(189d) Implementing a Recipe Based Framework to Support Product Lifecycle Management

The pharmaceutical industry to date has not fully leveraged data analysis methods such as multivariate techniques, e.g., multivariate statistical process controls, as achieved in some other industries.  It has been postulated that the lack of such analysis was in caused in part, by the ability of the pharmaceutical industry to absorb sub-optimal / inefficient processes.  We contend it is due to a more systematic challenge in the industry related to streamlined and effective data management. 

The data management challenge stems from the diversity of data generated across the lifecycle of a compound which needs to be linked and interpreted. For example, it is common for a compound developed internally to be transferred between 3-4 sites and up to 30 separate systems prior to commercialization.  Each system has valuable information that helps to drive key design and development decisions.  As more data and information is gathered across these source systems, it becomes exponentially more difficult to manage the isolated data streams   resulting in very high barriers to effectively use the information to create valuable knowledge.

To overcome these barriers, we will introduce you to a recipe based framework that is being implemented to facilitate knowledge lifecycle management.  The strategy will enable more routine application of multivariate techniques for which case studies will be demonstrated.