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Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape
Mariya Gromova1, Annegret Vaggelas1, Gabriele Dallmann1
1Biopharma Excellence GmbH, Munich, Germany.
Biomarker Insights
|December 21, 2020
Summary
Biomarker acceptance in drug development is increasing, with over half of recent drug approvals utilizing biomarker data. Advances in biomarker regulations are influencing this trend, impacting efficiency and therapeutic areas.
Area of Science:
- Biomarkers and drug development
- Regulatory science
- Pharmacotherapeutics
Background:
- Biomarkers are integral to all phases of drug discovery and development.
- Biomarker utilization can enhance the efficiency of drug discovery, development, and approval processes.
- The global regulatory landscape for biomarkers, including validation, qualification, and companion diagnostics, is evolving.
Purpose of the Study:
- To provide an overview of the current global regulatory landscape for biomarkers.
- To analyze the impact of recent regulatory advances on biomarker acceptance in drug development.
- To discuss the benefits, challenges, and opportunities of biomarker use in the current regulatory environment.
Main Methods:
- Review of current global regulatory frameworks for biomarker validation and qualification.
- Analysis of the legal framework for companion diagnostics.
- Assessment of biomarker acceptance trends in drug approvals over recent years.
Main Results:
- Over half of the analyzed drug approvals were supported by biomarker data.
- There has been a slight, though not continuous, increase in biomarker acceptance in recent years.
- Biomarker use is more prevalent in specific pharmacotherapeutic groups, including immunosuppressants, immunostimulants, diabetes drugs, antithrombotics, antineoplastics, and antivirals.
Conclusions:
- Biomarker acceptance in drug development is influenced by regulatory advancements.
- While growth is not uniform, biomarkers are increasingly supporting drug approvals.
- Understanding the regulatory landscape is crucial for leveraging the benefits and addressing challenges of biomarker use.
Keywords:
BiomarkerEMAFDAcompanion diagnosticsdrug approvaldrug developmentqualificationregulatory landscapeMore Related Videos
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