AGENDA AT A GLANCE

DAY 1
DAY 2

Unlocking Commercial Success & Global Supply in DACH’s Cell & Gene Therapy

Quality Assurance & Process Intensification
Decentralised Production for Next-Gen Cell & Gene Therapies
Single-Use & Facility Strategies
Overcoming Bottlenecks in Viral Vector Manufacturing
Manufacturing Innovations for Allogeneic and In Vivo Therapies
Industry Roundtables: What's Next for Bioprocessing in CGT?
Smart Factories: The Role of Digitalisation & AI
Key Takeaways
Supply Chain & Logistics
Drink Reception
End of Conference
VIEW DAY 1
VIEW DAY 2

Day 1

11 February 2026

GO TO DAY 2

8:30

Registration & Coffee

8:50

Chairman’s Address

Cristina Castro González de Vega, Head, Cell & Gene Value Chain Product Management, Roche Switzerland

Unlocking Commercial Success in DACH’s Cell & Gene Therapy

9:00

Opening Keynote: Pathways for CGT in Germany, Austria & Switzerland

  • Regulatory and reimbursement landscapes across Germany, Austria, and Switzerland
  • Manufacturing capacity, infrastructure, and scale-up challenges in the DACH region
  • Enablers for clinical-to-commercial transition of CGT therapies
Alessandro Linciano | Site MSAT Head, Cell & Gene Therapy, Novartis, Switzerland

9:25

A Global Vision for Cell and Gene Therapies

Karin Abitorabi | Head Process Development and Innovation, Minaris Advanced Therapies, Germany

9:50

Accelerating Innovation through Translational Incubators

  • Bridging early research and clinical development through translational ecosystems
  • Infrastructure, partnerships, and funding models that accelerate innovation
  • Enabling faster, de-risked pathways from concept to patient impact
Dr Heiner Apeler | VP Head of Biologics Development Bayer, Germany

10:15

Beyond the Bench: Industrialising CGT to Accelerate Market Access

  • Transitioning CGT from lab-scale development to industrialised manufacturing
  • Overcoming scale-up, cost, and supply chain barriers to market access
  • Aligning quality, regulatory, and operations for sustainable commercial delivery
Cristina Castro González de Vega | Head, Cell & Gene Value Chain Product Management, Roche, Switzerland

10:40

Networking Break

Decentralised Production for Next-Gen Cell & Gene Therapies

11:15

Manufacturing Practices in AAV Gene Therapy Manufacturing - Current Challenges and Future Solution

  • Key manufacturing challenges in AAV gene therapy, from upstream to fill–finish
  • Ensuring consistency, quality, and scalability across clinical and commercial stages
  • Emerging technologies and process innovations shaping future AAV production
Steffen Schulze, Strategic Analytics & Business Analytics Lead, Roche, Switzerland

11:40

Decentralising Cell Therapy

  • Rationale and models for decentralized cell therapy manufacturing
  • Operational, regulatory, and quality challenges across distributed sites
  • Enabling technologies and digital strategies to support decentralisation
Dr. Jan Spanholtz, CSO, Glycostemб Germany

12:05

12:30

Lunch Break

Overcoming Bottlenecks in Viral Vector Manufacturing

13:30

Optimising & Automating Viral Vector’s Personalised Vaccines PreGMP Steps : Reducing Complexity & Driving Scale

  • Streamlining pre-GMP workflows for viral vector–based personalised vaccines
  • Automation strategies to reduce complexity and manual intervention
  • Building scalable foundations for downstream GMP manufacturing
Gabriella Cotugno | Head of Vector Construction and Development, Nouscom, Italy

13:55

From Variability to Reliability: Automating & Standardising CAR‑T Manufacturing Workflows

Maria Knaub PhD | Global Scientific Engagement Manager, Cell and Gene Therapy, Terumo Blood & Cell Technologies, Germany

14:20

Optimising & Automating Viral Vector’s Personalised Vaccines GMP Production : Lowering Costs & Driving Scale

  • Optimising GMP manufacturing workflows for viral vector–based personalized vaccines
  • Automation strategies to reduce costs and improve process consistency
  • Enabling scalable, compliant production for broader patient access
Dr Loredana Siani | Senior VP of Technical and CMC development, Nouscom, Italy

14:45

Panel Discussions: How to Reduce Manufacturing Costs in CGT

  • Automation & AI – Impact on Cost and Scalability
  • Standardization, Tech Transfer & Regulatory Alignment
  • What Will the Future Look Like?

Moderator

Dr Henrieta Fraser | Head Of External Operations, Cell & Gene Therapy Catapult, UK

Panelists

Roman Mijnhart | Vice President Quality EMEA, Ultragenyx, Netherlands
Dr Loredana Siani | Senior VP of Technical and CMC development, Nouscom, Italy
Volker Huppert | Chief Development Officer, Glycostem, Germany

15:35

Networking Break

Poster Exhibition:

Accelerating Next Generation Cell Therapy Manufacturing with Scalable Immune Cell Engineering Workflows

16:00

Roundtable Discussions

  • Best Practices for Scaling Autologous Therapies: What's Working Today?
John Bridgeman | CSO, Immunokey, UK
  • Ensuring GMP Compliance in Closed System Environments
Volker Huppert | Chief Development Officer, Glycostem, Germany
  • Automation in Allogeniec Cell Therapy Manufacturing
Dr Jan Spanholtz | CSO, Glycostem, Germany
  • Process Optimisation & Automation to Scale Up Personalised CGT
Dr Loredana Siani | Senior VP of Technical and CMC development, Nouscom, Italy

