Biomedical Product Development
Harvard Extension School
BIOT E-225
Section 1
CRN 15756
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.
Registration Closes: August 29, 2024
Credits: 4
View Tuition Information Term
Fall Term 2024
Part of Term
Full Term
Format
Live Attendance Web Conference
Credit Status
Graduate
Section Status
Open