NEWSLETTER
Your exclusive source
of ATMP insights and updates
Stay updated on ATMP innovation and rare disease care across Europe
Have you heard about CREATIC LabtoP Talks ~ From Lab to Patient?
On November 22, 2024, the CREATIC team hosted the very first LabtoP Talk – a conversation on how Advanced Therapy Medicinal Products (ATMPs) make their way from the laboratory to the patient. In this recorded session, experts discuss the Hospital Exemption as a practical pathway for ATMP delivery. Whether you're a healthcare professional, researcher, policymaker, or simply curious about the future of medical innovation, this talk offers valuable insights into how cross-sector collaboration can shape access to advanced therapies.
About ATMP Newsletter
The CREATIC ATMP Newsletter is a joint effort by Masaryk University and the University of Copenhagen. MUNI | CREATIC (Masaryk University) has established a partnership with the University of Copenhagen, Leipzig University, and the Fraunhofer Institute for Cell Therapy and Immunology IZI to build a center of excellence in research and development focused on Advanced Therapy Medicinal Products (ATMPs). This Czech‑Danish collaboration behind the newsletter brings key updates, expert perspectives, and relevant regulatory developments in the ATMP and rare disease ecosystem, with a focus on Central Europe.
Highlights from the Latest Issue
Fit for patients, not templates
By PharmDr. Adéla Bártová, Health Economics Specialist at Masaryk University, Faculty of Medicine - CREATIC
Honestly, European HTA methodologies are still built for large, randomised studies
more than for the clinical reality of rare diseases and children.
In our mapping of 29 HTA guidelines across the 27 EU Member States and the UK,
16 documents (in 13 countries) refer to rare diseases, while only 12
(in 10 countries) address paediatrics. The main difference is qualitative...
European Union puts Advanced Therapies at the core of its new Life Science Strategy
Innovation is not enough: ATMPs deserve
innovative markets
A path to better include patients'
perspectives in the regulation of medicines
In this fifth edition of the CREATIC ATMP Newsletter, we shift our attention to the regulatory, ethical, and societal dimensions shaping the future of advanced therapies in Europe. This issue explores how evolving HTA frameworks, hospital exemption pathways, and early access mechanisms are responding, often unevenly, to the growing complexity of gene, cell, and tissue-based therapies.
We bring together expert commentary, policy analysis, and real-world case studies that highlight persistent disparities in access to innovative medicines, the limits of existing regulatory templates, and the need for more patient-centred, practice-aligned assessment methods. Alongside European-level developments, the newsletter offers a snapshot of national initiatives, emerging non-commercial models, and ongoing debates around transparency, data governance, and international cooperation.
Together, these perspectives underline a shared challenge: ensuring that regulatory ambition, ethical responsibility, and clinical reality move forward in step, so that advanced therapies can reach patients in a way that is not only innovative, but also fair, sustainable, and credible.
ATMP Newsletter Archive
Browse previous editions of the CREATIC ATMP Newsletter and stay informed about key developments in advanced therapies.
Issue #1 (online) | DOWNLOAD .pdf | Issue #2 (online) | DOWNLOAD .pdf | Issue #3 (online) | DOWNLOAD .pdf
Issue #4 (online) | DOWNLOAD.pdf
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