Evidence map›Paper›PMID 28993805›Full record

ArticleFrontiers in bioengineering and biotechnology2017

Addressing Pressing Needs in the Development of Advanced Therapies.

David Morrow, Anton Ussi, Giovanni Migliaccio

Abstract read
In one paragraph

Article in Frontiers in bioengineering and biotechnology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Review
  2. Piloting a scale-up platform for high-quality human T-cells production.Frontiers in cell and developmental biology · 2024
    Article
  3. Article
  4. Article
  5. Current landscape of clinical development and approval of advanced therapies.Molecular therapy. Methods & clinical development · 2021
    Review
  6. Article
  7. Review
  8. Automation, Monitoring, and Standardization of Cell Product Manufacturing.Frontiers in bioengineering and biotechnology · 2020
    Review
  9. Review
  10. Review
  11. Article
  12. 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

3 authors.

David MorrowEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, Netherlands.
Anton UssiEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, Netherlands.
Giovanni MigliaccioEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The commercial development of advanced therapy medicinal products (ATMPs) represents great opportunity for therapeutic innovation but is beset by many challenges for its developers. Although the ATMP field continues to progress at a rapid pace, evidenced by the increasing number of clinical trials conducted over the past few years, several factors continue to complicate the introduction of ATMPs as a curative treatment for multiple disease types, by blocking their translational pathway from research to the patient. While several recent publications (Trounson and McDonald, 2015; Abou-El-Enein et al., 2016a,b) as well as an Innovative Medicines Initiative consultation (IMI, 2016) this year have highlighted the major gaps in ATMP development, with manufacturing, regulatory, and reimbursement issues at the forefront, there remains to be formulated a coherent strategy to address these by bringing the relevant stakeholders to a single forum, whose task it would be to design and execute a delta plan to alleviate the most pressing bottlenecks. This article focuses on two of the most urgent areas in need of attention in ATMP development, namely manufacturing and reimbursement, and promotes the concept of innovation-dedicated research infrastructures to support a multi-sector approach for ensuring the successful development, entry, and ensuing survival of ATMPs in the healthcare market.

Indexed as

advanced therapy medicinal productfunding modelsmanufacturing technologyregulatory pathwayreimbursement mechanisms

Identifiers

PMID28993805
PMCPMC5622199

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.