Researchers and clinicians in Lund have introduced a new cooperative model designed to speed up patient access to cell and gene therapies. The initiative aims to address the challenge that, despite significant research progress, many advanced therapies do not reach patients due to lengthy development processes and high costs.
Cell and gene therapies have shown positive results for conditions such as cancer and neurological diseases. However, moving these treatments from academic discovery to routine healthcare use is often hindered by what experts call the "translational gap," where promising projects fail to progress.
In a recent article published in Molecular Therapy, Methods and Clinical Development, Anna Falk, together with colleagues at Lund University and Skåne University Hospital, outlined this new approach. According to Falk: "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."
The proposed model emphasizes integrated collaboration between universities, hospitals, and innovation partners from the outset of therapy development. Traditionally, these stakeholders work sequentially; however, this method brings them together early on. Hospitals are involved at initial stages of both development and production—a necessary step since healthcare providers play a role not only as users but also as part of the manufacturing process for these complex therapies.
Stefan Jovinge, research director at Skåne University Hospital, described this shift: "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."
To put their approach into practice, the team developed the Cell and Gene Therapy Navigator—a tool designed to monitor technical progress alongside clinical readiness and commercial viability throughout each project’s lifecycle. This allows teams to identify potential problems before they become barriers.
Gisela Helenius, head of the ATMP Centre at Skåne University Hospital explained: "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."
The researchers believe their model could serve as an example for other regions both within Sweden and internationally but stress that local adaptation will be necessary.
"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."
