Risk in vaccine research and development quantified.

To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While...

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Autores principales: Esther S Pronker, Tamar C Weenen, Harry Commandeur, Eric H J H M Claassen, Albertus D M E Osterhaus
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Lenguaje:EN
Publicado: Public Library of Science (PLoS) 2013
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Acceso en línea:https://doaj.org/article/f780d207783041ad8eaa316ed1524ba6
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spelling oai:doaj.org-article:f780d207783041ad8eaa316ed1524ba62021-11-18T07:52:45ZRisk in vaccine research and development quantified.1932-620310.1371/journal.pone.0057755https://doaj.org/article/f780d207783041ad8eaa316ed1524ba62013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23526951/?tool=EBIhttps://doaj.org/toc/1932-6203To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.Esther S PronkerTamar C WeenenHarry CommandeurEric H J H M ClaassenAlbertus D M E OsterhausPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 3, p e57755 (2013)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Esther S Pronker
Tamar C Weenen
Harry Commandeur
Eric H J H M Claassen
Albertus D M E Osterhaus
Risk in vaccine research and development quantified.
description To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.
format article
author Esther S Pronker
Tamar C Weenen
Harry Commandeur
Eric H J H M Claassen
Albertus D M E Osterhaus
author_facet Esther S Pronker
Tamar C Weenen
Harry Commandeur
Eric H J H M Claassen
Albertus D M E Osterhaus
author_sort Esther S Pronker
title Risk in vaccine research and development quantified.
title_short Risk in vaccine research and development quantified.
title_full Risk in vaccine research and development quantified.
title_fullStr Risk in vaccine research and development quantified.
title_full_unstemmed Risk in vaccine research and development quantified.
title_sort risk in vaccine research and development quantified.
publisher Public Library of Science (PLoS)
publishDate 2013
url https://doaj.org/article/f780d207783041ad8eaa316ed1524ba6
work_keys_str_mv AT estherspronker riskinvaccineresearchanddevelopmentquantified
AT tamarcweenen riskinvaccineresearchanddevelopmentquantified
AT harrycommandeur riskinvaccineresearchanddevelopmentquantified
AT erichjhmclaassen riskinvaccineresearchanddevelopmentquantified
AT albertusdmeosterhaus riskinvaccineresearchanddevelopmentquantified
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