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New (animal-free) approach methods (NAM) could be crucial to speeding up the fight against COVID-19, a team of researchers from the Center for Alternatives to Animal Testing – Europe (CAAT-Europe), based at the University of Konstanz, finds. In a new publication in Archives of Toxicology, the researchers argue that harnessing past advances made in the area of NAM technologies could accelerate the development of COVID-19 drugs and vaccines.

The importance of diversification
"SARS-CoV-2, the novel coronavirus responsible for the global COVID-19 outbreak, is likely to remain a threat to human health unless efficient drugs or vaccines become available", states Professor Marcel Leist, co-director and co-founder of CAAT-Europe (alongside Professor Thomas Hartung from Johns Hopkins University) and Chair of in-vitro Toxicology and Biomedicine at the University of Konstanz. "In this situation, using new animal-free approach methods for drug development, safety and efficacy as well as quality evaluation could speed up this process".

While animal-based testing is lengthy and likely to fail when a pathogen is specific to man or if the desired drug is based on specific features of human biology, NAM are species-specific (humans) and produce faster outcomes. For instance, NAM have already been successfully applied to predict genotoxicity (a major aspect in the formation of tumors) within days. Recent organ-on-a-chip technologies are allowing researchers to model different compartments, such as the lung and the immune system, and thus to generate data in a timely manner. Also, human antibodies targeting virus epitopes (the part of an antigen that is recognized by the immune system) can be generated in molecular biology laboratories within days without requiring animals. "We strongly believe that, with regard to drug discovery strategies, diversification, specifically the use of NAM, could prove key to global COVID-19 responses", state Marcel Leist and Thomas Hartung.

Scientific consultancy for the European Parliament
CAAT-Europe, supported by the Doerenkamp-Zbinden Foundation for animal free research, is heavily involved in ongoing initiatives to promote a wider use of existing NAM. The new editorial published in Archives of Toxicology comes out of CAAT-Europeʼs scientific consulting activities for the European Parliament. In April 2020, the advice provided by CAAT-Europe researchers informed a joint letter by 18 Members of the European Parliament (MEPs) to the European Medicines Agency (EMA) and the European Commission (EC) directorates of Innovation and Research and Health and Food Safety. In this letter, the MEPs sought to encourage a wider use of NAM – such as high-throughput screening methods, organoids, Artificial Intelligence (AI) and others – to speed up the development of COVID-19 vaccines and treatment.

"We are very pleased that both EMA and EC commissioners have responded positively, expressing their commitment to advancing research in this direction and to exploring the use of NAMs for drug development and safety assessment", says Marcel Leist.

Through these activities, CAAT-Europe has helped to set up a workshop chaired by the European Parliamentary Intergroup on the Welfare and Conservation of Animals, where Professor Thomas Hartung participated as part of the speakersʼ panel, together with representatives from the Innovative Medicines Initiative (IMI, a European initiative in the field of pharmaceutical research).

About CAAT-Europe
CAAT-Europe’s mission is to promote the development and implementation of NAM in toxicology and disease-modeling, with the affiliated research centres investing daily in the development and characterization of these novel methods. At the same time, CAAT-Europe has also emerged as an internationally-renowned platform for a range of communications and networking activities for various stakeholders engaged in promoting new concepts in regulatory toxicology.

The CAAT-Europe network includes policymakers, regulatory bodies and representatives from industry, animal welfare and consumer organisations who come together to work on regulatory roadmaps. It coordinates events, develops strategic projects promoting human-relevant toxicology and drug discovery approaches as well as humane science. CAAT-Europe is further present in the European Parliament, where it promotes the implementation of NAMs in legal texts and guidelines by providing scientific consultancy in the areas of science and technology options assessment.
 

Facts:

• Researchers from the Center for Alternatives to Animal Testing – Europe (CAAT-Europe) based at the University of Konstanz and at the Bloomberg School of Public Health at Johns Hopkins University in Baltimore find that new (animal-free) approach methods (NAM) could be crucial to the fight against COVID-19.
• Led by Professors Marcel Leist from the University of Konstanz and Professor Thomas Hartung from Johns Hopkins University, the CAAT-Europe researchers emphasize that NAM can help accelerate the discovery and development of COVID-19 drugs and vaccines because, in contrast to traditional animal-based testing methods, they are species-specific, less likely to fail if the desired drug is based on specific features of human biology and able to produce much faster outcomes.
• Original publication: Busquet, F., Hartung, T., Pallocca, G., Rovida C. and Leist, M., Harnessing the power of novel animal-free test methods for the development of COVID-19 drugs and vaccines. Archives of Toxicology (2020). URL: https://doi.org/10.1007/s00204-020-02787-2
• Scientific consulting activities provided to Members of the European Parliament by members of CAAT-Europe have led to commitment from the European Medicines Agency (EMA) and the relevant European Commission directorates to explore wider use of NAM for drug development and safety assessment.
• More information about the work performed by CAAT-Europe at: https://www.biologie.uni-konstanz.de/leist/caat-europe/