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.

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. Ca