Professor Gerd Geisslinger serves as Chair of Clinical Pharmacology at Goethe University Hospital and as Executive Director of the Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP), which is part of the Fraunhofer-Gesellschaft, Europe’s largest organization for applied research.
Fraunhofer conducts application-oriented research across a broad spectrum of scientific and technological disciplines. ITMP is one of six Fraunhofer institutes dedicated exclusively to health research. Established in Frankfurt am Main in 2021, the institute has rapidly expanded its presence with additional research sites in Hamburg, Berlin, Göttingen, and Munich/Penzberg, while new groups are currently being established in Heidelberg and Düsseldorf. At each location, ITMP works closely with leading universities, university hospitals, and industry partners, particularly within the pharmaceutical sector.
The institute’s strategic mission is to build a unique national network of translational expertise focused on immune-mediated diseases, including autoimmune disorders, chronic inflammatory diseases, allergies, infections, and immunodeficiencies. Given the substantial unmet medical need in these areas, ITMP collaborates with academic and industrial partners to advance innovative approaches for the early detection, diagnosis, prevention, and treatment of immune-related conditions.
To achieve this goal, ITMP brings together expertise across the entire biomedical innovation pipeline. Its technological capabilities span from target identification, drug and diagnostic development, and high-throughput screening of compound libraries to comprehensive preclinical and clinical evaluation of therapeutic candidates. More recently, the institute has also established strong competencies in AI-enabled drug discovery and development, including the application of large language models, foundation models, and agentic AI systems to accelerate biomedical research and innovation.
The Fraunhofer/vfa R&D 2035 policy paper suggests that translational medicine is “one of the greatest weaknesses of pharmaceutical R&D in Germany”. For a country with such a strong tradition in both basic research and pharmaceutical development, why has this gap emerged?
Together with our partner vfa, the German Association of Research-Based Pharmaceutical Companies, we sought to identify the key factors contributing to the so-called “valley of death” in pharmaceutical development in Germany. We therefore analyzed a range of parameters along the translational pathway and benchmarked Germany against other leading innovation ecosystems.
Our findings revealed that Germany possesses considerable strengths but also several structural weaknesses. Most importantly, there is a lack of a seamless, end-to-end translational process that efficiently connects basic discovery with clinical application and commercialization.
For example, Germany continues to lag behind countries such as the United States and Spain in patient recruitment for clinical trials, an essential prerequisite for rapid clinical development. Another critical challenge is the persistent gap between academia and industry. Many universities and public research institutions remain strongly focused on basic research, while translational projects often receive less recognition. Since translational research typically leads to fewer publications in high-impact journals, it is often not sufficiently rewarded within the current academic career system.
Organizations such as Fraunhofer together with start-ups can play a crucial role in bridging this gap. However, many promising translational projects struggle to secure the long-term funding required to advance innovations from the laboratory to the patient.
In my view, the most significant bottleneck is the fragmented funding landscape. Germany has separate funding mechanisms for basic research, translational research, and clinical development, but these programs are often insufficiently coordinated and frequently lack the long-term strategic commitment and scale needed to support continuous development across the entire innovation pathway.
To fully capitalize on Germany’s outstanding scientific excellence, we need a more integrated translational ecosystem—one that aligns incentives, strengthens public-private partnerships, and provides sustained support from discovery through clinical validation and ultimately into patient care.
And how can this gap best be closed?
In our strategy paper “Pharma R&D 2035 – Germany’s Innovation Framework for the Future”, developed jointly with vfa, we outline a number of concrete measures to strengthen Germany’s translational ecosystem. These include investment in research infrastructure, the expansion of public-private partnerships, faster and more innovation-friendly regulatory processes, and a stronger commitment to digitalization and data-driven research.
Ultimately, however, the key requirement is the establishment of a seamless end-to-end innovation pathway supported by continuous funding and an efficient regulatory framework. Today, basic research, translational development, and clinical research are too often funded and managed in separate silos. What is needed instead are integrated program structures that connect these stages through a common strategic roadmap and enable promising discoveries to progress without interruption from the laboratory to clinical application.
