We co-hosted a workshop exploring opportunities to reduce animal use.
We brought together international experts on second species testing in drug development in a landmark workshop.
Examining the Second Species Requirement in ICH M3 explored whether there may be opportunities to reduce the use of two species of animal in the same regulatory toxicity test.
Organised in collaboration with the Johns Hopkins Bloomberg School of Public Health, the Washington DC event attracted participants from around the world, both in-person and online.
The workshop examined the long-standing requirement for new medicines to be tested on both a rodent and non-rodent species (usually a dog or non-human primate) before they are tested in humans. There is growing interest in whether new technologies and other sources of evidence could help reduce or remove the need for testing on a second animal species, as well as helping to reduce animal testing more broadly.
The event gave a valuable opportunity for regulators, industry scientists, academic researchers, and animal protection organisations to discuss these questions, share perspectives, and explore how confidence in more flexible approaches could be built.
Almost 90 people attended from across four continents, reflecting the broad international interest in this important topic.
Speakers included representatives from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), alongside experts from Merck Healthcare KGaA and the UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).
Through presentations and audience discussions, participants considered a range of practical scenarios relevant to second species testing and discussed the scientific and regulatory considerations involved in introducing greater flexibility. The workshop also drew on lessons from the recent revision of ICH S1 which allowed an animal study used to assess the cancer risk of medicines to be waived in some circumstances. This demonstrated how a long-standing animal testing requirement can be re-evaluated as scientific understanding and technology evolve.
A key success of the workshop was in bringing together a diverse range of perspectives. The productive discussions revealed both the complexity of the issue and the value of open scientific dialogue. At a time when governments and regulators around the world are introducing strategies to reduce reliance on animal testing, the workshop was an important chance to consider how testing requirements should be re-evaluated as science advances, and how new approaches may support both reductions in animal testing and more human-relevant approaches to assessing the safety of new medicines.
We are now working with our colleagues at Johns Hopkins to develop a workshop report, which will be published in the coming months in a peer-reviewed journal and will help guide future discussions in this area.
Our Deputy Director of Science and Regulatory Affairs, Laura Alvarez, who was one of the co-organisers of the workshop, said: “The second species testing requirement has remained largely unchanged in regulatory guidance for many years, despite significant scientific advances and increasing opportunities to reduce reliance on animal testing. This workshop provided a unique opportunity to bring together a wide range of perspectives and expertise to discuss a complex scientific and regulatory issue in an open and constructive way. Progress in this area depends on a willingness to engage with different viewpoints, build confidence in a shared understanding of where avoidance of animal tests could be possible, and what evidence would be needed to support that.”
