The Use of Stability Modelling to Support Accelerated Vaccine Development & Supply
16th May 2022 | 10:00am EST / 7:00am PDT / 3:00pm GMT / 4:00pm CET | Didier Clenet, Research Scientist Formulation & Stability chez Sanofi Pasteur, Jos Weusten, Senior Statistician and Applied Mathematician at MSD (Oss, The Netherlands), Marilena Paludi, Lead Statistician presso GSK, and Cristiana Campa, Technical R&D Advisor at GSK |WATCH FOR FREE
Stability assessment is particularly relevant for vaccines, due to the typical need for cold storage to remain stable. When stability evaluation is exclusively based on real-time data, it may represent a bottleneck for rapid and effective vaccine access. Stability modeling for vaccines represents a key resource to predict stability based on accelerated stability studies. This Webinar session reports a cross-company perspective on stability modeling for vaccines, demonstrating that modeling approaches can be highly valuable to predict vaccines’ shelf life and behavior during shipment or manipulation. Also, it is demonstrated that modeling methodologies need to be tailored to the nature of the vaccine, the available prior knowledge, and the monitored attributes.
Presented by Didier Clenet, Research Scientist Formulation & Stability chez Sanofi Pasteur
Didier has joined R&D Formulation & Stability platform of Sanofi-Pasteur in 2011. He focuses his work on screening of formulations, stability modeling of bioproducts and advanced analytics for process optimization. For more than 15 years in Sanofi R&D, Didier was dedicated on physical and biophysical characterization of active ingredients, freeze-dried products and biotherapeutics (mAbs, ADC). He has extensive experience with bioproduct development and their stability predictions. He has published several articles in peer-reviewed journal, 1 book chapter and more than 20 presentations to his credit. He is coaching young scientists and performed courses in several Universities
Jos Weusten, Senior Statistician and Applied Mathematician at MSD (Oss, The Netherlands)
Jos has joined the Center for Mathematical Sciences of the Manufacturing Division of MSD in the Netherlands in 2018. Building on his wide experience during his previous work for in-vitro diagnostics and analytical chemistry, his work now focuses mainly on statistical support for biologics, in terms of method validation, method transfer, process characterization, experimental design, comparability, stability studies, et cetera. He is always searching for opportunities to develop and implement new data analysis strategies, such as Bayesian methods and analyses based on first principles rather than black box modeling. He coaches young scientists who are relatively new in the field of applied statistics in an industrial environment. He has published several articles in peer-reviewed journals.
Marilena Paludi, Lead Statistician presso GSK
Marilena is a Lead Statistician in Global Vaccines Technical R&D at GSK. She received a Mater Degree in Statistical and Economic Science from the University of Siena and joined GSK (prior Chiron Vaccines and Novartis Vaccines) in 1996, where she gained experience in statistics applied to the development of biological methods and preclinical studies, development of software for labs and manufacturing support. She is now focusing her work on providing general and technical statistical expertise to support all the non-clinical aspects of vaccine’s development, including processes, formulations, analytical and biological methods, and stability. She has participated in industry initiatives related to Quality by Design. She coaches young statisticians who are relatively new in the field of statistics applied to the specific environment of vaccine development. She has published several articles in peer-reviewed journals.
Cristiana Campa, Technical R&D Advisor at GSK
Cristiana Campa, PhD, is currently a Technical R&D Advisor and Fellow at GSK Vaccines, with involvement in scientific advocacy on CMC strategies and innovation. She has more than 20 years’ experience in biologics and related analytical and development strategies, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as 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 acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps