Innovate UK, a public body sponsored by the UK Government Department for Business, Innovation & Skills, has recently published a non-animal technologies roadmap for the UK. The document was developed in collaboration with the National Centre for the Replacement Refinement and Reduction of Animals in Research, the Biotechnology and Biological Sciences Research Council, the Defence, Science and Technology Laboratory, the Engineering and Physical Sciences Research Council, and the Medical Research Council. In addition, other stakeholders were consulted.
The non-animal technologies (NATs) relevant to the document are reported to include (but are not limited to) complex 3D tissue models, organ-on-chips, stem cell platforms, in silico tools and cell imaging approaches. The group suggests these are promising emerging technologies with a potential for economic growth:
The market potential is huge. The global market for cell based assays in drug discovery, safety, and toxicology will reach $21.6 billion by 2018. The estimated global market for induced pluripotent stem cells is expected to reach $2.9 billion in 2018, and the 3D cell culture market is expected to grow to about $2.2 billion in 2019.
The report starts with two disclaimers. First, the roadmap is:
not intended to represent a comprehensive set of activities with a precise timescale but should be seen as an illustration of the broad landscape.
Further, it is not intended as a commitment by the six organisations to implement its recommendations:
The issues outlined and the recommendations have come out of extensive discussions between the six organisations that are endorsing the roadmap and with many other key stakeholders. The participation and endorsement by the six organisations reflects their continuing interest in non-animal technologies, but should not be construed as a commitment to ensuring its delivery.
The document acknowledges what researchers increasingly have come to understand, that is animals are not good models for the study of human diseases:
The lack of translation of data from animals to man has far-reaching implications, from wasted resources spent on the early development of compounds destined to fail in humans, to large financial losses due to latestage attrition. Consequently, many organisations are increasingly interested in alternative non-animal technologies (referred to here as NATs) for providing information on the safety and efficacy of their products.
In addition, non-animal technologies have many benefits, such as
increasing throughput, cutting development time and costs, and providing mechanistic insights that are not possible with in vivo research. For these benefits to be realised there is a need for NATs to be scaled up for industrial use, scientifically validated and fully integrated into the pharmaceutical and chemical development pipelines.
What does the roadmap propose?
In the short term, strategies such as the following are put forward: tissue banks, a substantial reduction in animals used in research, use of complex in vitro models, databases for validation and confidence-building in NAT methods, bio printing to commercial scale, robotics, and an increase in ongoing cross-industry collaboration.
Sometime between 2020 and 2030 non-animal technologies are expected to be increasingly accepted by regulators as the better tests, become standard, and lead to better patient/consumer safety.
What does it all mean?
The document acknowledges the poor predictive value of existing animal models. When, for example, nine in ten drugs fail in humans after they have been found to be safe and effective in animals, is this not a good enough reason to cease animal research and direct all available resources to the (further) development of methods relevant to humans? What other industry would accept such a failure rate?
Let’s consider the aviation industry. If people knew that every time they board a plane there is a nine in ten chance that something will go wrong, possibly terribly wrong with deadly outcomes, would any sane person still use planes? This roadmap acknowledges the failings of animal models and anticipates that in some ten years’ time – if everybody does the right thing and collaborates – better, more human-appropriate technologies and methods will lead to better patient and consumer safety outcomes. Why can’t we have that improved safety sooner? Yes, this is a rhetorical question. The answer is of course: Too many vested interests.
This UK roadmap is a statement of intention, without concrete timelines or deliverables, without a commitment by its authors/collaborators to implement what’s been recommended. Just words. But even that is more than we have here in Australia.
Innovate Uk. (2015). A non-animal technologies roadmap for the UK. Advancing predictive biology. Innovate UK, the National Centre for the Replacement Refinement and Reduction of Animals in Research, the Biotechnology and Biological Sciences Research Council, the Defence, Science and Technology Laboratory, the Engineering and Physical Sciences Research Council, and the Medical Research Council.