Many recognize that knowledge is crucial to the success of every business. The pursuit of knowledge appears to be relentless but often it is not curated, cataloged, retained or shared very well. And the ever-increasing digitization of information just means it is becoming more difficult to manage knowledge in an unplanned way effectively. 

The management of knowledge was identified as a key theme in the BioPhorum Biomanufacturing Technology Roadmap, with a specific chapter devoted to discussing a future vision and its opportunities.

Truly understanding how to use knowledge and designing successful knowledge management (KM) solutions is difficult. This is why the BioPhorum Technology Roadmapping KM Workstream came together to develop the discussions in the KM roadmap chapter. It focused on how KM impacts on biopharmaceutical working practices and to determine the best practice tools and approaches to minimize waste and maximize the utilization of knowledge assets. 

The result is the paper called Knowledge Mapping for the Biopharmaceutical Industry: A Test Case in CMC Business Processes from Late-Stage Development to Commercial Manufacturing.

“Most of us don’t touch our products, we are knowledge workers,” said Robert Guenard, Senior Director – Manufacturing Sciences at Biogen, and an author of the paper. “I hope that people see knowledge as the asset it really is. I want organizations to use our tool to assess how they are doing, and then use this to meet the challenges and opportunities coming in the digital world.”

Knowledge flows

The paper shows how a clear KM approach can help businesses identify knowledge flows, assess the quality and criticality of those flows, and identify areas for improvement – and it demonstrates this through the familiar industry process of a manufacturing process and assay development.

It also discusses some high-level examples of how KM issues may be addressed using the principles of People, Process and Technology. The paper includes a tool so that organizations can repeat these KM assessments on their different business processes to understand their knowledge flow issues (see Figure 1) and develop fit-for-purpose solutions.

Figure 1: APQC’s Knowledge Flow Process describing how knowledge flows through an organization

Guenard suggests that businesses ask some big questions about their knowledge. “If this is our key asset, what framework do I use to look at knowledge in my organization, from creators to users, and the huge amount of tacit knowledge in people over the product lifecycle? How do we make sure that the energy and time people put in is captured in the enterprise?”

Making a difference

The risks of poor KM can be significant. A drug’s development could take longer because there’s a problem your organization has experienced before, but this wasn’t known and acted on for a current project. You may even waste time and money rediscovering something you’ve already invested in. These issues are exacerbated when staff leave and take their undocumented knowledge with them. 

However, the potential benefits of KM are extensive – if knowledge is treated as a critical asset. It can help increase the efficiency of a pharmaceutical enterprise, improve speed to market and lower the cost of drug development. Decisions will be made more quickly and with better information, and drug development will be faster with less physical experimentation when prior knowledge can be more effectively leveraged, particularly across products and/or platforms.

But if effective KM has so many benefits, why has it not been adopted more? Reasons include a lack of understanding of what ‘knowledge’ is and how it creates value, thinking that KM can be achieved through technology alone and because all knowledge does not have equal value but depends on its context. The BioPhorum paper discusses all of these issues and more.

Regulators already recognize KM as a critical enabler of a science- and risk-based approach to assuring the quality of medicines. For example, in International Conference on Harmonisation (ICH) guidance, KM has been highlighted as important in Pharmaceutical Development (ICH Q8), Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10). This regulatory focus is only likely to increase and the BioPhorum paper will help guide companies in developing a KM approach that will satisfy regulator concerns.

Next steps

The team plans to create a user requirements specification for a KM system and benchmark current technology to indicate its level of maturity. It will also look at developing a collaborative proof-of-concept and see how it can enhance cultural and behavioral norms to improve tacit knowledge in particular, but knowledge use as a whole.

Biopharmaceutical development is a hugely complex and costly venture and to do it successfully needs industry to use its many assets, which includes its vast stores of knowledge. Unfortunately, the reinvention and recreation of lost information are common, which is becoming increasingly hard to address without a coordinated program of work. Simply adding a software ‘sticking plaster’ will not solve such a complex challenge.

By continuing to evolve KM strategies in a collaborative environment, we can accelerate towards the vision described by the Technology Roadmapping team.