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

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 is being developed.

    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.

HESI Staff

Leadership Team

  • Marc Pallardy, PhD

    Université Paris-Saclay

  • Hervé Lebrec, PhD

    Amgen, Inc.

  • Curtis Maier, PhD

    GlaxoSmithKline

Committee Events

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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HESI Sessions at EUROTOX Virtual Congress 2021

Virtual congress, hosted by EUROTOX

The HESI Immuno-Safety Technical Committee (ITC) and Translational Biomarkers of Neurotoxicity (NeuTox) Committee will present their work at the EUROTOX Virtual Congress 2021 on September 28-30, 2021. Additionally, Dr. Syril Pettit, HESI Executive Director, will participate in the EUROTOX/SOT Debate as the SOT Debater on ...

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HESI ITC Committee 2021 Spring Meeting

Virtual meeting, hosted by the HESI ITC Committee

The HESI ITC Committee 2021 Spring Meeting will take place on May 6-7, 2021 from 9am-1pm EST. The virtual meeting is open to ITC Committee participants only.

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ITC Humanized Mouse Model Working Group Seminar Series

Virtual seminar series, hosted by the HESI ITC Committee

This ITC working group seminar series aims to provide informational background on existing or newly emerging case studies of humanized mouse models from various organizations, including The Jackson Laboratory, Taconic Biosciences, AstraZeneca, and the US Food and Drug Administration. The working group seeks to better ...

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				ITC Workshop Image_April 2020
	

THIS EVENT HAS BEEN POSTPONED IN RESPONSE TO COVID-19. PLEASE STAY TUNED FOR UPDATED DATE, TIME, AND OTHER MEETING DETAILS.

 

Background

The field of immuno-safety is a dynamic one in which changing public health concerns, novel biomedical research advances, and innovative technological developments constantly change the landscape and the way in which work is carried out and utilized. As this field requires combined expertise in both immunology and toxicology, the need for continued training and interdisciplinary interactions are critical for those who work within this field. This is essential both for those with an immunology background who seek to apply this expertise to drug development and safety, as well as those who wish to enhance their current drug safety expertise with a deeper understanding of immunology.

 

Objectives

-Review the background science of the immune system in both normal and diseased state
-Enhance awareness of toxicities associated with modulation of the immune system
-Provide a training mechanism that incorporates the latest science into preexisting drug development methodologies

 

Output

Beyond the dialogue that will be generated on the latest science, this training course will provide the opportunity to apply it to a drug development setting through the following means:

-Engagement and discussion with experts in the field will enable participants to see how the science translates to applicability in drug development
-The use of specific case studies will engage and illustrate to participants how they can systematically progress on a sample task [post_title] => Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune Related Safety Assessments [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => cancer-immunotherapies-biology-therapeutic-approaches-and-immune-related-safety-assessments-2 [to_ping] => [pinged] => [post_modified] => 2020-10-28 14:59:49 [post_modified_gmt] => 2020-10-28 14:59:49 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21939 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) ) [post_count] => 6 [current_post] => -1 [in_the_loop] => [post] => WP_Post Object ( [ID] => 24127 [post_author] => 14 [post_date] => 2021-08-06 15:45:26 [post_date_gmt] => 2021-08-06 15:45:26 [post_content] => [post_title] => HESI ITC Committee 2021 Fall Meeting [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => hesi-itc-committee-2021-fall-meeting [to_ping] => [pinged] => [post_modified] => 2021-09-03 14:43:46 [post_modified_gmt] => 2021-09-03 14:43:46 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=24127 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 19 [max_num_pages] => 4 [max_num_comment_pages] => 0 [is_single] => [is_preview] => [is_page] => [is_archive] => 1 [is_date] => [is_year] => [is_month] => [is_day] => [is_time] => [is_author] => [is_category] => [is_tag] => 1 [is_tax] => [is_search] => [is_feed] => [is_comment_feed] => [is_trackback] => [is_home] => [is_privacy_policy] => [is_404] => [is_embed] => [is_paged] => [is_admin] => [is_attachment] => [is_singular] => [is_robots] => [is_favicon] => [is_posts_page] => [is_post_type_archive] => [query_vars_hash:WP_Query:private] => 690cc698e339902dfee90426aafa9329 [query_vars_changed:WP_Query:private] => 1 [thumbnails_cached] => [stopwords:WP_Query:private] => [compat_fields:WP_Query:private] => Array ( [0] => query_vars_hash [1] => query_vars_changed ) [compat_methods:WP_Query:private] => Array ( [0] => init_query_flags [1] => parse_tax_query ) )

Committee Publications

Filter

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

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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