In Vitro Testing Industrial Platform

Toxicology in the 21st century

Ninna Berg(1), Bart De Wever(2), Horst W. Fuchs(3), Marianna Gaca(4), Cyrille Krul(5), Erwin L Roggen(1)

(1): Novozymes AS, Denmark; (2): Henkel, Germany; (3): CellSystems, Germany; (4) British American Tobacco; (5): Netherlands Organisation for Applied Scientific Research (TNO), The Netherlands 

Corresponding author: 
Erwin L Roggen 
Novozymes AS 
Department of Toxicology 
Krogshoejvej 36 
2880 Denmark 
Tel. +45 44464220 
e-mail: elro@novozymes.com 

This paper has been published in the journal ‘Toxicology in Vitro’ by Elsevier: the Official Journal of the European Society for Toxicology in Vitro and The American Society for Computation and Cellular Toxicology. Volume 25, issue 4, June 2011, ISSN 0887-2333www.elsevier.com/locate.toxinvit

Abstract

In November 2009 the In Vitro Testing Industrial Platform (IVTIP) organized a meeting entitled ‘Toxicology in the 21st century – working our way towards a visionary reality’. Participating delegates included scientists, key opinion leaders, developers and users of 3Rs-related tests and testing strategies.

This paper summarizes the lively discussions that were inspired by the views and opinions of the distinguished speakers as they addressed the selected topics. ‘The vision and its perceptions by different industries’: Concerns were expressed, but the focus was on the needs and expectations of the various stakeholders. ‘Possible impact of the vision on regulations’: It was clearly stated that in vitro tests and testing strategies do not have fewer limitations than in vivo approaches, and that validation also in the 21st century would be required. ‘The technological reality’:The in vitro community still is not near to fulfilling the needs and expectations of industry and regulators for most toxicological endpoints.

‘How far did we come?’ Many elements of the NRC vision and strategy were identified in the initiatives aimed at the development of non-animal based methods for screening, early decision making and risk assessment that have been and currently are supported by the European Commission (EC) and industry. There was a call for immediate implementation of new technologies and paradigms which were considered essential for making the vision a reality. Specifically mentioned were (i) physiologically-based pharmacokinetic (PBPK) /multiscale modelling for making a meaningful link between in vivo and in vitro, (ii) novel cell and tissue-based models to solve the issues test developers are facing, (iii) expanding the implementation of toxicogenomics from carcinogenesis to other toxicity endpoints, (iv) strengthening the development of systems biology by dedicated concerted actions, and (v) Toxicological Factors Analysis and Classification (TFACS). While it was recognized that each of the new approaches has a unique strength, integration of old and new technologies to integrated testing strategies (ITS) was considered to be the preferred way forward. Procedures and guidelines for putting together ITS should be established as soon as possible in order to facilitate proper implementation and acceptance. The importance of method harmonization and standardization was stressed. While the efforts by the EC and the European Partnership for Alternative Approaches to Animal Testing (EPAA) were recognized, there was an urgent call for more coordination of the efforts that are ongoing or initiated in the 3Rs arena at national and international level. Education, training, communication and dissemination were addressed. It was recognised that the EPAA, through its ‘Platform for Communication and Dissemination’, has a very important and central role in this area.

To conclude, the NRC vision and strategy for toxicity testing in the 21st century was unanimously considered as the right approach to enable a thorough, reliable and systematic approach to future toxicity testing. During this meeting a potential way forward was mapped out.

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