Risk Management in BioPharmaceutical Development and Manufacturing – Federman
Development and manufacturing a drug is one of the most difficult, lengthy, and costly endeavors a company or team can take on. Balance this with the fact that there are numerous unmet medical needs out there for millions of patients and the pressure mounts to deliver a drug with speed, precision, safety, efficacy, quality, and within budget. Besides toxicology studies, clinical trials, regulatory interactions, and a whole slew of other hurdles – there is the heavy lift of actually developing the processes and methods for manufacturing the drug itself and the development and characterization required to create a robust package of information for health authority approval. One aspect of these processes and development that is performed by project managers and associated functional team members is risk management. Proper risk management is integral for decisions on strategy, technical feasibility, regulatory submissions and compliance, possible accelerations, investments, and ultimately a guidance tool that enables key stakeholders to make project, program, and portfolio wide choices.
PMI Talent Triangle: Technical Project Management (Ways of Working)