7:45 am Registration & Coffee
8:30 am Chair’s Opening Remarks
Enhancing Clinical Success Through Rigorous Donor Characterization & Strategic Implementation
8:45 am Keynote Panel Discussion: Exploring Innovations & Challenges in Donor Selection for Allogeneic Therapies
Synopsis
- An overview of where the field currently stands with donor selection
- Advances in technologies for HLA typing, genetic profiling, artificial intelligence machine learning, and emerging biomarkers for improved donor-recipient compatibility
- Discussing what key logistical challenges are faced by the community currently and how we are going to overcome them
9:30 am Identification of Healthy Donor Phenotypic & Functional Signatures That Predict Allogeneic, Hypoimmune CAR-T Cell Potency
Synopsis
- Detailed analysis of surface markers and cellular phenotypes of healthy donor T-cells to identify traits associated with high potency in hypoimmune CAR-T cells
- Assessment of functional attributes such as cytokine production, proliferation capacity, and cytotoxic activity of donor T-cells to predict their effectiveness in allogeneic CAR-T cell therapies
- Identification and validation of specific biomarkers that correlate with enhanced potency and hypoimmunity of CAR-T cells, facilitating the selection of optimal donors for improved therapeutic outcome-
10:00 am Morning Refreshments & Speed Networking
Synopsis
As the donor community reunites, this session provides an opportunity to reconnect with peers and establish new, lasting connections.
Enhancing Clinical Success Through Rigorous Donor Characterization & Strategic Implementation
11:00 am Deep Characterization of HSC-derived Natural Killer Cells Reveals Features of Optimal Donors
Synopsis
- Sourcing NK cells from peripheral blood or umbilical cord blood units (CBUs) poses challenges due to donor variability, limited cell quantity and low expansion capability.
- ImmuneBridge will discuss a newly developed platform that leverages our proprietary small molecule IBR403 to enable large-scale expansion of hematopoietic stem cells (HSCs) from CBU segments
- Establishing a cost-effective, high-throughput screening pipeline using NKs differentiated from expanded HSCs (xHSC-NKs) while leaving the CBU cryopreserved and intact for manufacturing
- Functional assessment of xHSC-NKs revealed significant donor differences in proliferation, cytotoxicity, ability to withstand tumor rechallenge, and function in vivo or in cancer organoid models
- Best-in-class approach for low-cost and accurate identification of optimal donors for allogeneic cell therapy
11:30 am Optimizing Donor Selection: The Role of Young Healthy Females in Allogeneic iNKT Cell Therapies
Synopsis
- Young, healthy female donors often exhibit a robust and diverse immune cell repertoire, including invariant Natural Killer T (iNKT) cells, which can enhance the efficacy and persistence of allogeneic therapies
- Research indicates that iNKT cells from young female donors can have superior proliferative and other capabilities, making them ideal candidates for generating potent allogeneic cell therapies with improved therapeutic outcomes
- Utilizing iNKT cells avoids GvHD due to their immunomodulatory rather than autoreactive properties, promoting safer and more effective treatment options for patients
Accelerating Market Access Through Robust Donor Screening, Apheresis & Viral Testing Protocols
12:00 pm Navigating Donor Variability for More Consistent & High-Quality Allogeneic Cell Therapies
Synopsis
- Understanding the drawbacks and benefits of donor variability, including strategies to use this variability as a strength
- Highlighting the importance of initial donor characterization and intermediate process assessments to ensure the desired qualities are maintained throughout manufacturing, leading to a consistent final product
- Explore how different stakeholders, from R&D to quality control, address the challenges of donor variability
- Discuss common challenges in ensuring a consistent functional profile of cell products and define successful clinical models and critical quality attributes
- Examine the transition from R&D to large-scale manufacturing, focusing on maintaining donor characteristics and ensuring product consistency
- Discuss differentiation and activation protocols, and how to determine the optimal characteristics and activation levels required for effective patient outcomes
12:30 pm Lunch & Networking
1:30 pm Optimizing the Apheresis Process, Best Practices in Donor Recruitment & Viral Testing
Synopsis
- Explore the nuances of the apheresis process across different suppliers, including variations in equipment, protocols, and efficiency and identify key factors that contribute to an optimized and consistent apheresis procedure
- Delve into strategies for recruiting and screening donors, including the recruitment process, eligibility criteria, and comprehensive viral testing. Expand your understanding of the different assays used for viral testing and the types of samples that provide the most reliable results
- Gain insights into evaluating apheresis suppliers through functional testing and performance assessments, and further understand how to benchmark suppliers against industry standards to ensure the highest quality and most efficient apheresis processes
2:00 pm Roundtable with: Blood Centers of America
2:30 pm Afternoon Refreshments & Poster Session
The Fundamental Role of Diverse Donor Pools & Implementing Robust Systems for Traceability of Medical Products
3:30 pm Key Elements of Traceability for Medical Products of Human Origin
Synopsis
- Implementing robust systems for the unique identification and labeling of each medical product ensures accurate tracking from donor to recipient, facilitating recalls and ensuring patient safety
- Maintaining comprehensive and secure records of each step in the product’s lifecycle, including donor information, processing, storage, and distribution, to enable traceability and compliance with regulatory requirements
4:00 pm The Critical Role of a Diverse Donor Pool in Allogeneic Therapies
Synopsis
- A diverse donor pool increases the likelihood of finding optimal matches for recipients, reducing the risk of immune rejection and graft-versus-host disease (GvHD), thereby improving therapeutic outcomes
- Variation within a donor pool ensures a broader range of genetic and phenotypic profiles, providing the flexibility to match recipients with donors whose cells exhibit the best compatibility and functionality
- Maintaining a diverse and robust donor pool allows for greater adaptability in meeting the specific needs of different patients, including those with rare or complex conditions, ensuring that more patients can benefit from allogeneic therapies