A symposium entitled «Cellular therapies in Europe: the way forward» was held under the joint auspices of the EHA and the EBMT during the 24th EHA Congress (June 13–16 2019 in Amsterdam). The symposium was chaired by Nicolaus Kröger, President of EBMT and Herman Einsele on behalf of EHA.
Christine Chomienne, former EHA President and current Deputy Director for Scientific Affairs at the French National Cancer Institute (Institut National du Cancer, INCa) described what measures need to be adopted in order to foster preclinical research, clinical research and access to care when such disruptive technologies as immune effector cell therapies are industrialized and introduced into the clinic. The regulatory and operational frameworks need to be aligned for hospitals to provide access to treatment, and incentives from national and European institutions need to be provided to EU investigators who compete with their US or Chinese colleagues.
Jorge Sierra, President of the Sociedad Española de Hematología y Hemoterapia (SEHH), discussed current and future requirements needed for the safe administration of CAR-T Cells, and the reasons behind the stringent selection of active centers, in compliance with emerging national regulations and pharmas’ requirements. The complexity of the supply chain and the peculiar safety profiles of these personalized gene therapy medicinal products need to be dealt with by trained and coordinated teams, having access to specialized infrastructures and resources.
Christian Chabannon, Chair of the EBMT Cellular Therapy & Immunobiology Working Party (CTIWP), presented the EBMT strategy to register patients treated with CAR-T Cells, taking advantage of its existing registry for hematopoietic cell transplantation. The registry was significantly redesigned and enriched as the consequence of the EMA registry initiative, leading to EMA publishing a positive opinion for CAR-T Cell follow-up. EBMT centers are now registering treated patients throughout Europe. In addition, a survey was recently launched by the EBMT CTIWP to identify active programs, and the nature of their activities: delivering treatment with investigational or commercial CAR-T Cells. Capturing real-life data is essential to fully evaluate the therapeutic potential of these expensive treatments, and guarantee long-term safety.
The symposium attracted a high number of delegates, with a full room and overflow, and generated animated debates following presentations.
Collaboration between EBMT and EHA is ongoing, with the active preparation of the 2nd European CAR-T Cell Meeting that will be held in Sitges, close to Barcelona, from January 30th through February 1st, 2020, and various other initiatives.