179 - Preparing for the Unknown (S12E14)

This episode discusses strategic risk management and flexible design to prepare for future uncertainties in drug development. Dialogue on contingency planning, scenario analysis, and adaptive strategies with real-world examples is presented. Analysis is focused on building adaptability into the process and thinking ahead.

Various techniques for managing strategic risk, including contingency planning and flexible design, are analyzed. The role of regulatory requirements and the role of pharmaceutical processes are highlighted. Analysis of examples from Organic Process Research and Development (OPR&D) are included.