Day One Agenda
7:15am - 5:45pm | Boston, MA
7:15 am Registration & Coffee Networking Opens
8:15 am Chair’s Opening Remarks
Evaluating the Industry Definition of Potency Across Cell Therapeutics
8:30 am Defining Optimal Potency Outcomes Through High-Level Analytical Strategy to Support Assay Development
Synopsis
- Highlighting the importance of a well-constructed potency assay
- Rethinking potency as an accelerator to process development
- Determining what stability looks like with a potency assay
- Differentiating potency assays against other assays implemented across process development
9:00 am Implementing Clear Strategy to Determine the Aims of the Potency Assay in Use
Synopsis
- Ensuring clarity in outline of objectives prior to potency assay design
- Utilizing cell characterization data to inform understanding of what the potency assay intends to validate
- Aligning potency assay design with clinical data and stage of clinical trials
9:30 am Benchmarking Successful Potency Assays to Create a Unifying Vision of Best Practice
Synopsis
- Striving for the golden standard of cell therapy potency assays
- Discussing the measures of success when analyzing potency data
- Illustrating a uniform model of potency across the array of cell types
- Honing evaluative measures of potency assay success to understand positive and negative outcomes
10:00 am Lead Partner Presentation
10:30 am Morning Refreshments & Speed Networking
Deconstructing Regulatory Guidelines for Cell Therapy Potency Assays
11:30 am Highlighting Common Regulatory-Orientated Delays Due to Typical Potency Assay Development Approaches
Synopsis
- Reflecting on the feedback received on potency assays from successful vs. unsuccessful regulatory submissions Rethinking the primary focuses when addressing a potency assay
- Revolutionizing a streamlined approach to developing an approved potency assay
12:00 pm Evaluating Analytical Strategy Following Regulatory Input to Provide Clarity to the Industry
Synopsis
- Establishing cell therapy-specific guidelines for potency assay development
- Exploring how potency assay approval has evolved over the past year
- Reaffirming the primary elements of attention required to maximize regulatory approval
12:30 pm Lunch & Networking
Creating Quantitative Measurements of Potency to Conduct a Thorough Assessment
1:30 pm Verifying the Precision of Measurements Required to Adequately Measure Potency
Synopsis
- Maintaining a high degree of sensitivity and accuracy across all direct measurements
- Implementing advanced statistical analysis to ensure precision of measurements
- Analyzing potency data to judge the precision of measurements obtained
2:00 pm Program Partner Presentation
2:30 pm Navigating Error Analysis Data to Comprehend the Outcomes of a Potency Assay
Synopsis
- Utilizing a novel lack-of-fit assessment as a tool of error analysis
- Deploying predictive statistical formulas to tackle variance
- Locating the source of discrepancies highlighted from error analysis data
3:00 pm Afternoon Poster Session & Networking
Exploring Cell Manufacturing Options to Leverage Potency Assay Development
3:30 pm Addressing the Potential Potency Variations Following Cryopreservation of Cells to Maximize Validity
Synopsis
- Mastering the freezing and thawing procedures necessary for clinical use of cells
- Understanding the impact on potency due to cryopreservation procedures
- Adequately comparing potency data from fresh vs. cryopreserved batches of cells
4:00 pm Program Partner Presentation
4:30 pm No Wash, No Rest Potency Assay for Cryopreserved CAR-T Therapies
Synopsis
- Assessment of CAR-T killing without removal of cryopreservation medium
- T-cell assessment over multiple days without disruption
- Multi-parameter characterization of T-cells and target cells
5:00 pm Maintaining GMP Standards Across Cell Manufacture into Potency Assay Development to Follow a Licensed Approach
Synopsis
- Developing GMP standards for quantitatively testing potency and biological activity
- Setting the expectations of routine potency release testing to GMP standards
- Relating GMP testing and method to the mechanisms of action of the cell therapy
5:30 pm Chair’s Closing Remarks
5:45 pm End of Day One
