ATMP Denmark is seeking international experience

The experiences from the other countries will be used to qualify the next steps in the Danish ATMP effort.

The focus turns outward

In Sweden, Germany, Spain, Norway and the United Kingdom, authorities, hospitals and professional environments have chosen different paths into work with advanced therapies.

ATMP Denmark is now taking a closer look at selected initiatives and examining what lies behind the different models. How is the collaboration organized? How do you help researchers, clinicians and companies navigate the regulatory landscape? And what does it take to ensure production, training and the right competencies?

The goal is not to find one model that can be copied directly. It is to understand which choices the countries have made along the way, what has been difficult, and which experiences may be relevant in a Danish context.

The first patterns are beginning to emerge

The analysis is still in an early phase. But the first interviews already point to a common pattern: The task is largely about connecting the competencies that already exist.

This happens in very different ways. The German National Strategy for Gene and Cell Therapy and ATMP Catalonia both show attempts to create greater coherence across a complex field, but with different organizational approaches and at different levels. At the same time, experiences from, among others, the Swedish NACNET point to the value of more focused professional networks, where practitioners can share knowledge and concrete experiences across university hospitals.

“What is interesting is how context-dependent the solutions are. We see recognizable challenges across the countries, but very different choices about where and how to intervene,” says Kim L. Kryger, Senior Medical Advisor at ATMP Denmark.

What can actually be transferred to Denmark?

An experience may look promising in one country, but it requires the right conditions if it is to be used in Denmark. That is why ATMP Denmark’s international working group plays an important role. The group consists of clinicians and researchers from the Danish ATMP ecosystem, who have helped prioritize the cases. Now they will qualify the preliminary results and their relevance for Denmark.

Method: From 200 initiatives to ten cases

The analysis is being carried out together with VIVE, the Danish Center for Social Science Research, and Jakob Wested, Associate Professor at the Center for Advanced Studies in Bioscience Innovation Law at the University of Copenhagen. VIVE contributes experience from qualitative analyses in the health and welfare area, while Jakob Wested contributes legal and regulatory knowledge about advanced therapies.

More than 200 international initiatives were initially identified. After screening and prioritization, the field has been narrowed down to ten cases, which are now being examined more closely: eight through interviews with key individuals and two through desk research. The interviews are intended to provide insight into what is rarely clear in strategies and organizational charts: What works in practice, where do the problems arise, and what does the model require in terms of resources, competencies and mandate?

The analysis focuses in particular on four areas: professional networks, collaboration between actors, advice on rules and approval, and production, training and competencies.

The overall analysis is expected to be completed in the first quarter of 2027.

The initiatives ATMP Denmark is taking a closer look at:

• National Strategy for Gene- and Cell-based Therapies, Germany

• /NACNET, Sweden

• BioCAT/ATMP Catalonia, Spain

• Paul-Ehrlich-Institut, Germany

• ILAP and RASRM, United Kingdom

• ATMP Norway, Norway

• Cell & Gene Therapy Catapult, United Kingdom

• NHS England Foundation Trainee Pharmacist Program, United Kingdom