(184v) Data 1.0 before Pharma 4.0: From R&D to Supply Chain

The fundamental building block for AI, ML, Simulation, Pharma 4.0, and other sophisticated approaches is the DATA and the importance of its quality and availability (i.e. accessibility, cleanness, correctness, comprehensiveness, context, ..). However, this fundamental aspect mostly ignored, either the data is in silos, trapped in dispersed types and ELNs and vendor licensed platform, messy, noisy, incomplete, and so on. Although there have been different efforts in harmonizing the format, connectivity, and accessibility, still a sharable and customizable database and a collaborative platform (either for data governance or running models and simulation) is a big challenge.

In this presentation we will discuss on the complexity of data in the pharmaceutical industry from R&D to post manufacturing and demonstrate some work arounds and solutions for data curation and running models across organizations. The case studies will be from different types of applications and organization (such as CDMs, CMOs, biologics, small molecule, and supply chain). Democratization of numerical models and sharing models across stakeholders will be demonstrated on Cloud based and user friendly interfaces.