Pre-Conference Workshop Day

11:00 - 1:00 | Workshop B: Phase-Appropriate Development of Potency Assays for Starting Materials and UCART Cell-Based Gene Therapy

This workshop offers an in depth review of the critical components required to effectively demonstrate potency of cell based gene therapies. The presentation will provide insights into how to optimise the strategy for potency assays for starting materials and navigate the inherent complexities. We will address:

  • Potency assay development for UCART drug products is complex and often multimodal
  • Designing phase appropriate potency assays to support product characterization and development
  • Developing potency assays for starting material during early phase

Workshop Speaker:

Guillaume-Cornelis

Guillaume Cornelis
Senior Scientist, Team Leader
Cellectis

2:00 - 4:00 | Workshop C: Expression Based Assays and Functional Potency Assays: Determining the How and When

  • Among critical quality attributes which need to be monitored during drug development, potency is considered essential for its direct link to product efficacy. Developing the relevant set of potency assays for cell and gene medicinal products comes with numerous challenges due to the complex nature of the products and absence of standard approach.
  • This workshop will highlight several pragmatic approaches to consider when
    designing the potency assay strategy in the framework of current EU and USA
    regulatory expectations.

Workshop Speaker: 

François_Gianelli_VCLS

François Gianelli
Senior Director, CMC
Voisin Consulting Life Sciences

Lavi (2)

Lavi Thanabalasundaram
Regulatory Scientist
Voisin Consulting Life Sciences