NAMS WITHIN INTEGRATED SAFETY & EFFICACY EVALUATION OF CHEMICALS AND PHARMACEUTICALS

The vision of the NAMWISE project is to provide a supporting framework to pave a scientifically substantiated way towards a paradigm-shift in (eco)toxicology that will not rely on in vivo data.

To fulfil its vision the project will leverage the acquired knowledge on New Approach Methodologies (NAMs) and then gather new input from all stakeholders to refine, improve and optimize their use in regulatory contexts for chemicals and pharmaceuticals.

The project will merge under its umbrella inputs from a multi-disciplinary consortium comprising academia, NAM-developers, NAM users (CROs), regulators while reaching out towards societal expectations. The workplan of NAMWISE is organized along far-reaching objectives driven by the interest for all the stakeholders:1.

Sustain and amplify the momentum built by similar initiatives by combining expertise on in silico tools, in vitro assays and a widespread network with external projects.2.

Provide a pragmatic approach based on case-studies for hazard/risk assessment and drug efficacy that will guide the project in implementing NAMs strategies.

These procedures will be submitted to a peer-review to ensure that what the NAM community receive is of a high standard. 3.

Deliver an analysis of requirements in terms of standardization and validation of NAMs that benefits from the input of the PEPPER platform on pre-validation, a unique French initiative on NAMs based on public and private funding.4.

Foster fruitful interactions between stakeholders catalyzed by several actions, including a series of workshops and training initiatives targeted on the needs of CROs identified during the project. 5.

Propose a way forward for solving NAMs’ shortcomings and enhancing their drivers.Finally, the project will provide a white paper during its final open symposium that will render NAMWISE a major reference point and essential force for bringing forward proposals for animal-free chemical and drug assessments.