Marcel Leist

Marcel Leist studied biochemistry in Tübingen (Germany), and then obtained an MSc in toxicology (Guildford 1989), a PhD in pharmacology (Konstanz 1993), and a habilitation in toxicology/cell biology (1998). Since 2006, he has been head of the department of in vitro toxicology and biomedicine at the University of Konstanz (inaugurated by the Doerenkamp-Zbinden foundation), and director of the Center for Alternatives to Animal Testing in Europe (CAAT-Europe), a joint venture with Johns-Hopkins University. Before that, Marcel Leist worked as ‘Head of Department of Disease Biology’ on the discovery of neurology and psychiatry drugs in the Danish pharmaceutical company Lundbeck A/S from 2000-2006.

NextGen Basel 1

The ASPA Risk Assessment Workflow Framework

Various efforts have been made to propose strategies on how to innovate risk assessment of chemical substances. New concepts suggest the integration of exposure and hazard assessment models and the implementation of new approach methodologies (NAMs). Next-generation risk assessment (NGRA) may be used for large numbers of chemicals by employing models for rapid exposure predictions, high-throughput toxicokinetic modelling, and innovative (high-throughput) in vitro approaches for toxicity testing. While some case studies that demonstrate the applicability of NGRA approaches have been published, full operationalization of NGRA concepts in regulatory risk assessment of chemicals is limited. Under the Horizon 2020-funded ASPIS cluster umbrella, a workflow for NGRA is being developed. This workflow, entitled ASPA (Alternative Safety Profiling Algorithm), defines a tiered testing approach to guide the selection of NAMs, data assessment, and uncertainty quantification. ASPA's objectives are to provide visual and flexible guidance for collecting data and to connect new and available knowledge for data interpretation, enhancing the transparency and traceability of the decision-making process. The general concept and the critical aspects of ASPA will be iteratively refined following an evolutionary co-designing approach in close collaboration and open discussion with related initiatives sharing the same mission. Over time, ASPA will change in depth/detail, readiness level, incorporation of emerging technologies, and the different hazard and risk assessment principles. Implemented in the NAMASTOX virtual dashboard, ASPA will act as an NGRA web tool for the practical implementation of non-animal chemical risk assessment.