Scientific Program Day One
Wednesday | April 17 2024
8:00 am Check in & Coffee
8:50 am Chair’s Opening Remarks
Delving Into the Regulatory Perspective on Extended Characterization, Setting the Specifications & CQA to Evolve Your ADC From Discovery Through Clinical Development & Regulatory Filing
9:00 am Regulatory Considerations on Control Strategies for ADC Products – From the Biologics Perspective
Synopsis
• Overview of the review process for ADC products, with the focus on the biologics component
• Expectations on ADC characterization studies
• Expectations on ADC specifications, with the focus on potency assays
9:30 am Regulatory Considerations for Antibody-Drug Conjugates From the Small Molecule Perspective
Synopsis
- Overview of the review process for ADC products, with a focus on the small molecule
- Review expectations on payload-linker controls
- Discuss the expectations on DAR and residual impurities controls in the ADC drug substances and drug products
10:00 am Panel Discussion – Analyzing the Regulatory Expectations Around Specification Setting to Benchmark the Required Specifications & Accelerate Analytical Method Development
Synopsis
• Learning the regulatory expectations around setting specification for free drugs
• Exploring the commonly used methods to set specifications
• Understanding which qualities require specification setting
10:30 am Morning Break & Speed Networking
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and continue forging new and beneficial relationships. You will have the opportunity to present your work, and review presentations displaying novel approaches and findings
11:30 am Learning the Approaches to Extended Characterization to Answer Questions Surrounding Data Interpretation to Justify Your Data & Answers to Regulatory Authorities
Synopsis
• Understanding the need for extended characterization and the expectations surrounding it
• Exploring the various approaches towards extended characterization
• Navigating how to interpret data from extended characterization results
12:00 pm Understanding the Impact of Conjugation on CQA to be Able to Define CQA in MAb vs ADC & Reduce Workload to Ease the Filing Process
Synopsis
• Learning the differences in characterizing CQA in Mab and ADC
• Analyzing how conjugation affects CQA characterization
• Guiding analytical methods smoothly through development up to filing
12:30 pm Faster to Clinic Approach and the impact of ICH Q14 & ICH Q2(R2) on phase-appropriate drug development.
Synopsis
- Understanding ICH Q14/Q2(R2): This presentation will cover the new ICH Q14 and ICH Q2(R2) guidelines, focusing on their impact on each phase of drug development.
- Phase-Specific Strategies: We'll explore strategies tailored to each development phase, aligning with ICH Q14/Q2(R2) requirements.
- Correlation with New Guidelines: The talk will also highlight how the data requirements for each phase relate to the new ICH guidelines, ensuring compliance and efficiency.
1:00 pm Networking Lunch
Exploring Physiochemical Assays Outside of DAR Distribution/Characterization to Produce a More Holistic Analytical Profile of Your ADC
2:00 pm Analytical Strategy & Regulatory Consideration of Linker-payload in ADC Development
Synopsis
• Discussing regulatory perspective of linker-payload in ADC therapeutics
• Exploring small molecule related impurities and control
• Outlining analytical strategies of linker-payload in ADC programs
2:30 pm Investigation of High Molecular Weight Size Variant Formation in AntibodyDrug Conjugates: Microbial Transglutaminase-Mediated Crosslinking
Synopsis
- Reviewing extended characterization of HMW size variants in mTG-mediated ADCs
- Identifying primary source of increased level of HMW size variants
- Exploring approaches to minimize HMW size variants formation in in mTG-mediated ADCs
3:00 pm Roundtable Discussion – Evaluating Which Technique to Use to Characterize Conjugation of Your ADC to Arm Yourself With a Complete Dataset & Ensure Confidence in Your Analysis
Synopsis
• Identifying why characterizing conjugation is so important
• Exploring which analytical methods are the most suitable for characterizing conjugation
• Discovering how characterizing conjugation enhances understanding of your ADC
4:00 pm Afternoon Networking Break
5:00 pm icIEF Method Development for Charge Variants of ADCs Based on Their Structural Features
Synopsis
• Reviewing a capillary isoelectric focusing (cIEF) method development for charge variant determination of ADCs
• Discussing solubilizer and carrier ampholyte optimization
• Learning about method assessment and robustness
5:30 pm Chair’s Closing Remarks
5:35 pm Drinks Reception & Scientific Poster Session
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and continue forging new and beneficial relationships. You will have the opportunity to present your work, and review presentations displaying novel approaches and findings.