How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs

18 Jan 2019

CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.

3d illustration of T cells or cancer cells — Existing Registries Can Be Used For Postmarket Studies On CAR-Ts • Source: Shutterstock

The advent of chimeric antigen receptor (CAR) T-cell therapies – regulated as advanced therapy medicinal products (ATMPs) in the EU – is breaking many classical paradigms of drug development and approval and could change the way that companies, regulators and health technology assessment bodies make decisions in the future.

Although the lifecycle management of medicinal products is a long-standing regulatory requirement, it has taken on a new level of importance with regard to CAR T-cell therapies as these products...

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