At the same time, regulatory processes should be streamlined and accelerated through greater harmonization, standardized procedures, and the early involvement of regulatory experts throughout the development process. This would reduce delays, increase predictability, and make Germany a more attractive location for pharmaceutical innovation.
In my view, the most effective way to achieve these goals would be the creation of a national translational alliance that brings together all key stakeholders—funding organizations, universities, research organisations such as Fraunhofer, healthcare providers, industry, and regulatory authorities. Such an alliance could establish formal collaborative networks, provide professional project management across the entire value chain, coordinate priorities through regular strategic exchanges, and deploy targeted funding instruments to support the most promising scientific and technological innovations.
By creating a truly integrated translational ecosystem, Germany could significantly accelerate the journey from scientific discovery to patient benefit and strengthen its position as a leading global hub for biomedical innovation.
Last year Fraunhofer broke ground on a new location, in partnership with LMU Munich and Roche, focused on pandemic preparedness and diagnostics. Could you tell us more about this initiative?
Absolutely. In 2021, Fraunhofer, Roche, and Ludwig Maximilian University of Munich (LMU) launched a strategic partnership to strengthen research and innovation in immunology, infectious diseases, and pandemic preparedness. Supported by substantial investments from the Free State of Bavaria and the German Federal Government, we are currently establishing a new Fraunhofer research location of ITMP on Roche’s campus in Penzberg, one of Europe’s leading biotechnology hubs. On July 13, we will celebrate the topping-out ceremony together with distinguished representatives from government, science and industry.
The new facility is designed to become a leading center for translational research in pandemic preparedness. We will develop next-generation diagnostic technologies capable of rapidly detecting, characterizing, and monitoring emerging pathogens. At the same time, we will work on innovative therapeutic approaches and deepen our understanding of the immune responses that determine the course and severity of infectious diseases.
Beyond responding to future pandemics, the center will also contribute to advancing precision medicine by integrating cutting-edge technologies in diagnostics, immunology, data science, and AI-driven biomedical research. Our goal is not only to strengthen Germany’s preparedness for future health crises but also to establish a sustainable innovation ecosystem that accelerates the development of diagnostics and therapeutics for infectious and immune-mediated diseases.
What was the rationale behind choosing this field?
The decision was strongly influenced by the lessons learned during the COVID-19 pandemic. In May 2020, Roche was among the first companies worldwide to launch a diagnostic test for SARS-CoV-2. These tests were manufactured in Penzberg and played a critical role not only in tracking and managing the spread of the virus, but also in enabling the rapid generation of clinical and epidemiological data that supported the development of highly effective vaccines within the same year.
The pandemic also demonstrated that no single organization can successfully address a global health crisis alone. Effective pandemic preparedness requires close and coordinated collaboration between public health authorities, academic institutions, research organizations, start-ups, diagnostics companies, and pharmaceutical manufacturers. The unprecedented speed with which diagnostics, vaccines, and therapeutics were developed was made possible by such partnerships across sectors.
For Fraunhofer, this experience highlighted the importance of creating sustainable structures and capabilities that remain in place long before the next health emergency occurs. Strengthening our expertise in infectious diseases, immunology, and advanced diagnostics therefore became a strategic priority. The partnership with Roche and LMU provides an ideal framework for this ambition, combining scientific excellence, industrial-scale expertise, and direct access to clinical research and patient care.
Beyond pandemic preparedness, the technologies and knowledge developed through this collaboration will also have broad applications in other areas of medicine. Rapid diagnostics, biomarker discovery, immune profiling, and AI-supported data analysis are increasingly important for the prevention, diagnosis, and treatment of a wide range of infectious and immune-mediated diseases. In this sense, the initiative is not only an investment in future pandemic resilience, but also in the next generation of precision medicine.
How does it match Germany’s and Fraunhofer’s existing expertise?
