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CAR-T Meeting 2021 | The regulatory process for CAR-T in Europe: EBMT registry & GoCART

Jürgen Kuball, MD, PhD, University Medical Center Utrecht, Utrecht, Netherlands, discusses the main challenges in the regulatory process for CAR T-cells in Europe. One of the main challenges is the collection of long-term follow-up data. The general data protection regulation (GDPR) and the needed regulatory approval by an ethics committee make it a complex process. To streamline the regulatory process in Europe, the European Society for Blood and Marrow Transplantation (EBMT) has developed different strategies, such as the cellular therapy module of the EBMT registry, which received a positive qualification opinion from the European Medicines Agency (EMA). Additionally, to better structure the process of data collection and data access to all stakeholders, EBMT launched the GoCART coalition, a CAR T-cell community platform. This interview took place during the 3rd European CAR T-cell Meeting.

Disclosures

Scientific co-founder and shareholder of Gadeta. Inventor on multiple patents dealing with gdT cells and their receptors as well as isolation of engineered immune cells. Research support by Novartis, Miltenyi Biotech and Gadeta.

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