In summary, the researcher has presented a novel Pharmaceutical Product Knowledge Lifecycle (PPKL) Model as the second element of the Pharma KM Blueprint. The model is offered to encourage those responsible for the development, manufacture and distribution of biopharmaceutical therapies to think differently about the knowledge that is created during the lifecycle of a product. The PPKL Model proposed is an adaptation or reimagination of the ICH Q10 Product Lifecycle published in 2008 and incorporates the following novel features:
• The model highlights the vision for end-to-end (E2E) product and process knowledge asset visibility, transparency and availability in order to enable knowledge flow of critical knowledge to those that need it throughout the product lifecycle.
• The model includes the addition of a new lifecycle phase of New Product Introduction (NPI) to replace the Technology Transfer lifecycle phase.
• The model highlights that Technology Transfer is an activity that may occur multiple times across the product lifecycle.
• The model includes the addition of a new E2E process to capture the Technical Product Support and Continual Improvement activities that occur across the product lifecycle.
To further develop the Pharma KM Blueprint, Chapter Seven will next introduce the House of Knowledge Excellence (HoKE) Framework, as a strategic and a programmatic approach to managing knowledge in organizations.
Chapter Seven
Pharma KM Blueprint Part Three: Pharmaceutical Knowledge Excellence Framework – The House of Knowledge Excellence (HoKE)
[The] House of Knowledge Excellence Framework depicts the foundations for successful KM by outlining the relationships between knowledge enablers, pillars, practices, and the strategic objectives of the business. The four pillars—
people, process, technology, and governance— provide the strength of the framework. Kane and Lipa … assert that the power of this framework lies not only in explaining the function and role of each element of the “house,” but in the top-to-bottom integration that clearly links the KM program to the overall business strategy. (Calnan, Lipa, Kane, Menezes, 2018, Introduction, p. xix)
7 House of Knowledge Excellence (HoKE)
Chapter Five introduced the Pharma KM Blueprint with the principle of the need for the biopharmaceutical sector to manage and value knowledge as a critical asset.
Chapter Six illustrated the second element of the Pharma KM Blueprint, with the presentation of the Pharmaceutical Product Knowledge Lifecycle (PPKL) Model. Here, the third element of the blueprint is introduced in the form of, the House of Knowledge Excellence (HoKE) Framework.
The HoKE framework provides an opportunity to define what we mean by Knowledge Excellence and how it exceeds the mere management of knowledge. “Knowledge Excellence” is not simply the application of a series of discrete knowledge solutions or
the provision of sets of tools but rather about enabling and sustaining knowledge-focused business capabilities. The essence of the House of Knowledge Excellence Framework offers a holistic, programmatic approach to implementing KM founded on the four pillars of People, Process, Governance and Technology, in order to enable practical approaches to get knowledge to flow. HoKE requires a deep understanding about “how” work gets done on a day-to-day basis and how best to influence the behaviors of the employees or knowledge workers within the organization. Employees must be encouraged and enabled to think and act differently in how they seek and share knowledge.
The researcher proposes that the rationale for pursing capabilities in knowledge management should not be to merely satisfy regulatory expectations, as highlighted in ICH Q10, but to deliver value to the business and ultimately the patient.
The genesis of the House of Knowledge Excellence (HoKE) Framework stems from the industry consultation sessions in which biopharmaceutical sector KM practitioners highlighted the need to further define and visualize KM Strategy and KM Program design, as well as to define practical KM approaches. As informed by the literature review, very few biopharmaceutical organizations have implemented a programmatic approach to knowledge management, to date. Where organizations are pursuing KM, it often starts out as a discrete KM project to address a specific knowledge gap or business driver.
The House of Knowledge Excellence (HoKE), is a practical approach that organization may use to assist in either the development of a KM strategy, the roll out of a holistic KM program or in the identification of KM approaches that may benefit biopharmaceutical companies (Kane & Lipa, 2018). The title of the HoKE was specifically chosen to reflect the need to move beyond the compliance expectations of managing knowledge to realize the true business benefits of being excellent in the capture, curation and use of our knowledge.
