IEEE Spectrum breed · Technology

New Technologies Aim to Replace Animal Testing in Drug Development

Advanced 'organ-on-a-chip' systems and other novel methods are emerging as alternatives to animal testing, but widespread adoption faces significant hurdles.

Seventeen years ago, researchers developed a "lung-on-a-chip" model that mimicked human lung function, reacting to stimuli like living lungs. Despite initial skepticism and a requirement for animal testing comparison, the technology has advanced significantly.

These new approaches, collectively known as Novel Alternative Methods (NAMs), include organoids and interconnected organ-on-a-chip systems that better replicate human physiology than animal models. Computational simulations and AI also support these technologies.

Historically, a high percentage of drugs entering clinical trials fail, often because animal tests did not predict human responses. This inefficiency and ethical concerns have driven the search for alternatives.

Recent regulatory changes, including the FDA Modernization Act 2.0, now permit the use of NAMs in preclinical studies, signaling a shift away from mandatory animal testing. Agencies worldwide are also moving towards phasing out animal testing.

However, validating NAMs is a complex and costly process. Standardizing systems, ensuring consistent results across different labs, and proving their predictive accuracy compared to animal models are major challenges.

Cultural inertia within the scientific community also hinders adoption. Researchers are accustomed to animal models, and shifting to new technologies requires significant training, investment, and a change in established practices and career expectations.

Despite these challenges, proponents believe that with increased collaboration, data sharing, funding, and education, NAMs can eventually become the norm, potentially revolutionizing drug development and safety testing.

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