Evidence map›Paper›PMID 20190786›Full record

ReviewNature reviews. Drug discovery2010

Challenges with advanced therapy medicinal products and how to meet them.

Committee for Advanced Therapies (CAT), CAT Scientific Secretariat, Christian K Schneider, Paula Salmikangas, Bernd Jilma, Bruno Flamion, Lyubina Racheva Todorova, Anna Paphitou, Ivana Haunerova, Toivo Maimets and 58 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature reviews. Drug discovery, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 91 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 2 pooled it
–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

91 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
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  7. Article
  8. Article
  9. Article
  10. Review
  11. The Art of Stem Cell-Based Therapy.Advances in experimental medicine and biology · 2023
    Article
  12. Potency Assays: The 'Bugaboo' of Stem Cell Therapy.Advances in experimental medicine and biology · 2023
    Article
  13. Immunocytochemical characterization ofFrontiers in medicine · 2023
    Article
  14. Article
  15. Illustrative Potency Assay Examples from Approved Therapies.Advances in experimental medicine and biology · 2023
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article

31 more citing papers are in PubMed but not listed here.

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

68 authors.

Committee for Advanced Therapies (CAT)
CAT Scientific Secretariat
Christian K Schneider
Paula Salmikangas
Bernd Jilma
Bruno Flamion
Lyubina Racheva Todorova
Anna Paphitou
Ivana Haunerova
Toivo Maimets
Jean-Hugues Trouvin
Egbert Flory
Asterios Tsiftsoglou
Balázs Sarkadi
Kolbeinn Gudmundsson
Maura O'Donovan
Giovanni Migliaccio
Jānis Ancāns
Romaldas Maciulaitis
Jean-Louis Robert
Anthony Samuel
Johannes H Ovelgönne
Marit Hystad
Andrzej Mariusz Fal
Beatriz Silva Lima
Anca Stela Moraru
Peter Turcáni
Robert Zorec
Sol Ruiz
Lennart Akerblom
Gopalan Narayanan
Alastair Kent
Fabrizia Bignami
J George Dickson
Dietger Niederwieser
María-Angeles Figuerola-Santos
Ilona G Reischl
Claire Beuneu
Rosen Georgiev
Maria Vassiliou
Alena Pychova
Mette Clausen
Taina Methuen
Sophie Lucas
Martina Schüssler-Lenz
Vasilios Kokkas
Zsuzsanna Buzás
Niall MacAleenan
Maria Cristina Galli
Aija Linē
Jolanta Gulbinovic
Guy Berchem
Mariusz Fraczek
Margarida Menezes-Ferreira
Nela Vilceanu
Mikulás Hrubisko
Petra Marinko
Marcos Timón
Wing Cheng
George Andrew Crosbie
Nick Meade
Michelino Lipucci di Paola
Thierry VandenDriessche
Per Ljungman
Lucia D'Apote
Olga Oliver-Diaz
Isabel Büttel
Patrick Celis

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. They have therefore been subject to considerable interest and debate. Following the European regulation on ATMPs, a consolidated regulatory framework for these innovative medicines has recently been established. Central to this framework is the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA), comprising a multidisciplinary scientific expert committee, representing all EU member states and European Free Trade Association countries, as well as patient and medical associations. In this article, the CAT discusses some of the typical issues raised by developers of ATMPs, and highlights the opportunities for such companies and research groups to approach the EMA and the CAT as a regulatory advisor during development.

Indexed as

Government RegulationEuropean UnionGenetic TherapyHumansStem Cell TransplantationTissue Engineering

Identifiers

PMID20190786

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.