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EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management
The first formal conference of the EUropean Federation for Exploratory MEdicines Development (EUFEMED) held in London was the result of a collaborative effort of its founding associations: the Association for Applied Human Pharmacology (AGAH; Germany), the Association for Human Pharmacology in the P...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5776107/ https://www.ncbi.nlm.nih.gov/pubmed/29387006 http://dx.doi.org/10.3389/fphar.2017.00901 |
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author | Van Bortel, Luc Sourgens, Hildegard Breithaupt-Grögler, Kerstin Caplain, Henri Donazzolo, Yves Klingmann, Ingrid Hammond, Michael Hardman, Timothy C. Stringer, Steffan de Hoon, Jan |
author_facet | Van Bortel, Luc Sourgens, Hildegard Breithaupt-Grögler, Kerstin Caplain, Henri Donazzolo, Yves Klingmann, Ingrid Hammond, Michael Hardman, Timothy C. Stringer, Steffan de Hoon, Jan |
author_sort | Van Bortel, Luc |
collection | PubMed |
description | The first formal conference of the EUropean Federation for Exploratory MEdicines Development (EUFEMED) held in London was the result of a collaborative effort of its founding associations: the Association for Applied Human Pharmacology (AGAH; Germany), the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI; UK), the Belgian Association of Phase-I Units (BAPU; Belgium), and Club Phase-I (France). The conference focused on innovation and risk management in early clinical drug development. Among other innovations, immunotherapy in oncology and inflammatory diseases were discussed as well as the importance of adaptive trial designs in early clinical drug development. Consideration was given to assessing and mitigating risk in early clinical drug development, and included a preconference workshop. Different measures to minimize risks in healthy volunteers and patients in first-in-human trials were discussed in addition to the importance of non-clinical data, the need for reliable biomarkers, improved communication on adverse events (AEs) and well-trained study sites with ready access to intensive care units and clinical specialists. The need for a European-wide system for prevention of over-volunteering was also discussed. The conference provided opportunity to discuss these developments and concerns and the changing regulatory environment with stakeholders from academia, industry, and regulatory agencies including the European Medicines Agency (EMA). Presentations given by invited speakers are published on http://www.eufemed.eu/london-conference-2017/. |
format | Online Article Text |
id | pubmed-5776107 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-57761072018-01-31 EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management Van Bortel, Luc Sourgens, Hildegard Breithaupt-Grögler, Kerstin Caplain, Henri Donazzolo, Yves Klingmann, Ingrid Hammond, Michael Hardman, Timothy C. Stringer, Steffan de Hoon, Jan Front Pharmacol Pharmacology The first formal conference of the EUropean Federation for Exploratory MEdicines Development (EUFEMED) held in London was the result of a collaborative effort of its founding associations: the Association for Applied Human Pharmacology (AGAH; Germany), the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI; UK), the Belgian Association of Phase-I Units (BAPU; Belgium), and Club Phase-I (France). The conference focused on innovation and risk management in early clinical drug development. Among other innovations, immunotherapy in oncology and inflammatory diseases were discussed as well as the importance of adaptive trial designs in early clinical drug development. Consideration was given to assessing and mitigating risk in early clinical drug development, and included a preconference workshop. Different measures to minimize risks in healthy volunteers and patients in first-in-human trials were discussed in addition to the importance of non-clinical data, the need for reliable biomarkers, improved communication on adverse events (AEs) and well-trained study sites with ready access to intensive care units and clinical specialists. The need for a European-wide system for prevention of over-volunteering was also discussed. The conference provided opportunity to discuss these developments and concerns and the changing regulatory environment with stakeholders from academia, industry, and regulatory agencies including the European Medicines Agency (EMA). Presentations given by invited speakers are published on http://www.eufemed.eu/london-conference-2017/. Frontiers Media S.A. 2018-01-17 /pmc/articles/PMC5776107/ /pubmed/29387006 http://dx.doi.org/10.3389/fphar.2017.00901 Text en Copyright © 2018 Van Bortel, Sourgens, Breithaupt-Grögler, Caplain, Donazzolo, Klingmann, Hammond, Hardman, Stringer and de Hoon. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Van Bortel, Luc Sourgens, Hildegard Breithaupt-Grögler, Kerstin Caplain, Henri Donazzolo, Yves Klingmann, Ingrid Hammond, Michael Hardman, Timothy C. Stringer, Steffan de Hoon, Jan EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management |
title | EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management |
title_full | EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management |
title_fullStr | EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management |
title_full_unstemmed | EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management |
title_short | EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management |
title_sort | eufemed london conference 2017: exploratory medicines development: innovation and risk management |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5776107/ https://www.ncbi.nlm.nih.gov/pubmed/29387006 http://dx.doi.org/10.3389/fphar.2017.00901 |
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