Autoimmune - We are Live! (12)

Pre-Conference Workshop Day

Tuesday, March 19

7:30 am Check-In & Coffee

Workshop A

8:30 am Potency Assays 101: An Introduction


Developing potency assays for cell therapy products is a huge challenge. It’s a typical CMC issue that is a common cause for a clinical hold of a trial. This workshop is the perfect opportunity to be introduced to the topic so you have a better understanding before the main conference kicks off. 

Attend to Discuss:

• What is potency, and why is it so difficult in cell therapy? 

• Why is it needed and when to start testing? 

• How do you select THE assay? 

Workshop B

8:30 am Reviewing Regulatory Guidance for Potency Testing in Cell Therapy Products

  • Hadar Adams Director, Analytical Development, Atara Biotherapeutics Inc.


Potency remains a critical regulatory bottleneck when it comes to the approval of cell therapy products, with many recent examples of submission being rejected due to concerns surrounding potency.

Attend to Discuss:

• What are the key regulatory requirements regarding potency assays in the US and EU?

• How should we align cell therapy potency assay design, development, qualification/validation, and lifecycle management with FDA and EMA guidelines?

• What are the critical pain points when developing a potency bioassay?

10:30 am Morning Break & Networking

Workshop C

11:00 am Using Probability for Data Analysis & Model Building


Supposing you have some data, how should you use it to learn about the world? One approach is to use your data to build a model, and then compare that model to data you have not yet seen. This workshop will illustrate a systematic process for creating and analyzing models to answer your questions about assay development and specification setting in the context of clinical efficacy and process development.

Attend to Discuss:

• Understanding how your process leads to your data

• Building models from your data

• Updating models when new information becomes available

Workshop D

11:00 am Setting Specifications & Assigning Acceptance Criteria for Potency Assay Release

  • Monica Kukreja Associate Director, Quality Control, Arsenal Bio
  • Dong Xu Associate Director, Cell Therapy Analytical Development, TScan Therapeutics


To ensure that consistency of production is maintained, some level of control is required to limit the variability of the product from batch to batch – this premise forms the basis of specification setting. 

Attend to Discuss:

• Where to start when establishing a specification for a potency assay?

• How should you design your specification limits for release testing?

• How should you justify your specification limits to the FDA? 

1:00 pm Lunch Break & Networking

Workshop E

2:00 pm Considerations in Development of Vector Potency Assay in Cell Therapy

  • Taisen Hao Senior Scientist, Potency & Functional Characterisation, Bristol Myers Squibb
  • Khris Garcia Senior Scientist, Bristol Myers Squibb


Viral vector is a drug substance used for cell therapy. Measuring the potency of viral vectors is a key component of vector analytical control strategy to ensure high quality production and consistency between vector batches.

Attend to Discuss:

• How do you choose an appropriate biological readout to reflect MoA? 

• What is a suitable transduction and stimulation approach for measurement of CAR function? 

• How do you approach setting your analytical target profile?

• How should potency assays be used to assess viral vector attributes?

Workshop F

2:00 pm Strategies for Timing & Implementation of Potency Assay Development

  • Christopher Rold Vice President, Vector Development, Analytical Development & Quality Control, Adicet Bio Inc.


Manufacturing practices and the understanding of the product’s mechanism of action will inevitably evolve during clinical program progression. What are strategies developers need to consider for assay design, readouts, data interpretation, and tech transfer to avoid delays?

Attend to Discuss:

• Expected product changes developers may need to anticipate when thinking about potency assay design

• Strategies for assay design and data interpretation that will best accommodate an evolving product

• Use of assay raw materials, controls, and reference standards; what will be expected at a given development phase?

• How do you overcome common challenges when working with external partners? 

4:00 pm End of Workshop Day