New paper by Dr Gerry Kenna published by Expert Opinion on Drug Metabolism & Toxicology:
"Human biology-based drug safety evaluation: scientific rationale, current status and future challenges"
Abbreviated abstract: Animal toxicity studies used to assess the safety of new candidate pharmaceuticals prior to their progression into human clinical trials are unable to assess the risk of non-pharmacologically mediated idiosyncratic adverse drug reactions (ADRs), the most frequent of which are drug-induced liver injury and cardiotoxicity... The chemical insults can be detected using in vitro assays. These enable useful discrimination between drugs that cause high versus low levels of idiosyncratic ADR concern... Widespread acceptance and use of such assays has been hampered by the lack of correlation between idiosyncratic human ADR risk and toxicities observed in vivo in animals.
Sir David Amess MP, plus two of our Science Advisers: Dr Kelly BéruBé and Professor Geoff Pilkington
Sir David Amess MP hosted the launch event, which was full to capacity with senior scientists and MPs whose enthusiasm and support were palpable.
Working together, the Alliance will help to speed the transition away from animal testing, towards more efficient and predictive models based on human biology. Many breakthroughs are lost in translation from animals to humans. There is now a tremendous opportunity to make drug development faster and safer, using human relevant technologies. Some exciting technologies were highlighted at the meeting, including cutting-edge models of the liver, linked together with other organs to realistically mimic the human body.
Sir David said: “Britain is a world leader in life science research. But we had better look to our laurels if we do not want to be left behind, while others take the lead in embracing more predictive tools based on human biology. I wish the new Alliance every success with this hugely important initiative.”