Conference Day One
Wednesday | 29 November, 2023
7:00 am Registration & Coffee
8:00 am Chair’s Opening Remarks
Exploring the Concept of a “Gold Standard” Donor for Creation of the Ultimate Donor Pool
8:15 am Industry Leader’s Fireside Chat: Developing a Road Map From the Donor to the Final Product
Synopsis
A panel discussion from the industry leaders of the field to set the scene on the importance of effective donor selection. Ask your questions live to understand the expert’s thoughts on key topics including:
- Exploring demographics: to what extent do sex, age and health status play a role in potency?
- Creating the ultimate donor pool to drive the scalability of your product
- Improving registry breadth and depth to meet demand
9:00 am Donor Selection Is a Critical Component of Poseida’s Allogeneic CAR-T Programs
Synopsis
- Assessing potential for donor manufacturability and functionality for allogeneic CAR-T cells
- Implementation of a stringent potency assay for donor selection
9:30 am Using Donor Attributes to Improve Study Design & Outcomes
Synopsis
- Methods to pre-screen donors
- Important considerations when choosing allogeneic donors
10:00 am Speed Networking & Morning Refreshments
Synopsis
As this community unites for the first time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections
Utilizing Innovative Screening & Characterization Testing to Assess Donor Impact
11:00 am Deep Screening of Cord Blood Unit Donor Variability for Scalable Cancer Therapies
Synopsis
- Using multidimensional screening to discover the best in vitro efficacy
- Incorporation and analysis of process controls
- Understanding which donor features impact the final drug product
11:30 am Focusing on Donor Characteristics & Efficient Selection to Improve Allogeneic Cell Therapy Outcomes
Synopsis
- How proven transplant infrastructure deliver cell and gene therapies
- The complexity of HLA in cell selection
- The use of machine learning in informing cell/source selection
12:00 pm Donor Selection for Off-The-Shelf Allogeneic Cell Therapies
Synopsis
- Screening of donors, testing donors after procurement, and exploring various analytics
12:30 pm Lunch & Networking
Utilizing Innovative Screening & Characterization Testing to Assess Donor Impact
1:30 pm Excellos 360: Improving cell therapies to drive clinical trial success
Synopsis
- Cell therapy variability has a significant impact on clinical trial outcomes. Part of this variability is due to inconsistent or poorly understood donor starting material.
- Excellos has developed a deep cell characterization platform that identifies high quality donor starting material with greater potency.
- The Excellos 360 platform has also been utilized as part of our internal QbD applications for the evaluation of cell processing systems. The Excellos 360 platform can identify differences that various processing systems have on cell functionality and yield. This allows users to select starting material that is optimized to their specific manufacturing system, and to better optimize transduction efficiencies. The Excellos 360 platform assures more consistent product manufacturing with greater potency. This improves clinical success for the clients we serve.
1:45 pm Panel Discussion: Exploring the Importance of Standardizing Collections While Maintaining Donor Diversity for a Rich Pool
Synopsis
- Standardizing donor testing methodologies globally
- Important criteria to consider to sustain donor diversity
- Gaining insight beyond the typical starting information (i.e age, sex, disease history) for more clarity on the physical attributes of the donor
- Using the advanced donor characteristic details to increase populations areas of interest in study design and maximize downstream clinical success for patients
2:15 pm To Preselect or Not? Highlighting the Importance of Product Characterization for Random Material Selection
Synopsis
- Using single cell omics and RNA sequencing for the product characterization to determine key quality attributes of starting material
- Defining acceptance criteria
- Release testing with safety related specifications on product impurities, viability and functional testing for potency
2:45 pm Afternoon Break & Poster Session
Utilizing Innovative Screening & Characterization Testing to Assess Donor Impact
3:15 pm Implementing Innovative Screening & Characterization Prediction Model for Ideal Donor Selection
Synopsis
Gaining a more detailed understanding of the starting material characteristics, beyond the usual initial data points, (such as age, gender, and medical history)
3:45 pm Roundtable: Characterization of Donor Starting Material for Potential Drug Product Optimization
Synopsis
- Donor characterization and selection is one of the many untapped frontiers of cell therapy.
- A partnership between cell therapy developers and operators of starting material collections with decades of donor recruitment will get to the answers needed.
- The Blood Centers of America Advanced Therapies Network is preparing to launch a donor and cell characterization study utilizing artificial intelligence to study dozens of donor and cellular attributes with the aim of identifying how to better select donor for particular cell types and cell manufacturing and viability functionalities.