A success story on how an STSM strengthened the Barcelona-Rome collaboration at the interface of regulatory science and translational research for academic Advanced Therapy Medicinal Products (ATMPs).
From scientific exchange to a stronger translational pathway
“During my Short-Term Scientific Mission, hosted by Hospital Sant Joan de Déu (HSJD) in Barcelona from 30 August to 30 September 2026, I worked at the interface of regulatory science and translational research to strengthen the collaboration between HSJD and Ospedale Pediatrico Bambino Gesù (OPBG) in Rome. As a PhD student, I was able to support the exchange of expertise between the two institutions. The mission explored how innovative academic therapies, particularly Advanced Therapy Medicinal Products (ATMPs) and academic CAR-T cell therapies, can be translated more effectively from research into clinical development and, ultimately, patient access. Through direct exchanges with researchers, clinicians, and regulatory professionals, I gained a deeper understanding of how regulatory considerations can be integrated into academic product development. A key part of the STSM was comparing the European regulatory framework with national requirements, procedures, and timelines, and discussing how differences across EU Member States can affect academic developers and multicentre clinical trials, particularly those involving paediatric populations.”
A central lesson from the collaboration was the importance of considering regulatory strategy from the earliest stages of translational research. By sharing experiences and best practices, the HSJD and OPBG teams identified complementary expertise and concrete areas where closer cooperation can support academic investigators in navigating complex development pathways, from early translational research and clinical development through to Marketing Authorisation Applications and Health Technology Assessment.
One of the most valuable outcomes of the STSM was the strengthening of a cross-border professional network between HSJD and OPBG. Existing collaborations were reinforced, new connections were established, and opportunities for future joint research, training activities, workshops, and further exchanges in regulatory and translational science were. Building on ongoing collaborations, including the EPICA-DIPG project (European Paediatric Immunotherapy Trial with Combinatory Advanced Therapy Medicinal Products for DIPG) for the treatment of paediatric patients with Diffuse Intrinsic Pontine Glioma (DIPG), the two teams agreed, as an immediate follow-up, to maintain regular exchanges on the regulatory development of academic ATMPs. The STSM has thus provided a concrete foundation for sustained scientific cooperation, knowledge sharing, and future collaborative initiatives.
Maria Luisa D'Amore with Dr Alessandra Magnani at the Advanced Therapy Platform at HSJD in Barcelona during the STSM. Photo publication rights have been obtained
My experience
“For me, the STSM was both scientifically stimulating and professionally enriching. It reinforced my enthusiasm for science and deepened my interest in regulatory and translational research in the ATMP field. Above all, it showed the value of collaboration: bringing together complementary expertise, open scientific dialogue, and a shared commitment to translating innovation into improved patient access can turn complex challenges into concrete opportunities for progress. The next step will be to continue working together on ongoing projects, building on the knowledge and professional connections developed during the STSM to sustain collaboration between the Barcelona and Rome teams.”
