Conference Day Two
Thursday, March 13, 2025
We are Live in Boston!
7:45 am Check-In, Coffee & Light Breakfast
8:25 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
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
10:30 am Advancing Pivotal Clinical Trials: Strategic & Technical Insights for Assay Development
Synopsis
- Transitioning from early-stage to pivotal trials and leveraging proprietary editing techniques to ensure robust and reliable assays for clinical success
- Planning potency assays, evaluating parameters and regulatory impacts for accuracy and compliance
- Sharing data and case studies, addressing challenges to accelerate development and improve efficiency
11:00 am A Holistic Approach to Understanding CAR-T Drug Product Function Using Forced Degraded Material
Synopsis
- Emphasizing the importance of having highly accurate, precise, sensitive, and robust matrixed potency methods for CAR-T cell drug products
- Utilizing various potency methods such as IFNg secretion, cytotoxicity, proliferation, and viable cell count / viability to understand the impact of forced degradation on CAR-T cell function
- Matrixing potency methods provides valuable understanding of product quality
11:30 am Potency Pathway: Streamlining Assay Development for Seamless Technology Transfer, Robust QC Testing, and Strategic Lifecycle Management
Synopsis
- Exploring best practices for potency assay development to ensure effortless tech transfers to quality control labs
- Identifying ways to reduce reliance on complex tests and limit variability
- Reviewing quality control best practices to streamline potency testing workflows
- Evaluating potency assay lifecycle management strategies
12:30 pm Lunch Break
Driving Tech Transfer Between Analytical Development & Quality Control to Maintain Assay Integrity During Transitions
1:30 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
2:00 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
2:30 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