Antibody-Drug Conjugate Safety Committee

Mission Statement

The mission of the HESI Antibody-Drug Conjugate Safety Committee is to identify, optimize, and advance translational approaches to safety evaluation of Antibody-Drug Conjugates to improve safety and efficacy for patients.

Working Groups

  • ILD/Ocular Toxicity Workshop Planning and Publication

    The Pathogenesis of ADC-Associated Clinical Toxicities – Ocular and ILD

    • The ADC Safety Committee planned and executed a highly successful workshop in September 2025
      Co-Hosted by Dana-Farber Cancer Institute
    • Over 200 participants – many international leaders in the field across sectors and disciplines
    • Clinical Participation: Oncology, Pulmonology, Ophthalmology, Internal Medicine, Regulatory, etc.
    • Nonclinical Participation: Toxicology, Pathology, Chemistry, Regulatory, etc.

    Workshop content included:

    • Presentations and active discussion of case studies and data on the pathology, epidemiology, detection, monitoring, and treatment of ocular toxicity and interstitial lung disease resulting from ADC therapy.
    • Interactive panel discussions, real-time identification of gaps and opportunities.

    Outputs will inform the development/use of ADCs with reduced toxicity without compromising therapeutic benefit.

    The Committee is preparing a workshop proceedings manuscript for publication.

  • Ocular Interest Group

    This new group was formed in 2025 to develop new collaborative project concepts based on the learnings from the ILD and ocular toxicity workshop, potentially leveraging approaches such as collective data sharing and analysis, integrating across data types, and building consensus and decisional approaches.

  • ILD Interest Group

    This new group was formed in 2025 to develop new collaborative project concepts based on the learnings from the ILD and ocular toxicity workshop, potentially leveraging approaches such as collective data sharing and analysis, integrating across data types, and building consensus and decisional approaches.

  • Hematotoxicity Proposal Team

    This team was formed in 2025 to develop a new project proposal assessing nonclinical in vitro and in silico models/assays of hematotoxicity with ADC administration, to improve early screening and better understand hematotoxicity and off-target effects.

  • Gap Analysis - Completed

    An in-depth gap analysis was conducted through mid-2024 to identify research gaps and explore opportunities for addressing them:

    • Lack of availability or consensus on in vitro, in silico, in vivo methods to characterize and predict mechanisms of ADC toxicity
    • Heavy reliance on non-human primates (NHPs) for toxicity testing
    • Lack of strong collaboration across the clinical and non-clinical domains, loss of shared learning and opportunity to advance safety:efficacy ratios

     

HESI Staff

Leadership Team

  • Roger Tam, PhD

    Health Canada

  • Ronnie Yeager, PhD

    AbbVie

Committee Events

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Center for Patient and Consumer Safety

The Antibody-Drug Conjugate Safety Committee is part of the Center for Patient and Consumer Safety. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.

Other Committees in the Center for Patient and Consumer Safety:

For questions about the Center contact:
Center Director: Syril Pettit
Center Advisor: Lucilia Mouriès

Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403

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