STEP4NAMs

Working together to set the stage for NAMs in the development of drugs and medical devices

BioRegio STERN Management GmbH is the lead partner responsible for the new STEP4NAMs project (Step up the use for new approach methodologies to replace animal testing), which is promoting the use of new approach methodologies (NAMs) that can replace animal testing. The project is funded by the European Union as part of the Interreg North-West Europe (NWE) programme. Over the course of four years, the project aims to drive forward NAMs in an effort to remove the need for animal testing during the development of drugs and medical devices, while also improving clinical predictions. Ten project partners from six countries are developing a joint strategy to improve the acceptance of NAMs in the pharmaceutical and medical technology sectors, boost research and innovation capacities, and thus drive forward the approval of safe drugs and medical devices. The kick-off meeting was held in Stuttgart on 25/26 February 2025.

Organ-on-chip, organoids, digital twins, bioprinting, or bench-top simulations are all considered NAMs – new approach methodologies. Using the latest technologies, these methodologies simulate an organism and the effects of various active ingredients or interventions. NAMs are now frequently more efficient than animal testing and are permanently improving clinical predictions. The consortium of the European Interreg STEP4NAMs project met for the first time in Stuttgart in February 2025 to discuss and develop the planned project objectives. In concrete terms, the partners will work together over the next four years to develop a joint strategy to promote NAMs, conduct four pilot studies to validate proven methodologies, draw up an NAM validation handbook for researchers and development staff, and establish a training and support programme for various stakeholders.

BioRegio STERN Management GmbH is the lead partner, and responsible for managing, coordinating and implementing the project. “We are focusing on the field of pharmaceutical and medical technology,” explains project manager Dr. Margot Jehle. “We want to boost research and innovation capacities by implementing and validating cutting-edge technologies. In addition, we want to make it easier to introduce NAMs in the regions involved, because a lack of knowledge and regulatory uncertainty are often reasons for a lack of acceptance.”

STEP4NAMs will make focused use of transnational collaborations between the ten project partners from six countries – Germany, the Netherlands, Belgium, France,
Ireland, and Luxembourg. Through this approach, it will bring together stakeholders from across the entire value chain and beyond national boundaries. Funded by
Interreg North-West Europe (NWE), the project is being overseen by Maëlle Lebon as the representative of the project’s sponsor.

STEP4NAMs is the second BioRegio STERN Management GmbH project to promote NAMs. “The European project NAMWISE also deals with this topic, but focusing more on regulations,” explains Dr. Jehle. “STEP4NAMs, on the other hand, concentrates on applications in the bio-pharma and medtech sectors. We are delighted to be able to set an important focal point and actively drive forward the introduction of NAMs as we roll out these two projects over the coming months.”

The STEP4NAMs project will run for 48 months and has a total budget of €6,332,365.47. The EU (ERDF) is contributing 60 percent, which amounts to €3,799,419.27. The share for BioRegio STERN Management GmbH is €827,645.00, with the EU contributing 60 percent, which equates to €496,587.00. The amount to be contributed by BioRegio STERN Management GmbH is therefore €331,058.00.