STEP4NAMs (“Step up the use of NAMs to replace animal testing”) is a European Union co-funded initiative under the Interreg North-West Europe (NWE) program. Running from 2025 to 2028, the project brings together four academic partners and six business support organizations from six NWE countries. Its goal is to significantly accelerate the adoption of so-called New Approach Methodologies (NAMs)—including Organ-on-Chip (OoC), organoids, digital twins, and bioprinting—across the BioPharma and MedTech sectors.
Despite their clear scientific and ethical benefits, NAMs are still used only to a limited extent. STEP4NAMs addresses key barriers—such as regulatory challenges, a lack of cross-border collaboration, and insufficient practical training—through a strategic, hands-on approach based on three pillars:
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Strategic Planning – Development of transnational, sector-specific action plans
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Pilot Studies – Validation of NAMs through real-world use cases and best practice examples
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Training & Consulting Support – Tailored online and in-person training programs and targeted support, especially for small and medium-sized enterprises (SMEs)
The Role of the 3R-Center Tübingen
The 3R-Center Tübingen plays a central role in the STEP4NAMs project by integrating research, regulatory guidance, education, and public outreach. Our mission is to equip relevant stakeholders with the knowledge and skills needed to successfully implement NAMs and to reduce animal testing by developing and applying scientifically sound, human-relevant in vitro models.
1. Leadership of the Pilot Study: Validation of Organ-on-Chip Systems
We lead Pilot Study II, which focuses on the functional validation of OoC systems across multiple sites. This includes:
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Assessing functionality and long-term model stability
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Determining dose-response relationships using known compounds
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Testing blinded compounds to evaluate predictive accuracy
The results will contribute to a publicly available NAM Validation Manual and support SMEs in selecting the most suitable OoC platforms.
2. Training and SME Support
We design and implement targeted training programs to strengthen the capabilities of key stakeholders:
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Online Training (EDUCATE Program): Development of a free online training platform to provide foundational knowledge about OoC systems and their application as human-relevant NAMs. A certificate will be awarded upon completion of the free Moodle-based course.
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On-Site Training: Development and delivery of intensive one-week courses to deepen understanding of all relevant aspects of OoC systems and to teach the practical skills needed for their application.
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Tailored SME Support (ENABLE Program): Customized support for selected SMEs to help them integrate OoC systems into their workflows and value chains.
3. Coordination of the Strategic Advisory Board (SAB)
We are responsible for establishing and coordinating the SAB, which is composed of high-level experts from regulatory bodies, NGOs, and pharmaceutical companies. The SAB meets regularly to provide strategic guidance, feedback on pilot studies, and input on the long-term impact of the project. These insights feed directly into project activities.
By combining scientific innovation with practical training and strategic coordination, the 3R-Center Tübingen is making a significant contribution to a systemic shift toward human-relevant, non-animal testing methods in Europe.
