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The CSIRO says Australia has 5 years to maximise the economic and scientific opportunities on offer as part of the global shift to non-animal models in medical research.
With the use of animals in medical product development expected to decline, there is a risk to existing clinical industries if the country doesn’t keep pace with international trends.
The CSIRO is calling on the government, industry, research institutions and regulators to act.
A new strategy from the nation’s science agency, ‘Non-animal models: A strategy for maturing Australia’s medical product development capabilities’, argues international policy changes, model development and laboratory animal supply challenges are accelerating the move towards non-animal alternatives in the development of medical products such as drugs, vaccines, diagnostics and devices.
Last week Cosmos reported on the status of Australia’s use of laboratory animals in science and medical research, and the lack of systemic support for non-animal alternatives such as 3D cell cultures, organ-on-a-chip and tissue explants.
Greg Williams, health and biosecurity lead at CSIRO Futures, says the US and Europe have made policy and legislation changes clearly signalling plans to progress towards non-animal models, and are supporting these moves through dedicated funding programs.
“Australia doesn’t have those things,” Williams says.
That’s why the CSIRO’s strategy outlines a 5-year plan for how Australia’s medical research and development institutions and industries can keep pace with other countries, and take advantage of the global scientific and technological developments.
“This is a global capability that will continue to mature whether Australia acts or not,” Williams says. “The risks [of inaction] are that we miss out on the economic opportunities associated with these new products and services, and the quality and productivity of medical research diminishes compared to the countries that support the development and adoption of the technology.”
CSIRO says its strategy will help secure the future of Australia’s $1.4 billion (annually) clinical trials sector. It identifies 4 national opportunities from non-animal methods, in areas where Australia already has a competitive advantage or transferable skills.
The opportunities focus on aligning “local strengths, with local and global needs” Williams says.
Australia already has good platforms for drug candidate screening, so the first opportunity involves adopting more complex non-animal models, like organoids, into those systems.
Other opportunities include adopting organ-specific models for pre-clinical development and safety testing; non-animal models for precision (or personalised) health; and manufacturing and supplying the inputs used in non-animal models and methods.
Williams says in many cases, non-animal models already offer scientific and technical benefits over traditional models which rely on laboratory animals.
“Because they use human cells and data, non-animal models offer the potential to better predict human response compared to animals. This means that they can fail drug candidates faster, for example, and allows us to then reinvest those funds into drug candidates that are more likely to succeed. So you’re getting a better quality of research and you’re avoiding costs.”
He says some non-animal models also offer higher throughput – the possibility of testing of more compounds, or a wider range of experimental conditions in a shorter period of time.
The CSIRO report details the development of non-animal models in different organ systems, while noting there is variation depending on the model type, tissue and applications.
Organ systems where non-animal models have demonstrated equivalent or better outputs than traditional approaches using animals include the heart, lung, digestive system, skin, eye and liver. Those that show potential to do so within 15 years include the nervous system, pancreas, kidney, musculoskeletal and reproductive organs.
Ear, bone marrow and immune system were the only three identified where non-animal alternatives are yet to reach that point within the next 15 years.
Despite the 15 year timeframe, CSIRO says Australia needs to act within 5 years in order to take advantage of the global shift, which is already underway.
The strategy’s 10 recommendations seek to ensure the broader system explicitly supports the use of non-animal models.
Recommendations include establishing a consortium of regulators, researchers and industry to drive support for non-animal models; national data collection to track progress; and ensuring regulations and product approvals, such as TGA processes, explicitly support the use of non-animal models (as is the case in other countries).
“The federal government will need to be the one to take the lead on most of those, because we’re talking about nationwide investments in infrastructure, government regulation,” Williams says.
“But all of those would require really strong industry, research and government collaboration to deliver on.”
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