Driving Innovation from Discovery to Commercialization

Offered by UC San Diego Extended Studies, this course provides an in-depth exploration of managing complex programs in the life sciences industry, from discovery to commercialization. Students will examine project management across diverse therapeutic areas, including small molecules, biologics, cell and gene therapies, rare diseases, generics, biosimilars, and medical devices. The course covers key activities such as exploratory research, lead development, nonclinical and clinical studies, regulatory-aligned quality systems, manufacturing, and marketing. It also highlights strategies to address specific challenges in each therapeutic category and the growing applications of AI in biotech and pharma project management.

What You Will Learn

• How the Target Product Profile, which is the Product Scope in the biotech/pharma R&D, evolves throughout the product life cycle
• What is involved in the discovery phase of drug development
• The importance of Preclinical investigation and Good Laboratory Practice
• The crucial role of quality assurance and quality control and associated best practices and guidelines: Clinical Investigation and Good Clinical Practice; The study protocol, statistical analysis plan, final study report, Common Technical Document (CTD)
• How  Regulatory requirements reflects the quality systems in the industry
• What is involved  in the different meetings with the FDA (during development and pre-NDA)
• The rules governing Data management in biotech and pharma industry
• Integrated Chemistry Manufacturing and Control (CMC) throughout a biotech/pharma product development project and the maturity of Good Manufacturing Practice (GMP)
• How to optimize project performance in the biotech/pharma industry

Prerequisites

Prior to enrolling in this course, you should have completed Project Management Standards & Processes and Project Management Within a Scientific/Research Environment.

The next and last course in this series is Biotechnology Project Capstone, offered by the University of Washington.