Scientific Program Day Two
Thursday | April 18 2024
8:00 am Check in & Coffee
8:50 am Chair’s Opening Remarks
Enhancing Quantification of Free Drug to Set the Limits in the Free Drug Assays & Demonstrate Lack of Toxicity
9:00 am Development & Implementation of an SEC Method for Streamlined Analysis of Free Drug Related Impurities in Novel ADC Chemotypes
Synopsis
• Performing a FDRI analysis is critical for ensuring ADC product safety
• Exploring how new ADC chemotypes can pose challenges with respect to FDRI method development, and may not be a good fit for platform methods
• Assessing a new SEC method that has been developed to overcomes challenges of the previous RP method and is expected to be more easily adapted for new chemotypes
Turbocharging Bioassay Development to Overcome Long Development Times & Ensure You Can Update Development Conditions at an Earlier Stage
9:30 am Use of High Content Imaging to Turbocharge Cell-based Potency Assay Development for ADCs
Synopsis
- Discussing CMC Expectation & Strategy for Potency Methods for ADCs
- Exploring challenges of developing cell-based potency assays for ADCs in the current ADC landscape
- Making a case for using IncuCyte as a power-horse to enable multiple aspects of cell-based assay development including cell-line screening, optimizing seeding densities for cell-passaging, to find optimal incubation times for cytotoxicity assays which span several days
10:00 am Delving Into the Strategies for Developing Cell-Based Assays to Tackle Development Challenges & Produce a Standardized Approach
Synopsis
• Discussing how ADCs present significant challenges for analytical development including potency assays due to the complexity of the molecules
• Unveiling how regulatory agencies expect a functional cell-based assay from early stage of ADC development because it reflects the mechanism(s) of action, which is not covered by binding assays such as ELISA and SPR
• Discussing the challenges in developing a cell-based assay that is specific to the ADC molecule and can capture the structural/functional changes, as well as the solutions to overcome these challenges and potential standardization of cell-based assays
10:30 am Morning Networking Break
11:30 am Analytical Development & Improvement of Bioassay for ADC During the Method Lifecycle
Synopsis
• Discussing how for an ADC, a bioassay is recommended from early stage of development in order to reflect the mechanism of action which is directly related to the antibody but also to the conjugated drug. This particularity has the advantage to allow acquiring a better understanding of the method performance early in the product development
• Illustrating with examples how different steps during the method lifecycle (robustness study, method transfer, monitoring of the method performance, etc) allow improving the assay for late stage and registration
• Outlining how those changes can be managed, depending on the stage of the project and the extent of the change
Shattering the Mystery Behind DAR Distribution & Characterization to Platform the Process & Have Better Control Over It
12:00 pm Development & Application of Multiple DAR Methods: A Path to Well Characterized ADCs
Synopsis
• Understanding the importance of DAR and its distribution in ADC
• Exploring and comparing different DAR methods
• Cases study of application of DAR methods in product understanding and process development
12:30 pm Networking Lunch
1:30 pm Determining the Value in Assessing DAR Distribution to Understand the Level to Which to Control & Be Sensitive to It
Synopsis
• Review current analytical methods for DAR distribution assessment
• Learning a native LC-MS method for DAR determination
• Outlining a middle down /bottom-up method for DAR distribution
Overcoming Variability With Potency Assays to Reduce Complexity & Show Its Working in Representing the Actual Potency of the ADC
2:00 pm Understanding What a Potency Assay Entails to Understand Functionality of Molecule & Examine Novel MoA
Synopsis
• Overcoming the learning curve and understanding the characteristics of a potency assay
• Exploring how potency assays can explain functionality of the molecule
• Develop potency assay to examine novel MoA of target
2:30 pm Roundtable Discussion – Overcoming Challenges With Measuring Potency at a Cellular Level to Get a Clearer Readout of What is Happening in the Cells
Synopsis
• Examining why there are challenges associated with measuring potency at a cellular level
• Honing potency assays to enhance data production and understanding of cellular MoA
• Connecting data from potency assays to gain a clear understanding of your ADC