New Lund model aims to shorten the path to life-saving cell and gene therapies
Source: https://www.lunduniversity.lu.se/article/new-lund-model-aims-shorten-path-life-saving-cell-and-gene-therapies Parent: https://www.lunduniversity.lu.se/news
By tove [dot] smeds [at] med [dot] lu [dot] se (Tove Smeds) - published 17 February 2026
Anna Falk, Gisela Helenius and Stefan Jovinge. Photo: Tove Smeds, Lunds University och Skånes University Hospital
Despite groundbreaking research, many cell and gene therapies do not make it all the way to the patients. Researchers and clinicians in Lund have now presented a new model for cooperation that will shorten lead times and reduce costs – with the aim to give more patients access to advanced, potentially curative treatments.
In brief:
Why promising cell and gene therapies fail to reach implementation – and how a Swedish model aims to solve the problem
From discovery to reimbursement in healthcare: the Lund model points to a new path for advanced therapies
In recent years, cell and gene therapies have shown promising results in everything from cancer to neurological diseases. However, the path from academic breakthrough to becoming established in healthcare is a long one – and many projects are lost in the translational gap.
“As academic researchers it is totally reasonable to devote all your energy to getting through to the first clinical study. But this is not enough if the objective is for the therapy to actually reach patients. Somewhere along the line, the development must also be attractive for healthcare, investors and industry – and we must think about this much earlier than we do today,” says Anna Falk, professor of neuroscience at Lund University.
In a new research article in the journal Molecular Therapy, Methods and Clinical Development she presents, along with researchers at Lund University and Skåne University Hospital, a new working method. The goal is to break down the silos between academia, healthcare and innovation systems.
“At present, crucial technical, regulatory or commercial obstacles are often detected too late. And then it’s an expensive and slow process to make corrections – or the therapy never reaches the patients. We present a model and a tool that can provide support and reminders about which parts you need to have in place when you develop new advanced cell and gene therapies. It’s development support that can be used by all those working in the field,” says Anna Falk.
Bridging the translational gap through early collaboration
The core of the model is that the university, hospital and innovation stakeholders work in parallel and in an integrated way right from the start, instead of step by step. An important change is that the hospital is involved at an early stage in development and production – something that is necessary for cell and gene therapies, where healthcare is not only the user but also a part of the production chain. Here, it is clear that the conventional structures for drug development do not meet the needs of advanced therapies.
“It’s a paradigm shift in which the hospital not only receives or tests a finished product, but also all those involved – academia, hospital and innovation stakeholders – need in different ways to participate throughout the development process, manufacturing and quality control. There is a need here for a new working methods and tools. Together they constitute a model that has been developed in Lund,” says Stefan Jovinge, research director at Skåne University Hospital.
A practical tool: the cell and gene therapy navigator
As a practical tool, the researchers have developed the Cell and Gene Therapy Navigator, which follows a project’s technical, clinical and commercial maturity simultaneously. Using this approach, imbalances and future bottlenecks can be identified in time.
“It’s not enough to be the first to test the therapy on humans. If we want the therapies to reach many patients we must think about production, regulations and reimbursement right from the start. The Navigator works as a joint checklist and mirror for the project,” says Gisela Helenius, head of the ATMP Centre at Skåne University Hospital.
The researchers consider that the model could act as a template for other regions in Sweden and internationally – but that each region must build their own cooperation set-up locally.
“Our hope is that fewer promising therapies will get stuck or fall by the wayside – and that more patients actually get access to treatments that today remain in the lab.”
Contact
Anna Falk, director of LU-ATMP and professor of developmental biology, specialising in neuroscience, at Lund University\ +46 462220540\ anna [dot] falk [at] med [dot] lu [dot] se (anna[dot]falk[at]med[dot]lu[dot]se)
Profile in Lund University Research Portal
Gisela Helenius, head of the ATMP Centre at Skåne University Hospital\ +46 724620582\ gisela [dot] helenius [at] skane [dot] se
Stefan Jovinge, research director at Skåne University Hospital\ stefan [dot] jovinge [at] skane [dot] se
Publication
The Advanced Therapies model of Lund an integrated approach to accelerate access for many patients\ DOI: 10.1016/j.omtm.2025.101637
New Lund model
Why it is important
- Reduces the time and costs involved in developing advanced therapies
- Reduces the financial risks of the project before major investments are made
- Enhances conditions for long-term sustainable biotech companies
- Ultimately improves patients’ access to safe therapies with the potential to cure diseases
How the model is structured
The Lund model in an integrated working method to accelerate the development of cell and gene therapies from research to implementation in healthcare. Instead of stakeholders working step by step one after the other, development proceeds in parallel and in a close collaboration between the:
- university (research, process development, pre-GMP)
- hospital (regulatory framework, clinical trials, GMP-based production)
- innovation stakeholders (IP, commercialisation, investments, up-scaling)
A key principle is a clear division of responsibilities combined with a joint overall view. Each stakeholder is responsible for their area of expertise, but all stakeholders have an overall view of the entire development chain right from the start. Responsibility does get passed on, like in a relay race, but is shared and adjusted over time.
With this approach, technical, regulatory and commercial obstacles can be identified in time – before they become expensive bottlenecks.
A tool for avoiding bottlenecks
The tool is based on a three-dimensional follow-up of the project’s maturity in three areas:
- Technical maturity (e.g. process development, pre-GMP, scalability)
- Clinical maturity (e.g. regulatory requirements, study design, healthcare preparedness)
- Commercial maturity (e.g. IP, licensability, investor interest)
For each dimension there is a set of questions that are answered with yes, in progress or no. The answers are visualised in a colour scale from red to green, which makes it clear if the project is in balance – or if there are hold-ups in a particular area.
The Navigator is used in joint meetings between researchers, clinicians and innovation stakeholders to detect imbalances at an early stage, foresee future bottlenecks, prioritise the right initiatives at the right time and reduce the risk of reworking later.
The tool is a living document updated over time. It is designed to support long-term project management – not just to take a project to the first clinical study, but all the way to widespread patient access.
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Last updated: 2 Mar 2026 | press [at] medicin [dot] lu [dot] se