Gerald Unden, General Manager DACH at Shionogi, believes that healthcare leadership begins with giving the patients of tomorrow a voice in the decisions made today. In this interview, he explains why antimicrobial resistance requires a long-term model of innovation, how Germany can help shape sustainable access to reserve antibiotics, and why Shionogi is strengthening its DACH organisation
for future innovation in areas of high unmet medical need. His central message is clear: protecting modern medicine requires scientific commitment, responsible stewardship and policy frameworks that reward innovation before a crisis becomes unavoidable.
What motivated your transition from top-tier strategy consulting into executive pharmaceutical leadership, and how does your background shape your perspective on the healthcare sector?
My career began in strategy consulting (Ernst & Young & successor organisations), where I spent more than a decade working with biotechnology, pharmaceutical and medical technology companies. That experience taught me to evaluate healthcare decisions rigorously: the science, the economics, the organisational implications and, ultimately, the value created for patients.
Over time, however, I wanted to move from advising organisations to being accountable for the decisions myself. In 2014, while working with AbbVie during its corporate separation into Abbott and AbbVie, I was invited to join AbbVie as head of strategy and business development. That marked my transition from external advisory to direct commercial responsibility. During my seven years at AbbVie, I served as head of a leading immunology business in Germany.
Joining the pharmaceutical industry gave me direct responsibility for portfolio choices, commercial execution and patient access. My subsequent roles across biopharmaceuticals and diagnostics reinforced one important lesson: scientific innovation only creates value when healthcare systems can identify the right patients and provide appropriate access.
This perspective continues to shape how I lead today. I believe healthcare leaders must look beyond the patients who are visible in current market data. We must also represent the patients of tomorrow, whose future treatment options depend on the investment, evidence and policy decisions we make today.
That is what attracted me to Shionogi. The company’s long-term commitment to antimicrobial resistance demonstrates a willingness to remain in a scientifically critical field even when the conventional economic model is challenging. For me, this is where leadership and purpose come together.
Despite the commercial challenges associated with the anti-infective space, Shionogi maintains a dual business model that combines continuous investment in infectious disease research with strategic commercialisation. My role allows me to integrate my experience across management consulting, biopharmaceuticals, and diagnostics to advance this commercial framework.
How do you define the strategic mandate for the DACH region, and how does the German market compare to other European territories regarding anti-infective therapies?
My executive responsibility encompasses Germany, Austria, and Switzerland. While Germany represents the largest overall pharmaceutical market in Europe, the volume dynamics for antimicrobial resistance therapies differ significantly from other major European nations due to regional epidemiological variations. Countries such as Italy present a higher prevalence of severe drug-resistant infections, resulting in larger commercial volumes for advanced reserve antibiotics.
However, Germany serves as a crucial platform for market access, pricing evaluation, and upcoming product introductions. The primary mandate for our leadership team is to refine our DACH organisational structure to support our established antimicrobial resistance portfolio and prepare for future expansion into other disease areas where there is high unmet need.
For me, building the DACH organisation is not primarily an exercise in adding structures or processes. It is about creating the capabilities required to identify patient needs earlier, generate the right evidence and translate innovation into responsible access. If we prepare only for the patients and products we serve today, we will always be reacting. Our responsibility is to prepare for the patients who will need us tomorrow.
What is the current operational footprint of Shionogi in Germany, and what structural initiatives are you prioritising?
Shionogi established its corporate entity in Germany in 2019 with a focus on critical antibiotics. That period presented unique market access and operational hurdles. Following an initial consolidation phase under previous leadership, the German affiliate is transitioning out of its start-up stage.
Our current operational priority is to accelerate growth by implementing commercial excellence tools, strengthening customer-centric engagement, and preparing the infrastructure for multi-product commercial launches. We are moving from a single-product model to a broader portfolio, which requires adaptive field operations and enhanced commercial execution.
Industry experts frequently refer to the market for new antibiotics as broken. What structural economic challenges define this therapeutic space?
The paradox is that society wants these medicines to exist but also wants them to be used as rarely and as carefully as possible. That is clinically responsible, but it means that the value of an antibiotic cannot be measured solely by the number of units sold. Its value also lies in being available when other treatments fail, in protecting vulnerable patients and in preserving the ability to perform complex medical procedures safely.
