The Author(s) 2014. This article is published with open access at Springerlink.com Background and... more The Author(s) 2014. This article is published with open access at Springerlink.com Background and Objectives Fexinidazole is a 5-nitroim-idazole recently included in a clinical efficacy trial as an oral drug for the treatment of human African trypanoso-miasis (HAT). Preclinical studies showed it acts as a pharmacologically active pro-drug with two key active metabolites: sulfoxide and sulfone (the most active metab-olite). The present studies aimed to determine the best dose regimen for the treatment of stage 2 sleeping sickness patients, which could eventually also treat stage 1 patients. Methods Fexinidazole was assessed in 154 healthy adult male subjects of sub-Saharan African origin. Three initial first-in-human studies and two additional studies assessed a single ascending dose and multiple ascending doses (both
The inequity in access to COVID-19 vaccines that we are witnessing today is yet another symptom o... more The inequity in access to COVID-19 vaccines that we are witnessing today is yet another symptom of a pharmaceutical economy that is not fit for purpose. That it was possible to develop multiple COVID-19 vaccines in less than a year, while at the same time fostering extreme inequities, calls for transformative change in the health innovation and access ecosystem. Brought into the spotlight through the AIDS drugs access crisis, challenges in accessing lifesaving medicines and vaccines—because they are either not available or inaccessible due to excessive pricing—are being faced by people all over the world. To appreciate the underlying framing of current access discussions, it is important to understand past trends in global health policies and the thinking behind the institutions and mechanisms that were designed to solve access problems. Contrary to what might be expected, certain types of solutions intrinsically carry the conditions that enable scarcity, rationing, and inequity, an...
Lessons drawn from successes and failures with Covid-19 and Ebola should help shaping a robust he... more Lessons drawn from successes and failures with Covid-19 and Ebola should help shaping a robust health innovation system for infectious disease epidemics. Epidemic response research and development (R&D) can be mobilized quickly for public health priorities and yield medicinal products within months. However, to resolve epidemics, technological advances must be equitably accessible and deployed, and these examples expose the limitations of a supply-driven, fragmented R&D ecosystem relying primarily on the private sector to deliver health products. Efficient epidemic response requires a coordinated public health-focused, end-to-end R&D ecosystem for the development, registration, availability and use of pharmaceutical products. Since pivotal clinical trials can only be conducted during outbreaks, significant preparation must be done beforehand: strengthening clinical research capacity, developing pre-positioned trial protocols and clinical characterization protocols, as well as conducting discovery and pre-clinical research, manufacturing, and early clinical testing of candidate products. This will allow for speedy execution of clinical research early into an outbreak and delivering products within a short time. Effective interventions should be adopted and deployed ensuring equitable access during the ongoing outbreak. Measures to make products available where and when needed must be integrated throughout the R&D value chain.
[...]is the slow pace of progress in some areas, such as Alzheimer's disease2. [...]is the ri... more [...]is the slow pace of progress in some areas, such as Alzheimer's disease2. [...]is the risk of harm, such as adverse drug reactions. [...]mission-oriented' approaches require public stewardship5. Because setting priorities involves value judgements, it must not be done by technical experts alone. By the timely sharing of research inputs (such as specimens, compound libraries and data sets with appropriate protections), processes (such as protocols, trial designs and cost data) and outputs (including trial results and publications).
The Author(s) 2014. This article is published with open access at Springerlink.com Background and... more The Author(s) 2014. This article is published with open access at Springerlink.com Background and Objectives Fexinidazole is a 5-nitroim-idazole recently included in a clinical efficacy trial as an oral drug for the treatment of human African trypanoso-miasis (HAT). Preclinical studies showed it acts as a pharmacologically active pro-drug with two key active metabolites: sulfoxide and sulfone (the most active metab-olite). The present studies aimed to determine the best dose regimen for the treatment of stage 2 sleeping sickness patients, which could eventually also treat stage 1 patients. Methods Fexinidazole was assessed in 154 healthy adult male subjects of sub-Saharan African origin. Three initial first-in-human studies and two additional studies assessed a single ascending dose and multiple ascending doses (both
The inequity in access to COVID-19 vaccines that we are witnessing today is yet another symptom o... more The inequity in access to COVID-19 vaccines that we are witnessing today is yet another symptom of a pharmaceutical economy that is not fit for purpose. That it was possible to develop multiple COVID-19 vaccines in less than a year, while at the same time fostering extreme inequities, calls for transformative change in the health innovation and access ecosystem. Brought into the spotlight through the AIDS drugs access crisis, challenges in accessing lifesaving medicines and vaccines—because they are either not available or inaccessible due to excessive pricing—are being faced by people all over the world. To appreciate the underlying framing of current access discussions, it is important to understand past trends in global health policies and the thinking behind the institutions and mechanisms that were designed to solve access problems. Contrary to what might be expected, certain types of solutions intrinsically carry the conditions that enable scarcity, rationing, and inequity, an...
Lessons drawn from successes and failures with Covid-19 and Ebola should help shaping a robust he... more Lessons drawn from successes and failures with Covid-19 and Ebola should help shaping a robust health innovation system for infectious disease epidemics. Epidemic response research and development (R&D) can be mobilized quickly for public health priorities and yield medicinal products within months. However, to resolve epidemics, technological advances must be equitably accessible and deployed, and these examples expose the limitations of a supply-driven, fragmented R&D ecosystem relying primarily on the private sector to deliver health products. Efficient epidemic response requires a coordinated public health-focused, end-to-end R&D ecosystem for the development, registration, availability and use of pharmaceutical products. Since pivotal clinical trials can only be conducted during outbreaks, significant preparation must be done beforehand: strengthening clinical research capacity, developing pre-positioned trial protocols and clinical characterization protocols, as well as conducting discovery and pre-clinical research, manufacturing, and early clinical testing of candidate products. This will allow for speedy execution of clinical research early into an outbreak and delivering products within a short time. Effective interventions should be adopted and deployed ensuring equitable access during the ongoing outbreak. Measures to make products available where and when needed must be integrated throughout the R&D value chain.
[...]is the slow pace of progress in some areas, such as Alzheimer's disease2. [...]is the ri... more [...]is the slow pace of progress in some areas, such as Alzheimer's disease2. [...]is the risk of harm, such as adverse drug reactions. [...]mission-oriented' approaches require public stewardship5. Because setting priorities involves value judgements, it must not be done by technical experts alone. By the timely sharing of research inputs (such as specimens, compound libraries and data sets with appropriate protections), processes (such as protocols, trial designs and cost data) and outputs (including trial results and publications).
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