Phasing out animal testing for new drugs

In April, FDA announced plans to phase out the requirement for animal testing in preclinical safety studies and replace them with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays. The goal is to initially overhaul toxicity testing for biologics, specifically monoclonal antibodies, but testing for other modalities are also on the agenda. FDA has published a road map how it intends to implement reduced toxicity testing in animals in the next 3 years. This is a worthy goal, with a strong potential to produce more human patient relevant data and hopefully to speed up the pre-IND process and save money. In the test case of monoclonals an additional advantage is the lack of expression of human antigens in animal tissues. We read with interest a recent interview with Dr. Lorna Ewart, Chief Scientific Officer at Emulate, published by Nature Reviews Drug Discovery that highlights a number of important opportunities and challenges. In short, there is great promise in human organ-on-a-chip platforms; however more effort and money is needed to develop and validate them for many human organ systems including the immune system and the brain.