Integrating New Approach Methodologies (NAMs) to advance biomedical research and regulatory testing

Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to several of the following expected outcomes:Researchers are in possession of improved human-relevant New Approach Methodologies (NAMs) platforms that capture the genetic, phenotypic, age-related, immune, microbiome, and environmental exposure variability of the human population. These innovations support more equitable healthcare solutions and personalised treatment strategies across diverse life stages.Industry gets access to platforms that allow a faster pace of innovation for the development of more cost-effective targeted therapeutic interventions and improvement of the safety assessment of chemicals, other medicinal products, and medical devices.Patients benefit from innovative platforms and strategies that improve prediction, prevention and treatment of diseases, in particular through enhanced understanding of disease pathways and mechanisms.The general population is better protected through a safer environment, as these platforms enhance the detection and mitigation of risks posed by chemicals and other potentially harmful substances.Regulatory bodies gain confidence and trust in NAMs, supporting their integration into product development, risk assessment, and approval processes.Fewer live animals are used in biomedical research and regulatory testing. Scope:This topic aims to support the ongoing paradigm shift in biomedical research and safety assessment of chemical compounds by fully integrating NAMs across the entire research and regulatory spectrum, from basic discovery phase to clinical application, and regulatory testing of medicinal products and medical devices, and/or industrial and environmental