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

  • Fei Xie Principal Scientist, Allogene Therapeutics


  • 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

  • Jie Wei Director - Analytical Sciences, Tr1x therapeutics


  • 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

  • Abid Mattoo Senior Scientist Clinical Stage Analytical Development, Takeda Pharmaceutical Co. Ltd.


  • 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

  • Mike Lehmicke Vice President, Science & Industry Affairs, Alliance of Regenerative Medicine


  • 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


  • 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

  • Maayan Portnoy Senior Manager - Quality Control & Analytical Development, Minovia Therapeutics


  • 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

  • Ben Espen Principal Quality Engineer, Avobis Bio


  • 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


  • 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

  • Eric Smith Director - R&D, Marker Therapeutics, Inc.


  • 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


  • 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