Introduction

Knowledge Management (KM) is critical to the biopharmaceutical industry and the patients it serves as the industry is one based on knowledge.  Knowledge about products, processes, platforms and components.  Knowledge about risks and how to mitigate them.  Knowledge about what happened in the past, failed experiments and why decisions were made.  Knowledge in the form of ‘know how’, experience and expertise.  And much more.

The recognition of the importance of Knowledge Management has grown significantly in recent years, sparked by the promise of leveraging ‘prior knowledge’ in the regulatory guidance document Pharmaceutical Development, ICH Q8 in 2005.  This prominence grew larger when Knowledge Management was positioned as an enabler to an effective Pharmaceutical Quality System in ICH Q10 in 2008. 

Knowledge Management is defined by ICH Q10 as:

“a systematic approach to acquiring, analysing, storing, and disseminating information related to products, manufacturing processes and components.”

This definition is important yet arguably somewhat narrow in scope and infers a bias toward only documented knowledge (i.e. ‘explicit’ knowledge).  Over time, additional definitions of KM have emerged which provide a more holistic lens on knowledge management, inclusive of experience and know how (i.e. ‘tacit’ knowledge), such as the definition by APQC (apqc.org),

“applying systematic approaches to help information and knowledge flow to the right people, at the right time, in the right format and at the right cost, so they can act more efficiently and effectively to create value.”

And while ISO did not issue a standard on Knowledge Management until 2018, it also provides a helpful definitions of Knowledge and Knowledge Management.  Knowledge is defined as

“Human or organizational asset enabling effective decisions and action in context.  Knowledge can be individual, collective or organizational.  There are diverse views on the scope covered within knowledge, based on context and purpose. The definition above is general as to the various perspectives. Examples of knowledge include insights and know-how.  Knowledge is acquired through learning or experience.”

And Knowledge Management is defined as

“Management with regard to knowledge. It uses a systemic and holistic approach to improve results and learning. It includes optimizing the identification, creation, analysis, representation, distribution and application of knowledge to create organizational value.”

However, tangible progress in knowledge management has been slow and elusive for the industry.  As such, the PRST has engaged in research directed at creating a better understanding of what Knowledge Management is, why it is important and how organizations can advance in ‘how they manage their knowledge as an asset.’  The PRST has also advanced the dialogue between industry, regulatory agencies and academia through a number of symposia and conference presentations.  Following is a high-level guide to research conducted by the PRST and related publications and conference proceedings, followed by helpful references on these studies.