The framework was developed by the researcher, in conjunction with one other colleague M.J. Lipa, and published in 2017 as a book chapter entitled, The House of Knowledge Excellence – A Framework for Success (Kane & Lipa, 2018). The published work is presented herein in full, as the researcher believes that summarizing would do the HoKE framework an injustice. [Please note the footer page numbering reflects the contiguous thesis page numbers.] The 13 case studies analyzed via the HoKE framework are listed in Tables 4-8 and 4-9 on pages 94 and 95 of this thesis.
It is important in this point to acknowledge the contribution of my colleague M.J. Lipa to development of the HoKE Framework. The main development of the HoKE
framework was based on experience and work of the researcher. The model was validated by Lipa, as an experienced KM practitioner himself. The model was enriched by the addition of KM practice of taxonomy and additional enhancements to the lessons learned KM practice. Lipa also helped bring the HoKE visuals to life.
The following pages comprise of the published book chapter.
181
12
The House of Knowledge Excellence—
A Framework for Success
Paige E. Kane and Martin J. Lipa
CONTENTS
Introduction ... 182 A Framework for Knowledge Excellence ... 184
Challenges Shaping the Face of KM in the Biopharmaceutical
Industry ... 184 Dedicated KM Roles and Skillsets ... 213 Ownership and Stewardship ... 214 Partnership ... 215 Enablers Summary ... 218 Putting It All Together ... 218 References ...223
Republished with permission of Taylor and Francis Group LLC Books from A
Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry, Calnan, N., Lipa, M., Kane, P., & Menezes, J. C. (2018) permission conveyed through
Copyright Clearance Center, Inc.
182 A Lifecycle Approach to Knowledge Excellence
Introduction
The case studies shared in Section IV attest to the great progress being made with knowledge management initiatives that are underway throughout sev-eral organizations, the most common pitfall for many KM programs (across multiple industries) remains the failure to consistently deliver on their intended outcomes. In the author’s opinion, this comes about as a result of a lack of fundamental understanding about what organizations are really try-ing to accomplish with a knowledge management program.
Often, KM programs seek to deliver the outcomes of improved collaboration, or vibrant communities of practice, or the establishment of integrated knowl-edge repositories, or related goals. Although these aspirations may be valid leading indicators of KM success, we question are these really the meaningful outcomes that will garner sustained senior management support and ongoing investment?
Organizations are often tempted to pursue the silver bullet promised by software vendors (e.g., the next generation software tool that will solve all of the collaboration and connectivity problems faced by civilization) as their route to success. Although acknowledging these tools may well prove indispensable when utilized in the right context; deploying a collaboration, community, or connectivity tool risks being disconnected from what is most important to the business.
Even ICH Q10 Pharmaceutical Quality System (ICH Harmonised Tripartite Guideline 2008), which insightfully positioned KM front and center as a key enabler across the entire product lifecycle, has challenges from industry members and claim it is too vague or high level to establish any meaningful, sustainable focus for KM.
This lack of focus was highlighted in Knoco’s 2014 Global Survey of Knowledge Management (Knoco 2014), which uncovered a huge diversity in organizational reporting lines for KM programs, is a marker that industry—
including the biopharmaceutical industry—has not yet normalized on the In this chapter, the authors present a new model, The House of Knowledge Excellence, as a comprehensive framework for KM programs, which is based on benchmarking and experience of the biopharmaceutical industry and beyond. This model can be used to educate and build awareness of the benefits of a holistic approach, and also leveraged as a gap analysis tool for current KM programs to enable them to deliver additional value.
Editorial Team
183 The House of Knowledge Excellence—A Framework for Success
delivery of KM and how value is derived. As discussed in the survey, the KM solid line was reported most frequently as being in to one of HR, oper-ations, IT, strategy, learning and development, R&D, projects, or business improvement. However, the research shows more than 30 different areas of the business were cited as being responsible for KM programs, including a large percentage of KM programs that report directly to the senior manage-ment team. The authors do not suggest there is a single right answer, but this diversity is a clear signal there is some normalizing yet to occur on the what and the how of KM, and further it is the author’s opinion that the principal pitfall for KM lies in not inherently linking it to the Business Strategy.
