Elizabeth Smith

Liz Smith currently serves as Deputy Director, Regulatory Affairs for the Gates Foundation, providing regulatory guidance to foundation teams and development partners to ensure that regulatory strategies support timely and successful development and registration of products supported by the foundation’s grants. Before joining the foundation in 2020, Liz spent 28 years providing regulatory guidance and leadership, specializing in biologics, drugs, and cell and gene therapies in both consulting and corporate roles. Most recently, she was an early member of the Juno Therapeutics executive team,  first as senior advisor to the CEO and then as senior vice president of regulatory and quality, where she established regulatory strategies for multiple genetically engineered cell therapy assets initially developed at academic institutions (Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Research Center, and Seattle Children’s Research Institute) and then acquired by Juno after Phase I studies. She then served  as senior strategic advisor to the company’s development teams and the president of R&D.

Earlier, Liz  served as vice president of regulatory affairs at  Dendreon, where she expanded the regulatory strategy; chemistry, manufacturing, and controls (CMC); and  operations functions and led the regulatory  effort to obtain FDA approval of Provenge, the first  therapeutic cellular cancer vaccine for the treatment of prostate cancer.  Liz also held a variety of regulatory positions at Genentech, with responsibility for the CMC aspects of Herceptin, as well as Immunex  (acquired by  Amgen),  where she began her career in manufacturing. Liz holds a bachelor’s degree in biology (cum laude)  from Central Washington University.