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Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development

The COVID-19 pandemic challenged pharmaceutical and bioanalytical communities at large, in the development of vaccines and therapeutics as well as supporting ongoing drug development efforts. Existing processes were challenged to manage loss of staffing at facilities along with added workloads for C...

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Detalles Bibliográficos
Autores principales: Wickremsinhe, Enaksha R, Brockus, Catherine L, Murphy, Anthony T
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Newlands Press Ltd 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8288281/
https://www.ncbi.nlm.nih.gov/pubmed/34275332
http://dx.doi.org/10.4155/bio-2021-0120
Descripción
Sumario:The COVID-19 pandemic challenged pharmaceutical and bioanalytical communities at large, in the development of vaccines and therapeutics as well as supporting ongoing drug development efforts. Existing processes were challenged to manage loss of staffing at facilities along with added workloads for COVID related study support including conducting preclinical testing, initiating clinical trials, conducting bioanalysis and interactions with regulatory agencies, all in an ultra-rapid timeframes. A key factor of success was creative rethinking of processes and removing barriers – some of which hitherto had been considered immovable. This article describes how bioanalysis was crippled at the onset of the pandemic but how innovative and highly collaborative efforts across teams within and outside of both pharma, bioanalytical labs and regulatory agencies worked together remarkably well.