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.