New ‘Navigator’ Model Aims to Speed Cell and Gene Therapies to Patients

Despite promising research, many cell and gene therapies fail to reach patients due to lengthy development times and high costs. Researchers at Lund University and Skåne University Hospital in Sweden have developed a new collaborative model, including a “Cell and Gene Therapy Navigator,” designed to accelerate the translation of these therapies into clinical practice.

The Translational Gap in Advanced Therapies

Cell and gene therapies have demonstrated significant potential in treating a range of diseases, including cancer and neurological disorders. Still, the journey from initial scientific discovery to widespread patient access is often fraught with challenges. Many projects stall in what’s known as the “translational gap,” failing to overcome technical, regulatory, or commercial hurdles.

A New Model for Collaboration

The Lund University team, led by Professor Anna Falk of neuroscience, proposes a new working method detailed in an article published in Molecular Therapy Methods & Clinical Development. This model emphasizes breaking down silos between academia, healthcare providers, and innovation systems. The key is integrated, parallel work from the start, rather than a sequential, step-by-step approach.

“At present, crucial technical, regulatory or commercial obstacles are often detected too late. And then it’s an expensive and unhurried process to build corrections—or the therapy never reaches the patients,” explains Professor Falk. “We present a model and a tool that can provide support and reminders about which parts you require to have in place when you develop new advanced cell and gene therapies.”

The Hospital’s Evolving Role

A critical shift in the new model is the early involvement of hospitals in both the development and production of cell and gene therapies. Unlike traditional drug development, healthcare systems are not simply end-users but integral parts of the manufacturing chain. This requires new working methods and tools.

“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,” says Stefan Jovinge, research director at Skåne University Hospital.

The Cell and Gene Therapy Navigator

To facilitate this collaborative approach, the researchers developed the Cell and Gene Therapy Navigator. This tool simultaneously tracks a project’s technical, clinical, and commercial maturity, allowing for the early identification of imbalances and potential bottlenecks.

“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 suppose 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 Center at Skåne University Hospital.

Scalability and Future Implications

The researchers believe their model can serve as a template for other regions, both within Sweden and internationally, but emphasize the need for localized cooperation setups. Their ultimate goal is to ensure that more promising therapies reach patients who could benefit from them.

As noted in a recent overview of advances in cell and gene therapy, continued innovation and improved translation are crucial for realizing the full potential of these groundbreaking treatments.

Source: Lund University. “New ‘navigator’ model aims to speed cell and gene therapies to patients.” Medical Xpress. February 22, 2026.