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This document represents an enterprise-wide wealth of knowledge, comprised of lessons learned and new processes developed in response to the unprecedented challenges presented by the novel coronavirus pandemic.

In partnerships with key stakeholders, Thermo Fisher Scientific helped develop and manufacture the first vaccines and therapeutics addressing the pandemic caused by the novel coronavirus (SARS-CoV-2). Complimenting this effort, the clinical research group (CRG) of Thermo Fisher Scientific, has gained extensive clinical trial experience and is recognized as a clinical research market leader in managing

COVID-19 programs. These accomplishments required a level of creativity and agility never before seen in the pharmaceutical product development industry.

Key components of this global effort include: developing novel vaccine technologies; investing in advancements in vaccine and therapeutics manufacturing; and streamlining clinical development of pharmaceuticals for emerging and pandemic potential pathogens eligible for emergency use authorization (EUA). New and innovative technologies (mRNA, DNA, viral vectors) better suited to rapid manufacturing and adaptation to pathogen mutation are expected to dominate the global preventative and therapeutic space in the coming years.

This new operating manual is an invaluable internal resource as we engage with sponsors developing EUA-eligible products that address pandemics, endemics, public health crises and other rapid response scenarios. This forward-thinking and experience-driven playbook can be highlighted during client engagement as a major value-add when choosing PPD to drive their clinical studies forward.

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