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Societal challenges of precision medicine: Bringing order to chaos
Roberto Salgado1, Helen Moore2, John W M Martens3
1EORTC Pathobiology Group, Belgium; Department of Pathology GZA, Antwerp, Belgium; Breast Cancer Translational Research Laboratory, Jules Bordet Institute, Belgium.
Abstract:
The increasing number of drugs targeting specific proteins implicated in tumourigenesis and the commercial promotion of relatively affordable genome-wide analyses has led to an increasing expectation among patients with cancer that they can now receive effective personalised treatment based on the often complex genomic signature of their tumour. For such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework will be required. It is becoming increasingly evident that a re-engineering of clinical research is necessary so that regulatory considerations and procedures facilitate the efficient translation of these required biomarker assays from the discovery setting through to clinical application. This article discusses the practical requirements and challenges of developing such new precision medicine strategies, based on leveraging complex genomic profiles, as discussed at the Innovation and Biomarkers in Cancer Drug Development meeting (8th-9th September 2016, Brussels, Belgium).
Insights
Personalized cancer treatment using complex genomic profiles requires advanced biomarker assays. Regulatory frameworks and clinical research must adapt for effective precision medicine translation.
Area of Science:
- Oncology
- Genomics
- Biomarker Development
Background:
- Increasingly complex tumor genomic signatures drive demand for personalized cancer therapies.
- Affordable genome-wide analyses raise patient expectations for tailored treatments.
- Targeted therapies necessitate sophisticated biomarker assays for clinical application.
Framework:
- Development of complex biomarker assays requires a robust regulatory framework.
- Clinical research processes need re-engineering to align with precision medicine demands.
- Regulatory considerations must facilitate biomarker assay translation from discovery to clinical use.
Implementation:
- Practical requirements for developing precision medicine strategies based on genomic profiles are discussed.
- Challenges in translating biomarker assays into routine clinical practice are highlighted.
- The Innovation and Biomarkers in Cancer Drug Development meeting addressed these critical issues.
Implications:
- Successful implementation of precision medicine hinges on adaptable regulatory pathways.
- Efficient translation of biomarker assays is crucial for realizing the potential of personalized cancer care.
- A re-engineered clinical research approach is essential for advancing cancer treatment strategies.
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