AGORA · ATMP GMP Open Access Research Alliance - AGORA

We propose an academic & industrial partnership to facilitate safe and effective delivery of new advanced therapy medicines within the framework of the relevant EU regulations which our previous FP7 funded project have identified as creating unanticipated barriers to development of this field. Over 80% of advanced therapy medicines (ATMPs) trials in the EU are academic investigator led and sponsored. Many ATMPs are not making it to first-in-man trials due to the difficulties of academic manufacture to GMP compliance and the variation of application of the Directives between EU MS. We will deliver a supporting programme of resources to academic trialists to streamline their development programmes, enhance compliance with GMP requirements, develop industrial partnerships for improved manufacture and scale-up and establish the first university certified training programmes in cell/tissue engineering to address the critical shortage in scientific/technical/regulatory staff in this newly expanding field across the EU.The future supply of successful ATMPs to EU citizens will require partnerships between academic GMP facilities, contract ATMP manufacturers (CMOs) and the biopharma industry and this project will deliver the necessary support and training structure to create this partnership. The need for this project has been identified from the impact assessment part of our current FP7 project, “Academic GMP” and the culmination of the project will be a scientific analysis of the effect of the programme on the impact of the legislation relevant to ATMP development and provision across the EU.