ERASMUS-MC - Erasmus Universitair Medisch Centrum Rotterdam

Erasmus MC is the largest center for cancer care and research in the Netherlands offering the newest treatments and performing ground-breaking research. Approximately 30,000 patients are treated yearly by 150 clinical specialists. Erasmus MC is equipped with the latest instruments for cell therapy research, fully operational genomics and proteomics appliances as well as in vivo high-resolution imaging and microscopy. Expertise centers support the shared use of these advanced technologies.

Erasmus MC has pioneered preclinical development up to first clinical testing (in the EU) of gene-engineered T cells and lysate-loaded dendritic cells to treat cancer, participates in landmark patient studies/trials assessing ATMPs (from academia or industry) and provides standard-of-care T cell-based ATMP treatment. Erasmus MC has broadened ATMP access for a large patient population, including patients with less prevalent cancers. Erasmus MC has a dedicated team consisting of medical oncologists, hematologists, pulmonologists, neurologists, clinical pharmacologists and intensive care physicians involved in the clinical adoptive T-cell program.

Role within JOIN4ATMP

Erasmus MC leads work package 2 (road to standardized Good Manufacturing Practice-conform ATMP production across EU), and more specifically leads tasks related to ‘mapping inconsistencies in regulating GMP-conform ATMP processing across the EU’ (task 2.1) and ‘achieving consensus on an over-arching, dynamic regulatory framework for GMP-conform ATMPs’ (task 2.6). Besides work package 2, Erasmus MC is involved in activities towards other work packages as well, mainly towards work package 1 (defining and evaluating predictivity of clinical ATMP performance by currently required preclinical testing) and 3 (establishing a legal framework for co-sponsorship in international clinical trials) and to some extent 4 (helping academic and SME developers to understand economic ATMP value).

In addition, Erasmus MC is actively involved in performing one of the work packages-overarching real-world cases, namely, the trans-national execution of a phase 2 TCR T cell trial to treat melanoma and other cancers. With this trial, in which partners Charite and AP-HP are also involved, we will test the clinical implementation of ATMPs across national borders, which will enable us to identify legal and logistic challenges and draft solutions to those challenges. This task aligns with the larger objective to enhance wider access and ultimately fair pricing of ATMPs to patient populations within Europe.

Finally, Erasmus MC is also represented in the steering committee and involved in overall management regarding progress, communication and dissemination.

Main contact(s)

Prof. dr. Reno Debets

WP2 lead and member steering committee; adding general experience re: development and clinical implementation of T-cell ATMPs

Dr. Sofieke de Wilde

WP2 participant, adding managerial experience re: ATMP facility