ISPE 2022 Member of the Year: Martin Lipa - An Advocate for Knowledge Management

The Max Seales Yonker Member of the Year Award honors the ISPE member who has made the most significant contribution to ISPE during the past year. It is named in honor of a dynamic woman who contributed to ISPE in many different ways and served as a source of inspiration during her battle with cancer.

An active member of ISPE since 2014, Marty was a key contributor to the ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. In 2022, he shared his expertise in knowledge management through an ISPE webinar, an Expert Xchange, articles in Pharmaceutical Engineer-ing®, and ISPE’s iSpeak blog. He is also a standing member of the ISPE Regulatory Quality Harmonization Committee’s Europe-Middle East-Africa Regional Focus Group.

Knowledge Management Beginnings

Marty has nearly 30 years of biopharmaceutical industry experience and currently leads knowledge management for the Manufacturing Division of Merck & Co., Inc. His prior experience includes various roles in technology, engineering, software validation, and IT. Marty is a Lean Six Sigma Black Belt, has a PhD from Technological University Dublin with a focus on improving knowledge management and its interdependency with risk management, and is an active member of the global knowledge management community as a regular speaker and author.

Marty’s journey to becoming an expert in knowledge management started 14 years ago. “I did not know knowledge management was a ‘thing’ until 2008, which perhaps isn’t surprising since knowledge management has only been around for about 25 years now, while quality risk management (QRM) has had 70 years to mature. I was the new IT business partner to Mike Thien, who at the time was the Merck Senior Vice President of MS&T [manufacturing, science, and technologies] and new product commercialization. Concurrently, quality by design (QbD) had introduced the concepts of ‘knowledge management’ and using ‘prior knowledge’ and was just taking off, with the release of the associated ICH Guidelines Q8, Q9, and Q10,” he said.

“At the time, we had people working in research who were developing models but had no idea how they performed in real-life manufacturing environments,” Marty explained. “There was no feedback loop to report what worked and what didn’t work. So, there was this discontinuity across the organization between research and manufacturing. Similarly, manufacturing didn’t know that research had done troubleshooting on a given problem, or who to contact to find out if they had. There was wasted time and duplicate knowledge creation and inefficiency.

“At the same time, Merck was merging with Schering-Plough Corp.: one day we had 20 manufacturing plants, the next day we had 91, and the right hand truly did not know what the left hand was doing. That really highlighted the need to better connect people across the manufacturing network.”

The next steps helped establish a foundation in knowledge management, Marty said. “This led to a year of research and learning about knowledge management, with a heavy dose of bench-marking knowledge management in other industries. An immediate lesson was that knowledge management was not an ‘IT thing’ but needed to start with a focus on people and process. In time, I had the opportunity to lead the development of our initial knowledge management strategy following a Six Sigma design methodology. A recommendation of the strategy was to have a dedicated knowledge management group, and I was privileged to be selected as the leader of the newly established knowledge management Center of Excellence.”

Knowledge Management’s Value to the Industry

“Of course I’m biased, but I think knowledge management is crucially important to our business—it’s indispensable,” Marty said. “We are, after all, in a knowledge industry: people create new knowledge, build on the knowledge of others, and think for a living. In fact, almost everyone in our industry is doing knowledge management in some fashion every day, whether it is how we store and search for documents, find experts, capture lessons, transfer knowledge, or connect via communities. But the reality is that most of these knowledge management approaches are highly variable, likely not scalable, and tend to be overwhelmingly localized. These challenges are magnified in larger organizations, but in reality, apply to everyone in our industry given the challenges we face internally (complex products, cutting-edge science, global supply chains, and supply challenges) and externally” (competition, pricing pressures, global markets, and post-COVID-19 expectations for speed).

“I believe there are three distinct and compelling drivers for knowledge management. First, regulatory drivers, starting with knowledge management positioned as an enabler of the PQS in ICH Q10. Second—perhaps with the biggest prize—is leveraging knowledge management for business effectiveness, such as improving process robustness, accelerated problem-solving, more effective technology transfer, and the like. This motivation alone has propelled knowledge management in other industries to a higher level than the pharmaceutical industry has yet to achieve. And the third driver is people. We are in a war for talent with other knowledge industries (and sometimes with each other). I believe those who can help their employees best navigate what their organization knows, to free up their energy to focus on their meaningful work, will have a competitive advantage in attracting and retaining talent.”

As part of Merck’s knowledge management journey, Marty set up a Virtual Technical Network of more than 25 different communities of practice and more than 5,000 employees joined to ask questions and share knowledge. “Magic happened when people started exchanging ideas. We have had wonderful success stories of saving clinical supplies, cost avoidance, and sourcing urgent equipment and materials. Someone told us, ‘I joined the company and thought I just had the people in my office to help me, but then I joined the global community and realized there were more than 200 people willing to help me.’ Another engineer said, ‘I was always afraid to ask a question, but once I did, I realized people just wanted to help.’”

Sharing Knowledge

Sharing his knowledge with others comes naturally to Marty. “I am passionate about teaching others about knowledge management for a few reasons. First, it’s just in my nature to share and help others. Second, I have found the knowledge management community to be very generous of time, advice, and ideas. I think this is because many of the knowledge management approaches are pre-competitive: there are details and best practices to the ‘what to do’ but much of the heavy lifting is making these approaches work in the culture of your organization. I have seen our journey come full circle from student to teacher. We have learned from many respected organizations, including Shell, Rockwell Collins, Boeing, American Productivity and Quality Center (APQC), United States Navy Sea, Air, and Land (SEAL) Teams, Microsoft, and many others. As we have thought deeply and worked diligently, we’ve had great results with savings in excess of $100 million, and have for some time now been asked to share our success stories by the likes of NASA, Corning, the World Bank, Columbia University, and many organizations in our industry.”

Knowledge management is crucially important to our business—it’s indispensable. Almost every­one in our industry is doing KM in some fashion every day.

Along the way, Marty has also become a teacher as well as contributor to the foundation of knowledge management, as Anne noted her nomination. Marty’s “research and contributions are centered on the patient. This research and his other contributions to the practice of knowledge management are ultimately foundational for an effective pharmaceutical quality system and its goals of ensuring safe and efficacious products while also enabling a state of control and the basis for continual improvement. These contributions have also been linked to better decision-making during risk management activities, as well as helping address the drug shortage challenges currently faced by the industry.”

Marty thinks that knowledge management holds a huge amount of promise for the pharmaceutical industry’s future. “In a time of post-COVID-19 expectations for accelerated product delivery, geopolitical uncertainty, and supply chain challenges, when the external manufacturing world has to be dynamic, there has never been a more important time to connect knowledge and risk.”

“I’m proud to be a member of ISPE because it is grounded in the practice of connecting and sharing knowledge,” Marty said. The network of people I’ve been able to meet and interact with is immeasurable. I’m very appreciative of ISPE and humbled to be recognized through this award. I want to acknowledge that I’ve had many friends and colleagues who have helped me on my journey and would like to thank my colleagues at Merck Manufacturing Division and TU Dublin for all of their support and partnership every step of the way.”