A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies.
Japan
biomarker-driven drug development
clinical trial renovation
data ecosystem
disease blueprint
ecosystem for personalized therapies
genome medicine
personalized medicine
real-world data/evidence
Journal
Journal of personalized medicine
ISSN: 2075-4426
Titre abrégé: J Pers Med
Pays: Switzerland
ID NLM: 101602269
Informations de publication
Date de publication:
21 Apr 2022
21 Apr 2022
Historique:
received:
26
01
2022
revised:
30
03
2022
accepted:
15
04
2022
entrez:
28
5
2022
pubmed:
29
5
2022
medline:
29
5
2022
Statut:
epublish
Résumé
Advances in biotechnology have enabled us to assay human tissue and cells to a depth and resolution that was never possible before, redefining what we know as the "biomarker", and how we define a "disease". This comes along with the shift of focus from a "one-drug-fits-all" to a "personalized approach", placing the drug development industry in a highly dynamic landscape, having to navigate such disruptive trends. In response to this, innovative clinical trial designs have been key in realizing biomarker-driven drug development. Regulatory approvals of cancer genome sequencing panels and associated targeted therapies has brought personalized medicines to the clinic. Increasing availability of sophisticated biotechnologies such as next-generation sequencing (NGS) has also led to a massive outflux of real-world genomic data. This review summarizes the current state of biomarker-driven drug development and highlights examples showing the utility and importance of the application of real-world data in the process. We also propose that all stakeholders in drug development should (1) be conscious of and efficiently utilize real-world evidence and (2) re-vamp the way the industry approaches drug development in this era of personalized medicines.
Identifiants
pubmed: 35629092
pii: jpm12050669
doi: 10.3390/jpm12050669
pmc: PMC9143954
pii:
doi:
Types de publication
Journal Article
Review
Langues
eng
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