Over the first 18 months, JOIN4ATMP has made major progress in identifying the barriers that limit the development and fair access to Advanced Therapy Medicinal Products (ATMPs) in Europe, and in creating practical solutions to overcome them.
WP1 built a robust, searchable database of ATMP preclinical and clinical trials in Europe, identifying nearly 1,000 ATMP-related studies from the EU Clinical Trials Register. This mapping highlights early-phase trials where translation to patient use is often delayed. Surveys and expert interviews revealed how preclinical testing is performed, the models used, and where improvements are possible - such as better use of alternative methods and earlier regulatory engagement. A user-friendly web application was developed to share and update this data dynamically.
WP2 studied ATMP manufacturing under Good Manufacturing Practice (GMP) across the EU, revealing challenges such as limited facility access, inconsistent regulations, and shortages of GMP-grade materials. Recommendations include harmonising GMP rules, creating an EU-wide raw material database, supporting developers, and introducing a “parent–child” regulatory approach to speed approvals. A concept for an EU-wide GMP coordination hub was also developed to improve efficiency, reduce costs, and enhance patient access.
WP3 analysed real-world regulatory and clinical hurdles through case studies and a cross-country SWOT analysis. These showed barriers such as fragmented regulations, difficulties in trial design for small patient groups, and limited comparability of products. WP3 also explored alternative financing models to help non-commercial developers bring ATMPs for rare and ultra-rare diseases to patients.
WP4 focused on the economic and evidence aspects of ATMP access. It studied how real-world data is used in decision-making, tested a financial model (risk-adjusted Net Present Value model) to help early developers assess viability, and advanced proposals for sustainable reimbursement models that link payment to patient outcomes.
WP5 mapped regulatory barriers for academic and SME developers, compared support systems in the EU and other regions, and began designing a pan-European expert platform to connect regulators, developers, clinicians, and patients. It also examined public awareness and trust in ATMPs, finding strong variation between countries, and launched high-profile webinars to start a structured dialogue with patient communities.
Together, these achievements provide the scientific evidence, regulatory insight, and policy tools needed to accelerate ATMP development and ensure that innovative therapies can reach all European patients in a safe, timely, and equitable way.
