The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?
Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2018-10-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866118003308/type/journal_article |
| _version_ | 1811156864713359360 |
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| author | Joan E. Adamo Robert V. Bienvenu F. Owen Fields Soma Ghosh Christina M. Jones Michael Liebman Mark S. Lowenthal Scott J. Steele |
| author_facet | Joan E. Adamo Robert V. Bienvenu F. Owen Fields Soma Ghosh Christina M. Jones Michael Liebman Mark S. Lowenthal Scott J. Steele |
| author_sort | Joan E. Adamo |
| collection | DOAJ |
| description | Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps. |
| first_indexed | 2024-04-10T04:58:11Z |
| format | Article |
| id | doaj.art-8b14e219201d42419685be75a29c0df2 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:58:11Z |
| publishDate | 2018-10-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-8b14e219201d42419685be75a29c0df22023-03-09T12:29:41ZengCambridge University PressJournal of Clinical and Translational Science2059-86612018-10-01229530010.1017/cts.2018.330The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?Joan E. Adamo0Robert V. Bienvenu1F. Owen Fields2Soma Ghosh3Christina M. Jones4Michael Liebman5Mark S. Lowenthal6Scott J. Steele7Clinical & Translational Science Institute, University of Rochester Medical Center, Rochester, NY, USADepartment of Anthropology, University of Maryland, College Park, MD, USAWorldwide Safety and Regulatory Strategy, Pfizer Research and Development, Collegeville, PA, USADivision of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USAChemical Sciences Division, National Institute of Standards and Technology, Gaithersburg, MD, USAIPQ Analytics, LLC, Kennett Square, PA, USABiomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD, USAClinical & Translational Science Institute and Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, USABuilding on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.https://www.cambridge.org/core/product/identifier/S2059866118003308/type/journal_articleRegulatory scienceprecision medicineomicsUS Food and Drug AdministrationClinical and Translational Science Award |
| spellingShingle | Joan E. Adamo Robert V. Bienvenu F. Owen Fields Soma Ghosh Christina M. Jones Michael Liebman Mark S. Lowenthal Scott J. Steele The integration of emerging omics approaches to advance precision medicine: How can regulatory science help? Journal of Clinical and Translational Science Regulatory science precision medicine omics US Food and Drug Administration Clinical and Translational Science Award |
| title | The integration of emerging omics approaches to advance precision medicine: How can regulatory science help? |
| title_full | The integration of emerging omics approaches to advance precision medicine: How can regulatory science help? |
| title_fullStr | The integration of emerging omics approaches to advance precision medicine: How can regulatory science help? |
| title_full_unstemmed | The integration of emerging omics approaches to advance precision medicine: How can regulatory science help? |
| title_short | The integration of emerging omics approaches to advance precision medicine: How can regulatory science help? |
| title_sort | integration of emerging omics approaches to advance precision medicine how can regulatory science help |
| topic | Regulatory science precision medicine omics US Food and Drug Administration Clinical and Translational Science Award |
| url | https://www.cambridge.org/core/product/identifier/S2059866118003308/type/journal_article |
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