Towards More Human and Humane Testing: The Role of the Device Supplier Industry

Abstract

In vivo testing has been the gold standard for preclinical drug development and toxicology. However, animal-based methods often lack human relevance and have a low predictability rate, not to mention the enormous ethical and financial concerns associated with their use. For instance, according to the US Congressional Budget Office ( cbo.gov ), it takes an average of 10.5 years to take a compound from the preclinical phase to the market, with a cost of US$1–US$2 billion. 90% of drugs that are tested in animals and enter clinical trials fail due to lack of safety and efficacy — this fact questions the significance of in vivo testing. Cells in culture can recapitulate certain aspects of physiology and disease, as well as indicate drug responses and toxicity. Thus, they represent a sophisticated human-relevant and humane alternative. With advances in the in vitro field, it is anticipated that confidence will be gained towards a move away from traditional in vivo models. Specialised supplier industries have been a driving force in the transition to non-animal research, by translating new approach methodologies into scalable products that have been adopted by the regulatory and testing industries — but we are still at the beginning. In this article, we introduce the perspective of the device supplier industry on the current challenges and opportunities surrounding the adoption of new in vitro methods, with the goal of promoting effective co-operation with scientists and other stakeholders. In addition, we highlight some examples of where non-animal approaches have been used in regulatory submissions, as well as listing some educational and training resources that can help when selecting the most appropriate assay.