Exploring the appropriate use of animals within drug development
From International Journal of Toxicology
By Dr Helen Prior
“The NC3Rs is a UK-based independent scientific organization funding innovations and technological developments that advance the 3Rs - replacing or reducing the need for animals in research and testing, or applying refinements to enhance welfare where animals continue to be used. We regularly run workshops or host sessions at scientific meetings to bring the international community together to discuss opportunities to promote application of the 3Rs. In November 2018 we organised a symposium, 'Integration of consortia recommendations for justification of animal use within current and future drug development paradigms', at the American College of Toxicology (ACT) 39th Annual Meeting (Palm Beach, USA) to discuss how animals are used within the drug development process.
Many thousands, likely millions, of animals are used each year worldwide to test the safety of potential new medicines - work that is critical for the protection of healthy volunteers and patients if these new medicines proceed to clinical testing and further into widespread use. These toxicology tests are regulated by international guidelines, however, scientists are constantly looking for ways of improving the predictivity and human-relevance of the data packages. This may include adopting new non-animal (in vitro and in silico) approaches, minimising the number of animals used through best-practice study designs, or challenging the need for certain procedures or measurements within the animal studies.
Left to Right: Professor Ian Kimber (chair), Manchester University, UK; Dr Helen Prior, NC3Rs, UK; Dr Virginie Boulifard, Ipsen Innovation, France; Dr Tom Monticello, Amgen, USA and Dr Frank Brennan, UCB, UK.
There is a long history of companies working together to share experience and providing blinded data for critical review within larger, pooled datasets. Four of these current industry consortia came together for this symposium to discuss their projects, each investigating aspects around the appropriate use of different species of animals in nonclinical toxicology studies. These included i) whether the animal toxicity studies were predictive of the observations seen in human trials (IQ-DruSafe); ii) the value of the dog within drug development (European Federation of Pharmaceutical Industries and Associations - EFPIA); iii) the value of the monkey within development of monoclonal antibodies (Biosafe); and iv) whether a single species could be used more widely (NC3Rs).
Our short symposium review considers whether the different consortia recommendations can be aligned into realistic and practical approaches to improve future toxicology testing strategies, highlighting justification for the use of different animal species and opportunities for reductions in animal use within drug development.”
Article details
Integration of Consortia Recommendations for Justification of Animal Use Within Current and Future Drug Development Paradigms
Helen Prior, Thomas Monticello, Virginie Boulifard, Frank R. Brennan, Ian Kimber
First Published June 20, 2019 Meeting Report
DOI: 10.1177/1091581819852922
From International Journal of Toxicology
Dr Helen Prior is a Programme Manager at the NC3Rs in London UK, organising symposia and workshops and convening expert working groups across industry and regulatory agencies globally to explore and validate opportunities to apply the 3Rs to safety assessment during drug development.