Healthcare professionals are more and more demanding fast, top quality testing know-how for fast and dependable outcomes. Enter miDiagnostics, a healthcare know-how firm redefining the way forward for diagnostics and high quality management exams for biomanufacturing, is assembly this want by redefining the way forward for diagnostics. Its revolutionary options are significantly related for the rising discipline of cell and gene therapies, the place precision, pace, and scalability are crucial. Steering this forward-thinking agency is Dr. Katleen Verleysen, its CEO and a key determine within the life sciences sector. We caught up with Katleen under for extra info, within the wake of her current recognition within the European CEO of the 12 months Awards 2025.
Dr. Katleen Verleysen is a visionary chief sustaining a powerful place on the very cutting-edge of development. Recognised as an instrumental participant inside the life sciences sector, she has devoted greater than twenty years to advancing and enhancing its operations – leveraging her broad experience to guide the cost. She is uniquely ready to steer this mission, having achieved a major quantity of educational {and professional} success since first getting into the sphere.
Katleen’s journey started with the achievement of a B.Sc. and PhD in Analytical Chemistry from Ghent College, adopted by a postdoctoral fellowship at Duke College, North Carolina, inside the Division of Pharmacology and Most cancers Biology. Extra lately, she has accomplished certification in Synthetic Intelligence: Implications for Enterprise Technique from MIT Sloan College of Administration.
Throughout her instructional experiences, Katleen obtained a excessive calibre of rigorous scientific coaching that contributed in the direction of reshaping her mindset. She developed an unwavering dedication to evidence-based considering, analytical precision, and a steady drive to discover and be taught. These are ideas which have lengthy served Katleen, guiding her by means of each stage of her profession within the life sciences sector.
During the last 20 years, Katleen has been instrumental in founding, funding, and efficiently exiting a number of biotech and medtech corporations throughout each the US and Europe, holding numerous CEO, Senior Administration positions, and Board roles throughout the sector. This has included serving as CEO at Pronota, CellSeeQ, and DNameIt; and holding Board of Director positions at ImmunExpress, PharmaFluidics, and the Heart for Medical Innovation.
Each stage of Katleen’s skilled journey has been a steady studying expertise – from producing early stage proof-of-concepts to delivering scalable merchandise. These moments have taught Katleen learn how to successfully navigate complexity, construct performing groups centred round a shared imaginative and prescient, and translate cutting-edge science into tangible worth for sufferers and healthcare programs alike.
One in every of Katleen’s most up-to-date endeavours has included getting into the place of the brand new Chair of the Board of 4Tissue – an organization on a mission to revolutionise breast reconstruction following breast most cancers remedy by means of revolutionary regenerative medication. Whatever the challenge scope, Katleen leans upon her basis of information – acquired over twenty years of laborious work – to steer her choices, information her workforce, and obtain scientific excellence each step of the way in which.
“I draw from this broad expertise every day,” she informed us. “My scientific background helps me have interaction deeply with R&D; my entrepreneurial path sharpens my strategic considering; and my management journey has taught me that success depends upon authenticity, resilience, and creating environments the place folks can thrive. Briefly, I’ve discovered that management isn’t nearly path; it’s about grit, readability and communication, and persistently exhibiting up with function. That’s how I purpose to guide and proceed to develop.”
At present, CEO Katleen stands on the helm of miDiagnostics, steering the workforce with an knowledgeable hand. miDiagnostics was based in 2015, as a spin-out of the worldwide nanoelectronics chief imec with a big scale strategic collaboration with Johns Hopkins College, a premier medical analysis facilitation. Now, the corporate is on a mission to redefine the way forward for diagnostics and high quality management exams for biomanufacturing.