Critical antibiotics against multidrug-resistant bacteria should be understood as part of the infrastructure of modern medicine. Oncology, transplantation, intensive care and major surgery all depend on the ability to manage severe infections effectively.
Their value is therefore much broader than the price of an individual treatment course. They provide a clinical safety net for patients receiving highly complex interventions. If that safety net disappears, the impact will extend far beyond infectious disease.
This is also an example of what I mean by giving tomorrow’s patients a voice. The patients who will need a reserve antibiotic in several years cannot participate in today’s policy debate. Healthcare leaders must represent their future interests now.
How do European market access frameworks for reserve antibiotics compare, and where does Germany stand regarding reimbursement mechanisms?
I do not believe there is a single mechanism that will work identically in every healthcare system. But the principle should be consistent: society must reward the availability and value of critical antibiotics, not merely the volume consumed.
Stewardship and innovation should go hand in hand. Well-designed policy mechanisms- so-called “pull incentives” – can support this by providing sufficient predictability to sustain innovation while supporting responsible and clinically appropriate use of antibiotics.
Europe needs long-term ambition, but it also needs practical national solutions that can be implemented without unnecessary complexity. Patients cannot benefit from a policy mechanism that remains permanently under discussion.
At the moment, different European countries are addressing this market imbalance through distinct national policy frameworks.
In the UK, the National Health Service introduced a subscription-based reimbursement model. This framework provides a fixed annual fee to companies for access to reserve antibiotics, independent of the volume prescribed. This approach offers financial predictability and separates revenues from sales volumes.
In Italy, health authorities established a dedicated national fund of approximately EUR 100 million to finance reserve anti-infectives, removing the direct financial burden from individual hospital budgets.
In Germany, the regulatory framework incorporates specific structural adaptations for reserve antibiotics within AMNOG, the national process for assessing the added benefit and reimbursement conditions of new medicines. First, the health technology assessment submission process for qualifying anti-infectives involves a simplified dossier requirement compared to standard oncology or respiratory applications. Second, reserve antibiotics are granted an assumed additional benefit, exempting them from standard comparative benefit evaluations and allowing manufacturers to maintain agreed pricing structures across the product life cycle.
Why is maintaining investment in reserve antibiotics critical for the broader healthcare system?
The broader systemic value of reserve anti-infectives is frequently underestimated. Modern healthcare technologies, particularly advanced oncology interventions such as intensive chemotherapy and CAR T-cell therapies, rely on effective infection control. Immunosuppressed patients undergoing complex cancer treatments face significant risks from multi-drug-resistant bacterial infections.
Without effective reserve antibiotics as a therapeutic safety net, many advanced medical interventions cannot be delivered safely. In critically ill patients, reserve anti-infective therapy may represent only a small proportion of overall treatment costs while helping safeguard complex treatment pathways, including oncology therapies that may cost several hundred thousand euros. Treating antibiotics strictly as a cost item rather than essential healthcare infrastructure fails to reflect their systemic clinical necessity.
Given these economic headwinds, what is Shionogi’s strategic commitment to the anti-infective market?
Shionogi remains fully committed to the anti-infective space. As a Japanese pharmaceutical enterprise, our corporate philosophy prioritises long-term scientific commitment and patient care over short-term commercial trends. While many major global pharmaceutical companies have exited antimicrobial research and development over the past four decades, Shionogi continues to allocate capital to anti-infective clinical development.
To ensure sustainable operations, we advocate for national policy reforms that incorporate push and pull incentives. In Germany, we engage with parliamentary circles, clinical societies, and health policy stakeholders through initiatives such as dedicated parliamentary groups on antimicrobial resistance. The objective is to transition policy discussions from short-term drug expenditure toward evaluating the long-term economic and clinical value of infectious disease management.
How do you view recent European Union policy developments, such as proposed transferable exclusivity vouchers for priority anti-infectives?
European-level policy discussions regarding transferable exclusivity vouchers represent a positive recognition of the issue, but regional legislative processes move slowly. Highly complex administrative mechanisms may take considerable time to implement. Simple national pull mechanisms, such as those adopted in the UK and Italy, offer more immediate commercial predictability. We remain focused on supporting practical national initiatives in the near term while broader EU legislation develops.
