Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape
Biomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphas...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2020-12-01
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| Series: | Biomarker Insights |
| Online Access: | https://doi.org/10.1177/1177271920974652 |
| _version_ | 1819073793250820096 |
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| author | Mariya Gromova Annegret Vaggelas Gabriele Dallmann Diane Seimetz |
| author_facet | Mariya Gromova Annegret Vaggelas Gabriele Dallmann Diane Seimetz |
| author_sort | Mariya Gromova |
| collection | DOAJ |
| description | Biomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphasis on the validation and qualification of biomarkers, as well as legal framework for companion diagnostics. Furthermore, this article shows how the number of approved drugs with at least 1 biomarker used during development (biomarker acceptance) is affected by the recent advances in the biomarker regulations. More than half of analysed approvals were supported by biomarker data and there has been a slight increase in acceptance of biomarkers in recent years, even though the growth is not continuous. For certain pharmacotherapeutic groups, approvals with biomarkers are more common than without. Examples include immunosuppressants, immunostimulants, drugs used in diabetes, antithrombotic drugs, antineoplastic agents and antivirals. As a conclusion, potential benefits, challenges and opportunities of using biomarkers in drug discovery and development in the current regulatory landscape are summarised and discussed. |
| first_indexed | 2024-12-21T17:59:16Z |
| format | Article |
| id | doaj.art-5cbb06a7f080438fb277813f107e0157 |
| institution | Directory Open Access Journal |
| issn | 1177-2719 |
| language | English |
| last_indexed | 2024-12-21T17:59:16Z |
| publishDate | 2020-12-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Biomarker Insights |
| spelling | doaj.art-5cbb06a7f080438fb277813f107e01572022-12-21T18:55:06ZengSAGE PublishingBiomarker Insights1177-27192020-12-011510.1177/1177271920974652Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory LandscapeMariya GromovaAnnegret VaggelasGabriele DallmannDiane SeimetzBiomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphasis on the validation and qualification of biomarkers, as well as legal framework for companion diagnostics. Furthermore, this article shows how the number of approved drugs with at least 1 biomarker used during development (biomarker acceptance) is affected by the recent advances in the biomarker regulations. More than half of analysed approvals were supported by biomarker data and there has been a slight increase in acceptance of biomarkers in recent years, even though the growth is not continuous. For certain pharmacotherapeutic groups, approvals with biomarkers are more common than without. Examples include immunosuppressants, immunostimulants, drugs used in diabetes, antithrombotic drugs, antineoplastic agents and antivirals. As a conclusion, potential benefits, challenges and opportunities of using biomarkers in drug discovery and development in the current regulatory landscape are summarised and discussed.https://doi.org/10.1177/1177271920974652 |
| spellingShingle | Mariya Gromova Annegret Vaggelas Gabriele Dallmann Diane Seimetz Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape Biomarker Insights |
| title | Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape |
| title_full | Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape |
| title_fullStr | Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape |
| title_full_unstemmed | Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape |
| title_short | Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape |
| title_sort | biomarkers opportunities and challenges for drug development in the current regulatory landscape |
| url | https://doi.org/10.1177/1177271920974652 |
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