This initiative builds on some of Germany’s most significant strengths in biomedical research, clinical medicine, and pharmaceutical innovation. Fraunhofer’s role is to bridge the gap between scientific discovery and real-world application, and we do this through close partnerships with leading universities, university hospitals, and industry partners across the country.
LMU University Hospital is an excellent example. It was among the first institutions in Germany to treat COVID-19 patients and quickly became one of the country’s leading centers for clinical research and patient care during the pandemic. At the same time, Roche’s site in Penzberg played a pivotal role in the development and large-scale production of diagnostic tests. Fraunhofer contributed its expertise in translational research, technology development, and the integration of multidisciplinary competencies. Together, these complementary strengths created an ideal foundation for a strategic partnership in pandemic response and preparedness.
The collaboration also reflects Fraunhofer’s broader mission of building innovation ecosystems that connect academia, healthcare, and industry. Pandemic preparedness requires expertise across many disciplines—from immunology, virology, diagnostics, and data science to clinical research, regulatory science, and manufacturing. No single institution can cover this entire spectrum on its own.
As a result, the original partnership has evolved into a much broader network. Today, additional academic, clinical, and industrial partners are involved through the Pandemic Alliance Munich, a cluster initiative supported by the Free State of Bavaria. The alliance brings together a unique concentration of interdisciplinary expertise with the common goal of strengthening preparedness for future infectious disease threats and accelerating the development of innovative diagnostics, therapies, and preventive strategies.
Importantly, the capabilities being established will not only enhance resilience against future pandemics. They will also advance research and innovation in a wide range of infectious and immune-mediated diseases, creating long-term value for patients, healthcare systems, and society as a whole.
You have proposed the creation of a “Translational Alliance” between research institutes such as Fraunhofer, universities, and pharmaceutical companies in Germany that would not be limited to commercially attractive disease areas. Why is such a model needed?
The idea of establishing a Translational Alliance is one of the central recommendations of our strategy paper “Pharma R&D 2035 – Germany’s Innovation Framework for the Future,” which we developed jointly with the Association of Research-Based Pharmaceutical Companies (vfa).
The rationale is straightforward: while Germany has world-class scientific research, excellent universities, and a strong pharmaceutical industry, these strengths are still too often disconnected. As a result, many promising discoveries fail to progress efficiently from basic research to clinical application and ultimately to patient benefit. A Translational Alliance would help to overcome these barriers by creating a coordinated, end-to-end innovation ecosystem that brings together funding agencies, academia, Fraunhofer, industry, healthcare providers, and regulatory authorities within a structured public-private partnership.
Such an alliance would do much more than simply connect stakeholders. It would provide professional project management across the entire value chain, facilitate the sharing of expertise, data, and infrastructure, establish common priorities through regular strategic coordination, and ensure that the most promising projects receive the targeted support required to advance successfully through the translational pipeline.
Importantly, this model would also enable Germany to address diseases and health challenges that may not represent an immediate commercial opportunity but nevertheless impose a significant burden on patients and society. Areas such as rare diseases, emerging infectious diseases, antimicrobial resistance, and certain chronic immune-mediated disorders often require long-term investment and close collaboration between public and private partners. These are precisely the kinds of fields where a coordinated translational approach can create substantial public value.
More broadly, we believe that cooperation and coordination are far more effective than fragmentation and competition when it comes to addressing complex healthcare challenges. By pooling resources, infrastructures, scientific expertise, and clinical capabilities, a Translational Alliance could accelerate the development of innovative therapies and diagnostics, reduce duplication of effort, and strengthen Germany’s position as a leading hub for biomedical innovation.
Ultimately, the goal is not only to generate scientific breakthroughs, but to ensure that these breakthroughs reach patients faster and more reliably. That is the true measure of success for translational medicine.
And in which areas—such as rare diseases, antimicrobial resistance, or vaccines—could it have the biggest impact?
The translational gap is not limited to specific disease areas. As we discussed earlier, it affects not only conditions with limited commercial attractiveness but also highly innovative approaches that carry significant scientific, regulatory, or development risks. For this reason, we envision the Translational Alliance as a disease-area-agnostic platform, open to the most promising innovations regardless of the therapeutic field.
