The parent–child IND approach: an interpretation of FDA’s guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

Abstract

Advancements in cell and gene therapies are occurring at a rapid pace resulting in the opportunity for multiple versions of a product to advance quickly to clinical readiness. To translate these rapid advances into clinical benefit for patients, sponsors desire opportunities to progress these versions more efficiently through early phase clinical studies. The parent–child approach to the study of multiple versions described in recent FDA guidance has the potential to offer sponsors this pathway. However, this approach may be most advantageous to companies seeking to accelerate selection of a lead candidate, rather than companies prioritizing speed to market. Additionally, alternative use cases for parent–child INDs such as a staggered introduction of new versions are not discussed in FDA’s guidance. Although questions remain regarding how FDA will implement aspects of the guidance, the Agency has provided sponsors with a well-reasoned roadmap for the study of these versions in early phase trials.