Project description
Overcoming hurdles in advanced therapy medicines
In the realm of medicine, Advanced Therapy Medicinal Products (ATMPs) hold promise as revolutionary treatments based on genes, cells, and tissues. Yet, their potential is stymied by multifaceted challenges spanning scientific, clinical, regulatory, and commercial domains. These hurdles impede the development and widespread access of ATMPs, making it difficult for patients to access and benefit from cutting-edge therapies. In this context, the EU-funded JOIN4ATMP project assembles global experts to expedite European ATMP progress. By leveraging real-world data, it aims to identify hurdles and streamline regulations. JOIN4ATMP will produce a comprehensive information package and recommendations for equitable ATMP access across Europe. With support from industry and patient advocates, it ensures sustained coordination for advancing personalised medicine.
Objective
Advanced Therapy Medicinal Products (ATMPs) are medicines based on genes, cells and tissues for human use. They can provide patients novel treatment alternatives to significantly improve or even cure diseases that currently have no or inadequate standard-of-care options. However, significant challenges remain for the scientific, clinical and patient communities as well as commercial entities and regulatory, policy-making and technology-assessing bodies. The JOIN4ATMP consortium unites international experts and stakeholders with the mission to accelerate and de-risk European ATMP development and ensure wide-spread equitable ATMP access for patients with common diseases, rare non-cancer diseases and rare cancers in Europe. It 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 our 14 core partners. The core partners are joined by supporting partners active in ATMP development, production, application and regulation. Our team will use real-world data and experiences to achieve the most rapid and holistic map of current hurdles and the best way to improve support and regulation of ATMP development and use in the EU and associated countries. The JOIN4ATMP end-product will be a state-of-the-art information package circumscribing (i) currently existing and potential future hurdles preventing rapid and streamlined ATMP development and clinical translation and (ii) a defined set of recommendations to overcome these hurdles in a manner guaranteeing equitable access for patients throughout Europe. We are committed to the long-term operation of our network and take steps to assure its sustainability in order to inform and coordinate activities in Europe for the ATMP field, which will only gain in importance with the advance of personalized medicine in the future.
Fields of science
Programme(s)
Funding Scheme
HORIZON-CSA - HORIZON Coordination and Support ActionsCoordinator
10117 Berlin
Germany