That said, the alliance could have a particularly strong impact in areas where the societal and public health need is high, but where traditional market incentives alone are often insufficient to support development. Examples include rare diseases, antimicrobial resistance (AMR), pandemic preparedness, emerging infectious diseases, and certain chronic immune-mediated disorders. These areas frequently require long development timelines, substantial investment, and close collaboration between academia, healthcare providers, public funders, and industry.
A good example is antimicrobial resistance. Novel antibiotics are urgently needed from a public health perspective, yet the economic incentives for their development remain challenging. One such project is BTZ-043, a novel drug candidate against multidrug-resistant tuberculosis that we are currently advancing together with LMU. While the medical need is enormous, the development and commercialization pathways differ significantly from those of innovative oncology drugs or immune modulators. As a result, different funding models, risk-sharing mechanisms, and reimbursement approaches are required.
The same principle applies to pandemic preparedness. Vaccines, diagnostics, and therapeutics for future infectious disease threats must often be developed before a clear commercial market exists. Maintaining capabilities and infrastructure in these areas is therefore a strategic investment in public health resilience rather than a purely market-driven activity.
At the same time, the alliance should not be restricted to traditionally underserved disease areas. It could equally accelerate innovation in oncology, autoimmune diseases, neurological disorders, and other fields where scientific opportunities are abundant but translational hurdles remain significant. The goal is to identify the most promising innovations and provide them with the coordinated support required to move efficiently from discovery to patient benefit.
Ultimately, the greatest impact of a Translational Alliance would not be confined to any single disease area. Rather, it would lie in creating a framework that enables Germany to develop and translate breakthrough innovations more effectively wherever major unmet medical needs exist. By aligning scientific excellence, clinical expertise, regulatory support, and sustainable funding, such an alliance could help ensure that promising discoveries reach patients faster and more reliably across the entire healthcare landscape.
How is your institution approaching and utilizing these technologies?
Digitalization is becoming a key enabler of translational medicine, and at ITMP we are pursuing this opportunity on multiple levels—from data-driven research and AI-supported drug discovery to digital tools that improve clinical decision-making and patient care.
First, we benefit greatly from the multidisciplinary structure of the Fraunhofer-Gesellschaft and collaborate closely with several Fraunhofer institutes specializing in data science, artificial intelligence, and information technology. A good example is our IMMUVision project. Together with Fraunhofer IGD, which leads the technical development, and our pharmaceutical partner Lilly Deutschland, we are building a digital twin platform for patients with complex immune-mediated diseases. The platform enables standardized data integration, advanced visualization, and clinically relevant dashboards that help healthcare professionals better understand disease trajectories, personalize treatment strategies, and coordinate care across different healthcare settings.
Second, we have established dedicated in-house capabilities for data-driven and AI-enabled drug discovery and development. At our Hamburg site, a particular focus is on the development of analytical workflows for drug discovery data, implementation of FAIR data principles, and the application of advanced statistical and machine-learning methods to large patient cohorts. Identifying disease- and treatment-related biomarkers is especially important, as biomarkers help us generate and prioritize hypotheses, stratify patients, and ultimately guide experimental validation and therapeutic development.
Beyond these activities, we are actively exploring the next generation of AI technologies for biomedical research. In close collaboration with the University of Heidelberg, we are investigating the use of deep learning, foundation models, and autonomous AI agents across a range of healthcare and life science applications. Particular attention is being paid to large language models that can process and structure unstructured medical information, support clinical decision-making, facilitate knowledge discovery, and improve the efficiency of healthcare workflows.
These examples illustrate how digital technologies are already transforming the way we conduct research and develop new therapies. However, in my view, the greatest opportunity lies not in individual tools but in the creation of collaborative digital ecosystems.
