Tuesday 2nd December – Day 2 Main Conference - GMT (Greenwich Mean Time, GMTZ)
- Ian Rees - Assessor, MHRA
- Karin Hoogendoorn - Head Drug Product Development (CART, Oncology), Galapagos BV
- Malin Stridh - General Manager, MIDA Biotech B.V.
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
- Mehdi Gasmi - COO/CSO, SparingVision
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
- 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
- Karin Hoogendoorn - Head Drug Product Development (CART, Oncology), Galapagos BV
- 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
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
- 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?
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
- 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
- Dmitry Kalupin - CEO, Unlock Biology
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
- Wenshi Wang - SVP Tech & Ops, FosunKairos
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!
- 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
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)