BIOT E-225: Biomedical Product Development

Semester: 

Spring

Offered: 

2017

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