Connecting superior engineering with crucial medical wants, miDiagnostics helps a variety of companions in pharmaceutical companies, healthcare programs, and diagnostics. Its focus, nevertheless, lies in cell and gene remedy manufacturing – the place its influence will probably be most tangible. After a decade, miDiagnostics now stands as a famend firm entrusted by its clientele to ship forward-thinking options which can be compliant with probably the most stringent regulatory requirements.
miDiagnostics’ core programme focuses on fast sterility testing for CAR-T and different superior remedy batch releases. Utilizing its proprietary silicon-based PCR know-how, the corporate permits biopharmaceutical corporations to dramatically scale back launch instances for life-saving therapies. In a extremely specialised space – the place each hour issues – miDiagnostics’ platform might help save numerous lives by accelerating entry to personalised therapies.
On the coronary heart of miDiagnostics’ options is a revolutionary nanofluidic processer with embedded silicon know-how, paired with a compact, user-friendly reader. This platform delivers lab-quality outcomes from minimally invasive samples – with distinctive pace, reliability, and ease of use. By miniaturising and automating high-sensitivity molecular exams, miDiagnostics successfully eliminates the historically enforced trade-off between high quality and pace in decentralised settings.
“What started as a high-potential analysis initiative has advanced right into a scalable, real-world resolution that may turn into an integral a part of superior remedy workflows,” Katleen informed us in reflection. “Whereas we’re nonetheless early on this journey, the muse we’re constructing is strong – aimed toward lasting influence for each sufferers and the biopharmaceutical business.”
To make sure that its options profit all – sufferers and professionals alike – miDiagnostics takes an method rooted in co-creation. Slightly than providing off-the-shelf options, the corporate opts to construct them alongside its companions, starting every shopper engagement by first growing a deep, collaborative understanding of their particular wants, each scientific and operational. With this strategic method, miDiagnostics doesn’t merely work with its clientele, however works as one with them.
On the coronary heart of every part miDiagnostics does lies a deep dedication to folks. Whether or not pushing the boundaries of diagnostic science, pivoting a whole enterprise, or navigating advanced ecosystems, the corporate has and at all times will champion an unfaltering dedication to selling the human aspect of innovation. As Katleen defined: “Innovation solely issues if it reaches sufferers, if it empowers groups, and if it transforms lives. That’s the lens I apply to each determination I make as a CEO.”
Katleen leads miDiagnostics with kindness, authenticity, and deep humanity. She believes that robust management doesn’t start with hierarchy or authority: it begins with the power to attach, to hear with empathy, and to foster an surroundings by which folks really feel seen, revered, and empowered to contribute their absolute best. On the core of Katleen’s method stands clear and clear communication concerning the firm’s imaginative and prescient, technique, and most significantly, its values.
With that readability in place, Katleen has empowered miDiagnostics to construct a basis of belief – inside the workforce and its broader ecosystem. This ecosystem is advanced: comprising buyers, challenge sponsors, commercialisation companions, suppliers, design homes, and extra. Success on this networked local weather just isn’t merely about execution for miDiagnostics, however about alignment. For Katleen, it’s about making a win-win mindset, the place each stakeholder feels as if they’re a part of one thing bigger than themselves.
“This may solely be achieved by means of a management type that mixes imaginative and prescient with humility; path with openness; and technique with compassion,” she knowledgeable us. “I imagine in main as a human first: exhibiting up truthfully, listening actively, and interesting others as equals. In the end, my purpose as a frontrunner is to assist create not simply high-performing groups, however purpose-driven communities, the place folks really feel impressed to transcend what they thought doable, as a result of they imagine within the mission and in one another.”
After all, the journey has not been with out its challenges for miDiagnostics, although Katleen’s strategic, human-centric method has pushed the corporate ahead even within the face of adversity. Some of the defining challenges Katleen has confronted throughout her time at miDiagnostics has been navigating the transition from COVID-19 to a post-pandemic panorama.
