Translating Disruptive New Approach Methodologies (NAMs) into Practice

New Approach Methodologies (NAMs) have the potential to replace, reduce or refine animal use in the testing96 of medicinal products. Scientific progress in recent decades has delivered several animal-free NAMs that have the potential to transform how we understand human biology and assess the safety, efficacy, and quality testing in the health sector. However, a lack of knowledge, experience and confidence in the use of such novel methodologies has limited their adoption by end users, including, for example, industry and regulators.

This Challenge competition therefore looks to accelerate the adoption of NAMs in biomedicine and support companies that want to bring NAMs to the market. Applicants should propose innovative and disruptive NAMs addressing one or both of the following areas:

• Preclinical biomedical research
• Testing of medicinal products and medical technologies for safety, efficacy, or quality.

Human organoids or microphysiological systems (e.g. organ-on-chip, disease-on-chip), in chemico methods, digital twins, virtual patient simulations, AI-enhanced predictive models, mechanistic or integrated in silico platforms, 3D- advanced human tissue model are in scope.

Applicants to this Challenge call should already have:

• Proven the viability of their proposed solution in a lab environment at TRL 4 (lab or in silico);
• Have letters of intent of at least one of the following stakeholders: an industrial end-user or regulatory body interested in the proposed project; and
• Have access to an appropriate infrastructure to carry out the planned activities in Stage 1 and 2.

This Challenge supports ambitions to maintain and strengthen the health sector in Europe. It will:

• Accelerate the development and validation of disruptive NAMs for biomedical applications, including medicinal products and medical technologies
• Support regulatory innovation by providing evidence-based recommendations for the assessment of safety, efficacy, and quality of human health products using NAMs.
• Enable citizens to benefit from novel technologies that have been assessed through rigorous NAMs that have been validated to can predict potential effects in humans, and
• Provide industry with a harmonised and standardised NAM-based assessment toolkit that is faster and more flexible.