Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these executives who continue to shape the landscape of the biotech industry. This week we are recognizing:
Dr. Michael Mahler is CSO of Exagen, a biotech company dedicated to transforming the care continuum for patients suffering from debilitating chronic autoimmune diseases. Michael brings over two decades of leadership and innovation in autoimmune diagnostic research to his role at Exagen. Throughout his career, Dr. Mahler has held senior scientific and leadership positions at several diagnostic companies, where his transformative work has led to the discovery of novel autoantigens and the development of innovative diagnostic solutions. His scientific contributions have resulted in over 300 peer-reviewed publications and numerous patents, advancing the accurate diagnosis of autoimmune diseases. Prior to joining Exagen, he served as Senior Vice President of Research Development and Business Development at Werfen, where he was responsible for all development programs in the autoimmunity field, including instruments, software, and reagents. Dr. Mahler began his scientific career at the University of Heidelberg, earning his PhD. in Molecular Genetics. During his doctoral studies, he conducted research at the Scripps Research Institute under Professors Eng Tan and Michael Pollard, both internationally recognized pioneers in autoimmune disease research.
You’ve led science and business teams across Europe and the U.S., from startups to global players like Werfen. What are the common threads in your leadership style that have helped you succeed across such different environments?
For me, coaching, mentorship, and empowerment are foundational elements of success, particularly in an R&D environment. Science is inherently collaborative, and teams perform best when individuals feel supported, challenged, and encouraged to take initiative. I place a strong emphasis on creating an environment where team members can grow their skills, ask questions freely, and contribute their unique perspectives. Cultivating this kind of culture not only strengthens individual performance but also drives innovation across the organization.
In early development cycles, failure is common and often unavoidable. Maintaining excitement, curiosity, and perseverance is therefore essential. It’s important to celebrate small wins, learn from setbacks, and keep the team motivated despite challenges. This mindset helps sustain momentum, even in high-pressure or high-risk projects, and ensures that progress continues even when experiments or strategies don’t go as planned.
From a leadership perspective, I strive to balance technical credibility with strategic vision. Understanding the science deeply allows me to guide decisions and evaluate risk effectively, while keeping the bigger picture in mind ensures that projects are aligned with organizational goals. Equally important is strong cross-functional communication: coordinating across different teams, managing stakeholders, and clearly articulating objectives and expectations are all critical for driving projects forward successfully. By integrating these elements—mentorship, resilience, technical expertise, strategic thinking, and collaboration—I aim to create an environment where teams can achieve both scientific excellence and meaningful impact.
Tell me more about Exagen – what are you working on and what excites you most about Exagen’s pipeline and its role in reshaping autoimmune disease management?
At Exagen, we are pursuing several programs that are grounded in rigorous, cutting-edge science, all aimed at meaningfully improving patient care in autoimmunity. Beyond expanding our core product offerings, we are exploring applications across additional disease areas and indications, including disease activity monitoring, treatment response prediction, and chronic organ damage assessment. These initiatives reflect our commitment to not only addressing immediate clinical needs but also generating insights that can guide more personalized and effective treatment strategies over the long term.
From a disease area perspective, we continue to strengthen our leadership in rheumatoid arthritis. Our portfolio has expanded with the recent addition of antibodies targeting RA33 and PAD4, enhancing our ability to address unmet clinical needs in this area. These efforts are part of a broader strategy to translate deep scientific understanding into actionable tools that improve patient outcomes, empower clinicians with better data, and ultimately redefine standards of care in autoimmune and inflammatory diseases.
Autoimmune diseases are notoriously complex and heterogeneous. What do you see as the biggest scientific and diagnostic challenges still holding the field back?
Autoimmune diseases are inherently complex, and timely diagnosis remains one of the most significant challenges in the field. It often takes four to five years for patients to receive a definitive diagnosis—far too long, as irreversible damage can accumulate during this period. Reaching a diagnosis typically requires coordination among multiple clinicians, each contributing pieces of the puzzle to identify the underlying condition and initiate treatment strategies that can prevent long-term complications.
This reality underscores the critical importance of early diagnosis, which places a premium on reliable biomarkers. Unlike infectious diseases, where a single biomarker may suffice to establish a diagnosis, autoimmune diseases generally require a combination or panels of markers to generate meaningful, actionable information. Discovering and validating these biomarkers, and integrating them with advanced computational approaches such as machine learning, has the potential to transform patient care—enabling earlier interventions, more precise monitoring of disease progression, and tailored therapeutic strategies.
Moreover, the role of diagnostics extends beyond initial diagnosis. Once a patient’s condition is established, sophisticated diagnostic solutions can guide treatment selection, determine the need for escalation, and optimize long-term management. By combining early detection with data-driven decision-making, we have the opportunity not only to improve immediate patient outcomes but also to shift the trajectory of chronic autoimmune diseases—reducing irreversible damage, improving quality of life, and ultimately transforming standards of care in this complex and challenging field.
