New technologies require different thinking: 2 decades of cell-based methods for test development and validation for regulatory purposes


    Dr. Sandra Coecke

    Institute/Organization : IHCP JRC European Commission
    Department : ECVAM


    ECVAM as part of the European Commission ’ s Joint Research Centre focuses on emerging technologies with the potential to optimize and expedite the process of developing alternative methods and new testing strategies. These emerging technologies and in vitro cell culture methods provide an opportunity to extend risk assessment relevant to humans and advance our understanding of the relationship between chemical exposure and effect. ECVAM organizes workshops with experts and task forces to identify new technologies and critical processes for deriving cell-based test methods for application in regulatory toxicology. The methods are evaluated in relation to current use in human health hazard assessment approaches and specific gaps in the development, validation, and application of the methods are highlighted. A conceptual framework is often a deliverable of these expert meetings in order to move the methods and technologies into use and acceptance by the scientific and regulatory communities. In many occasions, these workshops lead to the initiation of large research consortia which subsequently apply for European funding schemes. ECVAM supports several of these initiatives with complementary in-house research programmes and by collaborating with local, national and international institutes and organisations. Areas of focus for additional in-house test development include neurotoxicity and developmental neurotoxicity (Coecke et al., Environ Health Perspect 2007). Currently, we identified and are actively pursuing sensor and omics technologies (Corvi et al., Environ Health Perspect 2006), fingerprint and pattern-based assessments, biomarker approaches, high-throughput screening and other technologies such as multi-electrode arrays, surface patterning and throughput image analysis in an attempt to automate conventional toxicological assays. By fostering the potential of emerging technologies combined with adequate in vitro cellular systems developed according to good cell culture practice principles (Coecke et al. Altern Lab Anim 2005) we hope to reshape hazard identification for European legislation.


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