Read the Conversation
Meeting highlights:
- Germany’s Role for Amgen: Second largest market outside of the US, first-launch market with immediate access to innovative therapies, key for R&D with Amgen Research Munich (ARM) for BiTE-platform technology, a pioneering approach in bi-specific T-cell engagement.
- Amgen’s Portfolio & Pipeline: Oncology (six cancer therapies - some based on BiTE technology), Cardiology (addressing one of the leading causes of death in the country), Osteoporosis (over 6 million patients in Germany), Inflammation, entering Rare Diseases with the acquisition of Horizon Therapeutics, and Biosimilars.
- Evolving Pharma Landscape in Germany: After a period of losing competitiveness and the introduction of the SHI Financial Stabilization Act, there was a difficult environment for innovation; with the launch of the National Pharma Strategy, the innovative pharma landscape in the country is heading again towards a more promising future.
- AI & Innovation: Amgen is a pioneer in merging bioscience and technology, investing in AI solutions / Collaborations with NVIDIA, DeepMind, and AWS to reduce the time to clinical trials, and Freyja, a supercomputer to analyze massive genetic datasets, predict protein structures, and optimize drug development.
- Amgen Attracting & Building Talent: Recognized as a Top Employer due to its commitment to diversity and inclusion, enhancing skillsets, and flexible workspace.
EF: What attracted you to the pharmaceutical industry, and what attracted you to join Amgen?
MH: First of all, I was drawn to the pharmaceutical industry because it is a cutting-edge, scientifically based sector with a lot of promise for the future. The fundamental motivation is to benefit humanity by giving them a better, healthier, and longer life, which truly appealed to me. For this reason, I began working in the pharmaceutical biotech sector shortly after graduating from university. Before Amgen, I had the chance to work for three companies, all of which were at the forefront of science and innovation. With Amgen’s innovation focus and deep-hearted mission, ‘To serve patients, ’ I found the perfect environment to lead their second biggest market. Shaping our pharma-political environment to the benefit of fast access to innovative medicines is an incredible opportunity.
EF: How do you assess the current environment in Germany following the key legislative changes, and how has Amgen's work been affected by the recent legislative changes?
MH: Germany has traditionally profited from the cutting-edge pharmaceutical sector; thus, this sector is significant to our country's economy. However, Germany lost its competitiveness over time compared to the USA and Asia Pacific. Due to budgetary constraints, the health ministry at the time introduced the Statutory Health Insurance Stabilization Act, which had three main components: first, they introduced additional AMNOG "guardrails"; second, they increased the mandatory rebates by 5% for 2023; and third, they introduced a combination rebate of an additional 20% for all medications that will be applied in combination therapies. This fundamentally undermined an innovation-friendly environment. While it did save some money to some extent, in the short term, it sent devastating signals and made innovation much more difficult, creating a hostile and constrictive environment for pharmaceutical companies in Germany.
Under the leadership of vfa (Verein forschender Arzneimittelhersteller), the entire innovative pharma-/biotech-industry aligned on key messages of the detriment consequences for Germany to then engage in a constructive dialogue with legislators and informed them of the consequences if they persisted in these innovation-hostile policies. Based on the various feedback from Headquarters, the government realized that it had gone too far. We noticed improvement and earned credibility.
Since we achieved a better understanding of the interlinked consequences of health, innovation, and economics policy, the federal government of Germany finally started to recognize that the innovative pharmaceutical and biotech sector is one of the few strategically significant industry pillars for the first time. Through their Pharma Strategy, the federal government highlighted eight distinct activities that will not only improve the state of our industry but also increase our competitiveness in terms of clinical research and prevention. These activities include, but are not limited to, enhancing clinical research, reducing bureaucracy, and utilizing digitalization. Overall, despite the difficulty we faced in 2023, the government realized they needed to make changes because they saw us finally not only as a cost factor in the health sector. They saw us as an important contributor to and access to innovation in conjunction with academia and clinical trials, as well as the economic contribution our industries bring to the country as an industry.
EF: Could you briefly describe Amgen's presence in Germany and the country's strategic importance to Amgen as a global organization?
MH: Germany is a country in which innovative pharmaceutical treatment options are launched first in general. Therefore, this has an elevated strategic value in the pharma sector, as well as for us as Amgen with headquarters in the United States. This essentially ensures instant access to innovation and innovative treatments for patients in Germany. Founded in 1980, Amgen is considered the world's largest independent biotech company. First and foremost, Amgen's primary goal is to thrive on a global scale by leveraging biology and technology to truly address some of the most difficult diseases around the world. In Germany, we have clustered our portfolio and medical offerings into four big therapeutic areas: oncology and hematology, cardiology, bone and inflammation, and rare diseases.
These pillars are focused on discovering medications that would ultimately improve humanity by enabling patients to live longer, better, and more fulfilling lives.
As we dug deeper into oncology and hematology, we pioneered cancer treatments that specifically target one of the most difficult diseases in the tumor area. Among these is the bispecific T-cell engager technology platform called BiTE. This research site is also based here in Germany, south of Munich. Due to its longstanding research focus on BiTE technology, Amgen Research Munich is one of our major research centers. They employ T cells, which are one of the body's natural defense cells. These cells occasionally lose their ability to target tumor cells. Yet, with a bi-specific approach, the T-cells restore their ability to identify, target, and eliminate cancer cells. Through this innovative approach, one first-class medicine provides exciting results in ALL, and another has already been approved for small-cell-lung cancer in the USA and is currently in the approval process with EMA.