17:00

Key Takeaways

17:15

Drink Reception & End of Day 1

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Day 2

12 February 2026

GO TO DAY 1

8:40

Chairman’s Address

Amy Brennan | VP, RDOI Cluster Leader, Sanofi, Ireland

Quality Assurance & Process Intensification

8:45

Addressing Quality Challenges Across the CGT Lifecycle

  • Managing quality risks from early development through commercial CGT manufacturing
  • Ensuring consistency, compliance, and control across complex CGT processes
  • Integrating quality-by-design approaches across the product lifecycle
Brian O Connor | VP Global Quality, Orchard Therapeutics, UK

9:10

Process Intensification and Lifecycle Management Strategy of Biopharmaceuticals Post Launch

  • Applying process intensification to enhance efficiency and robustness post-launch
  • Managing lifecycle changes while maintaining regulatory compliance
  • Driving continuous improvement across commercial biopharmaceutical manufacturing
Philippe Baumgartner | Director Manufacturing Sciences, Takeda, Switzerland

9:35

Process Intensification Opportunities, Challenges and Solutions: Product Quality, Harvest and Scale up Considerations for Intensified Processes

  • Key opportunities and challenges in implementing intensified bioprocesses
  • Impact on product quality, harvest strategies, and process control
  • Practical considerations for scale-up and operational robustness
Dr Bassem Ben Yahia | Head of Cell Culture Process Sciences, UCB, Belgium

10:00

Networking Break

Single-Use & Facility Strategies

10:30

Balancing Stainless Steel and Single-Use Systems in Modern Biomanufacturing Facilities

  • Strategic decision-making between stainless steel and single-use platforms
  • Cost, flexibility, and sustainability trade-offs in modern facilities
  • Hybrid facility models to support scalability and long-term operations
Mohamed S. Chtaini, Executive Director – Global Biologics External Collaborations & Manufacturing, Incyte, Switzerland

10:55

Improving as a CDMO - A Place for Stainless Steel

Paul Bennett, Principal Scientist, R&D, Bioproduction by Sekisui, UK

11:20

Intensification by Design: Integrated Continuous Biomanufacturing for Viral Vector Processes

  • Designing integrated continuous platforms for viral vector manufacturing
  • Benefits of intensification across productivity, consistency, and facility footprint
  • Technical and regulatory considerations for continuous viral vector processes
Dr Thomas Villiger, Professor of Bioprocess Technology, University of Applied Sciences and Arts Northwestern Switzerland FHNW, Switzerland

11:45

Lunch Break

Manufacturing Innovations for Allogeneic and In Vivo Therapies

13:00

CARKey™ – A multi-specific, dual receptor CAR T platform to overcome solid tumour antigen heterogeneity

  • Addressing solid tumour antigen heterogeneity through multi-specific CAR T design
  • Dual-receptor architecture to enhance targeting and therapeutic efficacy
  • Platform potential for broader applicability across solid tumour indications
Dr John Bridgeman | CSO, Immunokey, United Kingdom

13:25

Ensuring Genomic Integrity in Therapeutic Genome Editing: Mitigating Off-Target Risks in CGT Development

  • Ensuring genomic integrity in therapeutic genome editing
  • Mitigating off-target risks in CGT development
  • Detection, design, and regulatory strategies for precision
Dr. Sandra Ammann | Team Lead Genotoxicity, Institute for Transfusion Medicine & Gene Therapy, University Medical Centre Freiburg, Germany

13:50

Networking Break

Smart Factories: The Role of Digitalisation & AI

14:15

Panel Discussion - Turning AI Potential into Impact in CGT & Biologics Manufacturing

  • How is AI impacting site operations and workflows
  • Utilization of data – potency testing and real-time release
  • Regulators’ reaction to AI

Moderator

Alvaro Avivar-Valderas | Associate Director - Cell Therapy Technology & Product Engine, Takeda, Spain

Panelists

Dr Jan Spanholtz | CSO, Glycostem, Germany
Alexander Hanke | Associate Director, Statistics & Modelling at TRD Biologics & CGT, Novartis, Switzerland

14:50

Application of Digital Twins in Biologics Development

  • Digital twins to model biologics processes
  • Enhancing process understanding and predictability
  • Optimizing manufacturing performance and quality
Dr Thomas Sauer | Head of Microbial Platform, Global CMC Development, Sanofi, Germany

15:15

Smart. Digital. Manufacturing

  • Implementing smart manufacturing technologies
  • Leveraging digital tools for process efficiency
  • Driving data-driven production and quality improvements
Amy Brennan, VP, RDOI Cluster Leader, Sanofi, Ireland

Supply Chain & Logistics

15:40

Transport Validation & It's Impact on Site Selection & Global Logistics

  • Transport validation requirements in biologics supply
  • Impact on site selection decisions
  • Optimizing global logistics and risk management
Marcel van Houten | Director Global Supply Chain, Orchard Therapeutics, Switzerland

16:05

Supply Chain Excellence in Translational Medicine: Strategic Procurement for Clinical Innovation at Wyss Zurich

  • Strategic procurement to support clinical innovation
  • Enhancing supply chain efficiency in translational medicine
  • Enabling agile and reliable clinical operations
Michael Nägeli, Head Supply Chain Management, Wyss Zurich, Switzerland

16:30

Chairman’s Closing Rearks

16:30

END OF CONFERENCE

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