Drug Development: Key Issues in Regulation, Benefit vs. Risk, and Commercialization

This course is intended for medical students, graduate students, trainees, basic scientists, clinicians, and clinician scientists at Stanford to provide an educational and practical perspective of drug development: its incredible potential as well its challenges. Using a blend of seminars, debates, and case study analyses, the curriculum is focused on educating the audience on key regulatory issues and commercial considerations in product development, with an emphasis on cardiovascular applications. Seminar topics will include "Introduction to Regulatory Processes", "FDA Advisory Committee Meetings and Risk/Benefit/Approval Decisions", "Phase 1 Cardiovascular Safety Assessments in Drug Discovery and Development", "Case Study: Vioxx (Cox2 inhibitor) and the Cardiovascular Risk Question", "The Era of Requiring Outcomes Studies for Diabetes Drug Development", "Interface of Al and Clinical Trial Design", "Key Statistical Issues in Drug Development", "Reasons Why Phase 3 Programs Fail", "Commercial Considerations in Drug Development: Is there a Market?", and "Dissection of Presentations and Publications of Major Cardiovascular Trials", Drug Development: Key Issues in Regulation, Benefit vs. Risk, and Commercialization (MED227) complements the course MED225 - Drug Development: From a Concept to the Clinic offered in the Spring. Previous exposure to MED225 content is not necessary to participate in MED227. https://med.stanford.edu/cvi/education/cvi-courses/med227.html