Immunosafety Technical Committee (ITC)

Mission Statement

The HESI Immuno‑Safety Technical Committee (ITC) works to identify and address scientific questions related to immune safety and to strengthen the translation of immune safety findings into human health risk assessment.

It’s Key Objectives are to:

  • Advance immuno‑safety science by bringing together technical and scientific expertise from academia, regulatory agencies, and industry.
  • Support sound scientific decision‑making by contributing to the development of guidelines and regulations for immune safety testing.
  • Educate and engage stakeholders in safety science to promote the understanding, appropriate interpretation, and responsible use of immune safety data.

Regulatory Strategies and Risk Assessment Working Group

Mission: To lead cross-sector discussions among academic, regulatory, and industry organizations on key risk-assessment issues affecting drug development and human health.
Working Group Leadership: Birgit Fogal (Sanofi) and Ashwini Phadnis (Boehringer Ingelheim)
HESI Staff: Shermaine Mitchell-Ryan

  • Advancing Regulatory Acceptance of NAM-Based Immunosafety Assessment for Biologics and Immunomodulators

    This work stream is examining how new approach methodologies (NAMs) can be implemented in immune safety assessment. The team is conducting a comparative analysis of global regulatory guidance and developing case studies and educational tools to identify appropriate contexts of use, remaining scientific gaps, and the evidence needed to build regulatory confidence in NAM-based decisions.

    The team also played an essential role in planning and delivering the 2026 ITC workshop, “From Decisions to Evidence: A Context-of-Use Framework for NAMs in Immune Safety Assessment.” The workshop brought together experts from regulatory agencies, industry, and academia to evaluate the readiness and fitness of NAMs for specific immune safety applications and identify priorities for advancing their regulatory use.

    Planned Outputs: A regulatory landscape analysis, case studies, educational resources, a workshop report, and recommendations for advancing the fit-for-purpose use of NAMs in immune safety assessment.
    Leadership: Birgit Fogal (Sanofi) and Joseph Woska (ImmunityBio)
    HESI Staff: Shermaine Mitchell-Ryan

  • Carcinogenicity Weight of Evidence (WOE)

    This work stream is summarizing regulatory guidance and developing a weight-of-evidence approach for evaluating the carcinogenic potential of immunomodulatory therapies. The team is compiling case studies and relevant assays to clarify when additional carcinogenicity testing may or may not be warranted.

    Planned Outputs: A manuscript and webinar series describing a regulator-aligned weight-of-evidence framework.
    Leadership: Birgit Fogal (Sanofi) and Ashwini Phadnis (Boehringer Ingelheim)
    HESI Staff: Chrissy Crute

  • Best Practices for Cytokine Release Assays (CRA)

    This work stream is developing practical recommendations for the design, conduct, interpretation, and reporting of cytokine release assays used for preclinical hazard identification of protein-based biologics. The work focuses on mechanism-informed and fit-for-purpose use of these assays.

    Planned Output: A best-practices manuscript and decision framework outlining when cytokine release assays are warranted and how their results should be interpreted.
    Leadership: Marie-Soleil Piché (Charles River Laboratories) and Mark Collinge (Pfizer)
    HESI Staff: Shermaine Mitchell-Ryan

  • Autoimmunity and Immune-Related Adverse Events

    This work stream is examining the biological mechanisms underlying the loss of immune tolerance, clinical manifestations across organ systems, patient susceptibility and biomarkers, the predictive value of nonclinical models, emerging therapeutic modalities, and strategies for managing efficacy-toxicity tradeoffs.

    Planned Output: A workshop focused on autoimmunity and immune-related adverse events, with additional outputs to be defined through the scoping process.
    Leadership: Birgit Fogal (Sanofi) and Joseph Woska (ImmunityBio), Sean Hammond (ApConnix)
    HESI Staff: Shermaine Mitchell-Ryan

Method Development for Immune Safety Testing Working Group

Mission: To optimize and share methodologies used for immune safety testing across companies and research organizations and support the generation of appropriate preclinical data for protecting public health.
Working Group Leadership: Courtni Newsome (Johnson & Johnson) and Mike Oropallo (Merck)
HESI Staff: Chrissy Crute

  • Complex In Vitro Models (CIVMs) in Immuno-Safety

    This work stream is developing practical recommendations for the use of complex in vitro models in immune safety testing, including immune-competent microphysiological systems. The current focus is on the biological and technical requirements needed to model T cell-dependent antibody responses in vitro.

    Planned Output: A perspective manuscript describing the current state, requirements, limitations, and future qualification needs for complex in vitro TDAR models.
    Leadership: Nikki Marshall (GSK) and Mark Collinge (Pfizer)
    HESI Staff: Chrissy Crute

  • Predictive Immunogenicity Reference Panel

    This HESI-AAPS collaboration is evaluating standardized protein and peptide reference materials for use in in vitro T-cell activation assays. The initial multi-laboratory pilot assessed anti-PCSK9 monoclonal antibody analogs and examined material stability, assay performance, and sources of interlaboratory and donor variability.