Another crucial therapeutic area is cardiology, which is among the most prevalent diseases in our society. For instance, cardiovascular diseases have been responsible for around 350,000 fatalities in Germany last year. By addressing the main risk factors for heart attacks, such as LDL cholesterol regulated by PCSK-9, the likelihood of heart attacks, strokes, and other cardiovascular events can be significantly reduced. According to the WHO, osteoporosis is another significant area where there is still a high level of undertreatment leading to fractures. Approximately 6,000,000 German patients, mostly women, remain untreated, representing a sizable fraction of the population. Our medicine significantly reduces the risk of fractures with a bi-annual therapy. Another key therapeutic area is rheumatoid arthritis and Crohn's disease, which affect millions of people in Germany.
The recent acquisition of Horizon Therapeutics allowed Amgen to access the highly unserved new field of rare diseases, which complements our existing portfolio very well. Rare diseases make up the fourth pillar. Rare diseases only affect a small percentage of patients—less than five out of 10,000 are affected by a special disease.
As one of the pioneers in biotechnology, Amgen is one of the key experts in efficiently manufacturing biologics. Hence, biosimilars complement our portfolio within the identified four therapeutic areas. Amgen, therefore, offers further options for more affordable options each time a respective patent of a biological medicine expires.
EF: Do you, as Amgen, see a clear road ahead for bringing also rare disease treatments to market in Germany?
MH: Yes, we do. However, based on the very low patient numbers, it is often difficult or even impossible to find the appropriate comparator treatment in the clinical development programs. Hence, in collaboration with our pharma association vfa, we are attempting to modernize the AMNOG methodology, which has demonstrated value for more than a decade. Particularly for gene and cell therapy, the current AMNOG philosophy will have to evolve if patients in Germany will still benefit from early access to these innovations.
EF: The topics of AI and technology are hotly debated. How can you concentrate on practical, helpful uses of technology to improve your workflow and ultimately help the patient?
MH: Our organization has always relied heavily on innovation, which will support our mission ‘To Serve Patients.’ Internally, we consider it to be one of those pivotal times when our industry can benefit from combining both technological and biological innovation. We are currently focusing on merging these two technologies. We have also had the good fortune to collaborate for years with companies that specialize in artificial intelligence, such as OpenAI and Microsoft. As a result, we aim to use this technology to accelerate innovation throughout our entire value chain.
As a company, we completely embrace technology, and we have been making significant investments in data science, artificial intelligence, and other technologies for years. Our goal is to develop next-generation medications with the greatest possible impact. For instance, we discovered that AI will fundamentally change the way we conduct business along the whole value chain. We have already reached a point in the lab where we can significantly shorten the time for research and clinical development.
For this reason, Amgen has also developed a supercomputer named ‘Freyja’ in collaboration with NVIDIA. It's located at Amgen's deCODE genetics headquarters in Reykjavik, Iceland. It will assist our organization in analyzing the vast amount of data.
In addition to being on a learning curve, the staff has embraced AI wholeheartedly. To learn and use these tools as effectively as possible, we are adopting programs like Microsoft Co-pilot and ChatGPT, for instance, and rolling them out to approx. 20,000 people. This effort will help us to improve and accelerate business procedures with fewer resources.
EF: Do you have any partnerships or plans in place to prioritize the patient?
MH: Our innovation and omnichannel expert team focuses on improving patient services and patient programs. The innovative medicine combined with the appropriate patient support programs that mostly operate online ensures the best possible treatment outcome for patients. We, therefore, apply a holistic approach. This valuable combination is offered in all key therapeutic areas where patients can derive a significant improvement.
EF: How can you not only attract but also hold on to the greatest talent Germany has to offer in such a competitive sector for innovative technology and bio-pharmaceuticals?
MH: Amgen’s long-standing mission, ‘To Serve Patients,’ is deeply embedded in everything we do. This also informs our well-considered talent strategy and provides all talents with a deeper, fulfilling purpose. Critically important to us is also the emphasis on belonging, diversity, and inclusion. Our company's culture of empowerment, trust, and confidence—the fundamental values we uphold—is crucial, and we hope to capitalize on the variety of skills we possess. We also regularly perform horizon scanning, which helps to identify important macro trends and specific needs we as an organization may need for the future.
At the same time, we consider how we can help all talents in our organization grow by improving their skill set, educating them, and developing them in a meaningful way. We aim to determine how we may attract those individuals not just with our portfolio but also with how we collaborate with them and strive to maximize both the hiring process and growth phase assistance. Women in leadership positions are something else on which we place an adequate focus. Our organization's women in leadership initiatives are supported and strengthened by a variety of talent development programs.
All things considered, Amgen is often regarded as one of the best employers in various countries. This speaks to the quality of our work across all of our programs and the way we value diversity in our workforce. Additionally, our flexible working philosophy has set us apart from others. We wholeheartedly support the notion that employees can work from home or the office wherever they are most productive. At the same time, we defined cross-functional days in which we recommend office attendance to get the most productive results out of strategic reflections or cross-functional collaborations. Our employees value this approach highly since we have full confidence that they will manage their time effectively as we are primarily focused on the results. This provides us with an additional advantage in a talent market.
EF: As Amgen approaches its 45th anniversary, what message would you like to convey to your staff as you reflect on your achievements in Germany and approach this milestone?
MH: Amgen is an amazing company that has demonstrated over the years and decades that we truly place innovation at the forefront with discovering first- or best-in-class medicines in therapeutic areas of high unmet medical need. Let’s together embrace our unique moment to maximize innovation by applying artificial intelligence across all of our key business processes to accelerate processes or achieve results more efficiently. At this point, we are on a great path; the groundwork is solid, and we anticipate a bright future.
