How far could technological advances replace animal tests in evaluating medication safety?
The American Medicines Agency (FDA) took on a decisive turn in pharmaceutical development Thursday by gradually eliminating animal tests to assess monoclonal antibodies, treatments used in particular in oncology and for other complex diseases.
The objective: “to accelerate the drug development process”, to reduce “research and development costs and, ultimately, the price of drugs”.
“Thousands of animals, including dogs and primates, could ultimately be spared each year thanks to the establishment of these new methods,” also underlines the FDA. The United States had paved the way in 2023 to the marketing of drugs developed without recourse to the animal.
From now on, the FDA is taking action: it plans to launch a pilot program allowing manufacturers of monoclonal antibodies to carry out their toxicity checks (these are carried out before the tests on humans) by freeing itself from tests on the animal.
This strategy comes as the Trump administration scheduled for early April the abolition of 10,000 jobs in the Ministry of Health and Health Agencies, which is raising fears of delays in the approvals of new drugs.
Europe must also define actions this year to gradually emerge from animal experimentation in the safety assessment of chemicals, including drugs.
Alternative
European regulations are still requiring animal tests for the moment before marketing authorization. However, technological innovations offer alternatives in medical research, argues the Pro Anima scientific committee, which works to accelerate the transition to non -animal research.
A potential to be exploited insofar as, according to the National Agency for French Research, animal models do not make it possible to predict the toxicity for humans in at least 50% of cases.
In addition to artificial intelligence, organoids, cell culture systems which give miniature 3D copies of an organ, as well as the organs on chip, which reproduce the functioning of an organ on the scale of a memory card, are all new experimentation tools.
Capable of selecting molecules, testing their efficiency and toxicology with very little biological material, they are cited by large research organizations as a response to a regulation on experimentation which limits the use of animals more and more.
It remains to be seen to what extent these new approaches will be taken into account in the roadmap of the European Commission on the assessment of chemical risks, expected by the end of the year.
