Regulatory Acceptance of 3Rs Testing Approaches in Support of Medicinal Product Development

Sonja Beken holds a Master’s degree in Biological Sciences and a PhD in Pharmaceutical Sciences from the Vrije Universiteit Brussel (VUB), Belgium, as well as a Master’s degree in Applied Toxicology from the University of Surrey, UK. She is a European Registered Toxicologist. She serves as Coordinator of the Unit of Non-Clinical Evaluators at the Belgian Federal Agency for Medicines and Health Products, where she is responsible for overseeing the evaluation of non-clinical data submitted in support of all phases of drug development, including marketing authorizations, clinical trials, and EU and national scientific advice. In addition, she is Chair of the 3Rs Working Party at the European Medicines Agency, was the ICH Rapporteur for the revision of the S5(R2) Guideline, and is currently a member of the Implementation Working Group for ICH S7B/E14.

The NAM Navigator: Helping Researchers and Developers Gain Regulatory Approval for New Approach Methodologies

Martijn Nolte is the senior program manager for the “More Knowledge with Fewer Animals” program at ZonMw in The Netherlands, where he spearheads the shift toward animal-free research models. In this strategic role as a research funder, he advocates for the development and implementation of innovative animal-free methodologies, as well as responsible research in case animal experiments are required. Martijn’s career began with a PhD in Immunology from the Free University in Amsterdam in 2002, focusing on the physiology of the spleen. Following postdoctoral fellowships at the AMC in Amsterdam and Cancer Research UK in London, he established his own lab in 2006 at the AMC in Amsterdam. His research successfully bridged immunology and stem cell biology, leading him to Sanquin Blood Supply in 2011. There, he headed the Adaptive Immunity Lab and later became the Scientific Head of the Microscopy section. In 2021 he made a career move to ZonMw, the largest governmental funding agency of The Netherlands for (bio)medical and healthcare-related research. This journey from the intricacies of immune activation to an influential funding program is fueled by a singular passion: the belief that the future of science lies in our ability to innovate beyond traditional boundaries, replacing legacy methods with novel, human-relevant technologies that honor both scientific excellence and ethical progress.

Using fluorescence lifetime imaging microscopy (FLIM) to address the internalization of nanoplastics and their impact on metabolism in stem cell-derived organoid models

Ruslan I. Dmitriev has a long-standing research interest in live multi-parameter Fluorescence Lifetime Imaging Microscopy (FLIM) of 3D tissue models, which include spheroids, intestinal and ‘brain’ organoids. His team pioneered imaging oxygenation of neurospheres and metabolic imaging of the small intestinal organoids. He is an associate professor at Ghent University (Ghent, Belgium), head of Tissue Engineering and Biomaterials group and board member/ chair of Ghent Light Microscopy Core. His current research interests are in multiphoton FLIM, imaging-assisted organoid & tissue engineering, as well as visualisation of physiologically relevant (bio)molecular gradients in the living 3D tissue models of cancer and in tissue engineering.

Cultivating in vitro expertise: how RE-Place supports the use and development of cell culture systems in Belgium

Mieke Van Mulders is a Biomedical Scientist with a special interest in the use, development and regulatory acceptance of New Approach Methodologies (NAMs). Since 2017, Mieke has played a key role in the RE-Place project, a collaboration between Sciensano and the Vrije Universiteit Brussel (VUB). She was responsible for the development and optimisation of the RE-Place platform, which promotes knowledge sharing on alternative methods to animal testing within the Belgian life sciences community. Mieke is actively involved in activities that support the regulatory acceptance of NAMs such as the Belgian PARERE network. She also serves on the Management Board of the Belgian Society of Toxicology and Ecotoxicology (BelTox), where she leads the communication activities, and is a member of the Flemish and Brussels animal testing committees.

From Early Development to Early Adoption: Shaping the Dutch Ecosystem for Dynamic Human Models

Jetty van Ginkel is an innovation strategist with broad experience in guiding research and technological development towards practical application in healthcare. Drawing on her background in biomedical engineering and biophysics, she has been active across the innovation chain, supporting researchers and start‑ups, coordinating multi‑partner initiatives, and building public‑private partnerships that bring together academic institutions, companies, healthcare providers, patient organizations and governmental stakeholders.Her work focuses on creating conditions in which complex innovations can progress, from early scientific discovery to implementation, by aligning interests, building coherent strategies and fostering effective cooperation across sectors. As Managing Director of hDMT (since August 2025), she contributes to the national effort to advance and implement dynamic human models, such as Organ‑on‑Chip technologies, in the Netherlands. Jetty aims to help teams develop technologies that deliver tangible and lasting value for society.

Architecture-preserving tumor and tissue fragments as a scalable 3D platform for drug evaluation

Olivier De Wever is a Full Professor at the Laboratory of Experimental Cancer Research at Ghent University, Belgium. His research team specializes in modelling cancer using in vitro, ex vivo, and in vivo systems. The group has conducted seminal work on defining minimal information guidelines and developing step-by-step protocols for working with three-dimensional (3D) cellular structures. Elements of the tumor microenvironment—such as fibroblasts—are active drivers of tumor progression and treatment response and form an integral part of the team’s model systems. Professor De Wever has a collaborative mindset that has led to extensive translational research with clinicians, essential for establishing patient-derived and patient-relevant models. As head of the Clinical Tissue and Cell culture core facility he is ideally positioned to lead the establishment of ex vivo tumor models.

Patient-derived organoids-based platform for predicting toxicity in humans

Yotam Bar-Ephraim completed a PhD in immunology at the Amsterdam UMC after which he joined the lab of Hans Clevers at the Hubrecht Institute as a postdoc, where he investigated the use of patient-derived organoids as a model for developing immune therapies to cancer. After leaving academia, Yotam joined LUMICKS, an Amsterdam based research tools company, as a field application scientist after which he became a product manager at the same company. In June 2025, Yotam joined HUB Organoids (part of Merck KGaA) as product development manager, with the aim to direct the HUBs offering to best serve customers’ requirements.

Should 3D cultures for safety studies necessarily consist of human cells? 

Bert Devriendt holds a PhD in Veterinary Sciences from Ghent University, where he is currently associate professor of immunology at the Faculty of Veterinary Medicine. With more than 20 years of experience in immunology and bacterial enteric diseases, his research focuses on unravelling host–pathogen interactions at the mucosal surfaces in pigs. To this end, his group applies advanced 3D models, including intestinal organoids, and uses the insights obtained with these models to inform the development of oral vaccine strategies.