Evidence map›Paper›PMID 30298129›Full record

ArticleFrontiers in bioengineering and biotechnology2018

Recent Progress in European Advanced Therapy Medicinal Products and Beyond.

Tracy T L Yu, Pravesh Gupta, Vincent Ronfard, Alain A Vertès, Yves Bayon

Abstract read
In one paragraph

Article in Frontiers in bioengineering and biotechnology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing 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

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

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Value-based pricing for advanced therapy medicinal products: emerging affordability solutions.The European journal of health economics : HEPAC : health economics in prevention and care · 2022
    Article
  11. Article
  12. Regenerative Medicine Therapy in Malaysia: An Update.Frontiers in bioengineering and biotechnology · 2022
    Review
  13. Current landscape of clinical development and approval of advanced therapies.Molecular therapy. Methods & clinical development · 2021
    Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Mesenchymal Stem Cells Beyond Regenerative Medicine.Frontiers in cell and developmental biology · 2020
    Review
  19. Review
  20. Review
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

5 authors.

Tracy T L YuCentre for Craniofacial and Regenerative Biology, King's College London, London, United Kingdom.
Pravesh GuptaTissue Engineering & Regenerative Medicine International Society European Chapter - Business Plan Competition Organising Committee, London, United Kingdom.
Vincent RonfardUNT System College of Pharmacy, Fort Worth, TX, United States.
Alain A VertèsNxR Biotechnologies GmbH, Basel, Switzerland.
Yves BayonMedtronic-Sofradim Production, Trévoux, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cell- and gene-based therapies form one of the pillars of regenerative medicine. They have the potential to transform quality of life and improve the health status of patients with genetic and cellular defects, including genetic diseases, neurodegenerative diseases and tissue malignancies, amongst others. Despite numerous challenges, in the last decade, tremendous unified efforts by research and clinical scientists in academic, translational and industry settings have resulted in tangible outcomes in the form of many marketing authorizations and approved commercial firsts, such as Glybera®, Kymriah®, YESCARTA®, Holoclar®, and Luxturna™. This report presents a succinct analysis of developments in the regenerative medicine landscape, including immuno-oncology, with a focus on the European Union and examples of clinical and commercial successes and failures. The factors that led to these exciting developments in immune-oncology are also considered. Concurrently, several key issues, spanning from the identification of unmet clinical need, associated challenges, economic evaluation to policy improvements are emphasized. Furthermore, industry insights encompassing the five-dimensional research and development framework for the focused development of medicine, pricing and reimbursement issues, technology adoption and permeation of innovative advanced therapy medicinal products in the clinical set up are reflected upon, following elaborate discussions that transpired in different thematic tracks of Tissue Engineering & Regenerative Medicine International Society European Chapter 2017 Industry Symposium.

Indexed as

advanced therapy medicinal productsclinical translationeconomic evaluationimmuno-oncologymarket approvalregenerative medicinereimbursement

Identifiers

PMID30298129
PMCPMC6161540

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.