Day Three (15th May 2025) - CET/CEST (Cent Europe Summer, GMT+2)
- Karen Wohlers - Interim Team Lead Bioprocessing Development, Bluu Seafood
- A Representative - |, Novartis
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Zahra Rattray - Senior Lecturer, Strathclyde Institute of Pharmacy and Biomedical Sciences
- Stephane Busso - CLD Scientist, Biopharmaceutical Product Development, Fresenius Kabi
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Julia Müller - PhD Student, University of Applied Sciences and Arts Northwestern Switzerland
- Michel Eppink - Senior Director - Downstream Processing, Byondis B.V.
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Vighnesh Balan - Global Supply Chain Business Excellence Lead, Takeda
- Ulrich Rümenapp - Senior Biotech Program Lead, Bayer AG
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Omkar Kawalekar - Co-Founder, BlueWhale
- Andrew Harmon, MBA - Senior Consultant, Strategic Consulting, Latham BioPharm Group
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Lenny Zaffaroni, PhD - Senior Scientist, Bavarian Nordic
- Deborah Hol-Schop - Principal Scientist Upstream Processes, Byondis
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Niall Barron - Principal Investigator, NIBRT
- Lekan Daramola - Consultant, Freelance
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Sofia Carvalho - Senior Scientist, iBET
The applications of computational tools such as Artificial Intelligence and Predictive Modelling within the purification process
Bridging the gap between academia and industry in AI and Predictive Modelling adoption
Chromatography optimization
Reduction of manual tests to lower costs
Accelerating time to market with AI tools
Spotlight Presentation – Calling all Technology Thought Leaders!
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How CDMOs have evolved in the last 5 years and what to expect in the coming years
Geopolitical uncertainty and its impact on outsourced manufacturing
Collaboration to understand the changing needs of pharma and biotech
- Ulrich Rümenapp - Senior Biotech Program Lead, Bayer AG
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Tiffany Rau, PhD - Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
Overview of challenge landscape in Europe and beyond:
- Pricing, reimbursement, un-unified healthcare providers, HTA
- High cost of therapies, impacts on pricing and reimbursement
- Limited real-world evidence data
Global vs. regional considerations: Balancing harmonization with regional needs, adapting strategies, ethical considerations
Innovative strategies:
- Value-based pricing and innovative payment models
- Early & proactive engagement with payers and HTA bodies
Importance of patient advocacy and education
Navigating the complexities of the European regulatory and HTA environment
- Balancing the need for global harmonization with regional specificities
Spotlight Presentation – Calling all Technology Thought Leaders!
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- Verena Fischer - Lab Head Early Stage Upstream Development, Boehringer Ingelheim
This panel discussion will bring together experts from both upstream and downstream teams to discuss the challenges and opportunities in integrating these two critical stages of biomanufacturing. The conversation will focus on the harvest step as a key point of integration, exploring how upstream activities can influence downstream purification processes. Panellists will share insights on their limitations, expectations, and strategies for improving collaboration to reduce costs, optimize timelines, and enhance overall production efficiency.
- Thomas Jostock, PhD - Associate Director, Novartis
- Iris Bodenmann - Director, Cell Line Development, NewBiologix
- Yu-Tsan (Richard) Liu - Sr. Scientist, UCB Pharma
- Rundown from the week’s content and learnings:
- Regulatory Updates: navigating the latest EMA and MHRA Guidelines
- Addressing the Evolving Landscape of CDMOs and Pharma Companies
- CDMO Perspectives: Insights on Outsourcing Downstream Processing
- Best Practices: Sharing Knowledge and Expertise for Optimized Processes
- The Future of Downstream Processing: Trends, Innovations, and Challenges
- Cost considerations In downstream processing: optimizing for efficiency and profitability.
- Ben Weil - Director of Manufacturing, INmune Bio
Overcoming logistical and regulatory challenges
Cost reduction without compromising on quality
Opening conversations with regulators and healthcare hubs to capitalise on this expertise
- Regional differences (nationalised vs. private healthcare systems)
Potential for point-of-care manufacturing to enable truly personalised cell therapies
- Omkar Kawalekar - Co-Founder, BlueWhale
- Ben Weil - Director of Manufacturing, INmune Bio
- Ben Weil - Director of Manufacturing, INmune Bio
Overcoming logistical and regulatory challenges
Cost reduction without compromising on quality
Opening conversations with regulators and healthcare hubs to capitalise on this expertise
- Regional differences (nationalised vs. private healthcare systems)
Potential for point-of-care manufacturing to enable truly personalised cell therapies
- Omkar Kawalekar - Co-Founder, BlueWhale
- Ben Weil - Director of Manufacturing, INmune Bio