T2EVOLVE association launches to advance collaboration and innovation in advanced cell therapies across Europe

Launching the T2EVOLVE Association: a new independent, non-profit platform accelerating innovation and patient access in advanced cell therapies across Europe

University of Würzburg

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The T2EVOLVE consortium

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Credit: Benedikt Wagner

Advanced cell therapies, including CAR-T cells and other engineered immune cell therapies, are transforming treatment options for cancer and other severe diseases. However, significant scientific, manufacturing, regulatory, clinical, and access challenges remain. Addressing these challenges requires sustained collaboration that extends beyond individual projects, organizations, and national boundaries.

The T2EVOLVE Association has been established to provide a long-term framework for such collaboration. Through expert working groups, educational initiatives, stakeholder dialogues, technology scanning activities, and collaborative projects, the Association will facilitate knowledge exchange, support harmonization efforts, identify emerging challenges, and help accelerate the translation of innovation into meaningful patient benefit.

From a Successful Consortium to a Sustainable Association

The Association builds on a strong foundation created by the European T2EVOLVE project. Over the past five years, the project has helped shape discussions on regulatory innovation and evidence generation for advanced therapies, supported the development of novel preclinical models and translational approaches, fostered harmonization of immunomonitoring and analytical methodologies across Europe, and contributed to strengthening data interoperability and real-world evidence generation. Equally important, T2EVOLVE has promoted meaningful patient involvement through educational resources, improved informed consent practices, and initiatives designed to ensure that patient perspectives remain central throughout the therapy development pathway.

To address the most pressing challenges in the field, the Association will coordinate activities across five strategic workstreams: Patient Education and Advocacy; Clinical Translation and Correlative Research; Frontiers Innovation and Manufacturing; Regulatory Innovation and Policy Alignment; and Data Reuse and Artificial Intelligence for Advanced Therapies.

The University Hospital Würzburg (UKW) served as the academic coordinator and scientific driving force of the IMI-funded T2EVOLVE consortium, working alongside Bayer as the industrial co-lead. Under the leadership of Prof. Michael Hudecek, UKW brought together 27 partners from academia, industry, regulatory agencies, patient organizations, and healthcare institutions across Europe to accelerate the development and implementation of engineered T-cell therapies

Statements from the consortium

"The achievements of T2EVOLVE have demonstrated what is possible when stakeholders work together across disciplines, sectors, and borders," said Michael Hudecek, Chair of the T2EVOLVE Association and Professor of Cellular Immunotherapy at the University Hospital Würzburg. "To fully realize the potential of advanced cell therapies, Europe needs sustainable structures that transform collaboration into practical solutions. The T2EVOLVE Association has been created to provide exactly this environment."

"Our vision is to create a trusted and inclusive platform where scientific excellence, clinical experience, patient perspectives, industrial innovation, and regulatory expertise can converge," said Carmen Sanges, Executive Director of the T2EVOLVE Association. "By building bridges across sectors, countries, and ongoing initiatives, we aim to accelerate the translation of innovation into better outcomes for patients while ensuring that the momentum created by T2EVOLVE continues to grow into a sustainable European community."

"From a patient perspective, sustained collaboration and transparency are essential to ensure that innovation translates into real-world access and improved outcomes," said Maik Luu, Advisory Board member of the T2EVOLVE Association and Professor for Translational Medicine at the University Hospital Würzburg. "The T2EVOLVE Association represents an important step toward keeping patient needs at the center of advanced therapy development across Europe."

The Association launches with founding members representing leading organizations from across Europe and beyond, reflecting the multidisciplinary nature of the advanced therapy ecosystem. Membership opportunities, workstream activities, events, and collaborative initiatives will be announced throughout the coming months as the Association begins its first operational year.

T2EVOLVE Association

The T2EVOLVE Association is an independent, non-profit, multi-stakeholder organization dedicated to advancing innovation, collaboration, education, and policy alignment in advanced cell therapies. Established as the sustainability legacy of the IMI T2EVOLVE project, the Association provides a long-term platform for European collaboration that transforms dialogue into practical outputs for the advanced therapy ecosystem. For more information, visit www.t2evolve.com.