Beyond Animal Models: The Future of Product Development

The following article is an opinion piece written by Matt Stevenson. The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position of Technology Networks. 

Advances in cellular biology, computational modelling, and microphysiological systems are transforming the way researchers investigate biological responses. As scientists seek to generate more human-relevant data, new approach methodologies (NAMs) are providing new opportunities to understand the mechanisms that underpin toxicity and disease, complementing traditional testing approaches with increasingly sophisticated biological models.

This shift is helping researchers move beyond observing biological outcomes towards understanding why they occur, supporting more informed product development and strengthening the evidence used to substantiate products and safeguard consumers. Here, Matthew Stevenson, scientific substantiation senior manager at Imperial Brands Science, explores how exciting new technologies are reshaping modern scientific assessment and helping define the future of product development.

Why toxicology is changing

For decades, animal models have played an important role in advancing biological research, supporting scientists in investigating disease mechanisms, assessing products, and improving our understanding of human health. However, scientific progress has also highlighted the limitations of relying on a model to predict complex human biology. Differences in physiology between species can make translating findings into human outcomes challenging.

Understanding TT21C

This change in scientific thinking is encapsulated within the Toxicity Testing in the 21^st Century (TT21C) framework, developed by the US National Research Council. Instead of asking only whether a substance causes harm, TT21C encourages researchers to investigate how biological pathways are disrupted and how those disruptions ultimately lead to adverse outcomes.

Whether developing pharmaceuticals, consumer products, or next-generation nicotine products, researchers increasingly need evidence that examines if a biological response occurs and also explains why. Mechanistic insight generated through NAMs can therefore support more informed scientific decision-making throughout the product development process.

Building human-relevant evidence

The principles of TT21C are increasingly realized through NAMs. Rather than describing a single technology, NAMs encompass a diverse collection of scientific approaches, including advanced cellular assays, organ-on-a-chip platforms, high-content imaging, omics technologies, and computational toxicology. Each contributes a different layer of biological information, allowing researchers to investigate responses across multiple levels of biological organization.

Unlike conventional toxicology, which often focuses on observable outcomes, NAMs allow researchers to investigate the molecular and cellular events that happen long before visible signs of toxicity emerge. This provides opportunities to understand whether biological responses occur, plus the pathways responsible for driving them.

By integrating evidence from multiple complementary methodologies, scientists can build increasingly robust datasets that improve confidence in product assessments while providing greater physiological relevance.

The technologies driving innovation

Among the most exciting developments are organ-on-a-chip technologies. These miniature microphysiological systems recreate key aspects of human tissues, incorporating structural organization, fluid flow, and mechanical forces that are difficult to replicate using simple cellular laboratory models.

Various academic researchers, as well as Imperial Brands scientists, are already investigating organ-on-a-chip systems capable of modelling human tissue responses under controlled laboratory conditions. These platforms enable scientists to observe biological interactions in environments that more closely resemble those found within the human body, providing insight into disease mechanisms and chemical responses that may not be apparent using conventional in vitro methods alone.

Computational toxicology is also an increasingly valuable component of modern product assessment. By combining large biological datasets with predictive modelling, researchers can identify patterns, explore potential mechanisms of action, and generate hypotheses that can subsequently be investigated experimentally.

As advances in AI and machine learning continue, computational approaches will play an important role in integrating complex biological datasets and supporting evidence-based decision-making throughout product development.

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Demonstrating scientific confidence

The continued adoption of NAMs depends on technological innovation and scientific confidence.

As well as demonstrating the potential of these technologies, the challenge is to ensure they are sufficiently robust, reproducible, and standardized for widespread regulatory acceptance. Validation remains fundamental if data generated through human-relevant methodologies is to support product assessment and development decisions.

Collaboration therefore remains essential. Academic researchers, industry scientists, and regulatory organizations each play an important role in establishing best practice, developing standardized testing approaches, and building confidence in emerging methodologies.

For example, an article published in Archives of Toxicology positions NAMs as complementary approaches that can be integrated with existing evidence streams to support chemical assessment. By combining data from multiple biological, computational, and mechanistic methodologies, researchers can build a more comprehensive understanding of biological responses.

The future

Interest in human-relevant science continues to accelerate across the global research community. Regulatory agencies like the US Food and Drug Administration, governments like the current Labour administration in the UK, policymakers including the European Commission, and many research organizations and manufacturers are increasingly exploring how scientifically validated alternative methodologies can contribute to future product assessment frameworks.

The evolution of toxicology is no longer defined solely by advances in laboratory techniques, but by the convergence of engineering, computational science, and biology. As these disciplines continue to converge, researchers will be better equipped to generate human-relevant evidence that supports informed product development while supporting safer, more informed product development.