21 October 2019, Gothenburg/Sweden
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.
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.