Since the beginning of the year, Swelife has been funding National ATMP Coordination, a pilot study to coordinate ATMP initiatives in Sweden.
Advanced therapy medicinal products (ATMPs) are based on cells, tissues or genes. ATMPs are developing rapidly and international competition is fierce. To stay competitive, Sweden has invested in various cell and gene therapies over the years.
In the 2000s, several EU directives were introduced to regulate the quality and safety of cells and tissues used in human treatment. At that time, the regions in Sweden received government support to work on this, and a national project was formed to coordinate this. In 2010, the project was transferred to SKR and Vävnadsrådet was established.
Several initiatives working together
Almost ten years later, the CAMP (Centre for Advanced Medicinal Products) project was launched with funding from Vinnova, and around the same time Swelife funded an ATMP initiative, Swelife ATMP. It was decided to collaborate under the ATMP Sweden flag, and the ATMP 2030 initiative, also financed by Vinnova, started in 2019. Other initiatives in the area are CCRM Nordic, Swecarnet and OligoNova, among others.
This year, however, several initiatives will conclude, including CAMP and ATMP 2030. There is a concern that the valuable progress achieved may be lost.
“At that time, an initiative was taken by Lund University to discuss a national collaborative structure,” says Professor Mikael Wiberg, chairman of the CAMP board and project manager for the new Swelife project. “There were sometimes quite heated discussions in 2023. How would this structure be organised?
Funding for administrative coordinator
It was decided that a steering group and a coordination group should be set up. And this is where the Swelife project comes in. The money from Swelife can be used to finance an administrative coordinator and the face-to-face meetings needed to get the collaborative structure in place. The key is to establish a long-term and sustainable organisation and funding – preferably before 2024 when CAMP and ATMP 2030 close.
The steering group has now been established, comprising two representatives each from academia, university hospital regions, industry, and one patient representative. Their current focus is on prioritising tasks to ensure the most important work is completed. Additionally, they are assessing funding options and organisational structure.
Because there are certainly challenges left to solve, says Professor Wiberg:
“It’s about the sharing of health data and forms of collaboration. But long-term financing is also a key issue, as it’s not sustainable to rely solely on project funds.”
Coordination of ATMP initiatives
Sweden’s infrastructure for ATMPs is good, says Mr Wiberg, referring to initiatives taken in connection with “Vävnadsdirektivet” and CCRM Nordic. But how to get the therapies to patients in a sustainable way?
“We need to find ways for industry and the public sector to work together because ATMPs are different from other pharmaceuticals. It is not a pill in a bottle, but each ATMP will be different from the other because it is based on donated human tissue. We need to find development opportunities for when we can use the public sector and its infrastructure and when industry must take over. Long-term agreements on risk-taking and financing must be developed.”
2024 is a critical year for ATMP, continues Mikael Winberg.
“There is so much happening around the world now. The potential for development is huge. If we look at other countries, the uptake of ATMPs in healthcare has been much higher. We have to bite the bullet and solve these issues. It will cost money because we will never be able to withhold treatment options from patients.”