Rachel
Sawyer

Rachel is a Modality Solutions SME, working directly with clients to ensure proper design of logistics networks and use of cold chain systems.

She provides engineering guidance when conducting qualification and validation activities, including validation master planning and strategic facility planning. Rachel conducts product specific supply chain risk assessments and has experience supporting 10+ successful regulatory approvals including NDAs for small molecules and BLAs for mAbs, ADCs, vaccines, and a cell therapy in the US (FDA), EU (EMA), and UK (MHRA) with fast track and breakthrough therapy designations as well as accelerated approval pathways. Rachel reviews and writes SOPs for cold chain related processes to meet regulatory requirements for transport validation, drafts protocols and reports for testing and validation of processes, reviews data packages for reports, and conducts in-person cold chain consulting services and GDP site assessments.

She was also part of the Modality team supporting emergency clinical trial operations with Ebola vaccines and treatments for the NIH and BARDA in the Democratic Republic of the Congo and Liberia. Rachel was the lead engineer for the COVID-19 clinical trial project, coordinating with the trial sponsors, CROS, and clinical site staff, traveling to conduct cold chain assessments, recommend site-selection for clinical trials, and ensure adequate deep-frozen storage was available in the USA, India, South Africa, Peru, Colombia, Panama, and Puerto Rico.