    Planned Outputs: A manuscript describing the pilot study and a framework for a larger, externally funded ring trial that would expand the reference panel and support assay harmonization.
    Leadership: Sandrine Vessillier (MHRA) and Laurent Malherbe (Eli Lilly and Company)
    HESI Staff: Shermaine Mitchell-Ryan

  • Predictive Immunogenicity: In Silico Prediction and T-Cell Activation

    This scoping work stream aims to address the gap between predicted peptide-HLA binding and measured T-cell activation. The proposed study will use in silico HLA-binding tools to select peptides for testing under standardized experimental conditions across fully HLA-typed donors.

    Planned Output: A harmonized dataset linking predicted peptide-HLA binding with measured T-cell activation, accompanied by a manuscript describing the proof-of-principle study.
    Leadership: Morten Nielsen (Technical University of Denmark) and Laurent Malherbe (Eli Lilly and Company)
    HESI Staff: Shermaine Mitchell-Ryan

  • Evaluating Natural Killer Cell Function Assays

    This work stream is reviewing available natural killer cell functional assays that can be used in the preclinical setting to evaluate the effects of investigational drugs on immune function. The work considers established assays, emerging technologies, published case studies, and relevant regulatory perspectives.

    Planned Output: The manuscript “Current Approaches to Evaluating Natural Killer Cell Function in Non-Clinical Immune Safety Assessments.”
    Leadership: Jonathan Clingan (Genentech)
    HESI Staff: Shermaine Mitchell-Ryan

  • New Approach Methodologies Webinar Series

    This work stream brings together assay developers and subject-matter experts with experience in emerging immune safety technologies and methodologies. The series examines the scientific basis, readiness, limitations, and potential applications of these approaches.

    Planned Output: An ongoing webinar series on emerging NAMs and complex in vitro models for immune safety assessment.
    Leadership: Program-specific speakers and organizers
    HESI Staff: Chrissy Crute

  • NAMs for Viral Reactivation and Cancer Risk

    This scoping work stream is exploring approaches to improve nonclinical cancer-risk assessment for immunomodulatory therapies. The team will evaluate the scientific rationale and feasibility of assessing Epstein-Barr virus and KSHV/HHV-8 reactivation using NAMs alongside existing in vivo approaches.

    Planned Output: A proposed experimental strategy or collaborative research project evaluating NAM-based approaches to viral reactivation and cancer-risk assessment.
    Leadership: Hervé Lebrec (Independent Consultant)
    HESI Staff: Chrissy Crute

Translational Immune Safety Working Group

Mission: To examine immune safety testing and the interpretation of immune findings across nonclinical and clinical studies.
Working Group Leadership: Jean Sathish (Pfizer) and Ryan Polli (Novartis)
HESI Staff: Shermaine Mitchell-Ryan

  • Translation to Clinical Outcomes Work Stream: Translating Nonclinical Immune Safety Findings to Clinical Outcomes

    This work stream is developing an approach for evaluating the relationship between nonclinical immune safety findings and clinical outcomes. The initial feasibility assessment is using withdrawn or discontinued therapeutics as a test set to determine whether the necessary nonclinical and clinical information can be identified, standardized, and compared.

    The work includes a complementary effort to evaluate nonclinical immunotoxicology findings that were not considered clinically relevant.

    Planned Output: A feasibility analysis and translational framework for determining which nonclinical immune findings are predictive of clinical outcomes and how those findings should inform development decisions.
    Leadership: Wendy Komocsar (Eli Lilly and Company), and Meredith Steeves (Eli Lilly and Company)
    HESI Staff: Shermaine Mitchell-Ryan

  • Translational Relevance of NHP Immunotoxicities with T-Cell Modulators

    This work stream is evaluating the current use of nonhuman primate models in immunotoxicology and their ability to predict human immune responses to T-cell-modulating therapies. The team is identifying knowledge gaps in how NHP data are interpreted and applied in human risk assessment and considering complementary or alternative strategies.

    Planned Output: A manuscript describing the circumstances in which NHP models provide meaningful translational information and where alternative approaches may be more appropriate.
    Leadership: Lauren Gauthier (Takeda) and Ana Goyos (Johnson & Johnson)
    HESI Staff: Chrissy Crute

  • Comparative Immune Biology Work Stream: Comparative Immune Biology

    This work stream is evaluating where animal models provide irreplaceable value, where NAMs may complement or replace them, and how an integrated scientific approach can support fit-for-purpose model selection for immune safety assessment.

