Clinical Trial Design in Drug Development: A Regulatory Perspective

​This two-hour session will introduce students to the fundamentals of clinical trial design from a regulatory perspective, including study objectives and endpoints, patient populations, data integrity, and Good Clinical Practice (GCP). It will explore how sound study design and GCP support reliable clinical evidence for the development and approval of new medicines.

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​Speaker: Stephen Li, MS, MBA | Senior Vice President of Regulatory Affairs, Karyopharm Therapeutics Inc. and Part-Time Lecturer, Master of Science in Regulatory Affairs, Northeastern University

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​Stephen has more than 15 years of experience at EMD Serono and Merck KGaA, where he held regulatory leadership roles in the U.S., Canada, and Germany, including Head of U.S. and Canada Regulatory Affairs and Head of Global Regulatory Marketed Products. His experience also includes International Regulatory Affairs and Medical Devices. Earlier in his career, he worked at Baxter, ApoPharma, and IMS Health in Canada.

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​Stephen has taught and developed postgraduate Regulatory Affairs curricula for many years. He holds an Honours Bachelor of Science from the University of Toronto, an Executive MBA from Western University’s Ivey Business School, an MS in Regulatory Affairs from Northeastern University, and a postgraduate credential in Regulatory Affairs from Humber College.