Human skin grown in a lab, computer simulations, and new approaches to vaccine quality control. These are just some of the new ideas which experts say could reduce the number of animals used in developing, approving and producing medicines.
What if I told you that these technologies already exist and the trick now is to pull them together, apply them and have them accepted by authorities? Well, it’s true.
Some of these tools can be used by themselves, others can be combined to find innovative approaches to research and testing.
By using so-called Integrated Testing Strategies (ITS), major progress could be made in moving towards the 3Rs. This approach means using tailor-made combinations of animal and non-animal research methods in developing and testing new medicines, although hurdles remain before Europe makes the leap into this new era.
As we mentioned recently, the European Partnership for Alternative Approaches to Animal Testing (EPAA) – a joint effort by policymakers and industry – devoted its annual conference in Brussels to ITS.
The beauty of so-called Integrated Testing Strategies (ITS) is that it can mean using fewer animals which also generally means lower costs. As Dr Thomas Foerster of Henkel put it, this appeals “not just for ethical reasons but also for budget reasons”.
Ready for total replacement?
So why are some of the non-animal methods which are part of ITS not used universally instead of animals? Why can’t we replace animals altogether? Well, right now, even the best available non-animal methods are imperfect.
In some cases, testing how a group of cells in a dish respond to a new drug can be very useful but scientists also need to know how whole organs interact in the presence of the new substance.
Translation: dropping a new medicine on a few brain cells tells you lots of things about how the brain will respond. Testing this drug on some liver cells also tells you something about how the body will deal with this drug. But it’s not quite the same as seeing how the whole brain, liver, kidneys, heart and so on will respond as a whole.
For now then, it seems ITS can be used to reduce the reliance on animal models, but some animals will still be required.
Show me the data!
More research is certainly needed. The other big hurdle to clear is convincing regulators to accept these new kinds of experiment instead of traditional animal-based testing. According to several speakers at the EPAA event, the industry is reluctant to invest heavily in developing these kinds of non-animal methods unless regulators can guarantee that they will accept them.
For their part, regulators have been slow to make such a commitment until they’ve seen data proving that the new non-animal methods are as good as existing tests. It’s a classical catch-22. Perhaps the only option is to jump together.
Human nature is also a drag on progress. Scientists working in industry and toxicologists in regulatory bodies are used to current animal-based methods. They understand the techniques; they trust the results.
If ITS are to be embraced, experts who are familiar with them will need to be trained or recruited – which is no easy feat. There is also the global aspect. If new ITS were acceptable in Europe but regulators in the US, China and elsewhere would only accept traditional animal-based testing then new medicines would have to be tested twice – which would increase costs rather than reducing them.
Europe can take the lead in this innovative area but there’s no point running too far ahead of the pack.
The take-home from this year’s EPAA annual event was that ITS offer real promise for reducing the use of animals but making this kind of quantum leap is never easy. It looks like we’re at the beginning of a long but exciting story.