FP7 Grant Agreement No. 602366
“Advanced Therapy Medicinal Product Good Manufacturing Practice Open Access Research Alliance”
The AGORA project funding ended in October 2015 but it leaves behind an important legacy. The aim of the project was to address each of the current unmet needs and critical issues arising from our previous FP7 Academic Good Manufacturing Practise (GMP) study on the development and delivery of new advanced therapies for the treatment of cancers and regenerative medicine. Advanced Therapy Medicinal Products (ATMPs) are medicinal products based on gene therapy, somatic cell therapy or tissue engineering and AGORA planned to create a resource to boost biomedical and clinical research through provision of a platform to facilitate consultation with biomedical researchers in the field.
AGORA contributed to the framework of academic and commercial ATMP development through the establishment of a technology transfer network, training programmes, an interactive web-site, representation and provision of information on pathways, regulations, technologies and resources across the European Union.
We have generated new knowledge on the impact of advanced therapies regulations by:
- comparing the experience of partners and invited stakeholders;
- conducting a European survey of non-industry facilities in this sector;
- organising workshops, a major conference and a joint meeting with the EBMT for targeted, collaborative discourse;
- establishing a web-based platform for information exchange including the development of a document “tool-box”
- analysing publications and guidance from the perspective of better regulation principles;
- analysing innovation statistics in relation to advanced therapies.
In combination, we have obtained comprehensive feedback, data and evidence which has led to a very considered report that assesses how the new ATMP regulations are impacting on the academic sector which we presented to policy makers in response to the consultation document published by the Commission.
Moreover, the project has established a common platform that brings together academic researchers, clinicians, quality managers, qualified persons, clinical trials coordinators, legal and regulatory advisors and regulators. The project has reached out across the EU MS to facilitate integration across.
Dissemination activities have involved all members of the consortium and have included oral presentations at multiple national and international conferences including the European Association of Tissue Banks (Lund Sweden), the Professional Alliance for Cell Therapy (Vienna Austria), a TED talk (global on-line), the World Stem Cell Conference (London UK), the International Society for Cell Therapy (Las Vegas USA), the PDA conference (Amsterdam Netherlands), International Society for Cell Therapy – EU (Seville Spain).
The British Journal of Haematology has invited a review on the impact of ATMPs on the haematology transplant community and AGORA will be represented at the next EBMT meeting in Valencia in 2016 to present our research into ATMP development within conventional BMT facilities. Two members of the consortium have acted as advisors to the French medicines regulator during this reporting period. The AGORA consortium also submitted a report to the Commission in response to the consultation document on early phase trial GMP manufacture for ATMPs.
In summary, this project has been very active and cemented the position of AGORA as an important resource and knowledgeable representative of the academic GMP community in ATMP manufacture. It cemented existing and created new professional relationships, leading to new collaborations across the EU and providing a lasting resource for ATMP developers.
All that remains is for me to thank my AGORA partners, Dr Joana Namorado (EC Scientific Officer) and colleagues in the UCL EU R&D Office for their magnificent contributions.
Professor Mark Lowdell – AGORA project co-ordinator.