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:
Accelerated Stability Prediction for Biotherapeutics | 12 May 16:00 CEST | Virtual
Join us virtually from anywhere in the world on 12 May at the Virtual Europe Discussion Group (VEDG) for a discussion on "Accelerated Stability Prediction for Biotherapeutics". Network with local and international CASSS members. Registration for this free opportunity closed 8 May.
Attendance and Substitution Policy
CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.
Accelerated Stability Prediction for Biotherapeutics | 12 May | Virtual
Stability modelling is a useful tool to complement scientific product understanding. It simulates the change of a quality attribute during long-term storage, based on observed stability behavior over 3 or 6 months at four different temperatures. Combined with molecular understanding derived from product characterization (e.g., high resolution peptide mapping coupled to mass spectrometry), stability modelling enhances development decisions.
We will discuss how stability modelling of a well-characterized antibody-like protein can justify higher prediction factors for shelf-life assignments, and more robust assessments of comparative stability studies or investigations of temperature deviations.
Stability modelling has the potential to accelerate patient access and improve the product control strategy, without increasing the risk to patients compared to standard approach. This informs product understanding, leads to faster development and ultimately to more robust regulatory applications.
Markus Blümel
Novartis AG
Markus Blümel is Director in Biologics Analytical Development at Novartis in Basel. In his role, Blümel provides scientific leadership and oversees cross-functional analytical processes for biologics, such as reference standards, specification setting, stability testing, comparability assessments, and support of in-use stability and compatibility studies. Blümel is a chemist by training, holding a PhD from the University of Frankfurt, Germany. For more than 25 years, he worked in analytical development and characterization of biologics, supporting a variety of programs in early development until submission as well as commercialization.
Andrea Ji
Genentech, A Member of the Roche Group
Andrea Ji is a Staff Scientist in Pharmaceutical Development at Roche Genentech. She received her PhD in analytical chemistry from Purdue University at West Lafayette. She has >25 years of experience in bio-pharmaceutical CMC, spanning from pre-clinical development to product launch. Her focus areas include protein formulation development of various dosage forms and modalities, combination products, process development and validation, stability, and comparability.
Drago Kuzman
Novartis AG
Drago Kuzman is Director at Science & Technology Unit at Novartis Biologics, Slovenia. He’s been with Novartis for 23 years. He has previously led Protein Biophysics and Bioinformatics as well as an Development Innovation Group. Kuzman is well recognized and published several articles in the field of Stability Modeling. He is also Novartis' representative on BIO predictive stability working group. Kuzman holds a PhD degree in medical sciences and did his post-doctoral training in France.
Iulia Oita
Ziphius Vaccines
Iulia Oita is CMC-Head of Analytics at Ziphius Vaccines, where she has been since 2022. She is a pharmacist by training and received her PhD in Pharmaceutical Sciences from Vrije Universiteit Brussel in 2012. She has worked for over 15 years in the pharma industry, involved in pre-clinical and clinical analytical development of small and large molecules. In her current position, she coordinates outsourced and internal analytical activities.
Daniel Skomski
Merck & Co., Inc.
Daniel Skomski is a Principal Scientist at Merck & Co., Inc., in Digital Technologies for Pharmaceutical Analysis. He received his PhD in Materials Chemistry from Indiana University. At Merck, he has worked on diverse modalities in small molecules, biologics, vaccines, and long-acting delivery. His current focus areas are predictive stability modeling and computer vision-based image analytics. He co-chairs an IQ industry consortium working group on predictive stability and has authored >30 peer-reviewed journal manuscript publications.
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Register Now
Save your spot for the Virtual Europe Discussion Group on 12 May 2026. Registration for this free opportunity closes 8 May 2026.
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