“What we believe in, is putting the best biology we can into our models to mimic human biology”.

In recent years, there have been significant advances in technologies and resources to support drug discovery and drug developments; still the process remains lengthy and costly due to the high attrition rate of novel therapeutic agents at clinical stage.

Encouraged by the FDA modernisation act, pharmaceutical developers are changing practices and seeking alternatives to animal preclinical studies by using new methods, also called New Approach Methodologies (NAMs), including more relevant in vitro models, improved study designs, and more informative data outputs. This legislation has catalysed the engagement of the wider community to generate more pre-clinical models and strategies for regulatory consideration. The goal of future non-clinical safety/efficacy regulatory submission packages, is to advance the use of these enabling technologies by accurately predicting and characterising human responses.

While the idea was widely welcomed in 2022, the feasibility of replacing animal studies in regulatory packages raised questions around the state of evolving science and lack of technology-readiness. As a result, the FDA established a process to qualify the non-clinical testing methods resulting in the FDA Modernisation Act 3.0 bill introduced in February 2024. Interestingly, the review of applications that used qualified NAMs were expedited to encourage submission while accelerating data collection.

 According to Dr. Jan Lichtenberg, CEO Insphero (CH), “There is a lot of drive for reducing animal models in the industry because a lot of the new modalities for drugs do not work in animals, so researchers need models they can rely on and that give them proper data and also the regulatory agencies start accepting that it doesn’t make sense to force researchers to test on animal models that are not relevant”.