On 15th September 2021, the European parliament adopted a resolution vote to actively phase out the use of all animal testing and called for the definition of milestones and targets in order to progress human-relevant non-animal approaches. Although the vote is not considered legally binding, it puts considerable pressure on the European Commission to respond and act. Just two weeks later, a further announcement from the European Medicines Agency (EMA), indicated that they are putting in place special support to help developers replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines through the EMA’s Innovation Task Force (ITF). This task force is a multidisciplinary group consisting of scientific, regulatory, and legal representatives who provide a forum for early dialogue with applicants on innovative aspects in medicines development.
Within the pharmaceutical industry, it is well recognised that toxicology testing often poorly translates across species, resulting in late-stage failures and adverse drug reactions in human clinical trials. For example, it is estimated that preclinical toxicology studies in animals fail to pick up 50% of hepatotoxic compounds, and the percentage of human neurological toxicities detected in animal studies still only reaches approximately 60%. Nevertheless, pre-clinical safety testing in animal species is still an important tool in our armoury as many toxicities are successfully identified, thus preventing exposure of humans in early clinical trials. Furthermore, although our understanding of human relevant models has grown significantly over the past 5-10 years, there remains a lack of standardised and approved models which are recommended by the regulatory authorities for the pharmaceutical industry.
Even though it is encouraging to see a definite shift in attitude to animal testing and action being taken, it is expected that the move to eliminate animal testing of pharmaceuticals will not happen quickly. Evaluating, validating, and implementing new standardised human-relevant methods that are equally, if not more, predictive than animal tests will take considerable time. In the meantime, the move towards reducing and even eliminating animal testing should encourage additional investment in non-animal alternative methods and help drive research in this area.
The recent developments by the European parliament follow announcements by the US authorities. In 2019, the US Environmental Protection Authority (EPA) declared it would stop conducting or funding studies on mammals for chemical safety testing by 2035. Furthermore, the FDA published their Predictive Toxicology Roadmap in December 2017, and a publication last year gave the FDA/CDER’s perspective on non‑clinical testing strategies and their commitment to advancing new approach methodologies (NAMs) to support drug development.
Cyprotex has been developing human cell-based models for over 20 years and offers both in silico and in vitro models to predict human outcome. Therefore, we are well‑placed to address this urgent need for alternative methods. Many of these models are designed to be used at an early stage to improve safety and reduce risk at later stages where project delays or failures are very costly.
Contact Cyprotex to learn more about our human-relevant models.