Day One Agenda

7:30 am Check-In & Coffee

8:30 am Chair’s Opening Remarks

8:40 am Industry Leader’s Fireside Chat: Cell Therapy Potency Assays

  • Zhu Pirot Director & Technical Leader - Platform Competitive Generic Therapies Analytical Development, Bayer
  • Mariska ter Haak Senior Director - Analytical Development, IN8Bio
  • Darren Kamikura Scientific Director, Potency & Functional Characterization, Bristol Myers Squibb
  • Shibani Mitra-Kaushik Head, Product Control Analytics, Cell Therapies Cell Therapies Analytical Development, Takeda Pharmaceutical Co. Ltd.

Synopsis

• What progress have we made since the potency assays produced for the first commercialized cell therapy products? 

• What challenges are we still experiencing? 

• What do we think about the current regulatory guidance, and how do we interpret it?

9:30 am Analytics Supporting CMC Potency Activities in Cell Therapies – Current Challenges

  • Joseph lee senior director, Affini-T Therapeutics

Synopsis

• Discussing the rapidly changing expectations in analytical development activities supporting cell therapies – emphasis on potency

• Exploring viral vs non-viral delivery – potency for both drug substance (intermediate) and drug product

• Outlining key considerations for the development of potency assays for cell therapies

10:00 am Morning Break & Structured Networking

Synopsis

As this community reunites, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.

CAR-T & TCR-T

Establishing a Potency Assay Matrix for T Cell Products

11:30 am Matrix-based Approach to Potency Assay Development for Adoptive T Cell Therapies

Synopsis

• Developing phase-appropriate T cell potency assays, 

balancing critical quality attributes and available technologies

• Leveraging compliant characterization technologies to gain a 

well-rounded understanding of T cell functionality

• Establishing a potency assay matrix, maximizing correlation 

to clinical efficacy while minimizing late-phase risk

12:00 pm Evolution of a Cell Based Potency Assay from Early to Pivotal Clinical Stage

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

Synopsis

  • Early assay development strategy with a focus on model cell lines and controls
  • Transformation in the assay from supporting process development to drug product release and stability
  • Challenges in developing pivotal stage assays in cell therapy and use of matrix potency approach for complex cell therapy products

Other Cell Types

  • John Yu Director, Sana Biotechnology

Understanding Mechanistic Action to Develop Meaningful Assays

11:30 am Early-Stage Potency Assay Development for Regenerative Cell Therapies

Synopsis

• Leveraging advanced technologies to increase understanding 

of drug product mechanism of action towards establishing a 

meaningful matrix of functional assays

• Developing phase appropriate early-stage potency assays 

for the characterization of pluripotent stem cell-derived 

regenerative medicines 

• Moving from a characterization matrix to a suitable assay for 

drug product release and stability testing

12:00 pm Navigating Potency in Novel Cell Therapies: Macrophages & Mesenchymal Stem Cells

  • Rita Barcia Vice President - Process Development & Operations, SIRPant Immunotherapeutics

Synopsis

• Leveraging stage-appropriate potency assays

• Evolving your potency assay ready for pivotal 

• Developing novel ways to assess biological activity 

12:30 pm Lunch Break & Networking

Characterizing Effectively to Maximize Correlation with Clinical Efficacy

1:30 pm Development of a Long-term Restimulation Assay for the Functional & Phenotypical Characterization of CAR-T Cell Drug Products

Synopsis

• Employing short-term potency assays for CQAs fail to describe 

the “quality” of the Drug Product

• Investigating these Cellular Drug Products long-term better 

informs us on Manufacturing Processes and Clinical Efficacy

• Developing a long-term restimulation potency assay for the 

functional and phenotypical characterization of CAR-T cell drug 

products better informs us about the potency of our drug products

2:00 pm Analytical Assay Development for a TCR-T Cell Therapy Product with Transposase Integration

  • Dong Xu Associate Director - Cell Therapy Analytical Development, TScan Therapeutics

Synopsis

• Providing analytical support for TCR-T cell process 

optimization

• Developing transposase-specific analytical assays

• Balancing between efficacy and safety

2:30 pm Panel Discussion: Establishing a Correlation Between Potency & Clinical Efficacy

Synopsis

• What should we be measuring beyond IFN-gamma? What about 

cytotoxicity, proliferation, or others? 

• What measure(s) correlates best with clinical efficacy in T cell 

products?

• If we can’t correlate with clinical efficacy, what should we be 

concerned with?

Understanding Mechanistic Action to Develop Meaningful Assays

1:30 pm Early-Stage Potency Assay Development for iNK Products

  • Chui Yu Lau Associate Scientist, Century Therapeutics

Synopsis

• Understanding the mechanism of action of gene edited iNK cell 

products

• Developing a flow-based killing assay showing reproducibility 

and repeatability 

2:00 pm Assays to Measure Potency in Clonal Neoreactive T Cells (cNeT)

Synopsis

• Developing potency methods for a cNeT product and the 

associated challenges

• Selecting and introducing assays into a GMP environment for 

batch release testing

• Discussing challenges in potency method validation

2:30 pm Panel Discussion: Measuring Potency in a Non-Targeted Therapy

  • Monica Sassi Head of QC, Achilles Therapeutics Limited
  • Ena Wang Vice President, Cell Therapy, Nurix Therapeutics
  • Therese Choquette Head Of Analytical & Translational Sciences, Tigen Pharma

Synopsis

• How do you define potency for a non-targeted therapy?

• What should you measure when you don’t have a specific target 

cell to kill? 

3:00 pm Afternoon Break & Poster Session

Creating a Phase Appropriate Potency Assay Design & Development Strategy

4:00 pm Building a Strategy for Potency Assay Development

Synopsis

• Reviewing considerations for lifecycle management of potency assays

• Supporting product comparability needs through all stages of product development

• Exploring the interplay of manufacturing process development and potency assay development

• Understanding considerations for meeting health authority requirements for potency assays

4:30 pm Panel Discussion: Potency Assay Development Over the Development Lifecycle

  • David Schwalb Director - Analytical Development, Cell & Gene Therapies, Pacira Biosciences
  • Joseph lee senior director, Affini-T Therapeutics
  • Mariska ter Haak Senior Director - Analytical Development, IN8Bio
  • Emily English Vice President, Quality, Cartesian Therapeutics

Synopsis

• Should we start potency assay development early? Or should we wait until clearer signals emerge later in subsequent phases 

that a therapy is likely to be safe and efficacious? 

• How do we translate early phase potency assays into late phase assays? 

• At what stage do you begin to qualify and validate? 

5:15 pm Chair’s Closing Remarks

5:30 pm End of Conference Day 1