The Association of the British Pharmaceutical Industry and the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) have announced a new collaboration to explore whether the safety testing of medicines can be refined.
Current regulations stipulate that experimental medicines are assessed in at least two species – one rodent and one non-rodent (such as a min-pig of non-human primate) – before they can be tested in human trials.
According to Home Office statistics on repeat-dose toxicity tests (just one kind of test for which animals are used), in 2015 there were 9,636 procedures using mice, 29,597 with rats, 2,454 with dogs and 1,330 with non-human primates.
The new project will see NC3Rs ask pharma companies to share data on use of two animal species to determine whether current approaches are in line with best science and offer the highest level of patient safety, and explore if use of just one species pre-human testing could be sufficient.
“A number of similar studies have been published by others with differing outcomes on the need for testing in two species. Our project will have the advantage that we will have access to published and unpublished data and the expert input of industry and regulatory scientists,” writes NC3Rs chief executive Dr Vicky Robinson in a blog on the collaboration.
A working group convened by the NC3Rs and led by the group’s Dr Helen Prior, whose post is funded by the ABPI, will oversee the project, and a number companies have already committed to sharing data, it said.
ABPI and the NC3Rs have now been working together for 12 years on appropriate use of animals in testing.
“This collaboration has been incredibly valuable in supporting industry’s implementation of the 3Rs [reduction, refinement, and replacement of animals] across medicines development, to achieve both the best science and best animal welfare,” said Dr Paul Brooker, chair of the ABPI Nonclinical and Biological Discovery Expert Network (NaBDEN).
