Conference Day Two
Thursday, March 13, 2025
7:30 am Check-In, Coffee & Light Breakfast
8:20 am Chair’s Opening Remarks
Addressing Challenges with Mechanism of Action to Strengthen Assay Predictivity & Relevance
8:30 am Defining Mechanism of Action & its Impact on Potency Assays
Synopsis
- Analyzing how companies link mechanism of action with potency assay outcomes
- Identifying the challenges of demonstrating multiple mechanism of actions in potency assays
- Evaluating how to ensure potency assays reflect clinical effectiveness of therapies
9:00 am Establishing Mechanisms of Action for Non-Engineered T-Cells and MSCs
Synopsis
- Discussing the challenges and methodologies in developing potency assays for non-engineered T-cells targeting tumor-associated antigens with a focus on hypothesized mechanisms of action
- Exploring the use of digital PCR to demonstrate changes in gene expression for MSCs in the context of graft-versus-host disease
- Sharing insights and preliminary data on the hypothesized mechanisms of action for T-cells and MSCs
9:30 am Roundtable Session: Assessing Variations on Cell Products & Their Impact in Establishing Mechanism of Action Assays
Synopsis
- Evaluating genetic modifications to enhance understanding of cell therapy mechanisms of action
- Addressing challenges in developing potency assays for complex therapies
- Discussing strategies to mitigate negative impacts from the host environment
Join this roundtable session to engage with experts and explore innovative approaches to understanding and enhancing the mechanisms of action in cell therapy.
10:00 am Morning Refreshments
Optimizing Cell Line Selection & Characterization for Potency Assays to Enhance Reliability & Efficacy
11:00 am Advancing & Refining Potency Assays for CAR-T Cell Therapies
Synopsis
- Focusing on vector potency and the debate between interferon gamma and cytotoxicity as industry standards
- Achieving precision and accuracy, particularly in the context of CAR-T drug products
- Examining the forced degraded materials and evaluating its impact using various potency methods to understand product functionality
11:30 am Defining the Role of Characterization Assays in Potency Testing to Strengthen Product Development
Synopsis
- Exploring how characterization assays complement potency assays in product development
- Evaluating the additional data that characterization assays provide beyond potency metrics
- Reviewing how companies align characterization assays with clinical outcome measuresÂ
12:00 pm Lunch Break
Driving Tech Transfer Between Analytical Development & Quality Control to Maintain Assay Integrity During Transitions
1:00 pm Navigating Challenges in Tech Transfer During Clinical Trials to Ensure Seamless Transitions & Maintain Assay Integrity
Synopsis
- Identifying key hurdles in tech transfer during clinical trials, addressing the unique challenges faced when transitioning assays between different phases of clinical trials
- Reviewing best practices for ensuring assay integrity, implementing strategies to maintain assay integrity and consistency throughout the tech transfer process
- Exploring methods to minimize variability in potency assays, techniques to reduce variability and ensure reliable results when scaling potency assays during clinical trials
1:30 pm Navigating Challenges in Tech Transfer to Ensure Seamless Transitions & Maintain Assay Integrity
Synopsis
- Identifying key hurdles in tech transfer between analytical development and quality control teams
- Reviewing best practices for ensuring assay integrity during tech transfer
- Exploring methods to minimize variability when scaling potency assays
2:00 pm Panel Discussion: Ensuring Consistency in Assay Execution Post-Transfer to Quality Control to Maintain Reliability & Minimize Variability
Synopsis
- Evaluating strategies to maintain reproducibility during tech transfer
- Exploring technologies that support standardized potency assay execution across teams
- Reviewing communication practices that reduce assay drift post-transfer