Cargando…

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...

Descripción completa

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
_version_ 1783724063666995200
author Wickremsinhe, Enaksha R
Brockus, Catherine L
Murphy, Anthony T
author_facet Wickremsinhe, Enaksha R
Brockus, Catherine L
Murphy, Anthony T
author_sort Wickremsinhe, Enaksha R
collection PubMed
description 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.
format Online
Article
Text
id pubmed-8288281
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Newlands Press Ltd
record_format MEDLINE/PubMed
spelling pubmed-82882812021-07-21 Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development Wickremsinhe, Enaksha R Brockus, Catherine L Murphy, Anthony T Bioanalysis Perspective 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. Newlands Press Ltd 2021-07-19 2021-06 /pmc/articles/PMC8288281/ /pubmed/34275332 http://dx.doi.org/10.4155/bio-2021-0120 Text en © 2021 Newlands Press https://creativecommons.org/licenses/by/4.0/This work is licensed under the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/)
spellingShingle Perspective
Wickremsinhe, Enaksha R
Brockus, Catherine L
Murphy, Anthony T
Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development
title Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development
title_full Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development
title_fullStr Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development
title_full_unstemmed Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development
title_short Lessons learned from the COVID pandemic and its impact on bioanalysis and drug development
title_sort lessons learned from the covid pandemic and its impact on bioanalysis and drug development
topic Perspective
url 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
work_keys_str_mv AT wickremsinheenakshar lessonslearnedfromthecovidpandemicanditsimpactonbioanalysisanddrugdevelopment
AT brockuscatherinel lessonslearnedfromthecovidpandemicanditsimpactonbioanalysisanddrugdevelopment
AT murphyanthonyt lessonslearnedfromthecovidpandemicanditsimpactonbioanalysisanddrugdevelopment