Key Sessions
Lindsay Davies
Mesenchymal stromal cells - a novel approach to the treatment of type 1 diabetes
NextCell Pharma
Catriona Cromby
Igniting Innovation – Improving Patient Outcomes with Rare Disease Investment
LifeArc
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Tuesday 3rd December – Day 1 Main Conference - GMT (Greenwich Mean Time, GMTZ)
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Tuesday 3rd December – Day 1 Main Conference - GMT (Greenwich Mean Time, GMTZ)
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Registration
08:00 - 09:00
Registration & Coffee
Showing 1 of 1 Streams
Keynote Plenary
09:00 - 09:05
Welcome to Cell & Gene Therapy International: Europe – Chairperson’s Welcome
09:05 - 09:35
Opening Keynote from AstraZeneca
09:35 - 10:05
Igniting Innovation – Improving Patient Outcomes with Rare Disease Investment
- The forgotten millions: overview of the immense unmet need facing the rare disease community.
- How investment fuels recent breakthroughs, especially within cell & gene therapy
- The necessity of partnerships between researchers, investors, the industry, and patient advocacy groups to transform healthcare for rare diseases.
- Catriona Cromby - Associate Director for Technology Transfer and Rare Disease Challenge Lead, LifeArc
10:05 - 10:10
Transition to Track Rooms
Showing 2 of 2 Streams
Cell Therapy
Gene Therapy
10:10 - 10:40
Bridging the Gap: Accelerating Lifesaving Therapies
- Jan Talts - Chief Operating Officer, Amniotics
10:40 - 11:10
Spotlight Presentation
10:10 - 10:40
Case Study on AAV Gene Therapy Late-stage Development
- Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical
10:40 - 11:10
Spotlight Presentation
Showing 1 of 1 Streams
Networking Break
11:10 - 11:30
Morning Break
Showing 2 of 2 Streams
Cell Therapy
Gene Therapy
11:30 - 12:00
Mesenchymal stromal cells - a novel approach to the treatment of type 1 diabetes
- Lindsay Davies - Chief Scientific Officer, NextCell Pharma
12:00 - 12:30
Streamlining Success through Bioprocessing Decisions: Strategies for Multi-national Trials
- Ben Weil - Director of Manufacturing, INmune Bio
12:30 - 13:00
End to End Preparation is Key: a phase appropriate approach to commercial scale-up
- Pierce Kent - Head of CGT Supply Chain, Roche
11:30 - 12:00
Clinical Progress for Vectorised Antibodies Aided by AAV
- Pranav Puri, PhD - Senior Scientist, BioProcess Development, VectorY
12:00 - 12:30
Nuclear microRNA gene therapy: Use of AI-assisted discovery platform for transcriptional regulation
- Mikko Turunen, PhD - Founder and CSO, RNatives Inc.
12:30 - 13:00
Paving the Path for Innovation: Success Factors for Novel Gene Therapies
- Pre-emptive preparation for hurdles specific to novel gene therapies
- Mitigating risk strategies during early development
- Adaptable manufacturing solutions
- Engaging early with regulatory agencies to avoid bottlenecks.
- Considerations for first-in-human trials, including patient selection, safety monitoring etc.
Showing 1 of 1 Streams
Networking Break
13:00 - 14:00
Lunch
Showing 2 of 2 Streams
Cell Therapy
Gene Therapy
14:00 - 14:30
p38 MAPK inhibition - novel method to prevent CRS and enable safer administration of cell therapies
- Jeremy Skillington - CEO, Poolbeg Pharma
14:30 - 15:00
Streamlining Allogeneic Product Development with Platform Automation in 2D and 3D Systems
- Jason Dowd - Global Lead Cell Therapy Platform Process, Bayer
15:00 - 15:30
Spotlight Presentation
14:00 - 14:30
Next Generation Non-Viral Vector Development for Novel Gene Therapy Applications
- Overcoming issues of delivery efficiency and effectiveness of viral vectors such as AAV with cutting-edge non viral vector development
- The potential for improved safety for patients with more specific targeting
- Replacing viral with non-viral: how to implement
14:30 - 15:00
Novel Cell Engineering Platform for High-Yield AAV Production and Improved Manufacturability
- Larry Forman - CEO, CHO PLUS
15:00 - 15:30
Spotlight Presentation
Showing 1 of 1 Streams
Networking Break
15:30 - 16:00
Afternoon Break
Showing 2 of 2 Streams
Cell Therapy
Gene Therapy
16:00 - 16:30
Will AI accelerate Advancement? Computational Tools for Cell-based Therapy Production
- Mohamed Noor, PhD - Digitalization Manager, National Institute for Bioprocessing Research and Training (NIBRT)
16:30 - 17:00
Predictive analytics using AI augmented digital twins
- Christoph Herwig - Founder, Lisalis GmbH
16:00 - 16:30
Overviewing the Regulatory Landscape for Gene Therapies
- Echoes of the past: adapting existing guidelines to novel gene therapies
- Vector specific considerations surrounding safety and efficacy.
- Further evolution of considerations for emerging Non-Viral methods
- GMP requirements for gene therapy production, what quality control and consistency considerations need to be taken into account.
- Global Harmonization (or Lack Thereof): The complexity of navigating divergent regulations between countries/efforts towards international alignment.
- Recent changes in ICH Q2/Q14 and impact on gene therapy
16:30 - 17:00
From Promise to Patients: Translating Novel Gene Therapy Discoveries into the Clinic
- Charlotte Smerdon - Senior Director of Clinical Operations, Purespring Therapeutics
Showing 1 of 1 Streams
Networking Break
17:00 - 18:30
Evening Networking & Drinks Reception in Exhibition Hall
18:30 - 18:35
Close of Day One
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