The Horizon Europe project "NAMWISE" aims to significantly advance the adoption and application of New Approach Methodologies (NAMs) in the integrated safety and efficacy assessment of chemicals and pharmaceuticals. NAMs offer modern, animal-free alternatives for risk assessment and enable a more efficient, ethically responsible, and scientifically sound evaluation of substances.

As part of the project, a comprehensive collection of recommendations, practical guidelines, and training resources is being developed. These resources will support scientists, regulatory authorities, and industry in effectively validating, integrating, and applying NAMs. This will contribute significantly to the advancement of innovative testing strategies that meet current scientific and regulatory requirements.

Current Developments and Outlook for the NAMWISE Project

Progress So Far

On February 4 and 5, 2025, the kick-off meeting of the NAMWISE project took place in Chantilly, France. This initial meeting marked the official start of the project and brought together all partners to discuss the objectives and next steps. The fundamental structure of the project and the specific responsibilities of each partner were defined.

Planned Activities and Outlook

Throughout the project, a comprehensive catalog of existing New Approach Methodologies (NAMs) will be compiled. Additionally, regulatory challenges will be analyzed in detail, and various case studies will be conducted to assess the practical applicability and effectiveness of these methods. Special focus will be placed on examining validation and standardization requirements to promote the broader acceptance and implementation of NAMs.

BioRegio STERN will play a central role in conducting surveys and workshops and will be significantly involved in disseminating the project’s findings. This will be achieved through various communication channels, including LinkedIn, YouTube, and the project’s website/newsletter, ensuring that knowledge and insights reach a broad audience.

Application Areas and Impact

The NAMWISE project targets a wide range of stakeholders in the chemical and pharmaceutical industries, including NAM developers and users, contract research organizations (CROs), as well as scientists and researchers. Through close collaboration and knowledge exchange among these groups, the project will make a significant contribution to improving safety and efficacy assessments of chemicals and pharmaceuticals while promoting innovative, animal-free testing methods.

Project Duration and Funding

Duration: December 1, 2024 – May 31, 2027
Total Funding: €2,242,838.75 (of which €1,977,390 is provided by the EU)
Investment in the STERN Region: €70,000 (100% funded)

With NAMWISE and the active involvement of BioRegio STERN, we are laying the foundation for a forward-thinking, sustainable approach to safety assessment—for people, the environment, and innovation.

The Role of BioRegio STERN in the NAMWISE Project

• Work Package 2: Mapping Existing NAMs Knowledge and Frameworks
  BioRegio STERN is actively involved in surveying leading European academic and industry experts. The goal is to identify knowledge gaps, challenges, and key drivers related to the development, use, and acceptance of NAMs in various regulatory decision-making contexts.
• Work Package 4: Case Studies on the Effective Use of NAMs
  BioRegio STERN co-organizes stakeholder workshops to consult with experts from regulatory bodies, industry (including contract research organizations, CROs), and academia. Their feedback ensures the relevance and feasibility of the case studies.
• Work Package 5: Requirements for Validation and Standardization
  BioRegio STERN is also involved in organizing additional workshops to engage NAM developers and users from industry, CROs, and academia. The focus is on validation requirements, gold standards, and standardization principles for the widespread application of NAMs.
• Work Package 6: Communication, Dissemination, and Capacity Building
  BioRegio STERN plays a leading role in this work package. Responsibilities include:
  • Raising public awareness of the benefits of NAMs
  • Disseminating scientific publications and training materials
  • Organizing a partner forum for knowledge exchange to develop best practices and recommendations
  • Gathering feedback from academia and industry on training needs
  • Identifying expectations for CROs and providing targeted training programs
  • Implementing the Communication & Dissemination Plan (C&D Plan) in collaboration with project partners