Alliance calls on experts to join its new collaborative community, seeking to overcome regulatory and data challenges preventing the replacement and reduction of animal testing

The Pistoia Alliance, a global, not-for-profit that advocates for greater collaboration in life sciences R&D, has published new survey findings that reveal 77% of R&D professionals are not using in vitro cell-based alternatives to animal testing, and only 23% describe themselves as ‘very familiar’ with any kind of animal model alternative.

More than 350 survey respondents participated, including representatives from pharma companies, regulators, and CROs. The data revealed that regulatory concerns are a major barrier to non-animal model (NAM) adoption, experienced by 60% of respondents. This comes despite new laws, such as the FDA Modernization Act 2.0 that empower preclinical studies to adopt NAM, which may more accurately predict human therapeutic responses than traditional animal testing. Recognising the need for greater industry collaboration to overcome these shared challenges, the Pistoia Alliance is launching a new Non-Animal Models Community, and now calls on interested companies to participate and provide funding.

“We brought this idea to the Pistoia Alliance because non-animal models hold huge potential for transforming the clinical development landscape, and collaboration is critical to industrywide adoption of NAM. Companies are excited by the possibility of producing more accurate models than traditional animal testing that could speed up drug development and support their ESG goals. But, as this research shows, there are several regulatory, technological, and ethical hurdles that must be navigated before this becomes a reality,” comments Ellen Berg, CSO, Alto Predict. “The Pistoia Alliance is exactly the forum to bridge the gaps between regulators, pharma, CROs and technology experts, so we can accelerate the reduction of animal testing together.”

Of the respondents that are already exploring NAMs, the most used replacements were cell cultures (64%), in silico models (47%) and organoids (36%). Alongside regulatory concerns, respondents also cited unreliable data in replacement models (17%) as a barrier to NAM adoption. This is because the assay provider landscape is large and fragmented; many of the platforms used for in vitro NAMs are diverse and complex, involving various cell types, culture conditions, endpoints, and technologies. The lack of data standardization and accessibility across different NAM platforms complicates data integration and comparison, causing researchers to be uncertain about the quality of NAMs and their effective application.

“Supporting the 3Rs – reducing, refining, and replacing animal testing – depends on companies having quality data. Researchers must have confidence their non-animal models are reliable, and that data are in a submission-ready format,” comments Véronique François, Project Manager, Pistoia Alliance. “The Alliance has a strong track record of creating new data standards, including our Identification of Medicinal Products Ontology, and our In Vitro Pharmacology submission template developed in collaboration with the FDA. We hope this new Community will add another successful example that underpins our commitment to reducing the burden of regulatory submissions.”

“The Non-Animal Models Community will support the Alliance’s strategic priority of making R&D more sustainability driven. ESG is a priority for our members from both a growth and public health perspective, and the industry must ensure that new therapies are backed by ethical, sustainable operations,” comments Thierry Escudier, Portfolio Lead, Pistoia Alliance. “The NAM Community will sit alongside other sustainability initiatives in our project portfolio including our Carbon Footprint for Clinical Trials project. We now invite regulators, pharma, and animal testing groups to register interest in the project, so we can collectively build a more environmental and ethical future for the life sciences.”

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