7:45 am Check-In & Coffee
Optimizing Patient Dosing & Treatment for Enhanced & Lasting Therapeutic Outcomes
8:30 am Panel Discussion: Ensuring Lasting Therapeutic Responses from Allogeneic Therapy – Is Redosing the Way to Go?
Synopsis
- Examine the role of redosing in sustaining therapeutic efficacy and preventing disease relapse in patients receiving allogeneic therapies
- How do we determine if multiple doses are needed and if so, how do we determine how many?
- Is it better to use a one and done model or plan for multiple doses?
- Analyze the impact of treatment schedules and regiments such as lymphodepletion on patient outcomes when scheduling multiple doses
9:00 am Maximizing Treatment Outcomes Through Strategic Patient Selection by HLA Matching
Synopsis
- Explore the criteria for identifying patients who are most likely to benefit from allogeneic therapies, focusing on genetic, clinical, and demographic factors
- How can we determine which patient is more likely to have increased allogeneic rejection?
9:30 am Morning Break & Speed Networking
Preclinical
Achieving Reliable & Effective Genetic Engineering to Transform Allogeneic Cells
10:30 am Leveraging a TALEN Engineering Platform to Generate Potent & Safe Armored CAR-Ts
Synopsis
- Discussing the use of TALEN for advanced gene editing of T-cells
- Creating smart CAR-Ts that can respond to their environment and have efficient activity when encountering the tumor micro-environment
11:00 am Leveraging the Latest Allo-Evasion Technologies for Prolonged Therapeutic Effects
Synopsis
- Examine cutting-edge allo-evasion technologies designed to minimize immune rejection and prolong the efficacy of allogeneic therapies
- Discuss the mechanisms behind these technologies and their potential impact on patient outcomes and treatment longevity
11:30 am Panel Discussion: Understanding the Merits & Feasibilities of HLA Matching
Synopsis
- Explore the importance of HLA matching in improving patient outcomes and reducing the risk of allogeneic rejection in allogeneic therapies
- Evaluate the feasibility and logistical considerations of implementing HLA matching in clinical settings to optimize donor-recipient compatibility
- Discuss recent advancements and tools that facilitate HLA matching processes, enhancing the overall efficacy of allogeneic treatments
Manufacturing & Process Development
Laying the Foundations for a Seamless Transition into Large Scale Manufacturing
10:30 am Upscaling & Transferring Manufacturing of an Allogeneic Active Immune Therapy in Preparation for Commercialization
Synopsis
- Discussing key strategies to upscale manufacturing of an allogeneic dendritic cell cancer vaccine by partnering with CDMOs
- Vididencel is a maintenance immunotherapy designed to improve relapse-free and overall survival in AML
- Sharing strategies for a smooth tech transfer to take product manufacture to a larger level
11:00 am Expanding & Differentiating HSCs into NK Cells Using Stir Tanks for Large Scale Commercial Manufacturing
Synopsis
- Employing a unique molecule to effectively expand HSCs into NKs and various desired cell types
- Discussing the process of manufacturing in large quantities using bioreactors
11:30 am Panel Discussion: Key Considerations for Commercial Scale Manufacturing
Synopsis
- Dive into key factors required to realize commercial scale manufacturing
- Understanding when the right time for process lock is
- Discuss whether to involve CDMOs, when to do so, and how to assess readiness for external manufacturing
12:00 pm Lunch Break & Networking
Leveraging Cell Engineering to Maximize Anti-Tumor Properties of Allogeneic Cells
1:00 pm Unlocking the Potential of CAR-NK Approaches for Enhanced Tumor Recognition
Synopsis
- Discussing IDR regions engineered into CAR constructs with preclinical proof of concept showing increased condensate formation, signaling, potency and high antigen sensitivity compared to current 3rd generation CAR constructs against antigen low and high solid tumor and blood cancers
- Developing allogeneic off the shelf approaches in both T-cells and NK cells for use in cancer and autoimmunity
1:30 pm Building Novel Cell Designs to Deliver “Serial Killer” Engineered NK Cells with Enhanced Potency & Persistence
Synopsis
- Incorporating advanced genetic modifications that enhance T-cell and NK cell functionality for maximal anti-tumor activity
- Increasing survival and efficacy against solid tumors
Addressing Critical Bottlenecks to Manufacturing Larger Cell Batches to Unlock Mass Production
1:00 pm Approaches for Scalable Manufacturing of Engineered B-Cell Medicines: A New Class of Cellular Medicines
Synopsis
- Be Biopharma has developed a new class of cellular medicines – Engineered B-Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable and administered without pre-conditioning
- B-Cell Medicines (BCMs) are produced with ex vivo precision engineering of B-cells using CRISPR/Cas9 and homology directed repair-mediated transgene insertion followed by ex vivo differentiation towards plasma cell lineage
- Process development, optimization and scalable manufacturing strategies will be discussed
1:30 pm Maximizing Cell Viability by Preventing Exhaustion During Cell Expansion
Synopsis
- Explore innovative techniques to monitor cellular health and functionality throughout the expansion process
- Discover the impact of culture media and environmental factors on preventing cell fatigue and maintaining robust performance
2:00 pm Afternoon Break & Networking
Building Allogeneic Therapies for Commercial Success Through Purposeful Product Development & Regulatory Expertise
3:00 pm Case Study: Comparing & Contrasting Product Development of Allogeneic Therapies Versus Autologous from Preclinical All the Way to Clinical
Synopsis
- Sharing lessons learned from commercializing autologous CAR-T products and the application of these to allogeneic development
- Discussing new challenges and considerations that arise with allogeneic products
3:30 pm Panel Discussion: Navigating the Regulatory Landscape in Allogeneic Product Development to Gain Clarity & Advance the Future of Universal Cell Therapies
Synopsis
- Exploring the historical perspective that “your process is your product” and the implications of frequent process changes on regulatory submissions
- Examining key differences in regulatory expectations for allogeneic versus autologous therapies
- Discussing strategies for maintaining open communication with regulators to foster understanding and facilitate smoother approvals