Michael Torok, Ph.D., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive and effective risk and issue management of trial participant safety and data reliability, and chairs Roche’s Good Clinical Practice Council. Michael has held leadership roles in Clinical Operations, Contracts & Outsourcing, and Project Management at sponsors and CROs. He holds a Ph.D. in Biochemistry and Molecular Genetics from the University of Virginia and a certificate in Business Data Analytics and Machine Learning from the University of Chicago.

With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by the industry organization, TransCelerate, to co-develop and co-author a conceptual clinical quality management system framework and issue management framework. She was also a reviewer of the TransCelerate conceptual risk management framework. She leverages her depth of understanding of industry leading practices and regulatory guidance to define and apply strategic and tactical risk-based approaches to clinical trial implementation. practices.