Without an effective KM program, organizations risk not achieving the objectives established by their overall business strategy, which is of course uppermost in the minds of most senior executives. Indeed, establishing that KM plays an active role in accelerating products to market, improving stability of supply, helping to identify risks to product quality, or reducing the threat of recalls—emphasizes to senior management the true potential for KM. Unveiling this line of sight to the business strategy is even more critical in the current environment of the biopharmaceutical industry as it continues to transform due to a variety of trends and drivers.
A second common pitfall is from implementing that KM is not understanding how to establish successful, sustainable knowledge management solutions.
Like the old parable about the blind men and an elephant (Sato 1927), each believing they know what it is they have discovered, some involved in KM solution roll out claim too quickly and too easily that a KM program or solu-tion has been achieved without stepping back to understand the big picture and all associated interconnections.
It is crucial to understand this big picture, and create the right foundation on which to establish KM success. A holistic and comprehensive approach includes focus on people and process, in addition to technology and gov-ernance. Many have attempted KM, suggesting “if we build it [KM], they will come.” However, experience across multiple industry sectors has clearly illustrated this is not the case.
A 2014 study by APQC (2014) on managing content and knowledge explored the link between content management and knowledge manage-ment. Content management (CM) is a close cousin of KM is sometimes even treated as a KM solution yet more often than not it is implemented as an IT solution without a larger understanding of KM principles and practices. The APQC study found that organizations who have incorporated content man-agement as part of a formal KM strategy are seven times more likely to report their overall content management is effective than when content management is deployed on its own. This is just one example of how an effective KM strat-egy helps establish a solid foundation for business processes.
The purpose of this chapter is to present a new framework that describes how these key KM foundational elements of practices, pillars and enablers and overall business strategy relate to each other.
184 A Lifecycle Approach to Knowledge Excellence
A Framework for Knowledge Excellence
Research has proven that knowledge management programs that are focused on delivering targeted business results or outcomes are more likely to be both successful and sustainable (Prusak 1999; Chua and Lam 2005). It is critically important to select KM outcomes that will help the organization deliver on its strategic objectives as these are more likely to sustain the business investment in the KM program, elicit sponsor commitment, and enhance employee engagement. Aligning the KM program with the strategic busi-ness objectives increases the chances that the KM initiative will withstand the inevitable transitions in leadership, portfolio prioritizations, and other unforeseen challenges likely to present over time. Thus, conveying the best possible chance that the KM program will remain relevant, and continue to build on successes for the long haul.
It is imperative to think about knowledge management not simply as a solution, or as a tool—these both have narrow, restrictive connotations—but rather as a knowledge-focused business capability. A capability is defined as the ability to do something and in this case that something is to manage knowl-edge. In this chapter, we will henceforth refer to these knowledge-focused business capabilities as KM practices, which encompass the holistic application of the concepts to be presented in the upcoming framework.
Before the framework is introduced one final key concept must be addressed. KM is generally understood to encompass caring for, curating, directing, and making decisions about organizational knowledge assets.
More importantly, KM is about enabling knowledge to flow in order to achieve the desired business outcomes (higher quality, more stable supply, faster problem solving, increased employee engagement, etc.), which in turn, will help the business achieve its long-term strategic objectives.
Figure 12.1 introduces the House of Knowledge Excellence, which provides a framework to clearly link the KM program to the business strategy. By maintaining a clear line of sight from the business strategy to the support-ing KM objectives, a thoughtful and relevant KM strategy and supportsupport-ing KM program can be established. This alignment is critical to the KM pro-gram providing value in the eyes of senior leadership and other stakeholders within and outside the company.
The following sections will help to illustrate how the individual elements of the house relate to each other and will provide more insight and examples for each element.
Challenges Shaping the Face of KM in the Biopharmaceutical Industry When considering KM, in particular as a key enabler in delivering an ICH Q10-based Pharmaceutical Quality System, there are several questions that arise regarding the impact of recent external trends and drivers (Figure 12.2):
185 The House of Knowledge Excellence—A Framework for Success
• What are the opportunities for KM to have a meaningful impact in the biopharmaceutical industry?
• How can KM help biopharmaceutical companies deliver medicines and other therapies to patients more rapidly?
