Healixia Clinical Conference 2026
Join us for a full day - including lunch, coffee breaks and networking reception - where we touch upon different 'hot topics' in Clinical Research.
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Welcome and registration
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Keynote: From scientific excellence to global leadership: Can the EU Biotech Act strengthen Europe's competitiveness in clinical research and innovation?
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Europe is at a critical crossroads. While it continues to produce world-class science, it is steadily losing ground to other regions in attracting clinical research, investment and the commercialisation of innovation. Against an increasingly competitive global landscape, the EU Biotech Act represents a unique opportunity to reverse this trend—but only if it delivers bold and meaningful reforms. This keynote will examine whether the proposed measures are sufficient to restore Europe's competitiveness, what further action will be needed, and how success should be measured to ensure Europe remains a global leader in biomedical innovation.
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Defining the role of pragmatic clinical trials in cancer clinical research
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Defining the role of pragmatic clinical trials in cancer clinical research
Explanatory clinical trials, which evaluate therapeutic efficacy under ideal conditions, remain essential for understanding new therapeutic interventions. However, because they often apply stringent eligibility criteria, they may include patient populations that are not fully representative of those seen in routine clinical practice. In addition, their reliance on intermediate endpoints can create uncertainty about the applicability of results to real-world patients and everyday clinical decision-making. As a result, they may not always provide the optimal framework for addressing clinically meaningful questions based on patient-relevant endpoints or for guiding the optimisation of therapeutic strategies.
Incorporating more pragmatic elements into cancer clinical trials conducted in real-life settings could help address these limitations by improving patient-centredness, efficiency, and the generalisability of evidence. Broader eligibility criteria, follow-up aligned with standard clinical practice, and the involvement of community centres are examples of pragmatic features that can strengthen the external validity of trial results. Such an approach can also better reflect the interests and needs of key healthcare stakeholders, including health technology assessment agencies, clinicians, payers, and, most importantly, patients and caregivers.
Nevertheless, pragmatic trials—particularly those addressing the overuse of therapeutic interventions—present important challenges. These include patient acceptability, trial design and feasibility, alignment with regulatory frameworks, and the financial resources required to conduct such studies. This talk will explore how pragmatic clinical trials could help re-engineer the pathway from therapeutic development to patient access, and whether they can contribute to reducing disparities and inequalities in access to clinical trials, thereby accelerating therapeutic progress for all patients.
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Coffee break
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From fast and harmonized approval to trial completion : managing the full clinical trial lifecycle
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How can Europe remain an attractive location for clinical research while maintaining high regulatory standards?
This presentation will discuss current efforts to improve the efficiency and predictability of clinical trial processes across the trial lifecycle, from authorisation and site activation to patient recruitment, innovative trial approaches and the reporting of results in CTIS.
Particular attention will be paid to European and Belgian initiatives that seek to strengthen the clinical research environment for sponsors, investigators and patients alike
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Making clinical investigations work better under the MDR/IVDR: how to support sponsors
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While the MDR and IVDR have established a more robust regulatory framework for clinical investigations, their implementation has also brought increased complexity, administrative burden and uncertainty. Ongoing revisions to the regulations now aim to address these challenges and make Europe a more attractive and predictable environment for MedTech innovation.
In such a complex and demanding landscape, how can we, as experts, do more to support sponsors in delivering successful clinical investigations? The presentation will provide practical insights into how early collaboration between sponsors and CROs can help anticipate challenges, streamline clinical investigations and improve their efficiency and predictability, particularly for complex studies in Europe.
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Potential of AI in drug discovery
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Lunch
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Operational challenges when conducting clinical trials (panel)
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Panel discussion with Peter Bossuyt and Katrien Asnong (Imelda), Kathy Plachytka (freelance CRA), Virginie Barthel (NeoAlchemy Clinical), Dirk Meyssen (JnJ) and Katrien Tartaglia (ZOL)
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Towards a borderless Europe for clinical trial participation
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Coffee break
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Healixia Clinical Conference Award 2026
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Precision Therapy Logistics Gateway: Real-World Evaluation of an End-to-End Transatlantic Logistics Corridor for Advanced Biological Materials
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The rapid development of precision therapies is changing the requirements placed on pharmaceutical logistics. These therapies include cell and gene therapies, personalised mRNA vaccines, radioligand therapies and other advanced therapy medicinal products (ATMPs). The materials involved may be scarce, time-critical, temperature-sensitive and, in some cases, directly linked to an individual patient. This creates a different logistics paradigm. Established pharmaceutical supply-chain controls remain essential, but additional requirements become increasingly important. Against this background, the Precision Therapy Logistics Gateway (PTLG) was initiated by at.las, Brussels Airport, Air Cargo Belgium and Pharma.Aero. The initiative was established to examine how current
international logistics systems perform against the emerging requirements of precision therapies. A central component of the initiative was the establishment of a real-world transatlantic test corridor connecting the Antwerp life-sciences ecosystem with Dallas, Texas. Our session will focus on the insights this test corridor provided and the lessons learned for the sector.
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Back on Track - The anatomy of resilience
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At 23, a testicular cancer diagnosis interrupted his career as a professional athlete. Less than two years later, he returned to achieve his Olympic dream. Now, more than a decade later and after retiring from professional sport, this is a story about resilience that is still being written.
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Closing drink
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