Michael S. Louie, PhD | Co-Founder Life Sciences
About Michael
Dr. Michael S. Louie is a distinguished executive with over 35 years of experience at the intersection of pharmaceutical sciences and information technology. Currently serving as a Senior Advisor to multiple technology companies developing AI-based software solutions for the Life Sciences industry, including Benchling, , IT Solutions, ScaleIQ, and is a co-founder of Daikon AI. Dr. Louie provides strategic guidance to CEOs, co-founders, and senior leadership teams navigating the complex landscape of biotech and pharmaceutical innovation.
Most recently, Dr. Louie served as Chief Information Officer at Kodiak Sciences, where he led digital transformation initiatives, IT operations, cybersecurity, and information privacy across the enterprise. His exceptional 29-year tenure at Gilead Sciences—from Research Scientist to Vice President—exemplifies his unique ability to bridge scientific expertise with technological innovation. During his time at Gilead, he managed teams of up to 650 professionals across scientific and information technology disciplines, overseeing critical systems supporting R&D, clinical operations, regulatory affairs, manufacturing, and supply chain management.
Dr. Louie is recognized as a pioneer in establishing GxP computer validation programs, Part 11 and EU Annex 11 compliance frameworks, and comprehensive data integrity initiatives within the pharmaceutical industry. His deep expertise encompasses IT security, cybersecurity, system development lifecycle management, computer software assurance, risk management, and regulatory compliance. He has successfully led the implementation and validation of enterprise-wide digital infrastructure across all aspects of pharmaceutical operations, from drug discovery through commercial distribution.
A thought leader in pharmaceutical IT, Dr. Louie led corporate initiatives to adopt AI capabilities including AzureGPT, Co-Pilot, and Agentic AI for discovery research, finance operations, product quality, clinical research and productivity enhancements. He pioneered the use of cloud computing and virtualization to scale pharmaceutical operations while maintaining rigorous regulatory compliance. His extensive implementation experience spans laboratory information systems, manufacturing execution systems, clinical trial management platforms, regulatory submission systems, and quality management solutions.
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 foundation includes significant contributions to pharmaceutical process chemistry, including key roles in developing anti-viral drugs such as Tamiflu and Viread , with multiple patents and peer-reviewed publications to his credit.
As a certified trainer and frequent conference speaker, Dr. Louie has shaped industry best practices through keynote presentations on IT infrastructure qualification, GxP compliance, and cybersecurity. His expertise is sought after by boards of directors regulatory agencies, and technology vendors seeking to advance pharmaceutical operations through digital innovation. Dr. Louie's career represents a rare combination of deep scientific knowledge, executive IT leadership, regulatory expertise, and strategic vision—positioning him as a trusted advisor for organizations seeking to transform Life Sciences operations through technology while maintaining the highest standards of quality, compliance, and patient safety.