BIOT E-225: Biomedical Product Development




This course examines the design and development of new therapeutic products. Students learn through case-based studies of product development for pharmaceuticals, biologics, medical devices, and combination therapies. The course describes the steps of biomedical product development, from conceptualization, to design, to manufacturing, to regulatory approval and commercialization. The course discusses both technical and business factors that contribute to the success or failure of new biomedical products. Appropriate design of preclinical and clinical trials is also included. Students gain an appreciation for emerging technologies in stem cells, gene therapy, tissue regeneration, personalized medicine, and targeted therapies. Additionally, students learn about the special challenges presented by emerging biomedical technologies. By the end of the course, each student completes a project to propose a new biomedical device and identify the regulatory strategy, technical milestones, and business milestones for the new device.