Camille Peres (NRC): 9:10 AM - 10:10 AM
Title:
Abstract:

Han Xia (Eli Lilly and Company): 12:00 PM - 1:00 PM
Title: Heat, Risk, and Control: Thermal Hazard Management in R&D labs and Manufacturing
Abstract: Process safety in pharmaceutical development and manufacturing and the wider chemical industry demands rigorous, systematic approaches to two of the most consequential hazard categories encountered across the development lifecycle: thermal runaway and combustible dust explosions. This presentation reports the findings of a broad survey of pharma industry best practices in thermal hazard management — spanning early-stage laboratory screening through pilot and commercial manufacturing scale — and highlights the key themes, gaps, and recommendations that emerge from that survey. This presentation describes these findings in detail and provides a comprehensive framework for integrating thermal hazard assessment into the pharmaceutical development workflow from the earliest stages of chemistry design. In the context of thermal hazard assessment, we will introduce a novel risk prioritization methodology developed at Eli Lilly, termed the Lilly Energy Density (LED) function. This approach provides a systematic framework for evaluating the risk associated with thermal decomposition events and for prioritizing the sequence and scope of safety testing and evaluation activities. The LED enables development teams to make more informed, risk-proportionate decisions about which materials and processes require urgent thermal hazard evaluation, and which present sufficiently low risk to proceed without additional testing burden. The theoretical basis, practical implementation, and illustrative case examples of the LED function are presented and discussed.