Applying Project Management Principles to Biomedical and Pharmaceutical Product Development

Life science industries are very complex and require the management of large portfolios and programs which ultimately lead to the discovery and development of innovative therapeutic products. The umbrella of programs required to feed the pipeline of therapeutic candidates and their subsequent development into commercial products are much diversified and range from exploratory research, determination of novel biological pathways, lead discovery and development, pre-clinical studies, clinical trials, regulatory compliance and filings, manufacturing and sales and marketing. Along the way, best project management practice is essential to successful product completion and subsequent enduring market leadership. This course is divided in three major sections. In the first section we present an overview of the drug discovery and development life cycle, activities involved in the discovery phase, the evolution of the Target Product Profile, transition from laboratory to mass production of a drug and process chemistry, formulation, purity and stability testing. The second section covers in detail the development of pharmaceutical and biopharmaceutical products from pre-clinical to NDA approval, and launch to market. Finally, the last section presents the highlights of biomedical device development, its specific regulatory requirements, and a brief comparison between pharmaceutical and device development.

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.