Conference Day Two
Thursday | 30 November, 2023
7:50 am Coffee & Networking
8:50 am Chair’s Opening Remarks
Reviewing Real-World Clinical Data to Understand True Efficacy of Off-The-Shelf Therapies
9:00 am Infusion of an Allogeneic Non-Engrafting Cell Therapy to Enhance Initial Remission Rates in Upfront AML Treatment
Synopsis
- Description of an ex vivo expanded allogeneic stem/progenitor cell product generated from pooled donor cord blood
- Results from a phase 2 global randomized controlled trial using this product in patients with newly diagnosed AML
9:30 am Panel Discussion: Leveraging the Experience of Cord Blood Banking in Development of Cellular Therapies
Synopsis
Along with gaining insights into how to tap into the expertise of cord blood banks and access therapy-matched cord blood units (CBUs), you’ll get a better understanding of:
- Comprehensive benefits of cord blood as an allogeneic cell source for cellular therapy
- Characteristics and attributes of the existing cord blood inventory
- Importance of managing logistics for delivery of CBUs from the bank to the cell therapy developer
- Alternative banking and attribute models that may be needed in the future to support novel therapies
10:00 am Morning Break & Group Networking
Exploring Different Cell Sources for Best-In-Class Starting Material
11:00 am Cord Blood HSCs Expanded With a Novel Molecule as a Source for Immunotherapies
Synopsis
- Phenotypic, functional, and quantitative assessment of HSCs expanded with IBR403
- Small scale screening, and comparability to large scale manufacturing
- Functional qualification of NK cells derived from expanded HSCs
11:30 am Promises & Challenges of Choosing Pluripotent Stem Cells (PSCs) Lines for Future Allogeneic Cell Therapies
Synopsis
- PSCs Offer Sustainable Cell Source for Future Cell Therapies
- Not all PSCs Created Equal
- New Technologies of Generating Compliant PSCs
12:00 pm Lunch & Networking
Exploring Different Cell Sources for Best-In-Class Starting Material
1:00 pm Roundtable Discussion: Exploring Scalability Approaches for Platforms With Different Cell Source Starting Materials
Synopsis
- Discussing the inherent challenge of scaling up for commercial manufacturing if started with a limited starting material
- Exploring the advantages of an artificial pool of unlimited starting material such as iPSC
- Comparing scale up potential with iPSC versus scale out potential with CAR-T, NK, PBMC and mor
1:28 pm
Rethinking Clinical Trial Design to Improve Quality of Assessed Outputs
2:00 pm Connecting Developed Assets & Pre-Clinical Platforms to Shape Early Design of Phase 2 Trials in Cancer
Synopsis
- Many clinical trials and cell therapies for cancer fail in early pre-clinical and clinical stages. This failure can be attributed, in part, to poor translational of the cell therapy (asset) and the patient population (trial design)
- Here we demonstrate how human-based platforms can be leveraged to enable more successful phase II trials by the patient population and cell therapies that provide the most efficacy