However, Roche is pioneering and promoting the application of innovative in silico and in vitro approaches in preclinical research. In silico, computational, model-based simulations help us to identify promising drug candidates faster and with more precision. Modern, in vitro molecular biology techniques enable us to better translate findings from cellular systems to optimised animal models to humans. This route leads to a better understanding of diseases and provides valuable insights for Personalised Healthcare.
Furthermore, innovative microphysiological systems (organ-on-a-chip approaches) allow the profiling of test compounds under physiological conditions on cellular biochips in the most relevant human system. These promising approaches save time, reduce costs, and minimise the number of experiments and animal studies while making preclinical drug development programmes more precise and predictive for clinical trials.
To further advance
Minimise the number of animals used
Minimise any animal discomfort and improve welfare
Avoid or substitute the use of animals
With careful design, sophisticated statistical techniques and modern imaging, it is often possible to significantly reduce the number of animals used in research while still generating valid results, truly adding to the knowledge base.
This refers to decreasing the potential for causing animals distress and continuously seeking advancements in animal husbandry, care practices and environmental enrichment to provide the best possible conditions for animals.
Research animals are either replaced by methods not involving animals (absolute replacement) or by methods using only the cells or tissues of animals (relative replacement). Such alternative methods include cell and bacterial cultures, computer simulations, mathematical modelling, and the use of microphysiological human or animal systems.
The Ethical Committee of Animal Welfare at Roche comprises representatives from all research organisations within the Roche Group. The Committee advises on strategic matters related to animal welfare practice and policy, reviews and, where necessary, proposes changes and actions related to animal testing. It advances the 3Rs within Roche and also assists in communications with external governance and regulatory bodies.
When conducting animal studies, every project includes a detailed explanation of the research purpose, the likely effects on the animals, and the reasons why the results cannot be obtained using other methods. These research protocols are reviewed by state veterinary authorities in the European Union and Institutional Animal Care and Use Committees (IACUCs) in the United States and other parts of the world.
We regularly engage with animal welfare organisations to improve our mutual understanding and to exchange views on animal welfare-related topics. For example, we communicate regularly through Interpharma (Swiss Pharmaceutical Companies Association) with animal welfare organisations such as Swiss Animal Protection (SAP).
Before any medicine can be brought to market, clinical trials must first be conducted to establish that the medicine is both efficacious and well tolerated. However, before human clinical trials for new medicines can proceed, regulatory bodies worldwide require efficacy and safety data from studies conducted on animals. As research seeks new treatment solutions for complex diseases, such as neurodegenerative disorders, animal testing continues to be necessary in order to facilitate these developments.