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Chapter 5 - Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays

Published online by Cambridge University Press:  06 January 2024

By
Maren Downing ,
Mia Cirrincione ,
Adam Samuta ,
Kevin Leite ,
Sam Dolphin ,
Emily Muth ,
Jose Valdesuso  and
Brian Walsh
Edited by
Steven C. Schachter  and
Wade E. Bolton
Steven C. Schachter
Affiliation:
Harvard Medical School
Wade E. Bolton
Affiliation:
VentureWell/Rapid Acceleration of Diagnostics (RADx)
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Summary

The Rapid Acceleration of Diagnostics (RADx®) program’s success would be significantly diminished without the support of the Deployment Core. For a company to successfully bring to market an in vitro diagnostic (IVD) test, it requires expertise in a variety of areas. This is especially pertinent in a pandemic landscape, as timelines are greatly reduced and market demand is constantly changing. Within the RADx initiative, the Deployment Core was established to identify and provide these necessary resources. The Deployment Core was formed in May 2020 after the IVD companies’ needs became apparent, including the need for consultant expertise and various resources to support development and scale up. This chapter explores the challenges faced by many RADx companies and the lessons learned through the Deployment Core in addressing those needs.

Keywords

resource deploymentsupply chainmanufacturingregulatoryquality management system (QMS)procurementIndependent Test Assessment Program (ITAP)project managementclinical and analytical studies
Type
Chapter
Information
Accelerating Diagnostics in a Time of Crisis
The Response to COVID-19 and a Roadmap for Future Pandemics
 , pp. 88 - 102
Publisher: Cambridge University Press
Print publication year: 2024

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