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

HESI ITC Committee 2022 Fall Meeting

Hybrid meeting, hosted by the HESI ITC Committee

The HESI ITC Committee 2022 Fall Meeting will take place on October 18-21, 2022. The hybrid meeting is open to ITC Committee participants only.

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2022 SOT Annual Meeting

San Diego, CA, USA

A number of HESI Scientific Committees will be presenting at the upcoming Society of Toxicology meeting, which will be held virtually and in person in San Diego, CA March 27-31, 2022.

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HESI ITC Method Development Webinar Series

Immuno-Safety Technical Committee Webinar Series, Virtual

As part of the HESI ITC New Methods and Technologies Webinar Series, Dr. Phillipe Couttet of Novartis will give a talk titled "Single-cell omics in Immunology".

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HESI ITC Method Development Webinar Series

Immuno-Safety Technical Committee Webinar Series, Virtual

As part of the HESI ITC New Methods and Technologies Webinar Series, Dr. Adrian Roth, Principal Scientific Director at Roche, will give a talk titled “Novel Human Cell Models in Drug Development: How 3D, Organoids, and Organ on Chip Models can improve and renew current paths and our vision for the future” ...

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HESI ITC Committee 2021 Fall Meeting

Virtual meeting, hosted by the HESI ITC Committee

The HESI ITC Committee 2021 Fall Meeting will take place on October 14-15, 2021. The virtual meeting is open to ITC Committee participants only.

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Committee Publications

A Proposed Testing Framework for Developmental Immunotoxicology (DIT)

A group of thirty immunotoxicology experts from the U.S. and E.U. representing government, industry, and academia met in May 2003, in Washington, D.C., to reach consensus regarding the most appropriate methods to assess developmental immunotoxicology (DIT) for hazard identification, including under what conditions such ...

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