scholarly journals Role of Epidemiological Data Within the Drug Development Lifecycle: A Chronic Migraine Case Study

Author(s):  
Aubrey Manack ◽  
Catherine C. ◽  
Haley Kaplowitz
Bioanalysis ◽  
2021 ◽  
Author(s):  
Andrew P Mayer ◽  
Kristy J Fraley

Background: High-quality critical reagents are essential to the successful support of biotherapeutic drug development regardless of the analytical platform used for support. The lack of such a reagent, early in the development lifecycle of a biotherapeutic can have detrimental impact on resource and translation of data across development phases. Results: Here, a pharmacokinetic assay case study is shared that illustrates what can occur when there is a lack of a reproducible and sustainable critical reagent early in the development lifecycle of a biotherapeutic. Various assay formats and critical reagents, as well as reagents generation programs, were initiated to find a reagent and assay format which was fit for purpose. Conclusions: Identification of appropriate critical reagents early in the development lifecycle of a biotherapeutic as advantageous.


2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Francesco Calza ◽  
Marco Ferretti ◽  
Eva Panetti ◽  
Adele Parmentola

PurposeThe paper aims to explore the nature of initiatives and strategies of inter-organizational cooperation to cross the valley of death in the biopharma industry.Design/methodology/approachThe authors conducted an exploratory case study analysis in the Biopharma Innovation Ecosystem in Greater Boston Area (USA), which is one of the oldest, and most successful IE in the US, specialized in the Biopharma domain, by conducting a round of expert interviews with key informants in the area, chosen as representatives of the different types of actors engaged in the drug development processes at different stages.FindingsMain findings suggest that cooperation can contribute to surviving the valley of death by reducing the barriers within the drug development pipeline through the promotion of strategic relationships among actors of different nature, including the establishment of government-led thematic associations or consortia, agreements between university and business support structures, proximity to venture capitalist and the promotion of a general culture of academic entrepreneurship within universities.Originality/valueThe authors believe that this paper contributes to the literature by shedding light on the nature of the specific cooperative initiative the barriers in drug development and help to survive the valley of the death.


1987 ◽  
Author(s):  
William A. Worrall ◽  
Ann W. Stockman

2019 ◽  
Vol 38 (1) ◽  
pp. 94-102 ◽  
Author(s):  
Yvette Ciere ◽  
Evelien Snippe ◽  
Mariëlle Padberg ◽  
Bram Jacobs ◽  
Annemieke Visser ◽  
...  

2019 ◽  
Vol 3 (1) ◽  
pp. 1-9
Author(s):  
Robert M. Anderson ◽  
Amy M. Lambert

The island marble butterfly (Euchloe ausonides insulanus), thought to be extinct throughout the 20th century until re-discovered on a single remote island in Puget Sound in 1998, has become the focus of a concerted protection effort to prevent its extinction. However, efforts to “restore” island marble habitat conflict with efforts to “restore” the prairie ecosystem where it lives, because of the butterfly’s use of a non-native “weedy” host plant. Through a case study of the island marble project, we examine the practice of ecological restoration as the enactment of particular norms that define which species are understood to belong in the place being restored. We contextualize this case study within ongoing debates over the value of “native” species, indicative of deep-seated uncertainties and anxieties about the role of human intervention to alter or manage landscapes and ecosystems, in the time commonly described as the “Anthropocene.” We interpret the question of “what plants and animals belong in a particular place?” as not a question of scientific truth, but a value-laden construct of environmental management in practice, and we argue for deeper reflexivity on the part of environmental scientists and managers about the social values that inform ecological restoration.


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