Strategies for Timing & Implementation of Potency Assay Development

Time: 2:00 pm
day: Pre-Conference Workshop Day - Track B - PM


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?