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

ITC Professional Development Award

The HESI ITC seeks graduate students working in immuno-safety or immunotoxicology fields for a new HESI ITC Professional Development Award. This award offers an opportunity to attend scientific conferences, workshops, or courses, etc. to build core competencies and transferrable skills, and/or share your research. Awardees will also be welcomed to attend ITC’s Business meetings to learn about the emerging projects and science at HESI and to network with experts in the immuno-safety field.

  • Award: Selected candidates will receive up to $2000.00 USD award to support attendance at relevant scientific conferences, workshops, training courses, or another related opportunity that contributes to professional development (e.g., laboratory visit for specialized training or another venture – please described in the application form). Proof of attendance 30 days after such event is required to be submitted to ITC committee.
  • 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, or similar).
  • Application: To apply, please send along the following: 1) completed application form, 2) CV or bioksketch, and 3) one reference letter from your mentor to itc@hesiglobal.org
  • Deadline for submission: Friday, January 27th, 2023.

*All documents must be merged into a single pdf with your first and last name in file title.
* Your mentor letter can be sent separately if they desire.

If you have any questions about the HESI ITC or this award, please contact Dr. E’Lissa Flores or Dr. Shermaine Mitchell-Ryan.

Application Form

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

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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Nonclinical Safety Assessment of Engineered T Cell Therapies

Over the last decade, immunotherapy has established itself as an important novel approach in the treatment of cancer, resulting in a growing importance in oncology. Engineered T cell therapies, namely chimeric antigen receptor (CAR) T cells and T cell receptor (TCR) T cell therapies, are platform technologies that have enabled ...

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Development of the First Reference Antibody Panel for Qualification and Validation of Cytokine Release Assay Platforms: Report of an International Collaborative Study

Author links open overlay Immunomodulatory therapeutics such as monoclonal antibodies (mAb) carry an inherent risk of undesired immune reactions. One such risk is cytokine release syndrome (CRS), a rapid systemic inflammatory response characterized by the secretion of pro-inflammatory cytokines from immune cells. It is ...

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Cross-Company Evaluation of the Human Lymphocyte Activation Assay

Nonclinical immunotoxicity evaluation is an important component of safety assessment for pharmaceuticals. One in vitro assay that can be applied in a weight of evidence assessment is the human lymphocyte activation (HuLA) assay, an antigen recall assay, similar in many respects to the in vivo T-cell-dependent ...

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

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

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

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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