In this opening episode, we introduce the STEP4NAMs project and its vision: accelerating the adoption of New Approach Methodologies (NAMs) across North-West Europe.
Listeners will learn why NAMs matter for drug safety and medical device development, about the origin of STEP4NAMs,
how the project brings together experts from six countries and what impact the project aims to achieve for SMEs, regulators and the wider BioPharma and MedTech sectors.
In this episode we explore how four pilot studies are bringing New Approach Methodologies (NAMs) into real-world application. From digital twins and organ-on-chip models to organoids and bench-top simulations, these pilots demonstrate how science can replace animal testing with human-relevant innovation. Each pilot lead explains what they’re working on, what’s being validated, and how companies and researchers can get involved. You will gain insights into the open call participation.
In this episode from BioFIT in Strasbourg, experts from industry, academia, and innovation networks discuss why the adoption of New Approach Methodologies (NAMs) remains slower than expected despite scientific progress. Key barriers include limited training, practical implementation challenges, and regulatory uncertainty, alongside opportunities to move from innovation to application. The episode also introduces the STEP4NAMs Training and Support Programme, designed to build skills and support SMEs and other stakeholders in applying NAMs across the development value chain.