APPROACH
Advanced Therapy Medicinal Products (ATMPs) provide innovative treatment options for diseases that currently have no adequate standard-of-care options. These breakthrough therapies are available for rare genetic diseases, common immune diseases, cancer and tissue injury. However, scientific, clinical and patient communities and commercial, regulatory and technology-assessing bodies still face significant barriers to ATMP expansion.
Current legal and regulatory frameworks for drug development in the EU have been designed for standard drug production with large patient target groups. Meanwhile, several regulatory, clinical, economic and ethical issues remain unsolved and account for missed opportunities to develop ground-breaking technologies and ATMP success.
To tackle this challenge, the JOIN4ATMP consortium brings together all members of the European University Hospital Alliance with the existing EU-funded T2EVOLVE and RESTORE networks, and with active support from industry partners and patient representatives as core partners. The comprehensive scope of stakeholders involved in the project ensures a holistic assessment of current hurdles and the best way to improve support and regulation of ATMP development and use in the EU and associated countries. Success of the JOIN4ATMP project will be met through the achievement of specific objectives.