Andrea Redd Eli Lilly and Company

Andrea Redd is the current Associate Vice President of the Global Drug Delivery and Device regulatory affairs team at Eli Lilly headquartered in Indianapolis, Indiana. With over 24 years of experience in the pharmaceutical industry, Andrea has held multiple positions in R&D, project management, and regulatory affairs. Her early career focused on the microbial sterilization validation processes for injectable parenteral drug products. Using this knowledge, she transitioned into a regulatory scientist position focusing on container closure systems, including the development and submission of several new flexible bag container closure systems. She continued to assume more responsibilities, with a primary focus on the CMC aspects of drug development for both generic and new drug product submissions. She transitioned into combination products in 2014 as the FDA introduced increased regulatory requirements for submission of what was once viewed as "container closure systems", including pre-filled syringes and autoinjectors. Her expertise in both drug and device regulations has enabled her to successfully bridge the gaps that are often seen when a company that is heavily focused on drug product development enters into the combination product space.