EARL and EATRIS joined forces and signed a collaboration agreement in July 2014 regarding the establishment of a 89Zr PET/CT accreditation programme.
Despite advances on research at the molecular level with enhanced understanding of the underlying mechanism of diseases researchers continue to struggle with the process of advancing research findings towards healthcare products in development. In recognition of this, EATRIS (www.eatris.eu)
was founded in 2008 and entered operations in 2013 after being awarded permanent ERIC (European Research Infrastructure Consortium) legal status, a sign of the commitment of the 8 European countries participating in the initiative. EATRIS is a distributed infrastructure comprising over 70 non-profit and academic translational research institutions, collaborating to overcome bottlenecks in the development of drugs and diagnostics. One of the core activities focuses on the evaluation of new (targeted) antibody therapies.
EARL and EATRIS are aware of the need for an accreditation programme for 89Zr-PET/CT. Dedicated PET imaging studies are performed using 89Zr labeled antibodies allowing to study the pharmacodynamics and kinetics of antibodies as well as the level of specific targeting (in tumors). To this end it is essential that all PET/CT imaging devices within the EATRIS network and beyond are cross-calibrated and have harmonised image characteristics such that imaging data collected within the network can be shared and pooled and are of sufficient quantitative accuracy. The latter can be achieved by setting up a 89Zr-PET/CT accreditation programme similar to the already existing 18F PET/CT accreditation.
The set-up of this programme was split into several phases (Preparatory Phase, Testing/Validation Phase, Pilot Phase and Running Phase) in order to ensure a high quality outcome.
At the EANM’14 EATRIS presented the infrastructure that encompasses the complete translational pipeline up to clinical proof-of-concept, offering access to valuable infrastructure such as GMP manufacturing, high-end (molecular) imaging facilities, regulatory and clinical expertise and patient cohorts. EATRIS shares the goals of EARL-EANM to improve and advance scientific initiatives as well as clinical research projects. Together with EARL-EANM, EATRIS developed strategies towards harmonisation and standardisation of (multimodal) PET imaging to improve the quality and speed of transnational access to multicentre clinical trial activities, involving (molecular) imaging to support innovative first in man trials involving PK/PD and mode of action studies as a distinguished feature of the infrastructure.
The EARL 89Zr PET/CT accreditation programme was launched in 2020 worldwide available to all interested institutions.