IMPACT

Scientific impact
JOIN4ATMP will develop a science-based adaptive regulatory framework capable of dealing with specific ATMP characteristics and empowering academic and SME developers to energise and broaden ATMP development. Since early ATMP development stage regularly occurs at the research level and heavily relies on meaningful data, the project will also provide (pre)clinical datasets, evaluate preclinical models and methods for guidance on data reliability. This data will be produced in interoperable machine-readable format. Finally, JOIN4ATMP will publish its findings in high-impact papers.

Patient & healthcare impact
By boosting ATMP development and application, JOIN4ATMP will have a significant impact on European ATMP adoption and patient quality of life. The expected increase in ATMP production will decrease production and therapy costs of at least 50% while efficient communication will ensure patient education and adoption. Standardisation in production and application will further reinforce this aspect by increasing patient safety and ATMP quality. Functional communication of ATMP-applying clinics and GMP units with the coordinating EU-wide platform established within JOIN4ATMP will ensure fast, efficient, and cross-border supply of ATMP products. Healthcare costs will therefore be reduced by approximately 25%. Finally, by addressing unmet medical needs, ATMPs will avoid preventable mortality and tissue damage.

Social & structural impact
Targeted communication and information will improve trust in ATMPs, authorities, regulatory processes and healthcare systems. The creation of unified regulatory frameworks will solidify EC policy implementation and further support health equity. The use of efficient infrastructures will foster the provision of innovative solutions into clinical application, contributing to the expansion of ATMP in Europe.

Economic & technological impact
Out of the 144 ATMP trials initiated globally in 2022, Europe had the smallest share (11%). This observation might be partly explained by the difficult reimbursement of ATMPs, which remains a major roadblock for developers and health technology assessment bodies. The implementation of an EU-wide GMP coordination platform by JOIN4ATMP will increase the numbers of ATMPs developed on European soil. Informed developers and harmonised approval procedures will decrease the time to market by 10-20%, potentially making European ATMP developers more competitive and the EU more attractive as a site for production and clinical trials. New financing models and tools will enable developers to estimate realistically ATMP value and cost, therefore increasing the likelihood of successful market entry. Finally, accelerated ATMP transfer will foster earlier patient treatment, therefore reducing socio-economic costs for society and strengthening European workforce and economy.