasis, we are developing a medicine with the promise to achieve 100 percent clearance for more patients. When I look at the role Amgen Spain had in the development of these molecules, it makes me very proud. This innovation comes to the market due in large part to the work of the researchers with whom we partnered at various sites. Spain will continue to play an influential role in the development of Amgen’s global pipeline.
Spanish researchers have also been leading in publications that Amgen has written in international peer-reviewed journals. With RAS testing, the corresponding article was co-authored by Spanish researchers.
I believe that the quality of researchers and infrastructure that Spain has is a key asset. The economic crisis has provided an opportunity for people to realize that the biopharmaceutical industry, from startups to clinical research in major companies, can be a true growth engine for Spain’s future. This requires us to ensure that talent continues to be developed and remain here, meaning Spain needs to deliver high-level education. We must also ensure continued investment in Spain, and I hope appreciate the importance of innovation when patients receive it. When all three parts come together, I am very hopeful for Spain. The kinds of jobs our industry can offer are the same that every economy in the world is competing for. Spain is positioned well, but we need to make sure our talent understands that there is a future in Spain.
How important is Amgen Spain to the worldwide organization?
Spain is vitally important. We’re one of the big five European markets, and in terms of clinical research contribution and development one of the leaders in Europe. Given the importance of R&D for a company like Amgen, and the importance that Spain has on the map of R&D, this ranks Spain even higher than just the sales volume we have here.
That said, in my opinion Spain would be a more attractive jurisdiction for future investment and job creation if the business environment were more predictable. This would allow long-term planning for both industry and government, and would create solutions with less duplication and friction. Unpredictability comes at a costs, and in some cases could cause companies to consider investing elsewhere.
How confident are you about the future of Amgen in Spain over the next five years?
I’m very confident. We have an excellent and very passionate team here in Spain. A team that is fully committed and working hard to make our medicines available to patients that need them in our country, and a team that have proven themselves capable of generating innovative solutions and partnerships with governments and HCPs. We will continue to reach more patients with our existing medicines. And over the next five years, we plan to launch a number of novel medicines and new indications that we believe will significantly improve patients’ lives. It’s our mission, we’re good at it, and we’re committed to Spain for the long-term.
 
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