European Union Revamps Toxicology Testing in Attempt to Limit Animal Use, Improve Prediction

Extract

The U.K. clinical trial disaster earlier this year underscored at least one thing: Animal models poorly mimic human physiology.

Prior studies of the TeGenero leukemia drug, a monoclonal antibody, showed no sign of the catastrophic reaction that hospitalized six people. As companies increasingly develop protein-based therapies that specifically target human cells, animal models are likely to prove even worse at predicting how humans will respond.

“These types of drugs make up more than 50% of new-drug applications,” said Thomas Hartung, Ph.D., head of the European Centre for the Validation of Alternative Methods (EVCAM) of the European Union Joint Research Centre. “We can't use toxicology that is 60 years old.”

Now new tests are in the works. In March the center approved six new toxicology screens that promise to speed up research on some drugs while making others safer. These are the latest of several tests to spring out of a European initiative to minimize animal testing. Since 1991, the center has focused on reducing, replacing, and refining existing animal-based toxicology screens for drug, chemical, and consumer product regulation. Once the center validates a test, companies within the EU are required to use it.