Virtual Europe Discussion Group
The Virtual Europe Discussion Group provides opportunities for the broader community of industry, academic, and regulatory professionals to meet and share ideas and experiences. The group will discuss scientific challenges in the field of biopharmaceutical development and regulation with a focus on Europe.
The Virtual Europe Discussion Group goals include:
- Share learning across industry, academia, and health authorities across Europe, with a focus on speakers from across the region.
- Generate new scientific and technical insights and solutions for developing biopharmaceutical products in the future.
- Contribute to the expansion of CASSS’ mission, vision, influence, and community in Europe.
Click on the sections below for detailed information:
Platform Analytical Procedures | Virtual | 22 May 2025 15:00 CET
The Virtual Europe Discussion Group provides opportunities for the broader community of industry, academic, and regulatory professionals to meet and share ideas and experiences. Register by 21 May 2025.
Platform Analytical Procedures | Virtual | 22 May 2025 15:00 CET
Join Featured Speakers Mark Eggink, Byondis, Mark Milford, Eli Lilly and Company, Karen Rule, Pfizer, Inc., and Featured Panelist R. M. "Martijn" van der Plas, Medicines Evaluation Board. Register by 21 May 2025.
Featured Speakers
Mark Eggink
Byondis
Mark Eggink earned his PhD in analytical chemistry from Vrije Universiteit, Amsterdam, where he specialized in using multidimensional comprehensive chromatography and mass spectrometry to detect oxidative stress biomarkers. Since 2008, he has been working at Byondis (formerly Synthon Biopharmaceuticals). As a Principal Scientist, he leads a team dedicated to upstream and downstream process development support, method development, and quality control for innovative monoclonal antibodies and antibody-drug conjugates. His expertise spans chromatography, electrophoresis, and compendial testing, with a focus on critical quality attributes such as N-Glycans, aggregation, charge distribution, purity, fragmentation, and drug distribution. Additionally, he serves as an analytical project manager for various CMC projects and contributes to the analytical sections of regulatory documents.
Mark Milford
Eli Lilly and Company
Dr Mark Milford is an analytical scientist with over 25 years of industrial experience in the protein analytical field. Earning his PhD from the University of Southampton (UK), Mark’s industrial experience has spanned analytical roles in development, commercialization, and routine manufacture of biopharmaceuticals, most recently in the analytical testing of monoclonal antibody products. Currently holding a position of Director - Analytical with Eli Lilly, based at the Kinsale manufacturing facility, Milford has technical oversight of analytical aspects of new product introduction and commercialization for biopharmaceutical drug substances, both at the Kinsale manufacturing facility and across the Lilly analytical network, overseeing the analytical method lifecycle and driving analytical control strategy.
Milford has a particular interest in analytical procedure development, validation, and post-approval lifecycle from a large molecule perspective. As such, Milford holds the position of Industry Expert on the ICH Implementation Working Group for ICHQ2(R2) / ICHQ14, as well as Deputy Topic Lead for the EFPIA ICHQ2(R2) / ICHQ14 Support Group.
Karen Rule
Pfizer, Inc.
Karen Rule is a director in analytical R&D (Biotherapeutics Pharmaceutical Sciences) at Pfizer, based in Massachusetts, USA. She has been with Pfizer for 24 years working in multidisciplinary areas including bioassay/potency development, analytical project lead, and currently leads a group that is responsible for analytical regulatory strategy and authoring of analytical sections for the submissions across vaccines, mAbs, gene therapies, ADC, and other mAb-like products. Her experience has covered method development, characterization, comparability, control strategy, method validation/transfer, and health authority interactions. Over the past few years, Rule has been working with a team at Pfizer to help define the expectations and implement platform analytical procedures for late-stage products.
Featured Panelist
R. M. "Martijn" van der Plas
Medicines Evaluation Board
Dr R. M. (“Martijn’) van der Plas is a senior assessor for biological products at the Medicines Evaluation Board, and previously RIVM where he started working as assessor in 2000. His fields of attention include biosimilars, monoclonal antibodies, and recombinant proteins and plasma-derived products in general.
van der Plas obtained a PhD degree in 1999, with the thesis ‘Structure and Function of Human von Willebrand Factor’. He obtained a ‘doctorandus’ (M.Sc) degree in 1994 with a major in molecular pharmacology. van der Plas is a member of the Biologics Working Party (EMA/CHMP, Amsterdam) and an expert of the European Pharmacopoeia (Group 6B plasma products; MAB Working Party, EDQM, Strasbourg).
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Register Now
Save your spot for the NEW Virtual Europe Discussion Group on 22 May 2025. Register by 21 May 2025.
