FDA's Shift Towards Ethical Drug Development: The End of Animal Testing Era?

Animals have been used for research since ancient Greece, and have been crucial for discoveries of human anatomy and molecular physiology such as with William Harvey. Philosophers such as François-Marie Arouet (Voltaire) and Jean-Jacques Rousseau were against the use of animals for research. For decades, animal testing has been an integral part of the drug development process. From mice to monkeys, countless animals have been subjected to harsh conditions and procedures in the name of scientific advancement. Moreover, over 90% of drugs that pass animal tests fail in human trials. However, as our understanding of science and technology has grown, so too has our ability to develop alternative methods for testing drugs that are not only more accurate but also more ethical.

The Food and Drug Administration (FDA) has taken a bold step forward in this direction by no longer requiring animal testing for drug approval. The practice of animal testing has long been the subject of heated debate. Proponents argue that it is a necessary evil and that without it, we would not have the life-saving medications and treatments that we have today. They point to the many breakthroughs that have come from animal testing, from the discovery of penicillin to the development of vaccines for deadly diseases like polio and measles. However, others argue that animal testing is cruel and inhumane, causing untold suffering and even death to millions of animals each year. They argue that there are more ethical and effective alternatives available and that it is time for us to embrace these alternatives and put an end to the use of animals in the drug development process.

The FDA’s recent decision to no longer require animal testing for drug approval is a heartwarming victory for those who believe it is time for a change. This decision is based on the fact that advances in science and technology have given us new tools to develop and test drugs without relying on animal models.

What can we use then?

Revolutionizing Drug Discovery and Trials with Diseased Cell Lines

Diseased cell lines are ex vivo cell populations derived from resected tissue samples. They have several advantages over using mice for drug testing. Firstly, cell line testing is much faster and has higher throughput than animal testing, which can take months to complete. This speed allows researchers to quickly assess potential drugs' effectiveness and decide which ones to move forward with.

Cell line testing is generally less expensive than animal testing, making it a more accessible option for many researchers. Additionally, cell lines can be maintained and propagated in the laboratory, allowing for consistent and repeatable testing conditions. This enhances the reproducibility of the results, making it easier to compare results from different studies. Testing drugs on cell lines also eliminates ethical concerns associated with animal testing, such as pain, suffering, and the use of live animals.

Furthermore, cell lines can be derived from specific types of cells or tissues affected by a particular disease, allowing for more targeted testing of drugs that specifically target those cells. This specificity can provide valuable insights into the effectiveness of a drug that may not be possible with animal models.

Finally, diseased cell lines are the best to discover promising drugs as they have the closest molecular physiology to humans. This can help identify the most promising drugs and speed up the development process.

In conclusion, while animal testing remains an important aspect of drug development, the use of diseased cell lines can provide valuable early insights into a drug's potential and complement animal testing. Cell line testing offers several advantages, including speed, cost-effectiveness, reproducibility, ethical considerations, specificity, and high-throughput screening capabilities.

Patient-derived cells have been used for guided therapy in cancers, Hypertension, fragile X syndrome, SARS-CoV-2, schizophrenia, and Parkinson's ^11-24.

Check out cells, diseased cells and iPSCs from our suppliers and our own cells from Cellovations^®.

Organs-on-a-Chip: Advancing Biological Interventions, Disease Studies, and Drug Trials for Inflammatory Bowel Syndrome and Lung Inflammation

Organs-on-a-chip are a promising alternative to animal testing in the development of new drugs. These microfluidic devices contain living cells arranged to mimic the structure and function of specific organs, such as the heart, liver, or lungs.

The organ chips are made of human cells and can provide a better representation of human anatomy compared to animal testing, which can sometimes lead to inaccurate results. One of the key benefits of using organ-on-a-chip technology for drug testing is the improved accuracy in replicating human biological interactions. This innovative approach offers a more realistic simulation of drug behavior in the human body compared to traditional animal testing, which can vary in anatomy, physiology, and response to drugs. By using organs on a chip, researchers can identify potential safety and efficacy concerns earlier in the development process and better understand the complex biological interactions within the human body.

Additionally, organs on a chip offer a faster testing pace, as compared to conventional animal testing which can take several months. This expedites the drug development process and hastens the introduction of new treatments to the market.

Moreover, the utilization of organs on a chip eliminates numerous ethical concerns related to animal testing, such as distress, harm, and the utilization of live animals. This makes it a more desirable option for scientists seeking alternative methods to traditional animal testing.

Additionally, the use of organs on a chip enables the simultaneous testing of drugs on multiple organs, offering a more comprehensive understanding of a drug's impact on the body. This can help uncover potential side effects that might not be noticeable when testing a drug in isolation. These systems have been used to study inflammatory bowel disease, drug metabolism studies, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, Pathogen infection, lung inflammation, and edema^25-34.

In summary, using organs on a chip provides numerous benefits compared to conventional animal testing methods. These benefits include a more accurate representation of human biology, quicker outcomes, the elimination of ethical issues, and the simultaneous assessment of multiple organ interactions. These advancements are helping to enhance the drug development process and rapidly bring new treatments to the market with increased efficiency.

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Organoids for Disease Modeling, Regenerative Medicine, and Drug Discovery

Organoid cell culture is a state-of-the-art method of growing miniature, functional replicas of organs in the laboratory. These organoids closely resemble actual human organs and are capable of responding to drugs in a manner similar to human organs. This makes organoid cell culture a more precise and ethical approach to drug testing compared to animal testing. The FDA's promotion of this technique not only highlights its leadership in scientific advancement but also underscores its commitment to animal welfare and compassion.

One more benefit of using organoid cell cultures in drug testing is their efficiency and cost-effectiveness compared to animal testing. Organoids can be grown rapidly and easily in a laboratory setting, and they allow for the simultaneous testing of multiple drugs. This streamlines the drug development process and reduces the time and expense associated with animal testing. Moreover, because organoids are derived from human cells, there are no ethical concerns about using animals in testing, and the risk of species-specific differences that can impact animal test results is eliminated.

Unlocking New Frontiers in Medicine

They have been used in Tissue regeneration, Drug discovery, and development studies, Biomarker research, Precision medicine applications, the source material for xenografts, Infectious diseases, and treating common and rare diseases ^1-10.

Want to grow your organoids? Check out cells, diseased cells, iPSCs and ECMs from our suppliers and our own cells from Cellovations^® to create your own.

Conclusion

Adapted from Kim et. al., 2020 Nature reviews molecular cell biology

While the transition from animal testing to organoid cell cultures presents new challenges, the FDA's promotion of this technology is a vital step forward. There is still much to be learned about how organoids respond to drugs and how to maximize their use in drug development. Nonetheless, the FDA's commitment to using this technology demonstrates its dedication to both scientific advancement and ethical practices. By shifting away from animal testing, the agency is showing its belief that there is a more humane and effective way to test drugs.

The Monument to the Laboratory Mouse in Russia serves as a reminder of the sacrifices made by mice in the name of research, and the FDA's new approach aligns with the principles of the three Rs of ethical animal use in testing. This shift demonstrates that we can continue to advance science and technology while also valuing ethical practices and animal welfare.

Looking for support in organizing or planning your research? Get in touch with us at info@pelobiotech.com and schedule a meeting with our expert, Dr. Peter Frost and his team. They will be happy to be at your service.

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