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With digital transformation accelerating across the industry, pharma and biotech companies are increasingly aware that their most valuable asset is not necessarily a molecule or drug brand – it is most likely their petabytes of data.

This proposition is explored in detail in Biophorum's "Data governance needs in biomanufacturing position paper".

According to the authors, "These enormous proprietary information resources hold immense potential to drive business performance. But while data flows from various sources – including clinical datasets, patient data, customer complaints and manufacturing systems – it often faces the same critical challenge. Data is produced, formatted and stored in ways that leave it ill-suited for accessibility and reuse. The vast majority (80%) of data generated today is unstructured, and the high volume of data, especially manufacturing data, has very poor utilization. Only 1% of unstructured data is used or analyzed."

Sean Coombs, MedTech Technical Director, PM Group, one of the co-authors of the report says:

"A structured data and data governance culture is critical for successful project delivery. In the biopharma industry, systems are not always mature enough to handle the 'as designed/built' data set. We've been working with industry experts to understand the issues. Our goal now is to offer solutions," said Sean.


A critical culprit in this series of challenges is the lack of data governance policies and systems to support significantly higher volumes of data being generated. This problem will only be exacerbated as the volume of data grows exponentially with increased accessibility of information driven by industry 4.0 connectivity of IT and OT systems.


Read the full report


Sean Coombs is a member of PM Group's TechTeam, a unique group of over 70 subject matter experts driving innovation. Initiatives range from : Single Use Technologies, Industry 4.0; AR & VR; Cell and Gene Therapy; Robotics and Simulation and Modelling.