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PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology ® 27 Qualit y Enhancing knowledge via KM practices: a smart in- vestment. Indeed, the opportunity is that knowledge is central to managing risk, making decisions, and ensur- ing product quality. Ensuring that knowledge is effec- tively managed (e.g., on-demand access and availability) via KM practices is a smart investment in the interest of patients. Further connecting QRM and KM with a framework such as the RKI Cycle can help the "system" perform as intended while further improving the out- comes of each QRM and KM practices. Ask oneself: "What would I expect as a patient?" Would you not expect the best possible knowledge to be available to support risk assessments, risk control, risk review, and risk communication if you were waiting on a pharmaceutical company to deliver you a new lifesav- ing therapy? Would you not expect that pharmaceutical organizations "know what they know" and "can find and apply what they know" to deliver the best possible out- comes to you as a customer? Beyond the framework: opportunities for biopharma as a knowledge industry. It is easy for organizations and the people employed by them to become consumed with day-to-day business and lose sight of the broader system to which their functional work contributes. Or- ganizational structures, differing priorities, divergent governance processes, and countless other factors can contribute to "silos" in the business where people be- come narrowly focused. Systems thinking is a means to counter this trend, where one can "zoom out" to un- derstand how the system works as a whole and how the major elements interrelate. It was such an opportunity the authors recognized in proposing the RKI Cycle—that QRM and KM generally were focused on excellence in their respective domains—but little attention was paid to how they worked together to enable the PQS. When one expands that aperture even further, it is possible to see a broad-knowledge "ecosystem," where knowledge is connected and enables a great many processes in pharmaceutical organizations, includ- ing technology transfer, change management, devi- ation management and investigations, process vali- dation, and others. In fact, if one were to zoom out to see the entire business unit or enterprise mapped at a process level, one could envision the relationships between these processes and the knowledge gener- ated and consumed by each, and how that knowl- edge must f low between these various processes. Multiple such frameworks exist, including the Process Classification Framework (PCF) tailored for the phar- maceutical industry, developed by the American Pro- ductivity & Quality Center (APQC) and IBM (24), which provides a detailed breakdown of processes and activi- ties to run a business. At the highest level, this consists of process categories such as operating processes (e.g., develop vision and strategy, deliver products) and sup- port processes (e.g., develop and manage human capital, manage information technology). One can then drill down into deeper levels of the PCF to reveal process groups, processes, and activities. The current version of the APQC PCF for the pharmaceutical industry in fact contains over 1200 rows across the four-tier structure to fully define the activities associated with operating a pharmaceutical business. With such an understanding of the business, one can envision developing and deploy- ing holistic KM practices to enable the business at large (notably, such a foundational capability is called out by the APQC PCF as a support process). Yet a further opportunity is to recognize and exploit the strengths and synergies of related practices in sup- porting the overall mission of the business, including the practices of knowledge management, operational excellence, organizational change management, learn- ing, and development, digital, and human performance, at a minimum. Each of these aims to drive improve- ments of some sort in how business is conducted and can be co-deployed for enhanced impact and benefit. Conclusion KM practice is still highly variable within pharmaceu- tical organizations, many of which treat KM as discre- tionary even though it is called out as a key enabler to an effective PQS in ICH Q10 (5). Yet, expectations for managing knowledge appear throughout regulatory guidance (and also in industry guidance which was not discussed in this paper) and can be directly linked to effectiveness in risk management and risk-based deci- sion-making. ICH Q9(R1) provides a renewed opportu- nity for the industry to recognize the foundational role knowledge and KM must play in support of risk manage- ment and risk-based decision making. Devoting energy and resources toward managing knowledge can clearly deliver worthwhile results. Beyond the ICH Q9(R1) driver to recognize KM prac- tice, as a society, we face a time of rapid and unprece- dented change. Considering product complexity (e.g., advanced therapy medicinal products) cost pressure, continued realignment of supply chains, societal expec- tation for accelerated development, advancement of new technologies, continued pressure on innovation, and a constantly evolving regulatory and economic landscape, never before has it been more important to integrate risk and knowledge to benefit patients and, indeed, our busi- nesses and other stakeholders. Disclaimer The views expressed in this article are those of the au- thors and are not necessarily those of any organizations with which the authors are affiliated. References 1. ICH, Q9(R1) Quality Risk Management, Final version (2023).