Activities

In recent years, activities in the field of gene therapy (GT) have increased markedly. Large numbers of clinical trial applications are submitted to regulatory authorities. The first gene therapy product has been granted a marketing authorisation for the European market and more may be available soon.

In order to prepare the OMCLs for their role in the surveillance of the quality of GT products, a specific Working Group has been established within the General European OMCL Network. The role of this Working Group is to foster collaboration between OMCLs working in the field of GT products in order to save time and resources by sharing knowledge and technologies.

Currently the following OMCLs participate in the Working Group:

The GT Working Group meets once per annum to review the activities of the past year and to define the work programme of the following year as well as to discuss any relevant topics.

15th OMCL Gene Therapy Working Group Meeting

27 - 28 March 2025, Brussels, Belgium

The OMCL Gene Therapy Working Group held its latest meeting on 27-28 March 2025. This two-day event, hosted by Sciensano at their premises in Brussels (Belgium), brought together members of the group to promote collaboration and knowledge sharing and welcomed five external experts for an open session for exchange on the latest technologies and challenges.

The group members participated in closed working sessions focused on ongoing studies, with AAV vector analysis once again the central topic. The discussions also explored opportunities for broadening the scope to include other vector systems, alongside strategic planning for upcoming initiatives and future projects; building up laboratory capacity remained a key priority throughout.

The open session featured five guest speakers who shared valuable insights on recent data, market tendencies and challenges faced in the field. These interactions helped spark ideas for future collaboration and brought a fresh perspective to the group’s work.

Beyond the formal discussions, the event offered an opportunity for networking and informal exchange in a warm and collegial atmosphere, encouraging valuable connections and synergy.