
Dr. Michael S. Louie is a distinguished executive with over 35 years of experience at the intersection of pharmaceutical sciences and information technology. He currently serves as a Senior Advisor to leading technology companies developing AI-driven solutions for the Life Sciences industry, including Benchling, ScaleiQ, and others, and is a co-founder of Daikon AI. In these roles, he provides strategic guidance to CEOs, founders, and leadership teams navigating the complexities of biotech and pharmaceutical innovation.
Most recently, Dr. Louie served as Chief Information Officer at Kodiak Sciences, where he led enterprise-wide digital transformation initiatives spanning IT operations, cybersecurity, and data privacy. Prior to Kodiak, he spent 29 years at Gilead Sciences, rising from Research Scientist to Vice President. During his tenure, he managed global organizations of up to 650 professionals and oversaw mission-critical systems supporting R&D, clinical development, regulatory affairs, manufacturing, and supply chain operations.
Dr. Louie is widely recognized as a pioneer in GxP computer validation, Part 11 and EU Annex 11 compliance, and enterprise data integrity programs. His expertise spans cybersecurity, system lifecycle management, computer software assurance, and regulatory compliance across the full pharmaceutical value chain—from discovery through commercialization.
A forward-thinking leader in pharmaceutical IT, Dr. Louie has driven adoption of advanced technologies including AI platforms (e.g., AzureGPT, Copilot, and agentic AI), cloud computing, and virtualization to accelerate innovation while maintaining rigorous compliance standards. He has led large-scale implementations of laboratory systems, manufacturing execution platforms, clinical trial technologies, regulatory systems, and quality infrastructures.
Dr. Louie holds a PhD in Organic Chemistry from the University of California, Riverside, along with an MS in Chemistry from UC Riverside and a BS in Biochemistry from UC Davis. His scientific contributions include work on antiviral therapies such as Tamiflu and Viread, as well as multiple patents and peer-reviewed publications.
A frequent speaker and industry thought leader, Dr. Louie has delivered keynote presentations on GxP compliance, IT infrastructure qualification, and cybersecurity. His rare combination of scientific depth, executive leadership, and regulatory expertise makes him a trusted advisor to organizations advancing digital transformation in Life Sciences.
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