Strategies for Derisking Translational Processes for Biomedical Technologies
Inefficient translational processes for technology-oriented biomedical research have led to some prominent and frequent failures in the development of many leading drug candidates, several designated investigational drugs, and some medical devices, as well as documented patient harm and postmarket p...
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| Veröffentlicht in: | Trends in biotechnology (Regular ed.) 2017-02, Vol.35 (2), p.100-108 |
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| container_title | Trends in biotechnology (Regular ed.) |
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| creator | Abou-El-Enein, Mohamed Duda, Georg N Gruskin, Elliott A Grainger, David W |
| description | Inefficient translational processes for technology-oriented biomedical research have led to some prominent and frequent failures in the development of many leading drug candidates, several designated investigational drugs, and some medical devices, as well as documented patient harm and postmarket product withdrawals. Derisking this process, particularly in the early stages, should increase translational efficiency and streamline resource utilization, especially in an academic setting. In this opinion article, we identify a 12-step guideline for reducing risks typically associated with translating medical technologies as they move toward prototypes, preclinical proof of concept, and possible clinical testing. Integrating the described 12-step process should prove valuable for improving how early-stage academic biomedical concepts are cultivated, culled, and manicured toward intended clinical applications. |
| doi_str_mv | 10.1016/j.tibtech.2016.07.007 |
| format | Article |
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Derisking this process, particularly in the early stages, should increase translational efficiency and streamline resource utilization, especially in an academic setting. In this opinion article, we identify a 12-step guideline for reducing risks typically associated with translating medical technologies as they move toward prototypes, preclinical proof of concept, and possible clinical testing. 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All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 01, 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c562t-4c858a0007d0c22b734e66825f90163ebc7a594790a92465e8c5667f0b621ccb3</citedby><cites>FETCH-LOGICAL-c562t-4c858a0007d0c22b734e66825f90163ebc7a594790a92465e8c5667f0b621ccb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0167779916301135$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27499276$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Abou-El-Enein, Mohamed</creatorcontrib><creatorcontrib>Duda, Georg N</creatorcontrib><creatorcontrib>Gruskin, Elliott A</creatorcontrib><creatorcontrib>Grainger, David W</creatorcontrib><title>Strategies for Derisking Translational Processes for Biomedical Technologies</title><title>Trends in biotechnology (Regular ed.)</title><addtitle>Trends Biotechnol</addtitle><description>Inefficient translational processes for technology-oriented biomedical research have led to some prominent and frequent failures in the development of many leading drug candidates, several designated investigational drugs, and some medical devices, as well as documented patient harm and postmarket product withdrawals. Derisking this process, particularly in the early stages, should increase translational efficiency and streamline resource utilization, especially in an academic setting. In this opinion article, we identify a 12-step guideline for reducing risks typically associated with translating medical technologies as they move toward prototypes, preclinical proof of concept, and possible clinical testing. 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| subjects | Advocacy Algorithms Biomedical research Biotechnology Biotechnology - methods Biotechnology - organization & administration Candidates Clinical trials Device Approval Drug Approval - methods Drug Approval - organization & administration Drug Design Drugs Efficiency Equipment Design - methods Equipment Failure Analysis - methods Guidelines Innovations Intellectual property Internal Medicine Inventors Licenses Life sciences Medical devices Medical equipment Medical technology Models, Organizational Pharmaceutical industry Risk Risk Management - methods Risk reduction Strategy Success Technological change Test systems Translational Medical Research - methods Translational Medical Research - organization & administration Trends |
| title | Strategies for Derisking Translational Processes for Biomedical Technologies |
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