The Advanced Therapies model of Lund an integrated approach to accelerate access for many patients
Helenius, Gisela ; Jovinge, Stefan LU and Falk, Anna LU
(2025)
In Molecular Therapy Methods and Clinical Development
33(4).
- Abstract
Scientific breakthroughs in the field of cell and gene therapy lay the groundwork for therapeutic innovation, but their translation and integration into routine care is delayed by systemic inefficiencies and limited cross-sector alignment. The Advanced Therapies model of Lund is a proactive and integrated approach designed to accelerate the development of advanced therapies from discovery to reimbursement, facilitating close collaboration among three main entities: university, hospital, and the iActors (a coalition of the innovation system, incubators, investors, and industry). Unlocking the full potential of therapeutic innovation requires inclusive and proactive engagement from all entities to accelerate development timelines,... (More)
Scientific breakthroughs in the field of cell and gene therapy lay the groundwork for therapeutic innovation, but their translation and integration into routine care is delayed by systemic inefficiencies and limited cross-sector alignment. The Advanced Therapies model of Lund is a proactive and integrated approach designed to accelerate the development of advanced therapies from discovery to reimbursement, facilitating close collaboration among three main entities: university, hospital, and the iActors (a coalition of the innovation system, incubators, investors, and industry). Unlocking the full potential of therapeutic innovation requires inclusive and proactive engagement from all entities to accelerate development timelines, optimize resource use across the ecosystem, and ultimately deliver curative, cost-effective advanced therapies to patients. This will ensure broad patient access and establishment of optimal conditions for developing the next generation of cell and gene therapies, while also facilitating innovation and economic growth. To operationalize this model, we developed the Cell and Gene Therapy Navigator, a visualization instrument designed to track and optimize the development of advanced therapies within the model framework. This tool leverages three-dimensional visualization to provide a dynamic and comprehensive overview of progress of the advanced therapy development across the three crucial entities: university, hospital, and iActors. We are confident that working according to the model will minimize translational gaps and result in seamless good manufacturing practices (GMP) transfer, fewer re-works, faster time to first-in-human, and the creation of more viable biotech companies.
(Less)
- author
- Helenius, Gisela
; Jovinge, Stefan
LU
and Falk, Anna
LU
- organization
- publishing date
- 2025-12-11
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- advanced therapies, cell therapy, gene therapy, GMP, patient access, regulatory science, tech transfer
- in
- Molecular Therapy Methods and Clinical Development
- volume
- 33
- issue
- 4
- article number
- 101637
- publisher
- Cell Press
- external identifiers
-
- scopus:105022598061
- pmid:41376779
- ISSN
- 2329-0501
- DOI
- 10.1016/j.omtm.2025.101637
- language
- English
- LU publication?
- yes
- id
- 031906a2-7be5-437f-8692-6037a023c7c1
- date added to LUP
- 2026-02-10 11:29:11
- date last changed
- 2026-02-11 03:00:12
@misc{031906a2-7be5-437f-8692-6037a023c7c1,
abstract = {{<p>Scientific breakthroughs in the field of cell and gene therapy lay the groundwork for therapeutic innovation, but their translation and integration into routine care is delayed by systemic inefficiencies and limited cross-sector alignment. The Advanced Therapies model of Lund is a proactive and integrated approach designed to accelerate the development of advanced therapies from discovery to reimbursement, facilitating close collaboration among three main entities: university, hospital, and the iActors (a coalition of the innovation system, incubators, investors, and industry). Unlocking the full potential of therapeutic innovation requires inclusive and proactive engagement from all entities to accelerate development timelines, optimize resource use across the ecosystem, and ultimately deliver curative, cost-effective advanced therapies to patients. This will ensure broad patient access and establishment of optimal conditions for developing the next generation of cell and gene therapies, while also facilitating innovation and economic growth. To operationalize this model, we developed the Cell and Gene Therapy Navigator, a visualization instrument designed to track and optimize the development of advanced therapies within the model framework. This tool leverages three-dimensional visualization to provide a dynamic and comprehensive overview of progress of the advanced therapy development across the three crucial entities: university, hospital, and iActors. We are confident that working according to the model will minimize translational gaps and result in seamless good manufacturing practices (GMP) transfer, fewer re-works, faster time to first-in-human, and the creation of more viable biotech companies.</p>}},
author = {{Helenius, Gisela and Jovinge, Stefan and Falk, Anna}},
issn = {{2329-0501}},
keywords = {{advanced therapies; cell therapy; gene therapy; GMP; patient access; regulatory science; tech transfer}},
language = {{eng}},
month = {{12}},
number = {{4}},
publisher = {{Cell Press}},
series = {{Molecular Therapy Methods and Clinical Development}},
title = {{The Advanced Therapies model of Lund an integrated approach to accelerate access for many patients}},
url = {{http://dx.doi.org/10.1016/j.omtm.2025.101637}},
doi = {{10.1016/j.omtm.2025.101637}},
volume = {{33}},
year = {{2025}},
}