In its first 18 months, CHIASMA has made strong progress across science, technology, and regulatory engagement:
Collaborative foundations: The project successfully connected regulators, scientists, and industry. A major highlight was the first Regulatory Risk Assessors’ Summit, gathering over 70 stakeholders to discuss how to move towards animal-free safety assessment.
Development of new tools: More than 15 experimental and computational NAMs have been advanced, including high-throughput transcriptomics for predicting long-term health effects, in vitro barrier models (lung, skin, intestine, placenta), and predictive computer models for fish toxicity and nanoparticle effects on plants.
Knowledge infrastructure: A first version of the CHIASMA Knowledge Graph was created, linking curated datasets (e.g. Human Protein Atlas, KEGG, Gene Ontology) with experimental data. This provides a foundation for systems-based safety assessments.
Software platform: Work began on the CHIASMA SSbD Assessment Software Interface (CSI) – a “one-stop” digital platform where users can access, combine, and run NAMs in line with FAIR principles (Findable, Accessible, Interoperable, Reusable).
Quality and reliability: Protocols for inter-laboratory comparisons were established to ensure reproducibility and readiness for regulatory uptake.
Policy mapping: An in-depth analysis of EU and international regulatory frameworks was initiated, identifying where new methods can be best integrated.
Overall, the project is on track, with milestones and deliverables met as planned.