Immuno-Safety Technical Committee (ITC)

Mission Statement

The mission of the HESI Immuno-Safety Technical Committee (ITC) is to identify and address scientific issues related to immune safety and translation to human health risk assessment.

Key Objectives:

  • Leverage technical and scientific expertise from academic, regulatory, and industry organizations to advance immuno-safety science
  • Contribute to the scientific decision-making processes relative to the development of guidelines and regulations for immune safety testing
  • Educate stakeholders in safety science and promote the understanding and appropriate use of immune safety data

Mentorship Program

The HESI ITC seeks graduate students working in immunology, toxicology, pathology, or related field for a second cycle of their new HESI ITC Mentorship Program. This program will allow meaningful interactions between trainees and mentors to give insight on various career pathways and discuss how to streamline the mentees’ long-term goals. The second cohort will tentatively be from May – June 2023 with 4-5 one-on-one mentor meetings. As well as an opportunity to network with past mentees and expert immuno-safety committee members at our ITC annual meeting (25-26 April 2023).

  • Qualifications and Requirements: Eligible candidates must be currently enrolled in a graduate program (MS or PhD candidates) in immunology, toxicology, pathology or related field (cell biology, biochemistry, biomedical engineering, or similar). And must have completed at least one year in their program.
  • Submission window is now closed

If you have any questions about the HESI ITC or this program, please contact Dr. Shermaine Mitchell-Ryan

Congratulations to the 2023 Professional Development Awardees!

1. Ishita Choudhary, Louisiana State University
Research area: Investigating the mechanisms of ozone and allergen induce lung injury.

2. Jaclynn Meshanni, Rutgers University
Research area: The role of Lipid homeostasis in macrophages and its impact on the development of Pulmonary fibrosis resulting from Nitrogen mustard exposure.

Working Groups

  • Regulatory Strategies and Risk Assessment

    Regulatory Gaps
    This group aims to provide a review of regulatory guidance documents with an educational lean to serve as a primary reference for state-of-the-art assays, models, regulatory guidance, and references.

    Immunomodulation and Pregnancy Risk Assessment
    This work aims to evaluate and incorporate learnings on preclinical immune safety assessment of pregnancy risk in the presence of immunomodulatory therapy. The 2020 FDA/CBER-HESI Immunomodulators and Pregnancy Risk Workshop convened key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by longer in-depth discussion within each session, the goal was to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development. The 2020 HESI Symposium on Assessing Pregnancy Risk of Immunomodulators provided a broad overview of the role of the maternal immune system in the establishment, maintenance, and completion of a healthy pregnancy. The sessions covered both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy as well as address gaps in biology, current tools, and other aspects of pregnancy risk for consideration during drug development. An overview of marketed therapeutics highlighted current knowledge of the effects of immunomodulators on pregnancy in nonclinical animal models, potential class effects, and available data from patients exposed during pregnancy.

    Nanomedicine (Nanopharmacology)
    A position paper on the immunotoxicity assessment of nanomedicines is being developed.

  • Method Development for Immune Safety Testing

    NK/CTL Assays
    Under the method development working group, this project team is developing a manuscript that provides the tools and assays available to assess either cytotoxic T lymphocyte (CTL) or natural killer (NK) cell function.

    Examining the Use of Humanized Mice as a Preclinical Model in Drug Development
    This project is designed to identify gaps/issues highlighted from a committee-wide survey regarding the use of the model and to design specific projects to resolve important issues identified.

  • Translational Immune Safety

    Cytokine-Release Assay-In Vivo Cytokine Release
    This project is evaluating what parameters contribute to the variability in cyno control animals.

    FIH Dose Selection for Immunomodulators
    This work aims to determine a suitable course of action for establishing a first-in-human (FIH) dose for various types of immunomodulators.

    Drug Hypersensitivity Reactions
    This work will develop a compendium on how to assess and test for drug hypersensitivity reactions in both preclinical and clinical settings.

  • Education and Outreach

    Immunotoxicology Training Course
    The ITC convenes an annual training course on immune safety science. The training course will transition to a virtual modular format to broaden the committee’s reach and add flexibility to course offerings.

