Pre-Conference Workshop Day
Wednesday, May 25 2022

Registration at 8:00

WORKSHOP A

Outlining Key Specifications, CQAs, & Structure Activity Relationships
9:00 - 12:00

Characterizing an antibody-drug conjugate is essential to developing a robust analytical control strategy. This workshop will discuss the analytical studies, techniques, and challenges related to characterizing an ADC and how this information can be leveraged to develop the product quality specification.

Topics that will be discussed in this workshop include:

  • Overview of structure-activity relationship (SARs) and critical quality attributes (CQAs) for antibodies and ADCs
  • Discussion of different analytical assays and how they can be leveraged for SARs
  • Impact of SAR data on setting specifications and acceptance criteria including method selection for batch release and SAR study timing during development
  • Exploring other points to consider when setting specifications and acceptance criteria, such as clinical and manufacturing experience and statistics, and challenges with minimal batch history and/or variability and the potential impact to critical process parameters (CPPs)

 

Workshop Leaders

Hillary Schuessler

Hillary Schuessler
Director, Mass Spectometry
Merck & Co.

Elizabeth Schmidt

Elizabeth Schmidt
Scientific Leader, CMC Analytical
GSK

WORKSHOP B

Demonstrating How to Approach Comparability During ADC Development
1:00 - 4:00

Optimizing your comparability strategy is essential to mitigate risk and avoid delays in your clinical development programs. Ensuring consistency, quality and safety from preclinical through to commercialization phases comes with a set of unique challenges that ADC developers must tackle to quickly move their drug through the development process. This workshop will explore these key challenges in an interactive and thought-provoking manner.

Topics to be discussed during this workshop include:

  • Analytical comparability of ARX788 anti-HER2 ADC in late-stage global clinical trials
  • Which stages do you use different analytical methods during comparability?
  • Which assays do you need to include at different stages of comparability or clinical development stages?
  • Which comparability strategies exist when there has been a change in the CMC process?
  • Exploring various comparability testing strategies and sharing regulatory experiences and expectations

Workshop Leaders

Wayne Yu

Wayne Yu
Senior Scientist, Analytical & Formulation Development
Ambrx

Mysore Ramprasad

Mysore Ramprasad
Executive Director, Analytical & Formulation Development
Ambrx

Keith Canada

Keith Canada 
Senior Principal Scientist, High Throughput Materials & Biophysical Characterization
Merck & Co.