STEP4NAMs for SMEs & start-ups: Supporting human-relevant NAMs to reduce animal testing

STEP4NAMs is a European project aiming to accelerate the adoption of New Approach Methodologies (NAMs) in BioPharma and MedTech. NAMs include human-relevant testing, modelling and simulation approaches such as organ-on-chip systems, organoids, digital twins and advanced simulation models. They can support research, product development and regulatory decision-making, while contributing to the reduction, refinement and replacement of animal testing.

Whether SMEs & start-ups are already developing NAM-related technologies or are exploring how more human-relevant approaches could support their work. STEP4NAMs offers a practical pathway from first orientation to implementation, tailored support and industrial collaboration.
The programme is built as a step-by-step pathway free of charge: you start with EDUCATE, then move further with ENABLE and/or APPLY if this fits your company’s needs and level of readiness.

YOUR SME PATHWAY

1. EDUCATE: the mandatory online entry point

EDUCATE is the entry point to the STEP4NAMs programme. It is fully online, self-paced and open to everyone.

For SMEs & start-ups, the most important first step is the Core Module. It takes approximately 2 hours and gives a practical introduction to NAMs, their applications, the regulatory context and their relevance for BioPharma and MedTech.

Completing the Core Module is required to access further STEP4NAMs opportunities for SMEs & start-ups. After the Core Module, SMEs & start-ups can continue with more specific submodules. These focus on different NAM areas, including organoids, organ-on-chip systems, digital twins and benchtop simulations.

The submodules are not just additional learning content. Depending on the next step, they may also be part of the access requirements.

What SMEs & start-ups get from EDUCATE:

• a clear overview of NAMs and where they can be applied
• a better understanding of regulatory and implementation aspects
• a flexible online training format
• a certificate upon completion
• the foundation needed to apply for further STEP4NAMs support

2. ENABLE: tailored support for selected SMEs & start-ups

ENABLE is designed for SMEs & start-ups that want to move beyond basic understanding and explore how NAMs can be implemented in practice.
Selected SMEs & start-ups can benefit from tailored support, including mentoring, technical guidance, regulatory input, hands-on training and one-to-one expert support.

To apply for ENABLE, SMEs & start-ups need to complete the EDUCATE Core Module. In addition, a relevant EDUCATE submodule is required, depending on the specific ENABLE offer they apply for. This means that an SME interested in a specific on-site training or support offer should complete the Core Module first, then follow the submodule that matches the selected ENABLE pathway.

ENABLE can support SMEs & start-ups through:

• on-site training focused on applied NAM use
• technical and regulatory guidance
• one-to-one consulting tailored to individual project needs
• support with NAM selection and implementation
• hands-on learning in specialised environments

ENABLE is especially relevant for SMEs & start-ups that already have a concrete technology, product, use case or implementation challenge and need practical support to move forward.

3. APPLY: industry challenges for NAM implementation

APPLY is designed for SMEs & start-ups that are ready to test or further develop NAM-based solutions in collaboration with industrial partners.

Selected SMEs & start-ups work on real use cases provided by BioPharma or MedTech partners. The programme supports collaboration, mentoring and visibility, helping SMEs & start-ups connect their technologies with concrete industry needs.

• For the APPLY call in 2026, SMEs & start-ups need to complete the EDUCATE Core Module.
• From 2027 onwards, SMEs & start-ups will need to complete the EDUCATE Core Module and at least one relevant submodule before submitting an application for APPLY.

Through APPLY, selected SMEs & start-ups can:

• work on a real industrial challenge
• collaborate with a Challenge Provider from industry: IPSEN and/or Sanofi
• receive mentoring and training
• connect with investors, manufacturers and industry stakeholders
• gain visibility through European events and innovation platforms

APPLY is particularly relevant for SMEs & start-ups and start-ups with NAM-related technologies that have reached at least TRL 4 and have the internal capacity to carry out the proposed work.

WHAT DOES THAT MEAN FOR SMEs & start-ups?

The first step is simple: start with the EDUCATE Core Module online.

• It takes approximately 2 hours and helps SMEs & start-ups understand whether NAMs are relevant for their technology, product or project.

From there, SMEs & start-ups can choose the next step:

• If they need practical guidance, technical support or hands-on training, ENABLE may be the right pathway.
• If they are ready to work on a real industrial use case with BioPharma or MedTech partners, APPLY may be the right opportunity.

The programme is designed to let SMEs & start-ups start small, then move towards more targeted support when it makes sense for their company.