Conference Day Two
8:00 am Check In & Coffee
8:50 am Chair’s Opening Remarks
Bridging the Translational Gap for PKPD: Preclinical Approaches for Improved Translation of PK & Reduced Reliance of Animal Models
9:00 am Characterizing Critical ADME Parameters Influencing ADC Disposition & Enhancing Conjugation Stability for Improved Therapeutic Performance
Synopsis
- Identifying key ADME factors that affects ADC's behavior in the body their effectiveness
- Exploring strategies to improve conjugation stability to enhance ADC durability and therapeutic benefit
- Using preclinical insights to better predict human PK and reduce reliance on extensive animal testing
9:30 am Impact of ADC Stability on Safety & Translation of Preclinical Stability Data into Human PK Prediction: Species-Specific Considerations
Synopsis
• Defining key factors and implications of ADC instability on safety
• Exploring species differences in stability and PK, discussing ADC degradation in rodents vs. other species: Significance for model selection
• Translating preclinical stability data into human PK: Modeling approaches and predictive value
10:00 am Predicting Pharmacokinetic Properties of ADCs Using AI: Efficiently Ruing Out Poor PK Profiles
Synopsis
- Leveraging AI tools to predict ADC pharmacokinetics early in development and flag potential issues
- Streamlining candidate learning with traditional preclinical data to improve prediction accuracy and decision-making
- Integrating machine learning with traditional preclinical data to improve prediction accuracy and decision-making
10:30 am Morning Networking Break
11:00 am Session Details to be Announced
11:30 am Preclinical to Clinical Translational Pharmacology of ADCs & Combinations
Synopsis
- Preclinical models often overpredict ADC clearance and efficacy; clinical translation requires biomarkers and modelling
- Payload toxicities dominate; humans show lower tolerance than animals; combinations add overlapping risks
- Preclinical PDXs exaggerate responses; clinical outcomes are limited by heterogeneity and resistance
12:00 pm Session Details to be Announced
12:30 pm Lunch Break & Networking
Understanding Tumor Internalization: Investigating the Bioanalysis of Increasingly Complex ADCs to Better Understand Drug Clearance & Efficacy
1:30 pm Bioanalytical Strategies for Novel ADC Modalities: Challenges in Stability & in vivo Analysis
Synopsis
- Exploring advanced analytical techniques to assess ADC structural integrity and ensure product consistency
- Characterizing drug-to-antibody ratio (DAR) and conjugation sites to understand their impact on ADC behaviour
- Linking analytical findings to ADC clearance and efficacy for improved bioanalytical interpretation
2:00 pm Challenges in ADC Bioanalysis: The Impact on in vivo Biotransformation in Incurred Samples on Assay Designs
Synopsis
- Exploring how the impact of biotransformation in vivo affects the suitability of different assay formats
- Addressing how the impact of these biotransformation's were uncovered and the strategies used to manage them
2:30 pm Roundtable Discussion: How Can We Utilize Clinical Pharmacology Assessments to Inform Strategic Decision Making in the Clinic?
Synopsis
Insights, reflections and case studies into how organ impairment, drug interaction and special population clinical studies can be best utilized to set a trial up for success. Discuss these important questions:
• How early on should we be carrying out clinical pharmacology-based assessments?
• How can we utilize these as more than just ticking a box?
• What does the future look like for these kinds of studies?