Evidence map›Paper›PMID 42124779›Full record

ReviewThe Lancet regional health. Europe2026

A roadmap for supporting the development of advanced therapy medicinal products in a European framework.

Johan Van Eldere, Alessandro Aiuti, Silvia Martin Lluesma, Bjarne Kuno Møller, Britt Elmedal Laursen, Celeste Lebbe, Alejandro Piris, Javier Carmona, Gady Goldsobel, Ulrich Kintscher and 16 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet regional health. Europe, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Johan Van EldereEuropean University Hospital Alliance (EUHA), Warmoesberg 26, 1000 Brussels, Belgium.
Alessandro AiutiSan Raffaele Telethon Institute for Gene Therapy (SR-Tiget), University Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milano, Italy.
Silvia Martin LluesmaUniversity Foundation San Pablo CEU, Madrid, Spain.
Bjarne Kuno MøllerDept. of Clinical Immunology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200, Aarhus, Denmark.
Britt Elmedal LaursenDept of Molecular Medicine & Department of Oncology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200, Aarhus, Denmark.
Celeste LebbeDermato-oncology and CIC, Cancer institute APHP, Hôpital Saint-Louis, 1 Avenue Claude-Vellefaux, 75010, Paris, France.
Alejandro PirisVall d'Hebron Institute of Oncology (VHIO), Marsillach Center, Plaça Adolf Marsillach, 6-8, 08035, BCN, Spain.
Javier CarmonaVall d'Hebron Institute of Oncology (VHIO), Marsillach Center, Plaça Adolf Marsillach, 6-8, 08035, BCN, Spain.
Gady GoldsobelBerlin Institute of Health Center for Regenerative Therapies at Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, DE-13353, Berlin, Germany.
Ulrich KintscherCharité-Universitätsmedizin Berlin, Charitéplatz, 110117, Berlin, Germany.
Peter VandenbergheDept of clinical genetics and clinical dept of hematology, University Hospital Leuven, Herestraat 49, 3000, Leuven, Belgium.
Isabelle HuysDept of clinical pharmacology and pharmacotherapy, KULeuven, ON2 Herestraat 49 - bus, 5213000, Leuven, Belgium.
Bart GeersLeuven research and development and University Hospital Leuven, Waaistraat 6 - bus 5105, 3000, Leuven, Belgium.
Reuben BenjaminDept of Haematology, King's College Hospital, London and Comprehensive Cancer Centre, School of Cancer & Pharmaceutical Sciences, King's College London, Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK.
Victoria PotterDept of Haematology, Guthrie Clinic, King's College Hospital, NHS Foundation Trust, Denmark Hill, London, SE5 9RS, UK.
Chiara BoniniExperimental Hematology, IRCCS San Raffaele Scientific Institute, Milan and Università Vita Salute San Raffaele, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milano, Italy.
Fabio CiceriDept of Hematology and Bone Marrow Transplantation, IRCCS San Raffaele Scientific Institute, Milan and Università Vita Salute San Raffaele, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milano, Italy.
Gianvito MartinoDivision of Neuroscience, IRCCS San Raffaele Scientific Institute and Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milano, Italy.
Reno DebetsDept Medical Oncology, Erasmus MC, P.O. Box 2040, 3000 CA, Rotterdam, the Netherlands.
Hugo P H M van der KuyDept of Hospital Pharmacy, Erasmus MC, 3015 GD, Rotterdam, the Netherlands.
Stephan MielkeDept of Laboratory Medicine and Dept of Cellular Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska Institutet and University Hospital, H5 Laboratoriemedicin, H5 BCM Mielke, 141 52, Huddinge, Sweden.
Pontus BlombergKarolinska Centre for Cell Therapy, KCC, Karolinska University Hospital, Karolinska ATMP Center, H5 Laboratoriemedicin, H5 BCM Blomberg, 141 52, Huddinge, Sweden.
Ewa EllisKarolinska ATMP Center and Karolinska Centre for Cell Therapy, Karolinska University Hospital, H9 Klinisk vetenskap, intervention och teknik, H9 CLINTEC Transplantation, 141 52, Huddinge, Sweden.
Antonia M S MüllerDept of Transfusion Medicine and Cell Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Nina WorelDepartment of Pediatric Oncology and Hematology, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Annette KünkeleDepartment of Pediatric Oncology and Hematology, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advanced therapy medicinal products (ATMPs) represent a paradigm shift in medicine; however, their implementation in European health systems is often hampered by EU regulations. Amidst a rapidly evolving and increasingly competitive global landscape, dominated by the US and China, it becomes imperative that Europe strengthens its position. This requires establishing a dialogue with European authorities to devise new regulatory mechanisms and incentives paving the way for innovation in drug development and implementation. Here, experts from the European University Hospitals Alliance (EUHA) specialising in ATMPs, share their vision on changes needed at the regulatory and organisational level to incentivise the development and clinical use of ATMPs and ensure an equitable and fast access for patients, largely inspired by the problems encountered in an academic environment and in developing ATMPs for rare diseases. To achieve real-world impact, these solutions should be supported by competent authorities at regional, national, and EU levels.

Indexed as

Advanced therapy medicinal products (ATMPs)Clinical development of ATMPsDecentralised production of ATMPsEquitable clinical implementation of ATMPsHospital exemptionManufacturing of ATMPsReal world evidenceRegulatory framework for ATMPsReimbursement of ATMPs

Identifiers

PMID42124779
PMCPMC13158613

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.