Webcast | Virtual
Event Title
FDA Grand Rounds: Whole Genome Sequencing: A Powerful Scientific Tool that Delivered During the 2023 Pseudomonas Outbreak in Eye Drops
May 9, 2024
- Date:
- May 9, 2024
- Time:
- 12:00 AM - 1:00 PM ET
About the Speaker
Michelle Cockrell, B.S.
Microbiologist
Office of Regulatory Affairs
Irvine Medical Products Laboratory
U.S. Food and Drug Administration
About the Speaker
Michelle Cockrell received her undergraduate degree in Microbiology from the University of Oklahoma in 2017. She worked as a clinical microbiologist and molecular biologist for the Oklahoma State Department of Health where she developed an interest in whole genome sequencing and its significance as a tool for public health. In 2021, she moved to Irvine, California to start her career with the Food and Drug Administration. Now, she works as a microbiologist and lead for the whole genome sequencing workgroup for the Irvine Medical Products Laboratory.
About the Presentation
Whole Genome Sequencing has been used in FDA’s Human and Animal Food Laboratories for several years, but what about in the medical products laboratories? This presentation will discuss the application of this method as an additional analysis used during the 2023 Pseudomonas outbreak in eye drop products. ORS’ collaboration with the CDC and CFSAN partners led to key information that linked the outbreak strain to the implicated products, providing a scientific basis for FDA to pursue regulatory action.
Learning Objectives
- Define whole genome sequencing and state its basic purpose.
- Describe how whole genome sequencing can determine relatedness among isolates.
- Discuss how whole genome sequencing was used to link the implicated products to the outbreak strain during the 2023 Pseudomonas outbreak in eyedrops.