The First Central European CREATIC Conference
The unique First Central European CREATIC Conference, held in Brno on November 4-5, focused on addressing the key challenges in the development of cell and gene therapies in Europe. The event brought together numerous prominent European experts from various areas of the life cycle of advanced therapy medicinal products (ATMPs). The development of these cell and gene-based medicines is a highly personalized process, with their administration targeted to a narrow group of patients, predominantly those with rare diseases, for whom the development of these therapies is a critical medical need.
The First Central European CREATIC Conference on Key Challenges in the Development of Cell and Gene Therapies Connects Leading Experts from Across Europe
The unique First Central European CREATIC Conference, held in Brno on November 4-5, focused on addressing the key challenges in the development of cell and gene therapies in Europe. The event brought together numerous prominent European experts from various areas of the life cycle of advanced therapy medicinal products (ATMPs). The development of these cell and gene-based medicines is a highly personalized process, with their administration targeted to a narrow group of patients, predominantly those with rare diseases, for whom the development of these therapies is a critical medical need.
Thanks to significant international participation, the conference was able to address topics impacting the development and manufacturing of cell and gene therapies across Europe. Discussions on the direction of these therapies' development, new treatment options, and the accessibility of ATMPs for patients resonated throughout the presentations and open discussions. Regulatory challenges, evaluation processes, and reimbursement mechanisms, as well as the long-term sustainability and the importance of creating a supportive environment across the EU, remain both a challenge and an opportunity, highly relevant across Europe.
More than 90 invited experts from across the EU participated in the conference, representing various sectors and perspectives. The first session focused on the main regulatory and development challenges in Europe. Prof. Ulrike Köhl from Fraunhofer IZI shared key insights on the research and development of ATMPs and the expansion of cancer treatment boundaries, while Ana Hidalgo-Simon and Linda Aagaard Thomsen addressed critical regulatory challenges, particularly in pricing and reimbursement. The second session focused on the availability of these innovative therapies for patients, particularly through clinical trials and the question of their potential reimbursement. The third session explored the perspectives of preclinical research and the clinical applications of ATMPs. The fourth session brought discussions on specific products in development, modern manufacturing options, and challenges related to GMP production, as well as the obstacles encountered when trying to move these products from laboratories to patients.
CREATIC, as a unique center focused on the development, production, and ensuring access to modern gene and cell therapies for patients, tackles the complexities of modern therapies comprehensively, including regulatory and reimbursement mechanisms. CREATIC as Center of Excellence at MU in Brno also focuses on the Central European region, with the goal of supporting and connecting centers focused on developing and manufacturing ATMPs, aiming to increase the accessibility of modern medicines for patients.
The path taken by the CREATIC CoE was further reinforced through the discussions at the conference. It is clear that the current regulatory frameworks in Europe are designed for large-scale production for a broad patient population, whereas ATMPs, particularly those developed in academia, require a specific approach for individual patients. Collective efforts are needed in various areas to ensure that the latest scientific advancements reach patients in a timely manner, while ensuring their safety and quality. The conference confirmed that continued active efforts to innovate regulatory processes—so they better reflect the specifics of ATMPs and allow for their broader use in patient treatment across Europe—are one of the ways in which the CREATIC CoE can contribute to this goal.
The conference deepened relationships between all partners in the field of modern therapies and demonstrated that the Czech Republic is a strong player in this area. It also affirmed the ambition of the CREATIC Center of Excellence to become a leader in Central Europe in this field.
The CREATIC CoE will continue to focus on the further development of scientific knowledge and the accessibility of treatment methods for patients, supporting patients without diagnoses and advancing models for reimbursement and approval processes of ATMPs, not only within clinical trials or hospital exceptions.
