STEP4NAMs

​New Approach Methodologies (NAMs) are advanced digital and biotechnological methods that enable the testing of drugs and medical devices without the use of animals. They offer great potential to improve healthcare and innovation across Europe.

While most North-West Europe (NWE) regions are ranked as strong health innovators (according to the Regional Innovation Scoreboard), the adoption of NAMs still faces several barriers. A 2023 report by ECHA identified the key challenges:

• Lack of knowledge and awareness
• Regulatory uncertainty
• Limited funding opportunities
• Fragmented infrastructure

These issues vary across STEP4NAMs regions:

• Germany (DE): underfunded research and development
• Netherlands (NL): lack of hospital and lobbying networks
• France/Belgium (FR/BE): strong NAM ecosystems, but limited recognition
• France (FR): many isolated initiatives, lacking coordination
• Ireland (IE): strong UK ties hinder EU cooperation
• Luxembourg (LU): limited industrial presence

The Solution: Cross-Border Collaboration

EU-wide efforts to promote NAMs exist, but are scattered and lack coordination, especially in the BioPharma and MedTech sectors. STEP4NAMs addresses this gap by uniting partners from six NWE countries (DE, NL, FR, BE, IE, LU), building on their regional strengths to promote transnational cooperation.

The project offers:

• Access to well-established Life Sciences and MedTech networks in DE, NL, BE, and FR
  
• Expertise in key NAM areas such as tissue engineering, digital twins, organoids, and 3D-printed models
• Collaboration with pharma industry players, 3R (Replace, Reduce, Refine) networks, and complementary EU projects
• Active participation in major events to disseminate results

A Holistic and Practical Approach

STEP4NAMs engages BioPharma and MedTech stakeholders throughout the NAM value chain, with a strong focus on SMEs as key drivers of innovation. The main project outcomes include:

• A joint strategy and sector-specific action plans for NAM adoption
• Four pilot studies to validate four NAMs
• A comprehensive NAM Validation Manual
• A training and support programme for 186 participants to demonstrate NAM effectiveness

By fostering acceptance and uptake of NAMs, STEP4NAMs will strengthen innovation capacity, increase resilience in the health sector, and reduce animal testing in NWE.