Carlos O. Garner, Ph.D.
Eli Lilly and Company
Vice President, Global Regulatory Affairs
Dr. Garner joined Eli Lilly and Company in 1997 as a senior scientist where he led a laboratory investigating the drug metabolism, pharmacokinetics and pharmacodynamics of new chemical entities in animal models and human. His work in these areas supported the advancement of many innovative molecules into human testing, late clinical development, and the commercialization of innovative new medicines treating schizophrenia and cancer. Dr. Garner subsequently served as senior director of project management and research strategy overseeing the development of more than 50 programs in discovery and development and providing portfolio strategy and management to Lilly Research Laboratories.
Dr. Garner move into regulatory sciences in 2011 where he led the North American regulatory affairs support of Lilly’s Biomedicines development and product portfolio across neuroscience, musculoskeletal, urology, men’s health, cardiovascular, and immunology diseases, where his team brought a number of NMEs and NBE to market and supported the broad portfolio of marketed products. Dr. Garner currently leads the broader regulatory function for Eli Lilly and Company supporting all human health business units and global manufacturing. Dr. Garner has published many scientific articles on his research and in health policy and has been invited to provide national and international lectures on his research, drug discovery, drug development and regulatory sciences. Dr. Garner holds a bachelor’s degree in Chemistry from Auburn University and master’s and doctorate degrees in chemistry from Vanderbilt University.
Current Roles and responsibilities
Executive leader for North American regulatory affairs for Eli Lilly and Company. The organization is responsible for all US and Canadian human drugs, medical devices regulatory affairs, and global manufacturing regulatory affairs. Organization provides strategic and operational regulatory capabilities required for defining the strategy and requirements in support of clinical development, product development and marketed drug and medical device products across the company. Additionally, the organization leads external regulatory policy that shapes the US environment for innovative drug development. Provides leadership to Lilly drug discovery and development governance committees.
Serves on the board of directors for the Lilly PAC, and represents Lilly at the Pharmaceutical Manufacturers of America Scientific and Regulatory Advisory Committee and the National Academies of Sciences Forum on Drug Discovery, Development and Translation. Invited lecturer at the Indiana University School of Medicine and Purdue University. Director of the NIH NCATS & Lilly Scholars Program.