In the context of the qualified opinion of EMA for the cellular therapy module of the EBMT registry and the growing clinical use of CAR-T cell and immune effector cell therapies, the EBMT has decided to set up a governance structure of the CAR T Community. The EBMT Legal and Regulatory Affairs Committee (LRAC) and the cellular Therapy and Immunobiology Working Party (CTWIP) engaged with different key stakeholders such as national transplantation groups; clinical CAR T centers; disease-oriented scientific societies; pharmaceutical companies; patient advocates; health technology assessment bodies; regulators - to present and discuss this structure. The latter was approved by the EBMT Board during the June Board Meeting in Hamburg.
The LRAC and CTIWP have launched an open call for feedback and participation in workpackages (WP) as defined below - all EBMT Members as well as non members interested in CAR T therapies are invited to answer this open call until the September 1, 2019:
- WP1) Harmonization of core data sets, data protection, and exploration of future data sets
- WP2) Center accreditation standards
- WP3) Center educational standards
- WP4) The registry from an HTA perspective
- WP5) Scientific excellence
- WP6) Moving European policies and legislation forward