Pre-Con Workshop Day (27th April 2026) - CET/CEST (Cent Europe Summer, GMT+2)
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
- CMC Studies in the life cycle
- Requirements from Pre-Clinical to Phase 2 CT
- Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Patrick Garidel - Global Development CMC Biologicals, Boehringer Ingelheim
- Dzulija Kuzmenko - Sr. Scientist Biologics AD, Johnson and Johnson Innovative Medicines
- Rifat Kamarudheen - MSAT Emerging Tech Sr Scientist, Johnson and Johnson Innovative Medicines
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
CMC Studies in the life cycle
Requirements from Pre-Clinical to Phase 2 CT
Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Eva Diem - Process Expert; Bioprocess, Media & Analytics (BMA), Boehringer Ingelheim
- Simon Hawdon - Chief Technologist, CPI
- Martinus Capelle - Distinguished Scientist II in Drug Product Development & Delivery, Johnson & Johnson Innovative Medicines
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
CMC Studies in the life cycle
Requirements from Pre-Clinical to Phase 2 CT
Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
Breaking down departmental silos with cross-functional dialogue to answer:
The ICH Q13 Reality: how is the new guidance practically impacting process development, validation strategies, and regulatory filings?
Is the "digital twin" a practical tool for today or an expensive dream for tomorrow?
What is the first, most valuable step a company can take to leverage predictive modelling for continuous or intensified processes?
What is the single biggest organizational or cultural change required to successfully adopt continuous manufacturing?
How do we build and train the workforce of the future?
Beyond monoclonals, what will be the killer application for continuous processing in the next 5 years – Cell & Gene Therapies, vaccines, or other novel modalities?
- Shravan Kumar Eduru - AI Strategy Advisory, Angel Investor in MedTech & HealthTech
- José Ortiz Tena - Senior MSAT Manager, Roche
Device Integration: Connecting formulation science with patient-centric delivery systems. How do you design a formulation for an auto-injector from day one?
Aseptic Processing: How to approach and maintain aseptic conditions throughout final fill-finish stages to enhance safety?
Make vs. Buy: A strategic framework for navigating the fill-finish CDMO landscape. When should you build capacity, and how do you select the right partner?
The Regulatory Horizon: Preparing for future expectations in aseptic processing, data integrity, and the use of AI in manufacturing.
Sustainability: Addressing the growing need for sustainable and PFAS-free consumables in fill-finish operations.
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
- CMC Studies in the life cycle
- Requirements from Pre-Clinical to Phase 2 CT
- Case Study and Group Exercise
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
Takeda is committed to developing and producing life‑transforming therapies for the treatment of rare and complex diseases. In Austria, every step of the process for innovative medicines takes place: from R&D, plasma sourcing, to manufacturing, and distribution. Our employees help ensure that medicines from Austria reach more than 100 countries worldwide and that patients in Austria have access to Takeda’s innovative therapies.
At the production site in Vienna, every manufacturing step for therapies derived from human blood plasma takes place. These products can make a significant difference in the lives of people with rare and complex diseases, such as immune deficiencies or bleeding disorders.
During the tour, you will gain insights into one part of the process — the purification unit. In this purification step, specific proteins from human blood plasma are isolated and purified to produce life‑transforming therapies.
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Limited Spaces: Attendees must be registered for the pre-conference workshop day, and RSVP confirmed. Register for a spot by March 27th on the tour here.
Return transport will be provided by BioProcess International Europe.
- Lucia Gnauer - Head of PDT Process Development, Takeda