Dr Paul Brooker is Chair of the ABPI Nonclinical and Biological Discovery Expert Network (NaBDEN) and is President Europe, Middle East & Asia Pacific (EMEA) and President CRS at Envigo.
Science is never static and this means our science-based industry never stands still. As our knowledge and technology develop, industry is always reviewing, evaluating, and where necessary challenging the ways we research and develop new medicines.
We're very excited to announce the launch of a new collaborative project between the pharmaceutical industry and the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs), which will explore and evaluate the ways in which industry safety tests its new medicines.
Ensuring patient safety is our top priority in the discovery and development of new medicines. We use a huge range of research techniques to understand as much as possible about a new medicine and any possible side effects before it is taken by a patient. These approaches are agreed through scientific consensus between global regulators, industry and academic experts, and published in internationally agreed guidelines. They include computer modelling and in vitro tests in cells and tissues, then studying the effect of the new medicine in animals to explore possible side effects in a whole living organism. Current regulations routinely require medicines to be tested in at least two species, one rodent (i.e. mouse or rat) and one non-rodent, (i.e. dog, mini-pig or non-human primate), before they can be given to humans.
Our industry seeks to ensure it keeps pace with the latest developments in technology and advances in science by routinely reviewing and updating our practices. We also work with regulators to explore this new science and review how it may affect the current regulatory guidelines. Indeed, at any one time five to ten of the internationally agreed regulations may be under review. This on-going evaluation plays a vital role in allowing industry to continuously improve how to test the safety and efficacy of innovative life-saving medicines and get them to the right patients at the right time. In our preclinical work this allows us to review our use of animals in research and ensure we are implementing the 3Rs (reduction, refinement, and replacement of animals) to the greatest possible extent.
In this new project, NC3Rs will be working with companies to share data on their use of two animal species in the safety testing of new medicines. They will use these data to explore if our current approaches are in-line with both the best science and the best way to ensure patient safety. Or, to challenge our methods if new developments in science and technology offer the possibility of better approaches, which may also reduce or refine the use of animals in these tests.
This project builds on and extends the on-going ABPI-NC3Rs collaboration that is now in its 12th year. This collaboration has been incredibly valuable in supporting industry's implementation of the 3Rs across medicines development, to achieve both the best science and best animal welfare. This new project should be no exception, and will be a valuable part of our industry's continual efforts to evaluate and where appropriate improve our development of new treatments.
The NC3Rs has also published a blog on the new collaboration.