About This Course
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 explores the growing use of Artificial Intelligence (AI) and its current and prospective multiple applications across the biotech/pharma project management ecosystem.
This course is taught by UC San Diego Extended Studies.
What You'll Learn
- How the Target Product Profile evolves throughout the product life cycle from the Discovery phase to clinical trials and NDA application
- The crucial role of quality assurance and quality control and associated best practices and guidelines; Good Laboratory Practice (GLP); Good Clinical Practice (GCP); Good Manufacturing Practice (GMP)
- The rules governing data management in biotech and pharma industry
- Integrated Chemistry Manufacturing and Control (CMC) throughout a biotech/pharma product development project
- How to optimize project performance in the biotech/pharma industry
