A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

Nuala Calnan, PhD has over 20 years’ experience in the pharmaceutical industry and is currently an adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Dr. Calnan's focus is on the integration of Knowledge Excellence, Operational Excellence, & Cultural Excellence in delivering enhanced quality outcomes for the patient and has led a recent Irish Industry research study in this field examining the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA. She is currently a member of the St. Gallen University led team who were awarded a one-year research grant by FDA examining the role of Quality Metrics in determining risk-based inspection planning. Dr. Calnan also works closely with industry in the areas of Quality Excellence and Metrics, Data Integrity and Quality Culture development. Dr. Calnan co-leads the ISPE Quality Culture Team and the ISPE/ PQLI Task Team on Knowledge Management. Martin Lipa is an Executive Director in Merck Manufacturing (MMD) and leader of the MMD Knowledge Management Center of Excellence (Knowledge Management CoE). For the past 8 years he has worked to create Knowledge Management strategy for Merck Manufacturing and other functions across the Merck enterprise and to build capabilities and competency in Knowledge Management as an enabler of the company’s strategy. Lipa has over 20 years’ experience in the biopharmaceutical industry. Prior to focusing on Knowledge Management, he started his career as a Technical Operations engineer and then progressed through roles in shop floor automation, computer systems validation, new GxP facility startup, project management and clinical supplies. He is also a certified LSS Black Belt and specializes in change management techniques. Lipa is a recognized industry Knowledge Management thought leader and has helped organize multiple Knowledge Management conferences. He has also published industry specific works and features as a regular speaker sharing his experience and learnings. Paige E. Kane, CPIP, is a Director in the Merck Manufacturing Division Knowledge Management Center of Excellence. In addition she is a regulatory science researcher at Dublin Institute of Technology in Dublin, Ireland where she is pursuing a PhD focusing in the realization of the ICH Q10 enabler – Knowledge Management. For the past 10 years, she has been involved in developing and implementing Knowledge Management Strategies for Wyeth and Pfizer Global Supply with a strong focus on people, collaboration, and processes. Kane has over 25 years’ experience working in a regulated environment (including Genetics Institute, Wyeth, Pfizer, Monsanto, and the US Government). Kane has been responsible for developing and implementing Quality Systems for GLP, GCP and GMP, as well as Computer System Validation programs. In addition, she provided leadership and Subject Matter Expertise for multiple biotech startups in the US and Europe. Kane is the Co-Chair of the ISPE/ PQLI Task Team on Knowledge Management.and serves locally as co-chair of the Boston ISPE Student Development Committee. Jose Menezes, PhD is founder and director of one of the earliest Pharmaceutical Engineering programs in Europe and a pioneer on the use of PAT and QbD tools in bioprocessing. He is the recipient of a Presidential Award for Excellence in University-Industry collaborations. Dr. Menezes is a Professor at the University of Lisbon since 2005. He has published extensively on the subject of manufacturing sciences and technologies applied to pharma and biotech products. He earned Chemical Engineering BSc and MSc degrees and a PhD in Bioengineering from ULisbon. He worked for Ciba-Geigy in Switzerland and the nuclear industry also in Switzerland, before embarking on an academic career. During his 20 years at ULisbon, he spent multiple sabbatical periods in industry at different pharma companies in Europe, where he built, trained or managed several PAT and QbD teams. He is an active member of several societies and a Senior Member of AIChE, ISPE, PDA and IFPAC among other organizations. Dr. Menezes co-founded 4Tune Engineering Ltd in 2004 – an award-winning ISO 9001:2008 engineering services company – developing and implementing worldwide state-of-the-art manufacturing sciences and technologies solutions, to deliver quality risk management and excellence in corporate Knowledge Management over life-cycle.

Making the Case for Knowledge Excellence in the Biopharmaceutical Industry. Why KM is Good Business. Theory of Knowledge Management. Knowledge Management - A Japanese Perspective. Accelerating the Opportunity for the Pharmaceutical Industry through KM. Perspectives on Knowledge. Who Moved My Facts? Valuing Knowledge at Swissmedic - A Regulatory Agency's Perspective. A Regulatory Perspective: Generating New Knowledge from Dada: A Perspective from NASA: Knowledge Services and Accelerated Learning in NASA. An Academic Perspective: Knowledge Management the Orphan Enabler - Enabling ICH Q10 Implementation. An Academic Perspective: Effective Knowledge Assessment. Knowledge Management and the Evolving Regulatory Process. Practices, Pillars and Enablers: Foundations for Successful KM. The House of Knowledge Excellence: A Framework for Success. A Holistic Approach to Knowledge Management: Pfizer Global Supply. KM Evolution at Merck: Managing Knowledge in Merck Manufacturing Division. Integrating Knowledge Management with Quality Management Systems to Manufacture Pharmaceuticals Consistently and Reliably. Working with the IS/IT Function to Set Up Your Knowledge Management Project for Success. Knowledge Management Implementation: A Guide to Driving Successful Technology Realization. Practices and Case Studies in Enabling Knowledge Flow. Let's Talk About Knowledge Management: Learning from the Library of Alexandria Disaster. Rapid and Robust Product Development Powered by Knowledge Management Capability. Knowledge Management Case Study: Using Near Real-Time Data Analytics and Performance Metrics to Ensure a Robust and Resilient Supply Chain. Knowledge Management Elements in Support of Generation of CMC Regulatory Documentation. A People Approach to Managing Knowledge: Why Do You Come to Work and Who Are You Working For? Developing a Lessons Learned Process - Where Lessons Are Learned: A Case Study of Pfizer Pharmaceutical Sciences. Capturing Critical Process and Product Knowledge: The Development of a Product History File. Communities of Practice: A Story about the VTN and the Value of Community. Identification of Critical Knowledge: Demystifying Knowledge Mapping. The Practical Application of a User-Facing Taxonomy to Improve Knowledge Sharing and Reuse Across the Biopharmaceutical Product Lifestyle: A Case Study. Knowledge Based Product and Process Lifecycle Management for Legacy Products