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 Session Details to be Announced

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 Preclinical to Clinical Translational Pharmacology of ADCs and 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

11:30 am Session Details to be Announced

  • Marcel Hop Vice President & Lead of DMPK, Genentech

12:00 pm Roundtable Discussion: How Stable Should an ADC Be? Aiding with PK Predictability & Risk Benefit Ratio

Synopsis

  • Discussing the balance between ADC stability and release kinetics to optimize pharmacokinetics and therapeutic effect
  • Exploring how stability influences safety risks and the overall benefit-risk profile in clinical settings
  • Sharing perspectives on designing stability profiles that support predictable PK and maximize patient benefit

1:00 pm Lunch Break & Networking

Understanding Tumor Internalization: Investigating the Bioanalysis of Increasingly Complex ADCs to Better Understand Drug Clearance & Efficacy

2:00 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

2:30 pm Bridging Preclinical & Clinical Bioanalysis – Platforms & Assay Adaption from LC-MS to LBA

Synopsis

  • Discussing challenges and strategies for transitioning bioanalytical assays from LC-MS in preclinical studies to LBA in clinical settings
  • Highlighting assay adaptations needed to maintain accuracy and sensitivity across different platforms
  • Sharing best practices to ensure seamless data continuity and reliable ADC characterization throughout development

3:00 pm Challenges in ADC bioanalysis: The impact on in vivo Biotransformation in Incurred Samples on Assay Designs

  • Chris Beaver Executive Director, Global Head of Regulated Clinical Bioanalysis, Daiichi Sankyo

Synopsis

  • Interpreting complex analytes from in vivo biotransformation
  • Addressing assay specificity, sensitivity, and accuracy challenges
  • Adapting bioanalytical strategies for reliable quantification

3:30 pm Chair’s Closing Remarks

3:45 pm End of Conference Day Two

Synopsis

Close of 2nd ADC Pharmacokinetics & Clinical Pharmacology Summit