In vitro human models grow up, AI-powered tools to advance alternative methods, Certara launches Non-Animal Navigator™ solution and more
News on non-animal methods
APRIL 21 - 25, 2025NEWS, REPORTS & POSITION STATEMENTS
1. In vitro human models grow up
Organoids, microphysiological systems (MPS), and organ-on-a-chip devices continue to make steady progress and proceed down the path to technology maturity. Innovative developers are refining and validating their offerings to fit particular testing questions, such as drug-induced liver injury (DILI).
Current limitations of in vitro human models do not take away from their ethical reduction of animal use nor their potential to provide more realistic in vitro human responses in preclinical testing. Organoids and associated culture instruments such as MPS continue to generate more scientific proof as they gain technology maturity. “The growing published knowledge base and recent regulatory incentives accelerate their overall acceptance,” said Pierre Gaudriault, PhD, scientific chief business developer at Cherry Biotech.
2. A path forward advancing microphysiological systems
Microphysiological systems (MPS) are advanced laboratory models that mimic human organs using engineered tissues and microfluidic technology. Including organs-on-chips and 3D organoids, these tools allow scientists to study disease and test drugs without using animals. Despite their promise, MPS face several challenges that slow their widespread adoption. These include inconsistent standards, difficulties proving they work reliably, regulatory uncertainties, and limited data sharing between organizations.
A new paper in ALTEX identifies these obstacles and proposes practical solutions : creating international standards, establishing dedicated centers to validate MPS models, encouraging organizations to share data, and developing clear regulatory pathways. The authors highlight ongoing collaborative efforts, including international conferences and societies dedicated to advancing MPS technologies.
3. Summary of the 5th International Conference on DNT Testing
The 5th International Conference on Developmental Neurotoxicity (DNT) Testing (DNT5) took place in April 2024 in Konstanz, Germany. Experts from regulatory agencies, industry, and academia convened to discuss how best to integrate animal-free new approach methodologies (NAMs) into next-generation risk assessment.
The key topic was the application and further development of the recently established DNT in vitro test battery (DNT-IVB). For instance, it was discussed how data from cell culture methods could be used to predict safe human exposures. Many presentations demonstrated the field’s embrace of novel developments, including the development of AI-driven computational approaches, and the establishment of complex, electrically active brain organoids and other self-organizing structures.
4. Brazil authorized the use of transfusion surplus materials for conducting the Monocyte Activation Test (MAT)
The MAT is a fully in vitro method for detecting pyrogens — fever-inducing contaminants — based on the release of pro-inflammatory cytokines by human monocytes exposed to test substances. This assay is an advanced and ethical alternative to the traditional Rabbit Pyrogen Test (RPT), offering enhanced reproducibility and scientific relevance.
By permitting the use of transfusion surpluses, the Brazilian Ministry of Health significantly supports the national rollout of MAT, boosting its technical feasibility and regulatory acceptance. This decision complements the recent inclusion of MAT in the 7th Edition of the Brazilian Pharmacopoeia and underscores Brazil’s commitment to modernizing safety assessments in accordance with scientific and human-based best practices.
INTERVIEWS, NOMINATIONS & AWARDS
5. Prof Hartung awarded the Toxicology award from the German Society of Toxicology
Prof Thomas Hartung was flattered to receive the Toxicology award from the German Society of Toxicology from president Robert Landsiedel, for his lifetime achievements in this field. This prize has a very special taste to him, as this society (DGPT then) was the first he joined and the place where he gave his first scientific presentation.
TOOLS, PLATFORMS, CALLS
6. FRESCI launches a roadtrip mentoring to JRC summer school
The private company FRESCI offers a trip from Barcelona to Ispra for the JRC Summer School ; during which they wish to make the journey count through a roadtrip mentoring. This is an open initiative where participants will reflect on 3Rs, share research perspectives, and connect science, policy, and society — all on the road.
Departure : May 18 from Barcelona | Return : May 24 from Ispra. Limited seats available — FRESCI will contact selected participants by email.
7. AI-powered tools to advance alternative methods
The FC3R organised a webinar on AI-powered tools to advance alternative methods in scientific research.
The webinar featured speeches from Mariana Neves (BfR) who talked about SMAFIRA — a web tool for searching the scientific literature for alternatives, and Wynand Alkema (TenWise) who presented 3Ranker — a free tool to search for non-animal alternatives.
8. Precision meets accountability : The future of AI in R&D
AI is not just a tool for faster research – it is a catalyst for discovery. To support this, Elsevier, a global leader in advanced information and decision support, has launched ScienceDirect AI, a cutting-edge generative AI tool for researchers. It is designed to transform the way researchers work by enabling them to instantly extract, summarize and compare trusted insights from millions of full-text articles and book chapters on ScienceDirect, the world’s largest platform for trusted, peer-reviewed research.
INDUSTRY, BIOTECH & PARTNERSHIPS
9. Certara launches Non-Animal Navigator™ solution to help drug developers reduce reliance on animal testing
Certara, Inc., a global leader in model-informed drug development, announced the launch of its Non-Animal Navigator™ solution designed to help biopharmaceutical companies lead the transition ignited by the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. Based on Certara’s extensive experience working with FDA, EMA, and other major health authorities, the Non-Animal Navigator is a flexible solution that ensures each client’s development program is compliant, agile, and future ready.
“It is part of a growing industry adoption trend to use scientifically robust new approach methodologies (NAMs) like AI-enabled biosimulation to improve strategic decision-making and success rates at every phase of drug development.” said William F. Feehery, Chief Executive Officer.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. A novel 3D printed multi-material simulator for endoscopic stapes surgery
Italian researchers have developed and preliminarily validated a 3D-printed, multi-material, patient-specific simulator of the external and middle ear affected by stapes fixation — designed to train surgeons in endoscopic stapes surgery (SS).
The 3D Stapes Trainer represents a promising platform for training in endoscopic SS, offering a high-fidelity simulation that contributes to the development of the technical skills required in this demanding procedure.
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
3rd RISK-HUNT3R stakeholder symposium
The RISK-HUNT3R project will run the third edition of its public Stakeholder Symposium on 17 – 18 June 2025 in Helsinki, Finland. The Symposium will provide an overview of the ASPA NGRA workflow and linked case studies, as well as the developed integrative NAM toolbox, to outline the current scientific state of the art in next-generation risk assessment (NGRA) and what is needed.
This event follows the 3rd Conference on the Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments, organised by the European Commission on 16 – 17 June 2025 in Helsinki.
