Webinar: Streamlining the ATMP 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 webinar will focus on the challenges from navigating the regulatory pathway to access, using a rare condition as a used case.
The session will be chaired by Matt Bolz-Johnson, ATMP & Mental Health Advisor, EURORDIS.
Panelists at the webinar will include:
- Maria Pia Cicalese, San Raffaele Telethon Institute for Gene Therapy (TIGET) will showcase the current challanges and possible solutions in the development pathway, from pre-clinical through to patient access.
- Lerie Sollis, International Patient Organisation for Primary Immunodeficiencies (IPOPI) will share the experiences and insights from the patient community of the challenges and solutions for ATMP development through to patients access.
- Silva Martin Lluesma, Vall d’Hebron Institute of Oncology & CEU San Pablo University will summarise the operational, research and policy challenges and inform how Join4ATMP will streamline the ATMP development pathway.
The subsequent webinar of this series will take place on 12 May, focusing on the topic of Streamlining the CAR-T Development Pathway in the EU.
? Webinar One: Streamlining the ATMP Development Pathway in the EU
➡️ Register now!
?️ 10 April 2025
⏰ 12:00 to 13:30 CET
Agenda:
| Time | Topic | Speaker |
| 12.00 – 12.05 | Welcome and opening remarks | Matt Bolz-Johnson, EURORDIS |
| 12.05 – 12.35 | Strimvelis (Used Case) identifying challenges and soultions to streamline development pathway. | Each presentation is 12-15 minutes |
| From clinical development to patient accessFrom the patient communities perspective | Maria Pia Cicalese, TIGET Lerie Sollis, IPOPI | |
| 12.35 – 12.45 | Questions & Answers | All |
| 12.45 – 13.00 | Summarising the key opportunities to bringing innovative treatments from clinical trials, regulatory approval to patient access. | Silva Martin Lluesma, VHIO |
| 13.00 – 13.00 | Panel discussion: Explore how the current development pathway can be streamlinedDiscuss the possible policy solutions and opportunities for Join4ATMP to offer. | Chair: Matt Bolz-Johnson, EURORDIS Panellists: Maria Pia Cicalese, TIGET Lerie Sollis, IPOPISilva Martin Lluesma, VHIO |
| 15.25 – 15.30 | Final & Closing Remarks | All Panellists & Matt Bolz-Johnson, EURORDIS |