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AGORA – ATMP GMP Open Access Research Alliance

When the ECA started with the inauguration of a new ATMP Group a contact was established with the AGORA Group.
From 01 September 2013 until 31 October 2015, the European Commission has funded the AGORA Project (No. 602366) to propose an academic & industrial partnership to facilitate safe and effective delivery of new advanced therapy medicines within the framework of the relevant EU regulations. To avoid the loss of the collected AGORA knowledge and to get the possibility of ongoing improvement of this information (oder: of these data), ECA and AGORA decided to transfer the content of the AGORA website (especially the AGORA toolbox) to the website of the new ECA ATMP Interest group. Furthermore all AGORA Members get the opportunity to become a member of the new ATMP Group.”

The Project

Academic and hospital-based GMP facilities are major contributors to the development of ATMPs. They respond to clinical needs and provide medicinal products in an environment which, albeit compliant with industrial standards, is by definition not industrial. Data from the European Medicines Agency show that, currently, more than 85% of clinical trials of ATMPs are academic led (or academic spin out) and have not yet been taken up by industry. This figure suggests that the academic delivery of clinical trials is excellent and that no barriers exist but the reality is that few ATMPs are actually in clinical trials across the EU and the pipeline for development to licensed commercial medicines is poor. Academic trialists fear the cost and complexity of Good Clinical Practice (GCP) and GMP and try to avoid an ATMP classification.

Universities and research funding bodies are reluctant to support formal clinical trials (even at phase I/II) due to the cost, complexity, time and general lack of rapid scientific recognition. The nascent biopharma industry, however, relies on GCP-quality clinical data from first-in-man academic trials to raise funds for further clinical development of an innovative therapy that could ultimately benefit European citizens and strengthen European innovative capacity.

Despite the issues described above, there are many academic clinicians wanting to do trials of novel ATMPs but they generally lack the necessary infrastructure for GCP/GMP compliance. They also report that the regulatory burden hinders the establishment of new and successful facilities; in fact, success relies mostly on those facilities who have manufactured ATMPs prior to the implementation of the current legislation whereas new facilities find it most difficult to enter the stage.

From an industry perspective, the lack of comparability in the application of regulations across the EU is a disincentive to SMEs, funders and big pharma e.g. EVEN when the product attains a marketing authorisation some MS are allowing manufacture of competing products by hospitals under the Hospital Exemption Clause which devalues the commercial product.

Until October 2015, AGORA, a public sponsored project has generated 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

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.

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).

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.

>>> View the summary of AGORA achievements (Size: 122 KB)

AGORA Toolbox

With the end of the project’s funding period also editing of the AGORA toolbox ended but in order to retain the collected knowledge and documents the AGORA website was still kept online until end of 2017 and is now being transferred to the new ECA ATMP Working Group’s website. With this transfer a unique possibility was found not only to maintain the existing content but also to provide a platform for further discussions of interested persons in the field of ATMP.