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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Copyright © 2024 Berishvili, Piemonti, de Koning, Lindstedt, Scholz, Scott, Auxenfans, Johnson, Martin, Gunther, Mey, Potena and Thaunat. The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force’s position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices.
Author(s): Berishvili E, Piemonti L, de Koning EJP, Lindstedt S, Scholz H, Scott WE, Auxenfans C, Johnson P, Martin DE, Gunther P, Mey D, Potena L, Thaunat O
Publication type: Article
Publication status: Published
Journal: Transplant International
Year: 2024
Volume: 37
Online publication date: 14/10/2024
Acceptance date: 19/09/2024
Date deposited: 12/11/2024
ISSN (print): 0934-0874
ISSN (electronic): 1432-2277
Publisher: Frontiers Media SA
URL: https://doi.org/10.3389/ti.2024.13485
DOI: 10.3389/ti.2024.13485
Data Access Statement: This position statement does not present original data. It is informed by a comprehensive review of current regulatory frameworks governing ATMPs in transplantation, relevant policy documents, and expert consensus within the ESOT task force.
PubMed id: 39469665
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