Europe: Driving coordinated European action on cellular therapy access

In 2020, the European Hematology Association (EHA) and the European Society for Blood and Marrow Transplantation (EBMT) founded the GoCART Coalition – a European group of patient representatives, HCPs, pharmaceutical companies, regulators and medical organizations working together to promote patient access to novel cellular therapies. 

The GoCART Coalition is organized around five key pillars: data harmonization, standards of care, education and training, policy and advocacy and scientific excellence.   

Recognizing that there is significant overlap between different manufacturers on their requirements for site qualification processes, the standards of care group launched an expert-led working group to reduce the inspection workload for centers, while protecting product quality and patient safety. The group consisted of industry representatives, researchers, clinicians, nurses and JACIE colleagues.¹⁰³ Through this, they were able to launch a new initiative which would allow centers holding JACIE accreditation to opt for a reduced or remote audit focused on product-specific requirements for cell therapies (subject to market authorization holders’ agreement and obligations). This is the case for centers undergoing inspections with Bristol Myers Squibb, Janssen, Gilead and Kite and Novartis.¹⁰³ 

The education and training working group has also launched an initiative with industry partners and national country representatives to develop a CAR T-cell therapy passport to harmonize training requirements and educational materials for HCPs.⁶⁵ As part of this, they are consolidating a core training program consistent with JACIE accreditation requirements, with passports tailored to each HCP role.⁶⁵