Leslie Sam

President at Leslie Sam & Associates

Speaker

Leslie Sam is President of Leslie Sam and Associates, LLC, and Chief Quality Officer at Innomas Clinical Research. With more than three decades of experience in clinical development and global GCP oversight, she advises biotech, pharmaceutical, and CRO organizations on strengthening trial execution through disciplined oversight and risk-based strategy.

Leslie specializes in translating evolving regulatory expectations — including ICH E6(R3) — into practical Quality by Design and governance models that reduce development uncertainty and support regulatory confidence. A recognized industry speaker, she brings a pragmatic perspective to modern trial delivery in increasingly complex, technology-enabled environments.

She advocates for development strategies that generate robust, reliable evidence — recognizing that clinical trial decisions ultimately affect not only study participants, but patients, families, healthcare providers, regulators, and the systems that rely on sound science.