Knowledge You Need to Know
by Marty Lipa, Executive Director, Merck Manufacturing Division Knowledge Management and Learning Technologies COE
To help organizations address the many complexities of capturing, converting and communicating existing and emerging knowledge, ISPE’s Pharmaceutical Engineering magazine has put together an electronic supplement on knowledge management that features a collection of thought-provoking articles developed by regulators, industry, service providers and academia.
Over the past several years, there has been a growing interest in the practice of knowledge management in the biopharmaceutical industry. This is evident through the increased internal and external attention biopharmaceutical companies have focused on knowledge management (KM), including discussion on KM strategies, attendance and presentations at KM-related conferences, KM publications and KM-focused workshops.
There are many potential drivers for this increased interest and activity in knowledge management. For one, there has historically been insufficient knowledge collected in the industry of both explicit and tacit knowledge. Arguably, much explicit knowledge has been captured for a single purpose and not viewed as a reusable asset across the lifecycle of a product and into the future across products; and tacit knowledge – that is, expertise, know-how, experience – have been largely overlooked and poorly managed in such a complex, dynamic and challenging industry.
Next, the complexities of the overall businesses in the biopharma space have continued to dramatically increase. Consider increasing globalization; externalization of R&D and manufacturing; in- and out-licensing; ever increasing pressures on development timelines, productivity, cost and quality; and mergers and acquisitions. Each of these puts a strain on the continuity and flow of knowledge for any given company or supply chain.
Further, there are the growing expectations by the external community, including those outlined by the regulatory community with the Quality by Design paradigm, with the opportunity to leverage prior knowledge, and specifically, in ICH Q10 Pharmaceutical Quality System, which calls out knowledge management as a key enabler of quality throughout the entire product lifecycle.
Finally, although more effective knowledge management has been seen as an area of untapped potential, there have been many failures in past attempts in KM. The reasons are many, including when KM is equated with being solely an information technology solution (e.g., a repository or a search engine) or where there has been a lack of enabling process, culture, sponsorship, and/or stewardship to make the KM efforts meaningful and sustainable. Yet there is promise in the successes in KM witnessed in other industries that illustrate these failures can be overcome, and that there are real and tangible benefits for managing knowledge more effectively, including quality, cost, speed, employee engagement and many others.
This collection of articles provides you with a unique opportunity to learn from others in the biopharma space, including regulators, industry, service providers, and academia on their perspectives, experience and expectations around knowledge management.