Animal testing or animal experimentation, involves conducting experiments on animals to assess the efficacy of drugs, products, and medicines. This pivotal phase ensures the safety and toxicity levels of these substances before human trials. Its scope encompasses various industries including pharmaceuticals, cosmetics, and environmental testing. Additionally, biomedical research and education heavily rely on animal testing, as outcomes in laboratory animals often yield almost accurate insights into chemical exposure effects on humans.

Advocates for animal rights vehemently oppose animal testing, asserting its unreliability, cruelty, and potential hazards. They contend that findings from animal experiments may not reliably translate to human responses due to inherent species differences. A glaring example is substances benign to humans, such as raisins, grapes, and chocolates, which can be toxic to dogs. Global campaigns to ban animal testing reflect a collective effort to safeguard animal rights, prevent gratuitous harm and move towards accurate results reflecting the data from humans for humans.

Champions of animal testing assert its inescapable role in drug development, underscoring its significance in ensuring the safety and efficacy of new medicines.

Technological Leap Forward

Historically, before any drug is considered for human trials, developers relied on testing them on living animals (in vivo) or human cells and tissues in a controlled environment (in vitro). While in vitro testing is generally more cost-effective, expedient and quick, animal testing, primarily on mice, is believed to offer a more comprehensive understanding of a treatment's behaviour within a living organism. Although the predictive value of animal models varies depending on the specific diseases and treatments, companies must demonstrate that their treatment is both safe and effective in animal models to surmount regulatory barriers.

With strides in biotechnology, we now possess the capability to emulate human organs and physiology more accurately. Should these technologies surpass animal testing in their predictive capacity for drug effects on the human body, they may ultimately supplant some of the current animal testing requirements in drug development. While full replacement of animal disease models is improbable, these technologies are reshaping drug development, diminishing our reliance on animal models. This shift has the potential to expedite the process of introducing new disease treatments to the clinic and can be very cost effective, eventually, to patients.

The past years have witnessed a surge in discourse regarding alternatives to animal testing, particularly within India's pharmaceutical and biopharmaceutical sector. The question that looms is whether technology can guide us toward a future where animal testing becomes an antiquated practice.

A new US legislation has dispensed with the mandate for drugs in development to undergo animal testing before human trials. This landmark change aligns with the advocacies of animal rights groups and addresses concerns surrounding the efficacy and cost-effectiveness of animal testing and speed to the market.

In India, a recent amendment to the New Drugs and Clinical Trial Rules (2023) aspires to supplant animal testing with advanced, human-centric methods. These innovative methodologies pledge to assess the safety and efficacy of new drugs with greater precision, accuracy and compassion.

Embracing Technological Innovations

Researchers are now leveraging technology to transform drug testing. They are exploring methods such as humanised micro physiological models derived from stem cells, cell cultures, computer simulations, and even artificial organs. These pioneering techniques aim to replicate the human body's reactions to medicines with greater fidelity than traditional animal testing.

Digital Animal Replacement Technology (DART)

This advancement harnesses human microphysiological systems derived from stem cells, employs artificial intelligence and machine learning-powered digital prediction models. These models are integrated into modular assays that predict safety and efficacy concerns of pharmaceuticals and biopharmaceuticals intended for human use. DART can be seamless in integration into existing workflows, enhancing end-user engagement. This empowers users to assess the safety and efficacy of their assets, providing human-relevant data even before clinical trials commence and sometimes during routine batch testing stages. Within the developmental cycle of biosimilars, vaccines, biologics and even in the pharma domain, a strategic approach may involve a progressive evaluation of biosimilarity and efficacy equivalence. This includes the consideration of conducting animal studies when necessary and appropriate, based on remaining uncertainties. This approach aims to efficiently tailor study requirements.

Tissue Bioprinting

The advent of 3D printing has revolutionised various industries. This technology, now applied to bioprinting, utilises bioinks to carry cells, generating living tissues. Tissue bioprinting can replicate the 3D structure of human tissues, offering a more comprehensive understanding of a drug's impact compared to human cell cultures alone. Although still in its nascent stages, bioprinting technologies are poised to provide alternatives that closely mimic native human tissues. These alternatives are not only more ethical and responsible but also more affordable than animal models.

Organoids

While cell cultures serve as established methods for drug screening, they may not fully mirror how human cells function within the body. One alternative is organoids, miniature organs grown from stem cells under specific conditions. Similar to bioprinting, organoids hold substantial promise for advanced in vitro testing in early drug development, and potentially even in personalised medicine.

Organ-on-a-Chip

Organ-on-a-chip technology involves growing cells within minuscule chips that mimic the structure and behaviour of human organs. The diminutive size of these chips enables researchers to assess drugs more swiftly and economically than through animal testing. These organs-on-a-chip are employed to model a range of organs, including the liver, kidney, intestines, heart, and even the brain. Furthermore, these chips can be interconnected to replicate how a drug impacts various organs as it circulates through the bloodstream.

Challenges on the Horizon

Despite the promise of technology, hurdles remain. Novel methodologies must demonstrate their reliability to regulatory bodies. Replicating the intricacies of the human body in a laboratory environment is an arduous endeavour, necessitating comprehensive education for researchers to wield these technologies effectively. Additionally, securing regulatory endorsement for these innovative approaches is paramount for their widespread adoption.

DART, bioprinting, organoids, and organs-on-a-chip represent emerging technologies with the potential to enhance in vitro research's ability to forecast a drug's effects on humans. While they mark a substantial pole vaulting from the tradition of using animal models in the drug development process, their ability to predict drug behaviour is still limited.

Embracing a New Epoch

In the foreseeable future, it appears that animal models will remain a part of the equation, albeit to a lesser extent. This is owing to the advent of new techniques and enhanced experimental design. When animal testing is curtailed, drug development becomes more economical, expeditious, and ethically sound, benefiting all stakeholders. Technology stands poised to relegate animal testing to the annals of history within India's pharmaceutical and biopharmaceutical sector. By investing in these alternatives, India can emerge as a trailblazer in innovative and ethical pharma and biopharma practices; where testing medicines is not only more precise, cost effective but also more compassionate.

Raghavendra Goud Vaggu- Investor, Advisor & Startup Evangelist