To fully unlock the potential of digitalization, we need secure platforms that enable the sharing of data, computing resources, expertise, and analytical tools across institutional boundaries. Public-private partnerships, interoperable data infrastructures, and trusted data spaces will be essential for accelerating innovation while maintaining the highest standards of data protection and patient privacy. Ultimately, the combination of biomedical expertise, high-quality data, and advanced AI will allow us to make research more efficient, development processes faster, and healthcare more precise and personalized.
How could Germany reverse this trend?
Germany has lost ground in attracting industry-sponsored clinical trials for a variety of reasons, including lengthy administrative procedures, fragmented data protection requirements, personnel shortages at clinical sites, and most importantly often time-consuming contract negotiations between sponsors and healthcare institutions. Addressing these challenges will require coordinated action across the entire healthcare and research ecosystem.
Encouragingly, the German government has recently launched the Pharma and Medical Technology Dialogue, a cross-ministerial initiative that brings together policymakers, industry representatives, researchers, healthcare providers, social partners, and patient organizations. Its objective is to identify and implement measures that strengthen Germany’s competitiveness as a location for pharmaceutical and medical technology innovation. This is an important step in the right direction, as improving the framework conditions for clinical research must be a national priority.
In my view, however, one of the fundamental challenges is the high degree of fragmentation within the German clinical research landscape. Too often, clinical trial activities are organized at the level of individual institutions rather than through coordinated national networks. As a result, patient recruitment can be slow, study start-up times are prolonged, and valuable opportunities for collaboration remain underutilized.
To reverse this trend, Germany should establish comprehensive clinical study networks that facilitate patient identification, recruitment, and data sharing across institutions. Such networks should not be limited to university hospitals. They should also include non-university hospitals, specialist practices, outpatient clinics, and disease-specific centers of excellence combined with technologies from Fraunhofer. By connecting these actors through common standards and digital infrastructures, we can significantly increase patient access to clinical trials and accelerate study execution.
Digitalization will also play a crucial role. Secure and interoperable data platforms can help identify eligible patients more efficiently, reduce administrative burdens, and support multicenter studies. At the same time, a more harmonized interpretation of data protection regulations across Germany would improve legal certainty and make clinical research more attractive for sponsors while maintaining the highest standards of patient privacy.
Finally, we need to strengthen professional clinical research infrastructures at study sites. Dedicated study personnel, streamlined contracting processes, and standardized procedures can substantially reduce start-up times and enhance the quality and efficiency of trial conduct.
Germany has all the necessary ingredients to become a leading location for clinical research: outstanding medical expertise, highly qualified healthcare professionals, excellent science, and access to large patient populations. The key challenge is to connect these strengths more effectively through networks, digitalization, and coordinated action. If we succeed, Germany can once again become one of the most attractive destinations for clinical development and medical innovation in Europe.
Do you still feel that optimism today?
Yes, I do. In fact, some of this optimism has already been justified by recent developments. The launch of the German government’s Pharma and Medical Technology Dialogue is an encouraging signal that policymakers, industry, academia, healthcare providers, and patient organizations are prepared to work together on strengthening Germany’s innovation ecosystem.
Similarly, the High-Tech Agenda Germany recognizes biotechnology as a key technology and health research as a strategic field for future competitiveness and technological sovereignty. This demonstrates a growing awareness that innovation in pharmaceuticals, diagnostics, and medical technologies is not only important for public health, but also for economic growth and resilience.
Of course, strategies alone are not enough. The real challenge will be translating these ambitions into concrete funding programs, efficient regulatory frameworks, and sustainable innovation structures. Much work remains to be done.
Nevertheless, I remain optimistic. Across government, science, and industry, I see a growing willingness to collaborate and to think beyond institutional boundaries. This is exactly what we need to overcome the fragmentation that has traditionally slowed translation in Germany.
Fraunhofer is committed to contributing its full expertise to this effort. Our mission is to bridge the gap between scientific discovery and patient benefit. Ultimately, that is what translational medicine is all about: ensuring that excellent research makes a real difference in people’s lives.
At the end of the day, an invention becomes an innovation only when it reaches the patient.
