A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry (PDF)

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.