• How could an effective KM program support operational efficiencies for the company, improve employee engagement, and help address many of the other challenges that face the industry?
As discussed elsewhere in this book, in an environment of mergers and acqui-sitions, increasing regulatory expectations and baby boomers retiring (to name but a few), taking a fresh KM perspective of these challenges may be helpful.
Table 12.1 lists a subset of common challenges, trends, and drivers fac-ing the industry today, coupled with elements of business strategies (and
Understanding the impact of external trends and drivers.
186 A Lifecycle Approach to Knowledge Excellence
TABLE 12.1
Challenges, Trends, and Drivers Facing the Biopharmaceutical Industry
(a) Challenge, Trend, or
Past knowledge not easy to find/not findable
187 The House of Knowledge Excellence—A Framework for Success
(a) Challenge, Trend, or
Mergers and acquisitions Increase technical capabilities, optimizing that can be scarce (labor intensive and expensive)
Past knowledge not easy to find/not findable Emerging markets Effectively and efficiently
supplying products to
Challenges, Trends, and Drivers Facing the Biopharmaceutical Industry
(Continued)
188 A Lifecycle Approach to Knowledge Excellence
associated business objectives) that are typically invoked to address these challenges, with the potential barriers to knowledge flow identified that put that strategy or objectives at risk.
When examining challenges, trends, and drivers within the industry, it is important to emphasize there is no one-size-fits-all KM approach is avail-able to address them. However, when challenges are described in terms of knowledge flow barriers, common themes begin to emerge. Understanding
(a) Challenge, Trend, or
Baby Boomer retirement Business continuity Retirees not replaced when they leave
Retirees not willing to share knowledge meet the expectations of the new workforce Virtual/remote workers Reduction of facility
footprint
Reduction in people-to-people interaction—the water cooler and coffee station do not exist
Risk of colleagues not developing an internal network—less connectedness and awareness of other peers in the organization
TABLE 12.1 (Continued)
Challenges, Trends, and Drivers Facing the Biopharmaceutical Industry
189 The House of Knowledge Excellence—A Framework for Success
these knowledge flow barriers is the first step in defining which KM practices will be required to achieve success.
Furthermore, it is not just the KM practices themselves that will help to address the business drivers. In practice, a key factor lies in influencing how the work gets done. Successfully embedding KM practices within an orga-nization to ensure knowledge flow requires changes in the behavior of the people doing the day job. This is especially the case in large, well-established organizations that can be slower to adopt newer, more agile ways of working in response to changes in technology and the incoming workforce.
In another recent study conducted by Knoco (2014) the top reason cited for not doing KM was that the culture was not yet ready for KM. For KM to truly succeed, employees must think and act differently in how they seek and share knowledge, and recognize the value and importance of knowl-edge flow rather than knowlknowl-edge hoarding.
To address this People challenge, KM teams may opt to build skills and capabilities by leveraging tools from well-established change management methodologies. These methods can help to target the desired behaviors for knowledge seeking and sharing while identifying and addressing any risks to the successful realization of the KM program. Standardized processes and practices should be developed that embed knowledge seeking and sharing capabilities in the flow of the day-to-day work. These processes and practices should actively encourage employees to ask for help when solving a problem instead of using excessive time and resources to solve it through heroics.
It is also important to understand that as the millennial generation ascends to make up the majority of the workforce following the retirement of the baby boomers, work styles, norms, and company culture will begin to reflect this new generation of workers. Inevitably, the mechanisms and behaviors for sharing knowledge will also change and it is therefore imperative for the com-pany to acknowledge and address this in their KM strategy if it is to succeed.
A good example of this change is evidenced in a recent internal focus group undertaken by Merck. The focus group discovered that millennials have a preference for self-service or the use of a trusted network for finding informa-tion. When asked how they gather information to solve a problem outside of work, their response typically was Google and YouTube, somewhat tellingly
A good example of this change is evidenced in a recent internal focus group undertaken by Merck. The focus group discovered that millennials have a preference for self-service or the use of a trusted network for finding informa-tion. When asked how they gather information to solve a problem outside of work, their response typically was Google and YouTube, somewhat tellingly