Overview of the Biopharmaceutical Industry

Course Synopsis: The biopharmaceutical industry is one of the most dynamic, innovative, and controversial sectors in the global economy. This course provides students with a comprehensive overview of the industry; it begins by providing an high-level review of the industry, then explains key functions of a drug/device company by following the path of drug discovery and development before transitioning into the requirements for regulatory approval, then commercialization and closing with an assessment of potential future states of the industry. In addition to understanding the theory, case studies and the concluding group consulting engagement at the end will be heavily focused on real-world strategic challenges facing executives and investors. Learning Objectives: By the end of this course, students will be able to: Describe the various modalities being developed, as well as the structure, economics, and footprint of the industry. Explain the process of developing a product and gaining regulatory approval in the US, including discovery, pre-clinical research, clinical research and regulatory affairs. Understand the requirements for US commercialization, covering Sales, Marketing, Medical Affairs, Market Access, Policy, Data Analytics and Supply Chain. Debate ethical issues, public policy questions, and the future of medicine. Develop and present a team-based recommendation for a current biopharma issue.