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ESOT Roadmap for Advanced Therapy Medicinal Products in Transplantation : Navigating Regulatory Challenges to Enhance Access and Care

Berishvili, Ekaterine ; Piemonti, Lorenzo ; de Koning, Eelco J.P. ; Lindstedt, Sandra LU ; Scholz, Hanne ; Scott, William E. ; Auxenfans, Celine ; Johnson, Paul ; Martin, Dominique E. and Gunther, Penilla LU , et al. (2024) In Transplant International 37.
Abstract

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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
keywords
advanced therapy medicinal products (ATMPs), cell transplantation, organ transplantation, patient access, regulatory challenges
in
Transplant International
volume
37
article number
13485
publisher
Springer
external identifiers
  • pmid:39469665
  • scopus:85208081739
ISSN
0934-0874
DOI
10.3389/ti.2024.13485
language
English
LU publication?
yes
additional info
Publisher Copyright: Copyright © 2024 Berishvili, Piemonti, de Koning, Lindstedt, Scholz, Scott, Auxenfans, Johnson, Martin, Gunther, Mey, Potena and Thaunat.
id
f32aaeec-91e6-4f1b-aa86-58cf083fafcd
date added to LUP
2025-04-02 09:41:43
date last changed
2025-04-04 04:44:22
@article{f32aaeec-91e6-4f1b-aa86-58cf083fafcd,
  abstract     = {{<p>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.</p>}},
  author       = {{Berishvili, Ekaterine and Piemonti, Lorenzo and de Koning, Eelco J.P. and Lindstedt, Sandra and Scholz, Hanne and Scott, William E. and Auxenfans, Celine and Johnson, Paul and Martin, Dominique E. and Gunther, Penilla and Mey, Devi and Potena, Luciano and Thaunat, Olivier}},
  issn         = {{0934-0874}},
  keywords     = {{advanced therapy medicinal products (ATMPs); cell transplantation; organ transplantation; patient access; regulatory challenges}},
  language     = {{eng}},
  publisher    = {{Springer}},
  series       = {{Transplant International}},
  title        = {{ESOT Roadmap for Advanced Therapy Medicinal Products in Transplantation : Navigating Regulatory Challenges to Enhance Access and Care}},
  url          = {{http://dx.doi.org/10.3389/ti.2024.13485}},
  doi          = {{10.3389/ti.2024.13485}},
  volume       = {{37}},
  year         = {{2024}},
}