Descrizione del progetto
Superare gli ostacoli nel campo dei medicinali per terapie avanzate
Nel campo della medicina, i prodotti medicinali per terapie avanzate (ATMP. Advanced Therapy Medicinal Products) sono promettenti come trattamenti rivoluzionari basati su geni, cellule e tessuti. Tuttavia il loro potenziale è ostacolato da molteplici sfide che abbracciano i settori scientifico, clinico, normativo e commerciale. Questi ostacoli impediscono lo sviluppo e l’accesso diffuso degli ATMP, rendendo difficile per i pazienti accedere e beneficiare di terapie all’avanguardia. In questo contesto, il progetto JOIN4ATMP, finanziato dall’UE, riunisce esperti mondiali per accelerare i progressi europei in materia di ATMP. Sfruttando i dati del mondo reale, mira a identificare gli ostacoli e a semplificare le normative. JOIN4ATMP produrrà un pacchetto informativo completo e raccomandazioni per un accesso equo agli ATMP in tutta Europa. Con il sostegno dell’industria e dei rappresentanti dei pazienti, assicura un coordinamento continuo per il progresso della medicina personalizzata.
Obiettivo
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.
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HORIZON-CSA - HORIZON Coordination and Support ActionsCoordinatore
10117 Berlin
Germania