The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.
Catherine explains the biggest challenges labs face today—like fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science.
She outlines a step-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools.
Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments.
About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/