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Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations

BACKGROUND: Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation....

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Autores principales: Årdal, Christine, Baraldi, Enrico, Theuretzbacher, Ursula, Outterson, Kevin, Plahte, Jens, Ciabuschi, Francesco, Røttingen, John-Arne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885303/
https://www.ncbi.nlm.nih.gov/pubmed/29632669
http://dx.doi.org/10.1186/s40545-018-0135-0
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author Årdal, Christine
Baraldi, Enrico
Theuretzbacher, Ursula
Outterson, Kevin
Plahte, Jens
Ciabuschi, Francesco
Røttingen, John-Arne
author_facet Årdal, Christine
Baraldi, Enrico
Theuretzbacher, Ursula
Outterson, Kevin
Plahte, Jens
Ciabuschi, Francesco
Røttingen, John-Arne
author_sort Årdal, Christine
collection PubMed
description BACKGROUND: Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies. METHODS: DRIVE-AB, a project focused on developing new economic incentives to stimulate antibacterial innovation, held a European stakeholder meeting in February 2015. All SMEs invited to this meeting (n = 44) were subsequently sent a survey to gather more data regarding their areas of activity, completed and expected development costs and timelines, and business models. RESULTS: Twenty-five companies responded to the survey. Respondents were primarily small companies each focusing on developing 1 to 3 new antibiotics, focused on pathogens of public health importance. Most have not yet completed any clinical trials. They have reported ranges of discovery and development out-of-pocket costs that appear to be less expensive than other studies of general pharmaceutical research and development (R&D) costs. The duration ranges reported for completing each phase of R&D are highly variable when compared to previously published general pharmaceutical innovation average durations. However, our sample population is small and may not be fully representative of all relevant antibiotic SMEs. CONCLUSIONS: The data collected by this study provide important insights and estimates about R&D in European SMEs focusing on antibiotics, which can be combined with other data to design incentives to stimulate antibacterial innovation. The variation implies that costs and durations are difficult to generalize due to the unique characteristics of each antibiotic project and depend on individual business strategies and circumstances. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40545-018-0135-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-58853032018-04-09 Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations Årdal, Christine Baraldi, Enrico Theuretzbacher, Ursula Outterson, Kevin Plahte, Jens Ciabuschi, Francesco Røttingen, John-Arne J Pharm Policy Pract Research BACKGROUND: Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies. METHODS: DRIVE-AB, a project focused on developing new economic incentives to stimulate antibacterial innovation, held a European stakeholder meeting in February 2015. All SMEs invited to this meeting (n = 44) were subsequently sent a survey to gather more data regarding their areas of activity, completed and expected development costs and timelines, and business models. RESULTS: Twenty-five companies responded to the survey. Respondents were primarily small companies each focusing on developing 1 to 3 new antibiotics, focused on pathogens of public health importance. Most have not yet completed any clinical trials. They have reported ranges of discovery and development out-of-pocket costs that appear to be less expensive than other studies of general pharmaceutical research and development (R&D) costs. The duration ranges reported for completing each phase of R&D are highly variable when compared to previously published general pharmaceutical innovation average durations. However, our sample population is small and may not be fully representative of all relevant antibiotic SMEs. CONCLUSIONS: The data collected by this study provide important insights and estimates about R&D in European SMEs focusing on antibiotics, which can be combined with other data to design incentives to stimulate antibacterial innovation. The variation implies that costs and durations are difficult to generalize due to the unique characteristics of each antibiotic project and depend on individual business strategies and circumstances. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40545-018-0135-0) contains supplementary material, which is available to authorized users. BioMed Central 2018-04-05 /pmc/articles/PMC5885303/ /pubmed/29632669 http://dx.doi.org/10.1186/s40545-018-0135-0 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Årdal, Christine
Baraldi, Enrico
Theuretzbacher, Ursula
Outterson, Kevin
Plahte, Jens
Ciabuschi, Francesco
Røttingen, John-Arne
Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
title Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
title_full Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
title_fullStr Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
title_full_unstemmed Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
title_short Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
title_sort insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885303/
https://www.ncbi.nlm.nih.gov/pubmed/29632669
http://dx.doi.org/10.1186/s40545-018-0135-0
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