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A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies
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 approa...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9143954/ https://www.ncbi.nlm.nih.gov/pubmed/35629092 http://dx.doi.org/10.3390/jpm12050669 |
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author | Serelli-Lee, Victoria Ito, Kazumi Koibuchi, Akira Tanigawa, Takahiko Ueno, Takayo Matsushima, Nobuko Imai, Yasuhiko |
author_facet | Serelli-Lee, Victoria Ito, Kazumi Koibuchi, Akira Tanigawa, Takahiko Ueno, Takayo Matsushima, Nobuko Imai, Yasuhiko |
author_sort | Serelli-Lee, Victoria |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9143954 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91439542022-05-29 A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies Serelli-Lee, Victoria Ito, Kazumi Koibuchi, Akira Tanigawa, Takahiko Ueno, Takayo Matsushima, Nobuko Imai, Yasuhiko J Pers Med Review 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. MDPI 2022-04-21 /pmc/articles/PMC9143954/ /pubmed/35629092 http://dx.doi.org/10.3390/jpm12050669 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Review Serelli-Lee, Victoria Ito, Kazumi Koibuchi, Akira Tanigawa, Takahiko Ueno, Takayo Matsushima, Nobuko Imai, Yasuhiko A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies |
title | A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies |
title_full | A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies |
title_fullStr | A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies |
title_full_unstemmed | A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies |
title_short | A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies |
title_sort | state-of-the-art roadmap for biomarker-driven drug development in the era of personalized therapies |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9143954/ https://www.ncbi.nlm.nih.gov/pubmed/35629092 http://dx.doi.org/10.3390/jpm12050669 |
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