For full session descriptions, download the 2025 program:
8:00 am Coffee & Networking
8:50 am Chair’s Opening Remarks
Strengthening Donor Retention & Optimizing Cryopreservation to Minimize Supply Chain Risks
9:00 am Tackling Donor Recallability for Long-Term Success in Cell Therapy
Synopsis
- Enhancing donor engagement to ensure availability of high-quality samples over an extended period
- Navigating challenges in long-term donor tracking and desire to donate for consistent clinical outcomes
- Strengthening donor verification methods to support seamless trial progression
9:30 am Cryopreservation Strategies to Reduce Cold Chain Variability & Minimize Product Degradation
Synopsis
- Identifying risks in the chain between collection, transport, and receipt
- Minimizing product degradation by optimizing protocols for transfer and thaw
- Standardizing LN2 shipping and site-level handling to mitigate real world risks
10:00 am Roundtable Discussion: Enhancing Allogeneic Cell Therapy Success by Optimizing Donor Selection Early in Development
Synopsis
- Exploring how early collaboration between R&D and manufacturing enhances donor selection and long-term success
- Understanding which donor characterization methods drive consistency, efficiency, and clinical readiness
- Reducing downstream risks by integrating strategic donor profiling early in development timelines
10:45 am Morning Break & Networking
Updating Our Understanding of Regulations to Drive Long-Term Clinical Success
11:45 am *New Data* Leveraging Non-Animal Models to Improve Donor Selection & Product Reproducibility
Synopsis
- Uncovering new insights into how donor cell properties influence final product performance, even when engineered identically
- Applying non-animal systems to identify optimal starting materials for iPSC and peripheral blood-derived therapies, in line with new FDA guidance
- Improving product consistency by understanding therapeutic activity at the source and moving beyond the limitations of traditional animal models
12:15 pm Standardized Terminology & Labeling Using the ISBT 128 Standard
Synopsis
- Streamlining collection and manufacturing workflows with hybrid labels for donor-derived material
- Enhancing collaboration by aligning globally harmonized terminology and labelling practices
- Preparing for commercial readiness by embedding the ISBT 128 Standard early in product lifecycle development
12:45 pm Lunch Break & Networking
Synopsis
Private lunch hosted by Charles River. Please inquire at info@hansonwade.com for more information.
Boosting Product Quality & Investor Appeal by Addressing Cell Type Differences
1:45 pm Panel Discussion: Navigating Cell Type Differences to Optimize Donor Selection & Manufacturing
Synopsis
- Differentiating how different cell types introduce unique risk profiles that influence manufacturing decisions
- Highlighting the different methods of mitigating donor variability based on starting material cell type
- Aligning donor selection strategies with cell-specific functions to enhance product quality and scalability
2:30 pm Roundtable: Building Investor Confidence Through Scalable Donor Strategies in Allogeneic Cell Therapy
Synopsis
- Earning trust by showing control over biological variability with a proactive, data-informed donor strategy
- Linking donor sourcing strategies and metrics directly to the ability to reduce batch failure, lower cost of goods, and deliver on trial milestones
- Developing meaningful collaboration between sponsors and suppliers to build a robust donor strategy
3:15 pm Afternoon Break & Networking
Pulling Back the Curtain on Donor Screening Strategies to Accelerate Progress Together
4:15 pm Building Predictive Donor Screening for Allogeneic Cell Therapies from Biomarker Discovery to Clinical Validation
Synopsis
- Developing assays to holistically rank donors for prioritization in clinical manufacturing
4:45 pm Advancing Rapid Assays for Pre-Identifying Top Donors
Synopsis
- Enhancing donor screening strategies to pinpoint variability and maximize therapeutic efficacy
- Streamlining potency assays to enable rapid scalable donor selection for large-scale treatments
- Identifying key biomarkers to pre-select optimal donors and accelerate clinical translation