1-3 December 2025
Mercure Hotel MOABerlin, GermanyKey Sessions
Alexander Natz
Regulatory Panel Discussion – Navigating the Evolving European Regulatory Landscape for Cell and Gene Therapies
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Ian Rees
UK Update on Implementation of the Decentralised Manufacturing Framework
MHRA
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Tuesday 2nd December – Day 2 Main Conference - GMT (Greenwich Mean Time, GMTZ)
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Tuesday 2nd December – Day 2 Main Conference - GMT (Greenwich Mean Time, GMTZ)
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Streams
Showing 1 of 1 Streams
Registration
08:30 - 09:00
Registration & Morning Coffee
Showing 3 of 3 Streams
Cell Therapy
Gene Therapy
Round Tables
09:00 - 09:10
Chairperson's Opening Remarks
09:10 - 09:40
UK Update on Implementation of the Decentralised Manufacturing Framework
- Ian Rees - Assessor, MHRA
09:40 - 10:10
Panel Discussion: Bringing Cell Therapy to the Patient—Implementing Decentralised Manufacturing
- Karin Hoogendoorn - Head Drug Product Development (CART, Oncology), Galapagos BV
- Malin Stridh - General Manager, MIDA Biotech B.V.
10:10 - 10:40
Sponsored Scientific Track Presentation
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: RShah@informaconnectls.com
09:00 - 09:10
Chairperson's Opening Remarks
09:10 - 09:40
The Need for an Unbiased Assay to Detect and Quantify Replication Competent AAV in Clinical Vector Products
- Mehdi Gasmi - COO/CSO, SparingVision
09:40 - 10:10
Case Study: Potency Assays – Ensuring Consistency and Reliability for Gene Therapies – From Development to Standardisation
10:10 - 10:40
Sponsored Scientific Track Presentation: Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterisation
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: RShah@informaconnectls.com
09:30 - 10:40
Round Table Discussions
- Round Table 1: AI Revolution in CGT Manufacturing – Beyond the Hype: Where is it Having an Impact?
- Round Table 2: From Rare Diseases to Mainstream Markets: Unlocking CGT's Potential for Major Disease Indications
- Round Table 3: Supply Chain Mastery: Architecting Success from Bench to Market
Showing 1 of 1 Streams
Networking Break
10:40 - 11:20
Morning Coffee and Networking Break in Exhibition Hall
Showing 3 of 3 Streams
Cell Therapy
Gene Therapy
Focus Forum - Clinical Trial Design
11:20 - 11:50
How to Show Comparability for Fresh (Non-Cryopreserved) Autologous Ex-Vivo Gene Therapy Products, Manufactured across a Network of Decentralised Manufacturing Sites
- Karin Hoogendoorn - Head Drug Product Development (CART, Oncology), Galapagos BV
11:50 - 12:20
Case Study: Harnessing AI & Digitalisation for Cell Therapy Manufacturing Optimisation and Process Control
- Evaluating opportunities to integrate AI in CGT manufacturing
- Building data governance frameworks for verification & validation
- Developing more robust, adaptive to specific biology of cell therapies models
- Integration of AI process development and manufacturing
- Predictive analytics for CMC and manufacturing optimization
- AI-driven process development and real-time lot release
- Machine learning and digital twins: Applications & validation
- Overcoming challenges with limited data for AI models
- Data-centric processing: Integrating AI into CGT workflows
- Case study on AI-driven manufacturing success
12:20 - 12:50
Sponsored Scientific Track Presentation
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: RShah@informaconnectls.com
11:20 - 12:20
Panel Discussion: Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
- How to select CDMO partners? – Industry criteria for selection
- When / what stage of development should you bring on second CDMO?
- Understanding CDMO capacities, timelines, and capabilities
- Qualification, and quality agreements for commercial manufacturing
- Tech transfer: best practices and risk management
- Strategies for transferring product from development phase to CDMO for large scale production: How to scale up?
- Lessons learnt from transferring to CDMO and vice versa
- Increasing skills and experience in manufacturing of next generation CGT products
- Partnership and communication – how to partner most effectively with CDMOs?
12:20 - 12:50
Sponsored Scientific Track Presentation
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: RShah@informaconnectls.com
11:20 - 12:20
Panel Discussion: Innovations in Clinical Trial Design
- Strategies to shorten clinical development with compromising patient safety and product quality
- Design strategies for clinical trials
- Clinical endpoints – Key to success
- How to address clinical trial design for association therapies?
- Eric Halioua - President & Chief Executive Officer, PDC*line Pharma
Showing 1 of 1 Streams
Networking Break
12:50 - 14:00
Networking Lunch in Exhibit Hall
Showing 2 of 2 Streams
Cell Therapy
Gene Therapy
14:00 - 14:30
AI-Driven Dynamic Modeling for Optimising Cell-Based Immunotherapies
- Dmitry Kalupin - CEO, Unlock Biology
14:30 - 15:00
Qualifying and Validating Cell Counting and Viability Methods: Practical Considerations
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
15:00 - 15:30
Developing a Novel Digital PCR Based RCL (Replication Competent Lentivirus) Assay for Rapid Release of CAR-T Cells
- Wenshi Wang - SVP Tech & Ops, FosunKairos
14:00 - 14:30
Integrating Advanced Process Analytical Technologies (PAT) for Process and Product Monitoring and Quality Control
14:30 - 15:00
Panel Discussion: Beyond AAV- Non-Viral and Novel Delivery Systems – The Future of In Vivo Delivery Systems
Join industry experts as we explore the cutting edge of non-viral and next generation gene delivery. This dynamic discussion will cover:
- The Non-Viral Advantage – Where does it shine over viral vectors?
- Beyond the Liver – Innovative delivery routes (brain, tissue-specific targeting).
- Next-Gen Delivery Vehicles – How to utilise LNP and alternatives (EVs, VLPs etc) and machine learning-powered targeting
- Optimizing Payloads – Single vs. combination payload strategies
- Analytical & Regulatory Insights – Ensuring safety, efficacy, and consistency
- Future Trends – Will in vivo LNP therapies overtake ex vivo approaches?
- Collaboration & Acceleration – How can companies drive non-viral innovation?
Where is non-viral delivery headed? Let’s discuss the breakthroughs shaping the future!
15:00 - 15:30
Optimising LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
- Development of robust LNP delivery systems
- Optimising LNP engineering to minimize off site delivery
- Overcoming scalability and reproducibility challenges
- Critical parameters influencing LNP manufacturing efficiency, consistency, and scalability
- Optimising LNP formulation design
- Analytical control strategy for LNPs
- Manufacturing innovation: Reducing cold-chain dependence & improving temperature stability
- Supply chain considerations for commercial viability
- Case Study: Successful LNP Scale-Up
Showing 1 of 1 Streams
Networking Break
15:30 - 16:00
Afternoon Coffee and Networking Break in Exhibition Hall
Showing 1 of 1 Streams
Keynote Plenary
16:00 - 16:40
Regulatory Panel Discussion – Navigating the Evolving European Regulatory Landscape for Cell and Gene Therapies
This critical panel discussion brings together experts to explore the evolving regulatory frameworks affecting cell and gene therapy development in Europe.
- Alexander Natz - Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
16:40 - 16:45
End of Main Conference Agenda - Don't Miss Our 2 Post-Conference Workshops on 3rd December
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