Commercialization of Biopharmacueticals

Catalog description

Review organizational processes, regulatory, and environmental issues in the development and commercialization of biopharmaceuticals in the United States and globally. BUSAD 835 Commercialization of Biopharmaceuticals (3) This course reviews organizational processes, regulatory, and environmental issues in the development and commercialization of biopharmaceutical products in the United States and globally. Business development strategies and tactics that encourage innovation and enable biopharmaceutical organizations to prosper in changing business environments are emphasized. The regulatory environment globally and nationally is reviewed for its impact on biopharmaceutical discovery and commercialization, including the IND (investigational new drug) and NDA (new drug application) process and quality control/assurance. Organizational dynamics including culture, structure, ethical dimensions of management, and special considerations in global marketing are explored. Marketing and brand management, financial forecasting, and structuring sales and marketing are examined for their impact on successful commercialization of biopharmaceutical products.