1. A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies.
- Author
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Serelli-Lee, Victoria, Ito, Kazumi, Koibuchi, Akira, Tanigawa, Takahiko, Ueno, Takayo, Matsushima, Nobuko, and Imai, Yasuhiko
- Subjects
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DRUG development , *EXPERIMENTAL design , *INDIVIDUALIZED medicine , *NUCLEOTIDE sequencing , *REGULATORY approval - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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