It is a regulatory requirement that all drugs intended for human use go through safety pharmacology studies to determine the potential for adverse effect liabilities in major organ systems, including the respiratory, cardiovascular and central nervous systems. This currently relies on animal models, including rodents, dogs and non-human primates. Together with the Medicines and Healthcare Products Regulatory Agency (MHRA) and 28 other organisations (including companies and international regulators) we are working to increase the uptake of human tissue-based approaches to replace the use of animals and provide more predictive tools to determine the safety of drugs entering clinical studies.
Our initial priority has been to assess the current use of human tissue through a survey of the international safety pharmacology community. This has highlighted that human tissue use for safety assessment is currently limited, but there is increasing interest in adopting this approach. However, regulatory and supply issues are key barriers and these will form the main focus for future activities in this area.
A workshop was hosted to showcase the results of the survey to the international safety assessment and regulatory communities, and to come up with a strategy to overcome the barriers to wider uptake of human tissue models. The strategy included sharing information and best practice between researchers, and as such, the oral and poster presentations presented at the workshop can be downloaded below:
We are also supporting research through our CRACK IT open innovation platform with a Challenge focused on the development of human tissue-based models to assess cardiac contractility liabilities, and Solutions developing human tissue-based cardiac, liver and kidney models.
We are also investigating the development and adoption of human tissue-based models to replace animal use in asthma.
Holmes A, Bonner, F, Jones D (2015) Assessing drug safety in human tissues - what are the barriers? Nature Reviews Drug Discovery doi: 10.1038/nrd4662