The Relevance of Advanced Therapy Medicinal Products in the Field of Transplantation and the Need for Academic Research Access: Overcoming Bottlenecks and Claiming a New Time.
advanced therapy medicinal products (ATMPs)
clinical trials
rare diseases
regulatory processes
transplantation
Journal
Transplant international : official journal of the European Society for Organ Transplantation
ISSN: 1432-2277
Titre abrégé: Transpl Int
Pays: Switzerland
ID NLM: 8908516
Informations de publication
Date de publication:
2023
2023
Historique:
received:
31
05
2023
accepted:
12
09
2023
medline:
1
11
2023
pubmed:
12
10
2023
entrez:
12
10
2023
Statut:
epublish
Résumé
The field of transplantation has witnessed the emergence of Advanced Therapy Medicinal Products (ATMPs) as highly promising solutions to address the challenges associated with organ and tissue transplantation. ATMPs encompass gene therapy, cell therapy, and tissue-engineered products, hold immense potential for breakthroughs in overcoming the obstacles of rejection and the limited availability of donor organs. However, the development and academic research access to ATMPs face significant bottlenecks that hinder progress. This opinion paper emphasizes the importance of addressing bottlenecks in the development and academic research access to ATMPs by implementing several key strategies. These include the establishment of streamlined regulatory processes, securing increased funding for ATMP research, fostering collaborations and partnerships, setting up centralized ATMP facilities, and actively engaging with patient groups. Advocacy at the policy level is essential to provide support for the development and accessibility of ATMPs, thereby driving advancements in transplantation and enhancing patient outcomes. By adopting these strategies, the field of transplantation can pave the way for the introduction of innovative and efficacious ATMP therapies, while simultaneously fostering a nurturing environment for academic research.
Identifiants
pubmed: 37822447
doi: 10.3389/ti.2023.11633
pii: 11633
pmc: PMC10563816
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
11633Informations de copyright
Copyright © 2023 Piemonti, Scholz, de Jongh, Kerr-Conte, van Apeldoorn, Shaw, Engelse, Bunnik, Mühlemann, Pal-Kutas, Scott, Magalon, Kugelmeier and Berishvili.
Déclaration de conflit d'intérêts
Authors MM, KP-K, and PK were employed by Kugelmeiers Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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