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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Pre-Conference Workshop
The Impact of Pre-filled Syringe Components on Biopharmaceuticals 

21 October 2019, Gothenburg/Sweden

  • Platzhalter weiblich

    Andrea Hawe, PhD

    Coriolis Pharma

    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.

  • Simon Kervyn

    Simon Kervyn, PhD

    Datwyler
    Simon Kervyn graduated as a PhD in organic chemistry and materials from the University of Namur, Belgium in 2012. After research stays at National Institute of Materials Sciences in Tokyo and at UCLA, Los Angeles, he worked at the Coatings Research Institute in Belgium.
    He is now working for Datwyler as manager materials development. In this position he performs customer’s dedicated research to optimize the selection of rubber components to their applications. Furthermore, he works on the development of coated products for the Datwyler portfolio.
  • Koen Nuyts

    Koen Nuyts, PhD

    Nelson Labs

    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.

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    Susumu Uchiyama, Prof.

    Osaka University
    Susumu Uchiyama has been studying solution properties and structures of proteins for 20 years using various biophysical methods such as analytical ultracentrifugation and mass spectrometry. Factors that govern biophysical properties have been revealed based on the results from these methods. So far, he has more than 150 publications in international journals. Recent scope of his study focuses on the rational formulation developments of therapeutic proteins and quantitative analysis of protein aggregates. Especially how materials of container closure system affect stabilities of antibody dugs is one of his recent research interests.
  • Günter Waxenecker

    Guenter Waxenecker, PhD

    AGES MEA

    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.