In Search of System‐Wide Productivity Gains ‐ The Role of Global Collaborations in Preclinical Translation
[...]in the shadow of 2016's disappointing and abrupt end to the recent uptick in new drug authorizations, cause for optimism is somewhat blunted. [...]with the late stage clinical failure rates remaining stubbornly high , pipeline productivity is clearly sorely in need of efficiency gains. In...
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Published in | Clinical and translational science Vol. 10; no. 6; pp. 423 - 425 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
United States
John Wiley & Sons, Inc
01.11.2017
John Wiley and Sons Inc |
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Abstract | [...]in the shadow of 2016's disappointing and abrupt end to the recent uptick in new drug authorizations, cause for optimism is somewhat blunted. [...]with the late stage clinical failure rates remaining stubbornly high , pipeline productivity is clearly sorely in need of efficiency gains. In addition to the lamentable lack of standards in the field, a further major challenge facing translational scientists is a limited understanding of how disease in preclinical animal models translates to humans, which likely further contributes to the high attrition rate in phase II and III clinical trials . Another EATRIS program that can impact systemic inefficiency is underway in collaboration with the European Association of Nuclear Medicine (EANM), to enable multi‐center clinical trials utilizing PET imaging tracers using zirconium‐89 (89Zr), that finds increasing application in so‐called “immuno‐PET” studies of biologicals, nanomedicines, and cells. System‐wide improvements need not be limited to the technical bottlenecks affecting drug developers and research labs. There are a myriad of operational bottlenecks that plague the translational research system, such as efficient access to high‐quality biological samples with associated clinical data, access to pre‐competitive funding for the validation of promising tools such as imaging tracers, and reliability of the peer review system for selection of applied research projects. |
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AbstractList | [...]in the shadow of 2016's disappointing and abrupt end to the recent uptick in new drug authorizations, cause for optimism is somewhat blunted. [...]with the late stage clinical failure rates remaining stubbornly high , pipeline productivity is clearly sorely in need of efficiency gains. In addition to the lamentable lack of standards in the field, a further major challenge facing translational scientists is a limited understanding of how disease in preclinical animal models translates to humans, which likely further contributes to the high attrition rate in phase II and III clinical trials . Another EATRIS program that can impact systemic inefficiency is underway in collaboration with the European Association of Nuclear Medicine (EANM), to enable multi‐center clinical trials utilizing PET imaging tracers using zirconium‐89 (89Zr), that finds increasing application in so‐called “immuno‐PET” studies of biologicals, nanomedicines, and cells. System‐wide improvements need not be limited to the technical bottlenecks affecting drug developers and research labs. There are a myriad of operational bottlenecks that plague the translational research system, such as efficient access to high‐quality biological samples with associated clinical data, access to pre‐competitive funding for the validation of promising tools such as imaging tracers, and reliability of the peer review system for selection of applied research projects. |
Author | Ussi, Anton E. Hajduch, Marian Kort, Martin Aittokallio, Tero Coussens, Nathan P. |
AuthorAffiliation | 5 Institute of Molecular and Translational Medicine Faculty of Medicine and Dentistry Palacky University Olomouc Czech Republic 3 Institute for Molecular Medicine Finland (FIMM) FI‐00014 University of Helsinki 1 EATRIS ERIC European Infrastructure for Translational Medicine Amsterdam 1081 HZ Netherlands 2 Division of Pre‐Clinical Innovation National Center for Advancing Translational Sciences National Institutes of Health Rockville MD 20850 USA 4 Department of Mathematics and Statistics FI‐20014 University of Turku Finland |
AuthorAffiliation_xml | – name: 4 Department of Mathematics and Statistics FI‐20014 University of Turku Finland – name: 1 EATRIS ERIC European Infrastructure for Translational Medicine Amsterdam 1081 HZ Netherlands – name: 2 Division of Pre‐Clinical Innovation National Center for Advancing Translational Sciences National Institutes of Health Rockville MD 20850 USA – name: 5 Institute of Molecular and Translational Medicine Faculty of Medicine and Dentistry Palacky University Olomouc Czech Republic – name: 3 Institute for Molecular Medicine Finland (FIMM) FI‐00014 University of Helsinki |
Author_xml | – sequence: 1 givenname: Anton E. surname: Ussi fullname: Ussi, Anton E. email: antonussi@eatris.eu organization: European Infrastructure for Translational Medicine – sequence: 2 givenname: Martin surname: Kort fullname: Kort, Martin organization: European Infrastructure for Translational Medicine – sequence: 3 givenname: Nathan P. surname: Coussens fullname: Coussens, Nathan P. organization: National Institutes of Health – sequence: 4 givenname: Tero surname: Aittokallio fullname: Aittokallio, Tero organization: FI‐20014 University of Turku – sequence: 5 givenname: Marian surname: Hajduch fullname: Hajduch, Marian organization: Palacky University |
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Cites_doi | 10.1038/nbt.2786 10.1038/nrd.2016.33 10.1038/nrd3078 10.1038/nbt0417-297a 10.1371/journal.pbio.1001863 10.1126/scitranslmed.aal4101 |
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Copyright | 2017 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics 2017. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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Title | In Search of System‐Wide Productivity Gains ‐ The Role of Global Collaborations in Preclinical Translation |
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