How to manage when things go wrong in development: A Case Study

Development of new drugs and therapies is complex and fraught with risks and uncertainties. It’s not unusual to be confronted with challenges ranging from unexpected lab results to equipment and batch failures. Each challenge or failure is an opportunity to learn and strengthen both our knowledge and the project – so long as we invest the time and effort to really understand the root cause and fix the right problem. Of course, the investment should match the scale of the problem, and this is different for each situation. In this presentation, we will share case studies of challenges faced in drug development projects and the approaches we took to resolve them, including root cause analysis tools, further investigations and resulting remedial actions or CAPA plans.