Chairs: Julia M. Malinowska & t.b.c.
To support regulatory acceptance of innovative non-animal technologies and models (e.g., organ-on-chip (OoC), induced pluripotent stem cell (iPSCs)-based systems, high throughput testing (HTT), high-content imaging (HCI), and in vitro omics), it is essential to establish their scientific credibility and build confidence in the generated data. Despite their potential in regulatory toxicology, these advanced biological models and measuring technologies have seen limited adoption beyond research. This challenge is in part due to an underserved EU ecosystem regarding formal standardisation, technology transfer, and commercialisation between academia and industry. Standardisation in particular plays a crucial role in ensuring and demonstrating biological relevance, reproducibility, efficient reporting, and effective communication among stakeholders of these models and technologies. In this session we wish to address standardisation needs and opportunities in key areas of innovative non-animal technologies: Stem cell-based models: Overview of the current use of human iPSCs in regulatory toxicology. Liver organ-on-chip trial: Insights from an industrial consortium evaluating the reproducibility of OoCs using primary hepatocytes. HTT: The potential of HTT for generating large and reliable datasets from chemical libraries to enhance the trustworthiness of in vitro approaches. Additionally, integrating additional lines of evidence, such as in vitro Toxicokinetics (TK), can facilitate the translation of the in vitro toxicity screening data. HCI: A case study on Cell Painting to showcase how standardised image acquisition and analysis can be applied in toxicity studies. In vitro omics technologies (e.g., transcriptomics, metabolomics): The importance of implementing a standardised workflow, from experimental design to data reporting, to ensure high-quality and comparable results across studies, laboratories, and platforms. By addressing these standardisation challenges, we can accelerate the regulatory adoption of non-animal methods, bridging the gap between innovation and practical application in toxicology.
Speakers
- Sebastian Dunst – BARCODING CELL TOXICITY – USING THE CELL PAINTING PLUS METHOD FOR PHENOTYPIC PROFILING AND DETAILED MOA PREDICTION
- Matthias Gossmann – Accelerating regulatory acceptance through international cross-site ring trials: Current developments in drug development and food safety
- Florian Caiment – Standardising Omics Data for Regulatory Toxicology: Frameworks, Progress, and the Path Forward
- Benoit Cox- Qualification of a Human 3D Liver-on-Chip Model: Establishing a Cross-pharma trial to evaluate ADME and Toxicity Predictions in Pre-clinical Development
- David Pamies – The Role of Standards in the Development and Application of iPSC-Derived Assays and Organoids
- Donatella Carpi – Implementing High Throughput Testing to Accelerate the Adoption of In Vitro Methods
- Oliver Wehmeier – Development and Validation of a MAT-Assay-Variant Based on Assay-Ready THP-1 Monocyte and a Sensitive qPCR Read-Out