Drug development is a business which requires lot of foresight, high level of expertise in multiple specialized areas, and a significant investment. Despite all efforts, only a fraction of drug candidates ever make it to approval. The drug development process itself is very complex. The process timeline is stretched over very long period of time, often spread across multiple jurisdictions and cultures.
Multiple stakeholders are usually involved, whose business objectives, goals and priorities often clash. The industry is highly regulated, and compliance with all the demands in order to clear regulatory hurdles and get a product to the market is often the sole most important project risk. This approach to risk management approach is passive-aggressive rather than proactive.
Risks are future events or conditions that may have a negative effect on achieving program objectives for cost, schedule, and performance. Risks are defined by the probability of an undesired event or condition and the consequences, impact, or severity of the undesired event, were it to occur. Successful risk management should be implemented early in the project life cycle.
Issues are events or conditions with negative effect that have occurred (such as realized risks) or are certain to occur in the future that should be addressed.
Opportunities are potential future benefits to the program’s cost, schedule, and/or performance baseline, usually achieved through reallocation of resources.
Risk management is an endeavor that begins with requirements formulation and assessment, includes the planning and conducting of a technical risk reduction phase if needed, and strongly influences the structure of the development and test activities. Risk management should occur throughout the life cycle of the program.
Active risk management requires investment based on identification of where to best deploy scarce resources for the greatest impact on the program’s risk profile, and includes shaping and controlling risk, not just observation of its progress and reaction to risks that are realized.
Anticipating possible adverse events, evaluating probabilities of occurrence, understanding cost and schedule impacts, and deciding to take cost effective steps ahead of time to limit their impact if they occur is the essence of effective risk management.
Holistic perspective on risk, issue and opportunity management is focused on the program, its objectives and requirements, and any factors that may affect its cost, schedule and performance. Efficacy and intrinsic safety of the final product is therefore included in program’s performance.