National initiatives within advanced therapy

Several different projects are in progress in Sweden within advanced therapy medicinal products (ATMP), aimed at strengthening Sweden’s competitiveness within ATMP, helping large and small companies wishing to manufacture ATMP, and increasing the national exchange of knowledge and competence reinforcement within the development of cell and gene therapy. In this interview, Ann Novotny, project leader for regenerative medicine at Gothia Forum, tells us more about ATMP and the projects she is involved in.

Ann Novotny, projektledare på Gothia Forum

What are ATMP and why are they needed?

Advanced therapy medicinal products are difficult to describe in brief. There are four classifications of ATMP, and their common feature is that they are based on human cells, tissues or genes, which have been modified in some way to enable manufacture of the desired therapeutic medicine. There are currently not many approved ATMP on the market, but hopefully there will be more within a few years.

ATMP can treat diseases that in many cases are fatal; for example, there are today approved ATMP to cure cancer using a one-off treatment based on a modification of the patient’s own T cells. The need for ATMP is great, but the challenges are many, as clinical studies within the ATMP area require specialist competence and are extremely costly.

Can you mention any important projects in progress within ATMP?

In spring 2017, Vinnova chose to invest in the area by issuing two calls for funds, and two projects within ATMP received funding. The projects have a joint steering group, and collaborate closely.

  • Swelife-ATMP runs during 2017–2020, and the aim of this project is to strengthen Sweden’s competitiveness within ATMP, particularly within cell and gene therapy.
  • Centre for Advanced Medical Products (CAMP) runs during 2018–2023. The focus of this project is on production and logistics for small and large companies wishing to manufacture ATMP.

During autumn 2018, one further Vinnova-funded project started, which ran for 8 months. Advanced Therapies for the Healthcare of the Future had the vision of implementing ATMP in medical care and to cure patients. Vinnova has now issued a call relating to the continuation of vision-driven health, and the project plans to submit an application to continue.

What is your role in this area?

My role is to be the project leader for what is known as the “regulatory work package” within the Swelife-ATMP project. The content of the work package aims to provide guidance and support within the regulatory framework for ATMP, and also includes a process guide from pre-clinical to clinical for ATMP, with focus on the regulatory framework.

The regulatory team is also producing various templates/checklists, mapping hospital pharmacy functions, providing support to hospitals and companies for implementing ATMP in medical care, designing an educational programme focusing on the regulatory framework, and establishing a support function within the area in the regions.

I am also:

  • a co-opted member of the board and responsible for the regulatory work package in the CAMP project.
  • subsidiary project leader for Advanced Therapies for the Healthcare of the Future and
  • a co-opted member of Vävnadsrådet, VOG Cell (the Tissue Council, Cell Tissue Area Group), to maintain a close dialogue with the hospital and understand their challenges during the introduction of ATMP.

Who can you turn to if you need help within ATMP?

Information about the national initiatives is available on the website atmpsweden.se External link, opens in new window.. The website is maintained by CAMP and Swelife-ATMP, and aims to serve as a common portal for the national work conducted within the ATMP area in Sweden.