On the top of the pandemic, miDiagnostics developed one of many quickest, most correct RT-qPCR exams in the marketplace – a real benchmark in point-of-care diagnostics. When the urgency of the pandemic subsided, nevertheless, so too did the demand for such options. As with many diagnostic corporations, miDiagnostics was confronted with a stark actuality: select reinvention or danger irrelevancy.
While the business moved en masse towards respiratory panels and STI testing, miDiagnostics made the deliberate and daring determination to pivot in the direction of pharmaceutical companies – focusing particularly on the sphere of sterility testing in cell and gene remedy, the place their PCR platform can have a transformative influence. This pivot not solely required technological reorientation, but in addition robust management by means of a interval of nice uncertainty.
“Traders had been understandably cautious,” Katleen recalled, “inner groups had been anxious concerning the unknown and exterior stakeholders had been divided of their expectations. But we remained dedicated to our imaginative and prescient, adapting shortly, speaking transparently, and making data-driven choices to realign the organisation round a brand new, extra sustainable path. That strategic shift is now proving to be extremely profitable.”
A second vital impediment that miDiagnostics has navigated has been scaling its platform from lab-scale prototypes to industrial-grade, validated programs that may function reliably at scale. Innovation inside the discipline of diagnostics may be inconsistent, usually stalling between proof-of-concept and real-world implementation. miDiagnostics, nevertheless, has made vital strives on this sphere by embracing multidisciplinary collaboration, conducting rigorous validation, and interesting world-class companions to speed up industrialisation efforts, corresponding to Thermo Fisher.
Since becoming a member of miDiagnostics, Katleen has straight demonstrated that when a person is prepared to query their assumptions, adapt strategically, and lead with readability, transformation not solely turns into doable, however impactful. This angle in the direction of rising obstacles has formed Katleen’s method, opened her eyes to the significance of authenticity and transparency in management – enabling her to higher serve her workforce at miDiagnostics.
“I imagine we have to speak extra brazenly about resilience in management,” she informed us. “Not simply celebrating success, however acknowledging the paradox, the pivots, and the robust calls that include constructing one thing significant. True management just isn’t about having all of the solutions; it’s about being prepared to hear, adapt, and convey others with you on the journey.”
And for miDiagnostics, the journey is much from over; as we progress by means of 2025, the corporate is targeted on increasing its pharmaceutical companies providing – with a specific emphasis on ultra-fast, high-performance PCR sterility testing for CAR-T and different Superior Remedy Medicinal Merchandise. These are areas the place demand for pace, reliability, and compliance is simply rising over time and, beneath Katleen’s knowledgeable steering, miDiagnostics is well-positioned to help that development.
As for Katleen, she has by no means been one to observe a proper profession plan. As an alternative, the CEO has been lucky to come across alternatives all through her journey, making acutely aware choices primarily based on the place she at present is in life, the influence she believes she will make, and the time and power she will commit to every challenge. These ventures are by no means financially motivated, as a substitute pushed by function – particularly the potential for science and know-how to create significant change for sufferers and society.
Equally essential to Katleen is giving again. She believes it her accountability to mentor the subsequent era of leaders – particularly CEOs navigating the advanced panorama of life sciences. Having walked the trail from deep tutorial science to venture-backed entrepreneurship and govt management, Katleen recognises that sharing what she has discovered and studying from them in return is without doubt one of the most significant methods she will contribute to shaping a future constructed on function and innovation.
Transferring ahead, Katleen knowledgeable us that she’s going to proceed to watch the broader business because it advances, conserving an in depth eye on particular areas of curiosity. She shared: “Wanting forward, I stay energised by the promise of cell and gene therapies to redefine the boundaries of medication. I’m additionally more and more intrigued by the frontiers of neuroscience, synthetic intelligence, and their broader implications for human well being and society. These usually are not simply mental outcomes; they mirror a deep curiosity about the way forward for life, cognition, and connection.”
Contact Particulars
Contact: Dr. Katleen Verleysen
Firm: miDiagnostics
Net Tackle: www.midiagnostics.com
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