Panel Discussion on ATMP Regulation

Dsc 0231The CTGCT organised its first Panel Discussion on 29 May entitled: ATMP Regulation. The main takeaway from the very successful session was that the strong potential of the Slovenian ecosystem requires the will to collaborate and create new opportunities through partnerships.

The panellists were Dr Suzana Vidic from JAZMP, the Slovenian Medicines Agency, Dr Damjan Osredkar, clinician from UMC Ljubljana Paediatric Clinic who deals with the treatment of rare diseases in children, Dr Trudy Straetemans from UMC Utrech as an expert on ATMPs who is currently conducting a clinical trial on CAR-Ts, Dr Leila Amini from Berlin Centre of Advanced Therapies at Charité Berlin and Dr Tanja Španić, patient representative from Europa Donna. The event was moderated by Gregor Cuzak from CTGCT at Kemijski inštitut.

The event was attended by over 30 participants in the glass mansard hall of the Kemijski inštitut and other participants online at, where the video can also be accessed later. Participants on site came from various parts of the ecosystem, including researchers, biotech companies, industry and patients. Among these attendees were many who were leaders in their respective fields of work, so it was evident during the meeting that the room was indeed filled with top Slovenian experts and talent.

How do you go from potential to realising that potential was the obvious question. Back to regulation, the good news for attendees was that regulators, including the Ministry of Health, JAZMP and clinical experts, have already started to address some of the needs within the Slovenian regulatory framework to enable better translation from the lab to the bedside.

The guiding idea for what needs to be achieved in the regulatory process is that of a pair of two intersecting funnels, one becoming wider and the other narrower over time. Jeralaurlep The first represents the growing amount of resources, money and people involved, while the other represents the regulatory process, which becomes more demanding and narrowly defined as you get closer to market authorisation in the translational pathway. This theme emerged from the preparatory discussions with the participants and was visually represented during the introduction as well as in the scenography of the room by placing a ” do-not-cross” ribbon in the form of two crossed funnels on the roof of the attic.

The panellists addressed the main challenges posed by the regulation and made important contributions from abroad in the form of experiences, cases and opinions. The most important realisation was that, in addition to clear regulation, training and the exchange of knowledge and experience should also play a major role. Panels like this one are therefore very welcome and are also attended by almost all the key experts.

In the final part of the event, participants were invited to address their questions and comments to the panellists. The panel ended after 90 minutes, but the discussions between the participants continued over snacks and drinks.

Photos from the event can be found at:

The next CTGCT panel discussion will take place on 27 November and will focus on the topic of clinical research. One of the goals will be to attract more clinicians to the panel discussion as well as the audience.

Photos: Andrej Perdih