    Science Outreach
    These efforts aim to develop resources and activities for outreach at select scientific meetings and to create a platform to advocate and educate the next generation of immuno-safety scientists.

    ITC Website Development
    An ITC-centric website where both scientists and the public can find information on the field of immuno-safety has been developed. Visit the website here: https://immunosafetyresource.org/

    ITC Clearinghouse Database
    This work aims to create a clearinghouse/database that contains resource information related to the field of immune safety and to share information internally and externally to drive education and outreach. Visit the database here: https://immunosafetyresource.org/itc-databases/

Committee Resources

Speaker Bios

HESI Staff

Leadership Team

  • Marc Pallardy, PhD

    Université Paris-Saclay

  • Hervé Lebrec, PhD

    Amgen, Inc.

  • Curtis Maier, PhD

    GlaxoSmithKline

Committee Events

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Committee Publications

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Summary of a Workshop on Preclinical and Translational Safety Assessment of CD3 Bispecifics

Journal of Immunotoxicology, 2020

Kamperschroer C, Shenton J, Lebrec H, Leighton JK, Moore PA, ...

Currently, there is a multitude of CD3 bispecifics with different molecular designs and binding properties in preclinical and clinical development for the treatment of liquid or solid tumors. The key safety concerns with CD3 bispecifics are excessive release of cytokines, which may translate to potentially life-threating ...

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Comparison of Immune System Development in Nonclinical Species and Humans: Closing Information Gaps for Immunotoxicity Testing and Human Translatability

Reproductive Toxicology, 2019

Skaggs H, Chellman GJ, Collinge M, Enright B, Fuller CL, Krayer J, ...
  • HESI - Health and Environmental Sciences Institute

The developmental origins of human health and disease (DOHaD) is a growing field of health-related research that is based on the hypothesis that perturbations to the pre- or postnatal environment, in the form of xenobiotic exposure, stress, infections or nutritional deficits, may contribute to the manifestation of disease ...

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Cytokine Release: A Workshop Proceedings on the State-of-the-Science, Current Challenges and Future Directions

Cytokine, 2016

Grimaldi C, Finco D, Fort MM, Gliddon D, Harper K, Helms WS, ...

In October 2013, the Health and Environmental Sciences Institute Immuno-Safety Technical Committee (ITC) held a one-day workshop entitled, “Workshop on Cytokine Release: State-of-the-Science, Current Challenges and Future Directions”. The workshop brought together scientists from pharmaceutical, academic, ...

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Developing a Framework for Assessing Chemical Respiratory Sensitization: A Workshop Report

Regulatory Toxicology and Pharmacology, 2016

North CM, Ezendam J, Hotchkiss JA, Maier C, Aoyama K, Enoch S, ...

Respiratory tract sensitization can have significant acute and chronic health implications. While induction of respiratory sensitization is widely recognized for some chemicals, validated standard methods or frameworks for identifying and characterizing the hazard are not available. A workshop on assessment of ...

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HESI/FDA Workshop on Immunomodulators and Cancer Risk Assessment: Building Blocks for a Weight-of-Evidence Approach

Regulatory Toxicology and Pharmocology, 2015

Lebrec H, Brennan FR, Haggerty H, Herzyk D, Kamperschroer C, ...

Profound immunosuppression (e.g., AIDS, transplant therapy) is epidemiologically associated with an increased cancer risk, and often with oncogenic viruses. It is currently unclear how broadly this association translates to therapeutics that modulate immunity. A workshop co-sponsored by the FDA and HESI examined how ...

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The T-Cell-Dependent Antibody Response Assay in Nonclinical Studies of Pharmaceuticals and Chemicals: Study Design, Data Analysis, Interpretation

Regulatory Toxicology and Pharmacology, 2014

Lebrec H, Molinier B, Boverhof D, Collinge M, Freebern W, ...
  • HESI - Health and Environmental Sciences Institute

The T-cell-dependent antibody response (TDAR) assay is a measure of immune function that is dependent upon the effectiveness of multiple immune processes, including antigen uptake and presentation, T cell help, B cell activation, and antibody production.

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