You wrote the book on AI and precision medicine in autoimmunity. Where do you think AI is already delivering real value in diagnostics, and how might AI transform not just diagnosis but disease prediction, prognosis, and treatment selection in autoimmunity?
As you mentioned, I’ve written a book on the topic entitled ‘Precision Medicine and Artificial Intelligence – The Perfect Fit for Autoimmunity’, and I firmly believe that artificial intelligence (AI) has already transformed several industries. In healthcare, however, its impact has been more limited so far, largely due to the highly regulated environment. To date, we have seen only a few examples of AI fully integrated into clinical products, but the potential is enormous.
The fundamental opportunity lies in the ability to combine vast, complex datasets into meaningful, actionable insights. Healthcare generates enormous amounts of information—from genomics, proteomics, and imaging data to electronic health records and real-world patient outcomes. Yet much of this data remains underutilized. AI has the power to synthesize these diverse sources, revealing patterns and correlations that humans alone cannot detect. Over time, this could revolutionize diagnostics, treatment selection, outcome monitoring, and patient engagement, ultimately transforming how care is delivered.
We can already see early successes in oncology, where AI has been applied to predict treatment response, stratify patients, and optimize clinical decision-making. Compared to autoimmune diseases, oncology has benefited from more structured datasets and clearer endpoints, providing a blueprint for how AI can be deployed in complex, heterogeneous disease areas. In autoimmunity, the challenge is even greater, but the rewards are profound: AI could integrate biomarker panels, clinical histories, and patient-reported outcomes to enable earlier diagnosis, more precise treatment prediction, and long-term monitoring, significantly improving patient lives.
In essence, while the adoption of AI in healthcare will take time and careful navigation of regulatory, ethical, and technical challenges, the potential impact is transformative. By turning complex, multifaceted data into actionable insights, AI can help us move from reactive care to truly predictive, personalized, and proactive healthcare—unlocking the full promise of precision medicine.
You’ve led global teams and established strategic partnerships throughout your career. What’s your framework for deciding when to build capabilities internally versus pursuing collaborations or M&A?
My philosophy has always been to remain open to partnerships, recognizing that collaboration can be a powerful driver of innovation and progress. The key is to identify partners who are aligned in vision and values, and to structure relationships where all parties derive meaningful benefit. Partnerships that are reciprocal—where each side brings complementary capabilities, technologies, or infrastructure—often accelerate progress far more effectively than working in isolation. This approach not only leverages combined expertise but also allows for more ambitious goals to be pursued than would be feasible independently.
At the same time, I recognize that not all initiatives are suitable for collaboration. For projects that are strategically critical—particularly those involving proprietary technology, know-how, or sensitive supply chain elements—maintaining full control is essential. In these cases, partnerships must be approached with caution, and often, discretion is required to safeguard the integrity and competitive advantage of the project.
Ultimately, my philosophy balances openness with discernment: I seek opportunities to collaborate where synergy exists, while carefully protecting core strategic assets. This approach allows us to harness the power of shared expertise and resources without compromising the long-term vision or security of the company. In my view, the most successful organizations are those that can navigate this balance—leveraging partnerships to drive growth and innovation while preserving the essential elements that define their unique value.
Diagnostics often live at the intersection of science, medicine, and reimbursement. How do you think about aligning scientific innovation with clear clinical and commercial value?
At Exagen, we firmly believe that true innovation arises at the intersection of cutting-edge science and a deep understanding of the customer. From the earliest stages of development, we actively engage with our customers, as well as key opinion leaders, to uncover unmet clinical needs and the nuances that define real-world utility. These insights are not just peripheral—they shape the core of our product requirements and guide the direction of our innovation. By aligning scientific advancement with customer-driven insights, we ensure that the solutions we develop deliver meaningful clinical and commercial impact.
Yet, translating a novel idea into full commercial value is rarely immediate. The journey often spans years, encompassing rigorous clinical utility studies, regulatory processes, and achieving appropriate reimbursement. This reality makes it imperative to define the clinical need with precision from the outset. Critical elements, such as the intended use statement, serve as the foundation for clinical study design and, ultimately, the pathway to market success.
What sets this approach apart is its holistic integration of science, customer insight, and strategic planning. By embedding the voice of the customer into every stage of development, we not only increase the likelihood of clinical success but also create a framework where commercial value emerges as a natural consequence. In essence, this philosophy ensures that our innovations are not just technologically advanced—they are meaningful, impactful, and positioned to truly improve patient outcomes while driving sustainable value for the company.
