Pilot Rationale
Rationales for Each of the Four STEP4NAMs Pilot Studies.
New Approach Methodologies (NAMs) have the potential to substantially reduce reliance on animal testing while improving the clinical relevance, efficiency, and ethical robustness of pre-clinical research in the biopharmaceutical and medical technology sectors. The STEP4NAMs project addresses these barriers through the coordinated development and validation of four complementary pilot studies, each focusing on a distinct class of NAMs: digital twins, organ-on-chip systems, advanced bench-top simulation models, and patient-derived organoids. Together, these pilots are designed to generate practical validation evidence, transferable methodologies, and best-practice guidance. In this deliverable, the scientific, technical, and strategic justification for each pilot study is demonstrated. For each pilot, this document outlines the purpose and scope, methodological approach, relevance to regulatory and industrial validation needs, and expected contribution to the overall objectives of STEP4NAMs. The rationales demonstrate how the pilots collectively support SMEs, researchers, regulators, and other stakeholders in building confidence in NAMs and accelerating their uptake across the North-West Europe (NWE) region.
Exploring alternatives to animal testing - EU Research Journal
How can we accelerate innovation while reducing the need for animal testing? The latest feature by EU Research takes an in-depth look at the STEP4NAMs project and explores how New Approach Methodologies (NAMs) are transforming preclinical testing across Europe.
The article highlights our mission to support the validation and adoption of innovative technologies such as organ-on-chip systems, organoids, digital twins and benchtop simulations. It also showcases several of our pilot studies, shares insights from researchers leading this work, and explains how STEP4NAMs is helping companies, researchers and regulators bring these promising methods closer to everyday practice.
We are pleased to share the full article and invite you to discover how cross-border collaboration is paving the way for more predictive, efficient and animal-free testing in the Biopharma and MedTech sectors.
Read STEP4NAMs article here: Read online
Copyright:
Jehle, M., Penide. J., Sundararaman., S. (2026) ‘Exploring alternatives
to animal testing ’, EU Research, Summer 2026 vol. (46), pp.
10 - 12. DOI:
https://doi.org/10.56181/CXPW1495
- EU Research (Print): ISSN 2752-4728
- EU Research (Online): ISSN 2752-4736