What role does Shionogi fulfil within the medical community beyond product supply?
Because very few pharmaceutical manufacturers maintain active clinical research and development in antimicrobial resistance, Shionogi carries a responsibility to support clinical education, scientific exchange, and real-world evidence generation.
Commercial availability alone is insufficient. We invest in medical science liaisons, investigator-initiated clinical studies, and educational programs alongside key opinion leaders. This ongoing scientific collaboration helps healthcare professionals optimise antimicrobial stewardship and stay informed on emerging resistance patterns.
What strategic role does the DACH region play within Shionogi’s global and European network?
Germany serves as a primary reference market for European product introductions, sequencing, and clinical research engagement. Generating high-quality real-world evidence and early clinical insights in Germany provides useful data for other European markets where market access timelines are longer.
Our objective is to establish the DACH organisation as a centre of scientific expertise and operational excellence. With product introductions planned over the coming years, including expanded anti-infective indications, DACH will play a key role in driving regional strategy.
How are you adapting your commercial operations and internal capabilities to support upcoming product launches?
Preparing the organisation for an expanded portfolio requires introducing rigorous commercial excellence processes. We are updating our hospital account management strategies, customer segmentation, and stakeholder mapping.
In Germany, hospital purchasing and prescription decisions for reserve anti-infectives are governed by hospital antibiotic stewardship committees rather than individual physicians. Understanding these institutional decision-making processes is essential. We are training our key account managers and medical science liaisons to engage with these multidisciplinary committees, providing relevant clinical and diagnostic data to support clinical decision-making.
How do you maintain Shionogi’s corporate culture while expanding your teams in Europe?
Culture is not defined by statements on a wall or values displayed on a website. It is defined by how people behave when they make difficult decisions, engage with customers and work across functions.
I want our teams to combine high scientific standards with personal accountability. That means being transparent about what we know, equally transparent about what we do not know, and always considering the longer-term consequences of our decisions.
My personal leadership purpose is to give the patients of tomorrow a voice. Those patients are not sitting in today’s meeting, and they may not yet appear in today’s market data. But they will live with the consequences of the choices we make about research, evidence, access and organisational priorities.
If our people consistently bring that perspective into their daily decisions, then our culture becomes tangible. Healthcare professionals and partners will notice that we operate with scientific rigour, long-term commitment and a genuine sense of responsibility.
Looking ahead over a three- to four-year horizon, what are your primary strategic objectives for Shionogi in the DACH region?
Over the next three to four years, our ambition is to establish a fully integrated DACH organisation across Germany, Austria and Switzerland. We want to combine strong local market understanding with consistent regional capabilities in medical affairs, market access, commercial execution and patient engagement.
Strategically, we are evolving from a focused anti-infective organisation into a company addressing broader areas of unmet need. These could include areas with complex patient journeys and the necessity for close collaboration between healthcare professionals, diagnostics, patient communities and industry.
Our success should therefore not be measured only by the number of products we launch. It should be measured by whether we build the expertise, partnerships and access pathways that allow meaningful innovation to reach the right patients.
That is the organisation I want us to become: one that performs strongly today while building responsibly for the patients of tomorrow.
What final message would you share with international healthcare stakeholders and industry peers regarding antimicrobial resistance?
Antimicrobial resistance is not an isolated infectious-disease issue. It affects the foundations of modern medicine. Oncology, transplantation, intensive care, surgery and the treatment of vulnerable patients all depend on effective infection control.
Addressing AMR therefore requires shared responsibility. Industry must continue to invest in difficult science. Healthcare professionals must protect new antibiotics through responsible stewardship. Policymakers must create frameworks that recognise the value of having these treatments available, even when they are used sparingly.
My personal leadership purpose is to give the patients of tomorrow a voice. Many of the people who will one day depend on a new antibiotic or future medical innovations are not visible in today’s decisions. They cannot advocate for the research we fund, the evidence we generate or the healthcare structures we build.
We must do that on their behalf. If we wait until the need becomes fully visible, we will already be too late. The decisions we take today will determine which options patients have tomorrow.
