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Bioanalytics
Partner Presentation

Plan Early to Ensure a Successful ADA Assessment

Monday, November 10, 2025
10:30 AM - 11:30 AM CT
Location:360 Stage #1, Exhibit Hall

Sponsored By 
Bioanalytics Partner Presentation-Bioanalytics

    Partner Presentation Speaker(s)

  • HB

    Ha Bruno, PhD

    Associate Director, Chemistry, Manufacturing & Controls
    Certara
    Radnor, Pennsylvania

  • EO

    Elliot Offman, BSc Pharm, MSc, PhD

    Vice President, Clinical Pharmacology & Translational Medicine
    Certara
    Radnor, Pennsylvania

Description: Early planning for anti-drug antibody (ADA) assessment is essential to the successful development of biologic therapies. This presentation will highlight the importance of a phase-appropriate ADA assay strategy, show how proactive immunogenicity planning can support regulatory compliance and risk mitigation, while also enabling meaningful interpretation of translational pharmacokinetic and pharmacodynamic data to inform clinical decision-making. Attendees will gain practical insights into ADA assay design across development stages – from preclinical through to BLA submission. The presentation will also explore how to address the impact of ADA in translational and early development – illustrated through real-world case studies that demonstrate the benefits of early ADA considerations.

Learning Objectives:

  • Define a phase-appropriate strategy for ADA assay design from preclinical through BLA submission to ensure regulatory compliance and robust data generation.
  • Evaluate the impact of ADA on translational pharmacokinetics and pharmacodynamics to support clinical decision-making in early development.
  • Apply lessons from real-world case studies to understand how proactive ADA planning mitigates risk and improves biologic development outcomes.