Biomedical Product Development

Harvard Extension School

BIOT E-225

Section 1

CRN 15756

View Course Details
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.

Instructor Info

Sujata K. Bhatia, PhD

Professor of Microbiology and Immunology, Drexel University College of Medicine


Meeting Info

W 8:10pm - 10:10pm (9/3 - 12/21)

Participation Option: Online Synchronous

Deadlines

Last day to register: August 29, 2024

Prerequisites

Background in introductory biology and chemistry.

Notes

This course meets via web conference. Students must attend and participate at the scheduled meeting time.

Syllabus

All Sections of this Course

CRN Section # Participation Option(s) Instructor Section Status Meets Term Dates
15756 1 Online Synchronous Sujata Bhatia Open W 8:10pm - 10:10pm
Sep 3 to Dec 21
35555 1 Online Synchronous Sujata Bhatia Field not found in response. TTh 3:15pm - 6:15pm
Jun 24 to Aug 9