Rethinking Health Innovation at BioFIT 2025: STEP4NAMs Workshop & Partner Meeting in Strasbourg
This year’s BioFIT in Strasbourg provided an ideal backdrop for two intensive and inspiring days for the STEP4NAMs consortium. On 1 December, our partners gathered for the third internal project meeting, using the opportunity to align strategically and prepare upcoming milestones. One day later, we opened the discussion to the broader innovation community during our dedicated workshop at BioFIT — a chance to highlight how New Approach Methodologies (NAMs) can reshape the future of testing in Europe.
STEP4NAMs consortium
/ Copyright: Lara Tank/ BioRegio STERN Management GmbHSTEP4NAMs 3rd Partner Meeting
Palais des Congrès, Strasbourg
The day began with a warm welcome before we moved directly into the project’s core topics.
Progress Towards Pilot Studies - Preparations for the pilot studies are advancing rapidly and the project is nearing the selection of participants. Partners reviewed the latest outcomes from the desk research and regional stakeholder interviews, which now inform several major deliverables and guide the design of the pilot activities.
Training Programme Launching in Early 2026 - The consortium also continued shaping the framework for the STEP4NAMs training programme, scheduled to launch in early 2026. Contributions from ATU, the 3R Tuebingen, the University of Glasgow and the University of Luxembourg are helping to build a diverse and practice-oriented curriculum that will support capacity building across the NAM landscape.
More milestones are on the horizon — stay tuned for updates as STEP4NAMs continues to grow and new opportunities to engage emerge.
Exploring Barriers, Opportunities and the Road Ahead – Insights from the STEP4NAMs Workshop at BioFIT
Palais des Congrès, Strasbourg
During the BioFIT workshop, the consortium opened its ongoing analysis to the wider innovation community. The session provided a compact overview of the challenges shaping the adoption of NAMs and highlighted where action is most urgently needed.
Drawing on extensive desk research across the six partner countries and over 30 stakeholder interviews, the team presented several recurring themes. NAM developers emphasised barriers such as limited validation standards, difficulties in demonstrating human relevance and a lack of long-term funding options. Many also reported uncertainty about regulatory acceptance and noted that only one respondent had engaged directly with regulators so far. NAM users highlighted similar challenges and pointed to fragmented training opportunities and higher costs when multiple NAMs must be combined to replace existing animal-based workflows. Animal model developers, in turn, viewed NAMs as complementary and expected a gradual, not immediate, transition away from animal testing.
Across all stakeholder groups, four structural issues surfaced repeatedly: insufficient validation frameworks, gaps in education and hands-on training, short-term funding that does not support full validation cycles and regulatory systems that still rely heavily on animal data.
A Panel Bringing Together Expertise from Research, Industry and Regional Innovation
The workshop concluded with a panel discussion moderated by Ria Hein (BOM), featuring Dr Joaquín Penide (ATU), Prof. Dr. Ralf Kemkemer (Reutlingen University) and Kévin Plouchart (Medicen Paris Region). Together, they reflected on the barriers and opportunities identified in the STEP4NAMs analysis and shared perspectives from their respective fields.
The workshop marked a strong first public milestone for STEP4NAMs, offering valuable new connections within the NAM community and fresh momentum to drive the project forward.
Panel discussion at the workshop.
/ Copyright: Lara Tank/ BioRegio STERN Management GmbHDr. Margot Jehle, Project Lead
/ Copyright: Lara Tank/ BioRegio STERN Management GmbHLotte Konings (Brabant Development Agency) and Yaella Essed (InnovationQuarter)
/ Copyright: Lara Tank/ BioRegio STERN Management GmbHFurther information
Further Information about STEP4NAMs at: step4nams.nweurope.eu/
BioRegio STERN Management GmbH