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
Orphan drugs and indication stacking: When Orphan Incentives Fall Short
By Emma M. Q. S. Nielsen, Student assistant, Centre for Advanced Studies in Bioscience Innovation Law (CeBIL) & CREATIC
Is the EU about to fix a broken incentive system, or unintentionally weaken one of the few mechanisms that drives innovation in rare diseases?
The proposed pharmaceutical reform aims to limit “indication stacking” by reducing additional market exclusivity for repurposed orphan drugs. While this may address concerns around prolonged monopolies and high prices, it also raises a critical question: will developers still invest in expanding therapies to new rare disease indications under significantly weaker incentives?
With over 95% of rare diseases still lacking treatment, the stakes are clear. This article explores whether the current reform strikes the right balance, or risks slowing down innovation where it is needed most.
PRECISEU Best Practice Recognition in the Field of Advanced Therapy Medicinal Products
Cell and gene therapy – from science fiction to the hospital ward
Hospital pharmacists play an essential role in the CAR T-cell supply chain
In this sixth edition of the CREATIC ATMP Newsletter, we turn our focus to the practical realities of bringing advanced therapies closer to patients across Europe. This issue highlights how recent regulatory reforms, emerging national initiatives, and growing cross-border collaborations are beginning to reshape the ATMP landscape. Not only at the level of policy, but in clinical practice and system design.
Through expert perspectives, policy updates, and real-world examples, we explore key tensions between innovation, access, and sustainability. From evolving EU pharmaceutical legislation and new biotech initiatives to the rise of coordinated ATMP networks and non-commercial development models, this edition captures a field that is moving beyond ambition toward implementation.
Together, these insights point to a central challenge: how to translate Europe’s scientific and infrastructural potential into accessible, scalable therapies in a way that is coordinated, equitable, and grounded in patient needs.
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 | Issue #5 (online) | DOWNLOAD.pdf
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