Thursday 18th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
- What to start early in the process?
- How early is too early to consider strategy for scaling up?
- How to define the right commercial scale early in development
- Best practices for locking in scalable processes from the start
- Designing therapies with long-term success in mind—beyond Phase 1
- Key considerations for commercial scale up, reimbursement, raw material availability, and regulatory approvals
- Pathways to developing safe, reimbursable therapies with broad patient access
- Francesca Vitelli, PhD - Former VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
- Kate Rochlin - Chief Operating Officer, IN8bio
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: Partners@informaconnectls.com
Onechain Immunotherapeutics developed a stromal-free bioprocess for the novo generation of γδ T cells from cord blood (CB) CD34+ HSPC or iPSC-derived CD34+, using recombinant Notch ligands, eliminating the need for expanding these cells from peripheral blood or other sources. The process can yield functional γδ T cells that can be armed with CARs with cytotoxic activity against multiple cancer cells. This strategy is highly scalable, consistent with GMP guidelines, and represents a step forward in the field of allogeneic, off-the-shelf CAR-T cell therapies.
- Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.
Through a series of case studies this session will focus on the latest innovations and advances in next-generation therapies.
- Explore cutting-edge preclinical and clinical case studies driving the future of cell and gene therapy.
- Discover how data-driven innovation is transforming therapy development, from control and targeting to tackling undruggable diseases.
- Unpack the challenges vs. traditional approaches, advancements in new modalities, and the manufacturing needs shaping commercialization of future therapies.
Key Case Studies Areas Include:
- Gamma Delta T Cells & T Cell Engagers
- mRNA, RNA, & NK Therapies
- Multiplex & Combination Cell Therapies
- 3D Bioprinting & Scaffold Development
- Solid Tumours & Expanding Disease Areas (Autoimmune, Neurology, Cardiometabolic)
- Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
- Reagan Jarvis - Chief Executive Officer and Co-founder, Anocca
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
Join industry leaders as we explore how AI, digitalization, and advanced analytics are transforming cell and gene therapy manufacturing. This dynamic panel will dive into:
- AI-Powered Manufacturing: How AI-driven models, predictive analytics, and digital twins are optimizing process control
- Process Analytical Technologies (PAT): The latest breakthroughs in real-time monitoring, automation, and data-driven decision-making
- Overcoming Data Challenges: Strategies to build robust AI models despite limited datasets
- Success Stories: Case studies showcasing AI and PAT integration for improved yield, efficiency, and product quality in cell and gene therapy manufacturing and process development
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting