Ending drug research on animals will require multipronged approach

The U.S. Food and Drug Administration’s recently published Roadmap to Reducing Animal Testing in Preclinical Safety Studies may have caused a stir across the pharmaceutical and biotech industries, but I wasn’t surprised. I’ve been working in drug development for 30 years and can tell you that the truth is the 3Rs (reduce, replace, and refine) principle for animal testing has been a goal in development for decades.

Beyond the ethical implications, relying on animals to test new drugs is inherently imperfect. More than 90% of drugs that appear safe and effective in animals fail in human trials due to safety or efficacy issues. Traditional animal models often fall short of predicting human outcomes. High costs and supply chain limitations (such as scarce non-human primates) underscore the urgency to adopt human-relevant alternatives. 

I’ve spent my career — primarily as the co-founder of biosimulation company Simcyp, which was acquired by Certara — focusing on translational modeling to predict the behavior of drugs in the human body with the aim of accelerating the development and regulatory approval of safer drug products and bringing them to the patients. Through this work, I’ve seen the potential of alternatives to animal testing but also how challenging it will be to make the FDA’s vision a reality within the three-year timeframe it set out.