21 October 2019, Gothenburg/Sweden
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last ten years with growing responsibilities in business development and technical roles. He is currently Director of Technology and Development at Terumo in Belgium.
Philippe graduated in Biotechnology from the University in Ghent, Belgium and worked as a scientific researcher at the Catholic University of Leuven.
Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment.
Philippe also serves as expert in ISO technical committees TC76 and TC84.
Andrea Hawe, is co-founder and Chief Scientific Officer of Coriolis Pharma, a science-driven contract research organization supporting drug product development of biopharmaceuticals, with focus on formulation development, lyophilization technologies and analytics (GMP and non-GMP) of biopharmaceuticals. Andrea has received her PhD degree in Pharmaceutical Technology from the Ludwig Maximilian University of Munich, Germany in the field of protein lyophilization and formulation. Prior to founding Coriolis Pharma (2008), Andrea has worked as post doctoral scientist at Leiden University, The Netherlands, on different projects related to protein characterization, innovative fluorescence based methods, development of heat-stable formulations for third world countries and immunogenicity. She is an expert for protein formulation and protein characterization, and has published more than 50 articles in peer-reviewed journals.
Roman Mathaes is Head of Pharmaceutical Services at Lonza DPS. In this role, he is responsible for primary packaging development and testing as well as device testing, tox and technical batch drug product manufacturing and the Lonza DPS lab automation group.
In his previous role at Lonza DPS, he was a Sr. Group leader in the Analytical Department performing drug product stability studies and leading the Lonza particle core facility.
Before his assignment Roman, worked within the Roche/Genetech network Basel/San Francisco.
Roman is a pharmacist by training and holds a PhD in pharmaceutical technology.
Roman is a adjunct member of the Pharmaceutical Department University Basel and authored 30 research papers in the field of Biotech Drug Product Development.
Koen received his Ph.D. in organic chemistry from the Catholic University of Leuven, Belgium. He has spent two years as a Marie Curie post-doctoral fellow at Procter & Gamble, Brussels Innovation Center, Belgium, during which he focused on process discovery and development. Currently, Koen works at Nelson Labs Europe as study director for Extractable and Leachables projects.
Günter Waxenecker is the Head of the Department Biologicals, Preclinical & Statistical Assessment at AGES MEA
Günter Waxenecker is biotechnologist and started in Research at Sandoz, later Novartis Research Institute in Vienna and worked as Project Leader and Program Manager in R&D for Igeneon, Pelias and Intercell. He holds a Master degree in drug regulatory affairs and is also lecturer in technical colleges.
Since 2007 he is working for the Austrian Federal Office for Safety in Health Care, and is involved in the evaluation of clinical trial applications, scientific advices, marketing authorisation applications and life-cycle processes. He is member of the CHMP Safety Working Party, representative to the EMA Pandemic task force, is drafting group member for different CHMP guidance documents.