In the opening statement of the BioPhorum chapter on the topic, Knowledge Management is defined as follows: “Knowledge Management (KM) is the process of capturing, developing, sharing and effectively using knowledge to drive a business, such as patient, product and process information. It is a multidisciplinary and cross-functional approach to achieve target metrics and other company objectives. It includes dimensions of people, process, content and technology.”[1 – Biomanufacturing technology roadmap – Knowledge Management, Dixon et al, BioPhorum, 2017
In the original roadmapping document it was acknowledged that KM was in an evolutionary stage within the biopharmaceutical industry and that, knowledge is produced and consumed in different ways by different generations. Coupled with governmental, economic and regulatory pressures effective KM strategies were defined as a critical need:
- health costs and growth have added regulatory pressure
- knowledge is a valuable asset that needs curation
- inconsistent practice is widespread
- tacit knowledge is generally not managed well
- volume, complexity and breadth of data is outstripping systems capability to manage it
- increased flexibility is a must
- growth through divestiture and acquisition adds to this complexity
- strategies for tacit knowledge management capture and retention are critical
- ICH Q8-12 is starting to address the need for better structured and coordinated approaches to KM
Biopharmaceutical companies are increasingly pan global and disperse which makes effective KM increasingly critical to ensuring consistency of practice on a global scale that can cross borders and language barriers. Coupled with changes in working culture and practice, employee mobility challenges knowledge retention as never before. This coupled with the need for speedy and ready availability of (the correct) knowledge challenges an industry where effective collaboration is increasingly critical to success.
The biophorum roadmapping team recognize that leaving to KM to chance or to self organize are not viable options. The cost of poor data management, inconsistent specifications and poor knowledge flow through organisations is difficult to measure accurately but is acknowledged by all to be a significant issue for everyone.
Key challenges may be summarized as follows:
- a weak or poorly defined KM strategy risks alienating the business from the outset
- cultural as well as technical adoption is critical
- People, process, content and technology must be given fair weight and consideration
- leadership commitment, as in any change initiative, is fundamental to success
- establishing a KM culture must be treated as organizational change management
- strategy implementation is an evolutionary roadmapping endeavor, not a single step change and will require organizational and individual resilience to succeed
The Biophorum technology roadmapping KM team recently embarked on an exercise to try to illustrate how application of KM best practice could be achieved using a knowledge mapping approach. To achieve this the group chose to map CMC business processes as a test case. The resulting paper, is available here. In developing this work the team developed a tool to help companies map their knowledge assets and help categorise them so that they can be better understood and strategies developed to help improve the flow, retention and sharing of those assets.
KM System User Requirements Specification
The roadmapping team are also developing a high level URS to specify requirements under the broad headings of people, process and technology. The URS is a high level document intended to form a consistent framework for companies wishing to develop/specify system, requirements for their KM solution. Recognising that companies are unlikely to describe a single monolithic system from the outset the team have also worked up an accompanying RFI that describes use cases for Investigations and Control Strategy systems.
Illustration of how a KM system may sit within existing siloed business systems to aid in the development and delivery of an effective and comprehensive control strategy.
<figure from TRM KM Roadmap doc>