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Monday 2nd December, 2024 – Pre-Conference Day - GMT (Greenwich Mean Time, GMTZ)
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Monday 2nd December, 2024 – Pre-Conference Day - GMT (Greenwich Mean Time, GMTZ)
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Showing 1 of 1 Streams
Registration
08:00 - 09:00
Registration & Coffee
Showing 2 of 2 Streams
Tech Transfer for Advanced Therapies
QbD Applied to the Development of Cell & Gene Therapies
09:00 - 09:30
The Tech Transfer Landscape for Advanced Therapies
- Overview of the Tech Transfer landscape, specifically in regard to CGTs: a complex and new field.
- Key challenges when approaching tech transfer (in house or outsourced).
- Considerations for IP and regulation.
09:30 - 10:15
Realizing the Promise of Cutting Edge Technologies for CGT Production during Tech Transfer
- Identifying and assessing commercial potential of novel technologies for use in CGT production.
- Due diligence processes during technology evaluation.
- Balancing innovation with market needs.
- Working collaboratively with multiple stakeholders.
- Considering your therapeutic development needs and how to align with cutting-edge technologies.
10:15 - 10:30
A Therapeutic Developer’s Guide to Successful Tech Transfer
- Navigating the tech transfer process from a developers perspective
- Key milestones and challenges along the journey:
- Finding a suitiable CDMO
- Scaling up
- IP hurdles
- Building a winning team, what expertise and partnerships were crucial for successful tech transfer
09:00 - 10:30
Relevant Regulatory Background in the Field of CGT + QbD/Quality by Design (QbD) Concept and Approaches
Relevant Regulatory Background in the Field of CGT and QbD
- Laws and Guidelines
- CMC requirements
- Definitions
Quality by Design (QbD) Concept and Approaches
- Gain a practical guidance to QbD
- How to apply QbD
- Step by step approach from Target Product Profile to critical process ranges
- Generation of product and process knowledge
- Learn how to link product and process characterization together
- Overview of development throughout the lifecycle
- Specificities to CGT
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Showing 1 of 1 Streams
Networking Break
10:30 - 11:00
Morning Break
Showing 2 of 2 Streams
Tech Transfer for Advanced Therapies
QbD Applied to the Development of Cell & Gene Therapies
11:00 - 11:30
IP and Legal Considerations within Tech Transfer for your Therapeutic Development
- Importance of IP protection in tech transfer for CGTs.
- Strategies for patenting and protecting CGT inventions.
- Managing IP ownership and collaborations with universities/research institutions, as well as vendors.
11:30 - 12:00
Wrap Up Q&A
11:00 - 12:00
Risk Management Methodologies and Practical Considerations
- Different Risk management methods and tools
- Learn how to assess risks and managing the risks
- Linkage studies
- Examples for Failure Mode, Effect and Criticality Analyses (FMECA)
- Case studies in the field of CGT
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Showing 1 of 1 Streams
Networking Break
12:00 - 13:00
Lunch
Showing 1 of 1 Streams
QbD Applied to the Development of Cell & Gene Therapies
13:00 - 14:30
Stages in Process Development + Process Characterization
Stages in Process Development:
- Examining design, qualification and validation - Discover what to do and when
- Pre-requisites to start production for clinical studies
- Product and Process development & characterization
- How to define preliminary critical quality attributes (pCQAs)
- Linkage studies of preliminary critical quality attributes (pCQAs) and preliminary critical process parameters (pCPPs)
Process Characterization:
- Small-scale process model definition and utilization
- Learn how to use small process models
- Statistical models
- Proven Acceptable Range studies & Design Space development
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Showing 1 of 1 Streams
Networking Break
14:30 - 15:00
Afternoon Break
Showing 1 of 1 Streams
QbD Applied to the Development of Cell & Gene Therapies
15:00 - 16:00
Process Development Gene Therapy & Cell Therapy – Typical Studies and Specific Requirements
- Process overview
- Objectives of main processing steps
- Cell lines (generation & characterization) - regulatory requirements
- Materials and risks
- Where processing under GMP needs to start?
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
16:00 - 16:30
Wrap Up & Feedback
16:30 - 16:35
Close of Pre-Conference Workshop Day
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