    Planned Output: A manuscript or scientific framework supporting evidence-based selection of animal models and complementary NAMs for immune safety studies.
    Leadership: Smita Salian-Mehta (Gilead Sciences) and Tracey Papenfuss (StageBio)
    HESI Staff: Shermaine Mitchell-Ryan

  • CRA in Cynomolgus Monkeys Work Stream: Cytokine Variability in Cynomolgus Monkeys

    This work stream is evaluating factors that contribute to variability in cytokine concentrations in control cynomolgus monkeys. The goal is to distinguish natural biological variability from test article-related immune effects and improve the interpretation of cytokine data in nonclinical studies.

    Planned Output: A manuscript describing baseline cytokine variability, contributing factors, and recommendations for interpreting cytokine measurements in cynomolgus monkey studies.
    Leadership: Lynn O’Donnell (Pfizer)
    HESI Staff: Shermaine Mitchell-Ryan

  • Comparative Immune Biology Webinar Series as a Separate Work Stream: Comparative Immune Biology Webinar Series

    This work stream convenes experts in translational immunology to discuss animal models used in immunotoxicology and their relevance to human immune biology. The 2026 Society of Toxicology continuing education course serves as the foundation for the series.

    Planned Output: A webinar series examining comparative immune biology, model selection, and translation to humans.
    Leadership: Smita Salian-Mehta (Gilead Sciences) and Tracey Papenfuss (StageBio)
    HESI Staff: Shermaine Mitchell-Ryan

    Please retain this as a separate work stream from the Comparative Immune Biology project. One is a webinar and educational series, while the other is developing a scientific framework for model selection.

Education and Outreach Working Group

Mission: To educate and communicate with the scientific community and the public about issues related to immunosafety science and its application to human health risk assessment.
Working Group Leadership: Tracey Papenfuss (StageBio) and Nikki Marshall (GSK)
HESI Staff: Chrissy Crute

  • Scientific Seminars and Outreach at Professional Societies

    This work stream coordinates ITC continuing education courses, symposia, roundtables, presentations, and other activities at relevant toxicology and immunology conferences. It also supports engagement with academic immunologists, increases awareness of ITC science, and helps recruit new cross-sector participants.

    Planned Outputs: Continuing education courses, scientific sessions, roundtables, presentations, webinars, and other outreach activities.
    Leadership: Varies by conference or activity
    HESI Staff: Shermaine Mitchell-Ryan and Chrissy Crute

  • Immunosafety Training Course

    This on-demand virtual course provides comprehensive education in immunosafety science. It includes 45 lectures organized into six modules covering immune safety tools, therapeutic modalities, immune toxicities, regulatory considerations, and advanced or specialized topics.

    Planned Output: An on-demand virtual immunosafety training course hosted on the new learning platform.
    Leadership: ITC subject-matter experts
    HESI Staff: Shermaine Mitchell-Ryan

  • Immunosafety Outreach Manuscript

    This work stream is developing a manuscript that introduces immunosafety as an emerging discipline connecting basic immunology, translational science, and clinical application. The manuscript will advocate for earlier and more proactive consideration of immune safety in immunology education, research design, and therapeutic development.

    Planned Output: A manuscript provisionally titled “Translational Immunology and Immunosafety: Immunologists as Architects of Effective and Safe Therapies.”
    Leadership:
    HESI Staff: Shermaine Mitchell-Ryan

Past Work Streams

  • First-in-Human Dose Selection Commentary

Resources



ITC CIVMs in Immunosafety Webinar presents Dr. Linda Griffith
Watch Video


HESI Immuno-Safety Career Symposium
Watch Video


ITC CIVMs in Immunosafety Webinar presents Dr. Donald Ingber
Watch Video

Blog Posts

ITC

Advancing Immune Safety: HESI ITC Drives Innovation from Bench to Translation at SOT and IMMUNOLOGY2026

post

Read more
ITC

Advancing Immuno-Safety: Exploring Complex In Vitro Models through the HESI ITC Webinar Series

post

Read more
ITC

Advancing NAMs in Immunosafety: How ITC Is Shaping the Conversation

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ITC

Launching ITC Immunosafety in 2026: the Science, the People, and the Future of Safety Assessment

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Committee Events

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Committee Publications

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HESI Staff

Leadership Team

  • Marc Pallardy, PhD

    Université Paris-Saclay

  • Hervé Lebrec, PhD

    Sonoma Biotherapeutics

  • Mark Collinge

    Pfizer

Center for Translational Sciences

The Immuno-Safety Technical Committee (ITC) is part of the Center for Translational Sciences. 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 Translational Sciences are:

For questions about the Center contact:

 

Contact Us

Health and Environmental Sciences Institute (HESI)

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

740 15th Street NW, Suite 600
Washington, DC 20005

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