Animal testing refers to the scientific experimentation conducted on animals to assess the safety, efficacy, and potential side effects of pharmaceutical products before they are deemed fit for human use. In fact, animal testing remains a fundamental element in pharmaceutical research. Animal testing involves conducting carefully designed and regulated experiments on animals to evaluate biological and physiological responses to test agents, determine toxicological profiles, and understand the potential benefits of novel pharmaceutical compounds, which pave the way for the development of life-saving drugs, including antibiotics, cancer therapies, and vaccines that revolutionized modern medicine. For as long as it has existed, the practice of animal testing for human benefit has raised ethical concerns and sparked debates worldwide. However, recent developments in global legislation have brought forth new laws, including the FDA Modernization Act 2.0, which aims to address these concerns while maintaining the safety and efficacy of products that undergo testing.

Understanding Animal Testing in the Pharmaceutical Industry

For centuries, animals have been used to unravel and test the mysteries of biology and medicine, which have led to groundbreaking discoveries. With animals as surrogates for human subjects, researchers attempt to gauge the risk that new products and therapies might have on humans. From the pioneering work of Louis Pasteur and his rabies vaccine to the development of insulin for diabetes treatment, animal models have played a pivotal role in saving countless lives and advancing medical knowledge.

Various animal species are used for animal testing, including mice, fish, rats, rabbits, guinea pigs, hamsters, farm animals, birds, cats, dogs, mini-pigs, and non-human primates (monkeys and, in some countries, chimpanzees). However, rodents (mice and rats) make up 95% of research laboratory animals due to their small size, short reproductive cycle, short lifespan, and close physiological and genetic resemblance to humans, providing a highly effective and adaptable mammalian system for studying human diseases.

fda-modernization-graphics-3

Why is animal testing Bad Science?

Annually, more than 115 million animals are used worldwide in experimentation or to supply the biomedical industry. Most of these animals never see the light of day, are trapped in a cruel experimentation cycle, and are housed in cages until euthanized. Some are even forced to endure unimaginable pain and suffering before their deaths, such as inhaling toxic fumes, being immobilized in restraint devices for hours, having holes drilled into their skulls, or having their skin burned or spinal cords crushed. In addition to such torments, these animals are deprived of their natural needs, socially isolated, and intentionally traumatized.

Animal experimentation is used to inform human biology and health sciences; however, despite its best intentions, and its impact on human health, the question of animal experimentation’s efficacy has been subjected to little systematic scrutiny.

Medicine as a science should be evidence-based; however, it may be surprising to consider that animal experimentation is typically viewed as the gold standard without critical examination of its validity. In fact, about 92% of drugs that pass preclinical animal tests fail to enter the market due to a lack of effectiveness and safety problems that were not predicted by these tests as intended. However, the scientific community remains hesitant to completely discard animal experimentation due to the lack of knowledge and expertise in cutting-edge non-animal techniques that can achieve similar or better outcomes.

Understanding the FDA Modernization Act 2.0

The FDA Modernization Act 2.0 is an updated version of the original FDA Modernization Act, which was passed in 1997. This update seeks to modernize and streamline the regulatory process for approving drugs, medical devices, and other products while also addressing the concerns surrounding animal testing. The bill essentially refutes the Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. The legislation does not actually ban animal testing but allows the use of alternatives to reduce reliance on animal studies.

One of the key provisions of the FDA Modernization Act 2.0 is the promotion of alternative testing methods. It introduces regulatory flexibility concerning the acceptance of alternative testing data and acknowledges that advancements in science and technology have provided viable alternatives to traditional animal testing. The Act encourages researchers and pharmaceutical companies to explore and invest in these alternatives with the goal of reducing and eventually replacing the need for animal testing.

Building on Better Science (Alternatives to Animal Testing)

For a long time, animal testing was regarded as the gold standard of preclinical testing. However, the reliance of the pharma industry on animal testing has been decreasing due to the development of more translational experimental models. Moreover, the legitimization of alternative testing methods by the FDA Modernization Act 2.0 has pushed the industry to a shift toward more humane and scientifically advanced testing approaches. Some of these alternative methods have been used in pharmacological research for years, such as:

alternatives-to-animal-testing-graphics-scaled

Quantiphi’s Approach Towards Cruelty-Free Science

As a part of our healthcare and life science industry offerings, Quantiphi, in partnership with Transcell, has pioneered an innovative AI-based approach that combines many of the best-understood animal testing replacement strategies to create the Digital Animal Replacement Technology (DART) solution. DART combines human biology with advanced digital technologies to predict drug safety and efficacy accurately, eliminating the need for animal testing in many scenarios. DART uses ethically sourced human stem cells, and an artificial intelligence (AI) powered Digital Workstation to predict drug safety based on stem cell-drug interactions. This approach marks a major milestone not only for Quantiphi and its partner Transcell but also for the pharmaceutical industry to demonstrate ethical and sustainable practices across the value chain.

Conclusion

Animals share fundamental characteristics with humans, such as pain, fear, and suffering. Using human safety as a justification for animal experimentation is an outdated rationale with the ability to apply modern technology in the domain. Not only is it unethical, but in some cases, less accurate testing due to significant physiological and genetic differences between humans and other animals, which contributes to poor scientific outcomes.

Current legislation, such as FDA Modernization Act 2.0, has the potential to revolutionize the pharmaceutical industry and related life sciences sectors by promoting alternative methods to animal testing. This shift towards more humane and scientifically advanced approaches is facilitated by prioritizing their development and adoption. Increased collaboration and information sharing among stakeholders is expected to drive innovation and expedite the implementation of these alternatives, which use scientifically proven models that will ethically and responsibly replace antiquated science.