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FIPSE 4.5 Webinar
The FIPSE Conference Series
and Vaccine Manufacturing
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The agenda of this webinar is as follows:
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The mission of the FIPSE conferences (14 min)
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Christos Georgakis, Tufts U., FIPSE Trustee & President
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FIPSE 1 to 4: What has been tried and achieved (14 min)
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Dominique Bonvin, EPFL, FIPSE Trustee & Treasurer
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Presentation on: "Quality by Digital Design for vaccine process development and manufacturing" (30 min)
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Cleo Kontoravdi, Imperial College
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Panel discussion (45 min)
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Claire Adjiman, Imperial College FIPSE Trustee,
Panel Chair,
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Cleo Kontoravdi, Imperial College,
Panelist
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Cristiana Campa,
GlaxoSmithKline,
Panelist
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Christos Varsakelis, Janssen Pharmaceutical,
Panelist
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Julia O’Neill,
Moderna,
Panelist (only in the first session)
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Biographical Sketches of Main Speaker and Panelists
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Cleo Kontoravdi is
Reader in Biosystems Engineering at the Department of Chemical Engineering, Imperial College London. Her research focuses on the application of systems engineering principles to bioprocessing. A large part of it is dedicated to understanding what process factors
control the quality of therapeutic protein products and to efforts of controlling these to achieve better production and quality targets. To achieve this, her group follows a holistic approach that combines experimentation with model-based design and optimisation
tools, which is an excellent vehicle for the industrial implementation of Quality by Design. She holds M.Eng. and Ph.D. degrees in Chemical Engineering from Imperial College London.
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Cristiana Campa, Ph.D.,
is currently a Technical R&D Advisor and Fellow at GSK Vaccines, with more than 20 years of experience in biologics and related analytical and development strategies gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing
on the development, validation, and transfer of analytical methods for the release and characterization of several vaccine products, first as a senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by
Design (QbD) principles implementation for vaccines. After the acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration. Until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation,
Knowledge Management, and Development roadmaps.
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Christos Varsakelis
leads the AI/ML compound profiling team in the Janssen Pharmaceutical Companies to accelerate drug discovery & development timelines. Before joining Janssen, Christos was a Senior Manager of Global Analytics & Innovation in GSK Vaccines focusing on
in silico process development. Besides working in the pharmaceutical industry, Christos has an accumulated professional experience that spans Geoconsulting, the stock market, and the chemical industry. Christos
holds a Ph.D. in fluid mechanics at UCLouvain in Belgium. He also holds a B.A. in Mathematics from the Aristotle University of Thessaloniki, Greece, and an M.Sc. in Applied Mathematics from ETH Zurich, Switzerland. His motto is innovation = cash.
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Julia O’Neill
is a Distinguished Fellow and leads the Modeling and Statistics team for Moderna as a Technical Development Leadership Team member. O’Neill worked at Merck as
Senior Scientific Fellow (Statistics) in Regulatory & Analytical Sciences. She was also Director in Global Technical Operations, with a primary focus on vaccines and biologics. She has over 30 years of experience bridging statistics and chemical engineering
in the pharmaceutical and chemical industries. Her education synthesizes statistics and engineering, with an MS in Statistics from the University of Wisconsin and a BS in Chemical Engineering from the University of Maine.
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