Alternative Methods are Replacing Animal Testing in Biomedical Research
The transition from animal testing to new approaches such as organ chips and artificial intelligence is gaining momentum in biomedical research.
The world of biomedical research is undergoing a major transformation toward new approach methodologies, such as organ chips, organoids, and computational tools, alongside new steps taken by international regulatory bodies.
The Transition Process from Animal Models to New Methods
Donald Ingber, leader of the team that developed the human lung chip at the Wyss Institute at Harvard University, introduced an alternative method to tissue culture and animal testing. Researchers like Ilka Maschmeyer from TissUse state that pharmaceutical companies relying solely on animal data are being denied clinical research permits.
High Clinical Failure Rates and NAM Technologies
The fact that approximately 92 percent of drugs tested on animals fail in clinical trials clearly demonstrates the limitations of animal models as human surrogates. Known as new approach methodologies or non-animal methods, these technologies encompass advanced organoids and artificial intelligence tools.
New Decisions by Regulatory Authorities
The FDA Modernization Act 2.0, which came into effect at the end of 2022, explicitly approved new methods in preclinical studies. The FDA updated the phrasing in drug development regulations while committing to making animal studies the exception rather than the rule.
Challenges in the Validation Process and Future Expectations
The validation of new methods requires extensive and costly studies in terms of standardizing systems, securing workflows, and proving clinical benefit. Deeper collaboration between academic circles and industry is essential to overcome these obstacles.