Research alliance for advanced therapy medicine development
ATMP products are based on gene therapy, somatic cell therapy or tissue engineering. The AGORA (ATMP GMP open access research alliance - AGORA) project has undertaken a number of actions to address previously unmet needs and critical issues as a result of human cell therapy regulations. AGORA has created a framework to promote consultation with biomedical investigators and support ATMP researchers in complying with regulations. The project resources also make sure that these medicines are developed from the earliest phase right through to commercial trials. An interactive website has a summary of achievements, a blog and an ATMP-toolbox for the consortium and members. Add to that a technology transfer network, training programmes, provision of information on pathways, regulations, technologies and resources across the European Union. These measures have led to very successful results during the three-year initiative. To generate new knowledge on the impact of regulations, AGORA analysed publications on advanced regulation principles and innovation statistics for advanced therapies. Collation and exchange of information was achieved using a survey of non-industry sector members and comparison of experience of partners and selected stakeholders. Dissemination was via conferences, meetings and workshops. A report assessing the impact of new ATMP regulations on the academic sector presents concrete suggestions to policymakers in response to the consultation document published by the Commission. Moreover, the project has brought together all key players – academic researchers, clinicians, quality managers, clinical trials coordinators, legal and regulatory advisors and regulators. Through their substantial platform, AGORA will continue to deliver the necessary support and training to support all parties interested in ATMP development. The ultimate result will be the provision of more advanced healthcare for all citizens.
Keywords
Advanced therapy medicine, good manufacturing practice, cell therapy, regulations, report, platform
