The Rise of iPSCs in Drug Discovery: Regulatory and Legislative Changes Driving the Shift from Animal Models

The use of animals in biomedical research has been a longstanding practice, but it has become increasingly controversial due to concerns over animal welfare, ethical considerations, and the limited relevance of animal models to human biology, which contributes to the non-decreasing translational gap. The FDA has been encouraging the use of novel technologies in drug development, including iPSCs, and has issued guidance documents outlining the regulatory considerations for the use of these technologies¹. This regulatory support for iPSC-based drug discovery is likely to encourage more companies to invest in the technology and accelerate its adoption.