Michael S. Louie

Michael Louie is Senior Vice President of Digital Transformation and Chief Information Officer at Kodiak and has served in this position since February 2022. He is responsible for driving Kodiak’s move to a platform driven business model based on modern digital solutions and an enterprise data model to facilitate internal and external business operations. He leads the execution of digital initiatives, influences strategic corporate drivers, and facilitates cross-functional partnerships to ensure that business critical outcomes are achieved.

Previously, Dr. Louie was Vice President of Analytical Operations and Information Systems at Gilead Sciences which he joined in 1993. His initial efforts in process chemistry resulted in multiple invention patents, publications and developing commercially feasible drug substance processes for Tamiflu® and nucleotide analogs used to treat HIV and viral hepatitis. In roles of increasing responsibilities from 1998-2022, Dr. Louie focused on implementing many digital technologies to support discovery research, cybersecurity, clinical, regulatory, medical affairs, drug safety, quality, laboratory, manufacturing, supply chain, human resources, finance, and commercial operations. He established enterprise-wide programs in computer validation, Part 11/Annex 11, and data integrity to support GxP operations and controls for IT systems that are subject to information privacy and SOX compliance. Dr. Louie also led the Analytical Operations unit which focused on analytical sciences, stability, CMC registration filing, outsourcing and GMP testing to support pharmaceutical development and the commercial supply chain. Prior to joining Gilead, he worked in organic synthesis at Shell Agricultural Chemicals and Monsanto and analytical chemistry at Syntex Corporation.

Dr. Louie earned his Ph.D. in Organic Chemistry from UC Riverside and B.Sc. in Biochemistry from UC Davis.