Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs

Catalog description

Biopharmaceutical protein products have been successfully used to treat a number of diseases and currently represent a large segment of the product pipeline in most major pharmaceutical companies. More than half of the current top 20 blockbuster drugs are biopharmaceuticals. Drugs like Activase, Humira, and Avastin have revolutionized the drug industry in treating the unmet medical needs of many patients. With innovation at the heart of the biopharmaceutical industry, this course is aimed at developing the student s understanding of the application of basic research in molecular biology and genetics to the development of novel drugs for treating diseases. The course is designed to provide an overview of biopharmaceutical protein drug development and manufacturing processes with an emphasis on regulatory affairs activities. The class has been developed and is taught by a former VP of biopharmaceutical product development with over 30 years of experience in biotechnology and the biopharmaceutical industry. The course director will provide insights into the unique challenges and opportunities facing the biopharmaceutical industry and how they relate to regulatory affairs. Subject area experts from industry will also participate as guest lecturers. Prerequisite: Permission required to register.