Pre-Conference Workshop Day

9:00 Workshop A

Optimizing ADC Process Development to Deliver on Accelerated Timelines

Synopsis

Being first-in-class is at the forefront of ADC developers minds, however, moving quickly through preclinical and clinical development is currently restricted by extended manufacturing timelines. Therefore, creating a process from the outset that can support Accelerated Approvals and speed is becoming a greater priority for all ADC developers.

This workshop is your opportunity to learn how to optimize process development to deliver to shortened timeframes.

Join this workshop to:

• Analyze smart processing and how it can quicken timelines

• Increase productivity and efficiency of the process development

• Review regulatory expectations for accelerated programs

• Explore opportunities for reduced requirements for the marketing application

• Discuss how to best leverage health authority interactions

12:00 Lunch Break

1:00 Workshop B

Establishing a Scalable Process to Move from Lab to Clinical & Commercial Scale Quickly & Robustly

Synopsis

Scaling-up production from lab-scale to clinical and commercial scale is one of the biggest roadblocks in ADC process development. Scaling-up can be challenging as both speed and robustness need to be considered. This workshop will provide you with the toolkit to establish a robust process that can support scale-up in a timely manner.

Join this workshop to:

• Understand how dose and concentration changes with larger volumes

• Develop the right scale-down model to mimic full-scale processes

• Ensure process reproducibility

• Discuss the technologies required to create a robust process

• Learn how each component of the development affects scale up

4:00 End of Pre-Conference Workshop Day