Transforming project management by embracing agility in biopharma companies: perceived added value, challenges, and risks

Drug development is at the heart of a pharmaceutical company's primary mission and directly contributes to its core competencies and competitive advantage. The success of a pharmaceutical company hinges on its ability to bring a drug to market safely and quickly while keeping development costs as low as possible. Project management is essential to manage the broad interaction among human, budgetary, and technical variables to meet time, scope, budget, and quality constraints within all phases of developing a new medicine. The current stage-gated drug development approach is structurally rigid, linear, and optimized to weed out low-probability ideas and select ones with a high probability of technical, scientific, and commercial success for full development. However, in rapidly changing environments, where speed is a key success factor, such predictive project approaches reach limitations. This study explores whether Agile methodologies can live up to their promise as an adaptive approach heralded as a solution to changing requirements and flexibility and address demands for increasing productivity, efficiency, and innovation while simultaneously reducing drug development costs. More specifically, through a case-study-focused methodology, our communication examine how Agile approaches are being perceived and applied across different phases of drug development in the context of a mid-sized Belgium biopharmaceutical company. We explore how Agile project management practices have been implemented to understand better the challenges, opportunities, and risks of implementing Agile methods in pharmaceutical drug development.