Applying Project Management Principles to Biomedical and Pharmaceutical Product Development

This course, offered by the University of California, San Diego (UCSD), is the third in a series of four online courses that comprise the “Biotechnology Project Management Online Certificate Program.” This program is jointly developed and delivered by the University of Washington and UC San Diego.

The life sciences industry is highly complex and requires the management of extensive portfolios and programs that ultimately lead to the discovery and development of innovative therapeutic products. These programs span a wide range of activities, including exploratory research, identification of novel biological pathways, lead discovery and development, nonclinical studies, clinical trials, regulatory-aligned quality systems, manufacturing, and marketing. Throughout this process, the application of best practices in project management is critical to the successful discovery, development, and commercialization of new therapies.

The course addresses various therapeutic areas, including small molecule drugs (and small peptides), biologics, cell and gene therapies, and rare diseases. It also includes a dedicated module on the development of medical devices. Additionally, the course features a module on the development and commercialization of generic drugs and biosimilars. For each therapeutic category, the course explores specific challenges, and the strategies used to overcome them. Finally, the course explore the growing use of Artificial Intelligence (AI) and its current and prospective multiple applications across the biotech/pharma project management ecosystem.

WHAT YOU’LL 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

This course is taught by UC San Diego Extended Studies.