Eurordis - Rare Disease Europe

Webinar: Streamlining the CAR-T Development Pathway in the EU

Home » Webinar: Streamlining the CAR-T Development Pathway in the EU

The aim of our Join4ATMP webinars will be to showcase the challenges in the ATMP development pathway, from pre-clinical research, GMP manufacturing through to clinical translation, market approval, price reimbursement and ultimately patient access.

Patient involvement in the ATMP development is critical to ensure the identification of meaning outcomes and endpoints that can demonstrate clinical efficiency, patient safety and therapeutic value.

These webinars will start the engagement with patient community and warm up the discussion on the hurdles of the existing ATMP development pathway, specifically to:

• Identify the existing changes and hurdles for ATMP research and development pathway.
• Chart the solutions to speed up and make leaner the development pathway to cultivating a viable and healthy pipeline of new ATMPs.
• Explore the opportunity of JOIN4ATMP to identify the key huddles and barriers and co-design the recommendations that can strengthen the ATMP eco-system in Europe.

The webinars will explain the transformative nature of CAR-T treatment using a haematology example as well as how patient safety and efficacy of these innovative treatments is being improved. The challenges to translate a promising asset from pre-clinical through GMP manufacturing and clinical trial pathway, to regulator approval will be showcased in three presentations

The session will be chaired by Matt Bolz-Johnson, ATMP & Mental Health Advisor, EURORDIS.

Panelists at the webinar will include:  

• Antonia Mueller, Medical University Wien will present an example of a CAR-T patient to illustrate what treatments are available, how they work and the areas which are being improved. Antonia will also show how genes are engineered to reduce toxicity for heamotological conditions and detail areas to further improve they treatments by exploring the effectiveness of aminal models and alternatives to predict safety and efficacy in humans. Finally showcase the current challanges and possible solutions in the development pathway.
• Reno Debets, Erasmus University Medical Center will present on how research is developing to explore treatment for solidy tumours and alternative targets for treatment such as TCR-T cells and present the case study to decentralized manufacturing, showcases the the current challanges and possible solutions in the development pathway.
• Silva Martin Lluesma, Vall d’Hebron Institute of Oncology & CEU San Pablo University will finish the presentations to show the current challanges and possible solutions to bringing innovative treatments from clinical trials, regulatory approval to patient access.
• Natacha Boplaños, Lymphoma Coalition, will share the experiences and insights from the patient perspective on the current challenges for CAR-T development pathway and propose key solutions.

The first webinar of this series will took place on 10 April, focusing on the topic of Streamlining the ATMP Development Pathway in the EU.

? Webinar Two: Streamlining the CAR-T Development Pathway in the EU
➡️ Register now!
?️ 12 May 2025
⏰ 14.00-15.30 CET

Agenda: