Lund Model Proposes Parallel University-Hospital-Industry Track to Bridge Cell Therapy Gap

Cell and gene therapies are among the most scientifically promising developments in modern medicine - capable in some cases of producing lasting remissions or functional cures in conditions that no conventional drug could address. Yet the gap between a promising academic result and a therapy that patients can actually access remains dauntingly wide. Many programs that succeed in early clinical studies never reach healthcare reimbursement. The reasons are rarely about efficacy: they are about manufacturing costs, regulatory complexity, and a development pipeline built for conventional drugs that does not fit the distinctive challenges of living-cell and viral-vector therapies.

A team at Lund University and Skane University Hospital has published a new collaborative model in Molecular Therapy, Methods and Clinical Development designed to address the structural causes of that gap. The core argument is that academia, healthcare systems, and innovation stakeholders need to work in parallel from the beginning of development - not sequentially, as they typically do now.

Why the conventional drug development model breaks down

Standard pharmaceutical development follows a broadly linear sequence: academic discovery, technology transfer, industrial development, clinical trials, regulatory approval, then healthcare procurement. That model was built around small-molecule drugs and biologics, where the hospital's role is to prescribe and administer a finished product manufactured elsewhere.

Cell and gene therapies don't fit that template. Many require manufacturing processes - growing patient-derived cells, viral vector production, quality control - that involve or depend on hospital infrastructure. The hospital is not just the end-user of the therapy; it is often a necessary part of the production chain. Involving hospital systems only late in development, as a customer to hand a finished product to, means discovering incompatibilities and constraints after enormous resources have been invested.

"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," said Anna Falk, professor of neuroscience at Lund University.

The Lund model's structure

The model calls for Lund University, Skane University Hospital, and innovation stakeholders to work in integrated parallel tracks from the earliest development stages. Academic research, clinical assessment, manufacturing planning, regulatory strategy, and commercial viability analysis all proceed simultaneously rather than in sequence.

"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," said Stefan Jovinge, research director at Skane University Hospital.

A key feature is the early identification of obstacles. The current sequential model tends to detect critical technical, regulatory, or commercial problems late in the process - at which point corrections are expensive and slow, or the therapy is simply abandoned. Early parallel engagement is intended to surface those problems while the program is still flexible enough to address them at manageable cost.

The Cell and Gene Therapy Navigator

The practical tool accompanying the model is the Cell and Gene Therapy Navigator - a structured framework that tracks a program's technical, clinical, and commercial maturity simultaneously. The Navigator functions as a shared checklist and diagnostic instrument for cross-disciplinary project teams, highlighting imbalances between the different development dimensions before they become blocking problems.

"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," said Gisela Helenius, head of the ATMP Centre at Skane University Hospital.

Scope and what it does not claim

The model was developed in the specific context of Lund and Skane - a particular academic medical center ecosystem in southern Sweden with its own regulatory environment, healthcare financing structure, and institutional relationships. The authors explicitly note that other regions would need to build their own cooperation arrangements locally, adapting the principles rather than transplanting the model wholesale.

The paper presents a conceptual framework and practical tool, not outcomes data. Whether programs that adopt the Lund model approach show higher rates of reaching reimbursed clinical use than programs that do not has not been demonstrated empirically - that comparison would require tracking multiple programs over years to clinical deployment.