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Cell & Gene Therapy International Europe
1-3 December 2025
Mercure Hotel MOABerlin, Germany
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Key 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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Showing 1 of 1 Streams
08:30 - 09:00
Registration & Morning Coffee
Showing 2 of 2 Streams
09:00 - 09:10
Chairperson's Opening Remarks
  • Klara Kulenkampff - Implementation Lead, Process Engineering & Technology, Bayer
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
  • Santiago Recuenco - Manager, Deloitte AG
  • Karin Hoogendoorn - Head Drug Product Development (CART, Oncology), Galapagos BV
  • Malin Stridh - General Manager, MIDA Biotech B.V.
  • Guido Moll - Assistant Coordinator EU-H2020 ATMP & GMP Projects, Charité, Universitätsmedizin Berlin
10:10 - 10:40
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
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
Advances in Analytical Method Development for the Characterisation of AAVs.
  • Christine Le Bec - Deputy CTO, Head of Analytical Development & QC, Sensorion
10:10 - 10:40
Sponsored Scientific Track Presentation: Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterisation

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Showing 1 of 1 Streams
10:40 - 11:20
Morning Coffee and Networking Break in Exhibition Hall
Showing 2 of 2 Streams
11:20 - 11:50
AI-Driven Dynamic Modeling for Optimising Cell-Based Immunotherapies
  • Dmitry Kalupin - CEO, Unlock Biology
11:50 - 12:20
Qualifying and Validating Cell Counting and Viability Methods: Practical Considerations
  • Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
12:20 - 12:50
Fosunova-T Manufacturing and Release Platform and its Product in Autoimmune Applications
  • Wenshi Wang - SVP Tech & Ops, FosunKairos
11:20 - 11:50
Panel Discussion: Beyond AAV- Non-Viral and Novel Delivery Systems – The Future of In Vivo Delivery Systems
  • Gonzalo Fernández-Miranda - CEO and Co-Founder, CureAge Therapeutics
11:50 - 12:20
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
12:20 - 12:35
Sponsored Scientific Track Presentation - A Representative from Chromatan
Showing 2 of 2 Streams
12:50 - 14:00
Networking Lunch in Exhibit Hall
13:00 - 13:45
Round Table Discussions
  • Round Table 1: AI Revolution in CGT Manufacturing – Beyond the Hype: Where is it Having an Impact?

Leader: Guido Moll, Assistant Coordinator EU-H2020 ATMP & GMP Projects, Charité, Universitätsmedizin Berlin

  • Round Table 2: From Rare Diseases to Mainstream Markets: Unlocking CGT's Potential for Major Disease Indications

Leader: Hiroyuki Usuda, Scouting & Transaction Lead, Business Development, Astellas Pharma Europe Ltd

  • Round Table 3: Supply Chain Mastery: Architecting Success from Bench to Market
  • Guido Moll - Assistant Coordinator EU-H2020 ATMP & GMP Projects, Charité, Universitätsmedizin Berlin
  • Hiroyuki Usuda - Scouting & Transaction Lead, Business Development, Astellas Pharma Europe Ltd
Showing 2 of 2 Streams
14:00 - 15:00
Panel Discussion: Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
  • Wenshi Wang - SVP Tech & Ops, FosunKairos
  • Martina Ochel - Chief Operating Officer, CuraCell
  • Bernd Muehlenweg - SVP, Head of Global Business Development, Cell Therapy - Global BD iPSC Cell Therapy, Evotec
  • Ulrich Ruemenapp - Senior Biotech Program Lead, Bayer AG
15:00 - 15:30
Integrating Advanced Process Analytical Technologies (PAT) for Process and Product Monitoring and Quality Control
14:00 - 15:00
Panel Discussion: Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
  • Wenshi Wang - SVP Tech & Ops, FosunKairos
  • Martina Ochel - Chief Operating Officer, CuraCell
  • Bernd Muehlenweg - SVP, Head of Global Business Development, Cell Therapy - Global BD iPSC Cell Therapy, Evotec
  • Ulrich Ruemenapp - Senior Biotech Program Lead, Bayer AG
15:00 - 15:30
Integrating Advanced Process Analytical Technologies (PAT) for Process and Product Monitoring and Quality Control
Showing 1 of 1 Streams
15:30 - 16:00
Afternoon Coffee and Networking Break in Exhibition Hall
Showing 1 of 1 Streams
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
Monday 1st December – Day 1 Main Conference
NextWednesday 3rd December, 2025 – Post-Conference Workshops
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