“Running the Gauntlet”: Formidable challenges in advancing neglected tropical diseases vaccines from development through licensure, and a “Call to Action”

dc.citation.firstpage2235
dc.citation.issueNumber10
dc.citation.journalTitleHuman Vaccines & Immunotherapeutics
dc.citation.lastpage2242
dc.citation.volumeNumber15
dc.contributor.authorBottazzi, Maria Elena
dc.contributor.authorHotez, Peter J.
dc.contributor.orgJames A. Baker III Institute of Public Policy
dc.date.accessioned2021-10-06T14:15:37Z
dc.date.available2021-10-06T14:15:37Z
dc.date.issued2019
dc.description.abstractTranslational science for new biotechnologies (e.g. drugs, vaccines, devices, or diagnostics) depend on the development of a robust ‘business case’. This is driven by complex scientific, technical, logistical, financial and operational elements to determine the feasibility and probability of traversing the “valleys of death” leading to licensure. The potential results in terms of profitability and financial realization, called ‘product value proposition’ play a crucial role in establishing incentives for investment during and after development. With this review, our goal is to summarize the challenges in taking vaccines against neglected tropical diseases (NTDs) from development through licensure and provide a perspective that these vaccines can have measurable public health and economic profitability and market success. Understanding these processes and its challenges would open the opportunity to accelerate and advance these essential NTD vaccines through the last mile towards licensure and for the delivery to afflicted populations in low- and middle-income countries.
dc.identifier.citationBottazzi, Maria Elena and Hotez, Peter J.. "“Running the Gauntlet”: Formidable challenges in advancing neglected tropical diseases vaccines from development through licensure, and a “Call to Action”." <i>Human Vaccines & Immunotherapeutics,</i> 15, no. 10 (2019) Taylor & Francis: 2235-2242. https://doi.org/10.1080/21645515.2019.1629254.
dc.identifier.digitalRunning-the-Gauntlet
dc.identifier.doihttps://doi.org/10.1080/21645515.2019.1629254
dc.identifier.urihttps://hdl.handle.net/1911/111469
dc.language.isoeng
dc.publisherTaylor & Francis
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/),
dc.title“Running the Gauntlet”: Formidable challenges in advancing neglected tropical diseases vaccines from development through licensure, and a “Call to Action”
dc.typeJournal article
dc.type.dcmiText
dc.type.publicationpublisher version
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