Tracking Cells In Vivo to Better Understand Durability & Mechanism of Action

11:45am: Accurate Representation of the Human Immune System to Front-load Clinical Safety

• Understanding why model organisms have limited utility for cell therapy translation
• Front-loading safety and efficacy with in vitro models
• Translational data from model organisms

12:15pm: Group Discussion: Analysing Durability & Expansion Data to Gain an Understanding of What is Happening at a Cellular Level

• Reviewing cell data from clinical trials to understand durability level

• Assesssing expansion data to understand clinical outcomes

• Using this data to gain a better understanding of persistence at a cellular level

12:45pm: Networking Lunch

Widening the Scope of Clinical Trials to Other
Indications to Improve Clinical Trial Data &
Guarantee Regulatory Approval

1:45pm: Accelerating Development of CAR-T for Autoimmune
Disease Through Translational Medicine

• A translational talk highlighting CAR-T therapy in autoimmune disease

• Methods for evaluating activity and safety in various patient populations

• Recent and emerging data

Jenell Volkov, Senior Director Translational Medicine, Cabaletta Bio

2:15pm: Group Discussion: Optimising the Clinical Development of T cell therapies In Autoimmune Diseases

• Transferring lessons from oncology to autoimmune diseases
• Emerging challenges

Marlene Carrasco Alfonso, Global Clinical Head, Immunology Cell Therapy, AstraZeneca

Karin Enarsson Ringqvist, Senior Clinical Program Director, AstraZeneca

2:45pm: End of Clinical Development Track

Translating Manufacturing for Other Cell Therapies & Indications to Increase Efficacy & Ensure Success During Dosing

Chair: Frederik De Vos, Senior Director Quality Operations Advanced Therapies Platform, Johnson & Johnson

11:45am: Translation of PSC-Derived ProtoNK Platform: A
Unique CMC Process & Targeting Metastasis of Paediatric
Sarcoma

• Novelty of ProtoNK platform

• Development of our internal GMP manufacturing capability

• Moving towards clinical trial on lung and liver metastasis of Ewings sarcoma

Allen Feng, Founder & Chief Scientific Officer, HebeCell Corp

12:15pm: Novel CARs & New Applications – Implications for CMC, Process, & Analytics

12:45pm: Networking Lunch

Driving Automation in Manufacturing to Quicken
CAR-T Production & Improve Scalability

1:45pm: Advances in the Promise of CAR-T Automation

• Supply challenges for CAR-T

• Automation benefits and options

• Enabling data to support CAR-T for autoimmune disease

Houman Dehghani, Vice President Process and Analytical Development, Cabaletta Bio

2:15pm: How to Launch & Scale Up Successfully a Commercial CAR-T Product

• Main challenges in launching and scaling up CAR-T manufacturing and patient supply
• Driving patient experience as a critical success factor for an effective launch and accelerated growth
• Automation as an enabler of accelerated growth

Birk Vanderweeen, Senior Vice President, Global Manufacturing & Supply, Legend Biotech

2:45pm: Development of a Scalable Upstream & Downstream CAR-T Manufacturing Workflow at the Multi-Litre Scale

• Intensifying CAR-T cell expansion via optimisation of perfusion parameters in stirred-tank bioreactors
• Scaling up CAR-T production from 250mL to 2L in stirred-tank bioreactors
• Characterisation of a scalable and automated solution for downstream CAR-T cell harvesting and buffer exchange

Pierre Springuel, PhD Candidate, University College London