Immunosafety Technical Committee (ITC)

Mission Statement

The mission of the HESI Immunosafety 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

  • 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.

  • Cytokine Release Assay-Standards Study

    This study is a cross-site evaluation of positive and negative controls for a cytokine release assay.

  • Examining the Use of Humanized Mice as a Preclinical Model in Drug Development (Scoping Phase)

    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.

  • 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 Hypersensitive Reaction

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

  • Scientific 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.

  • Nanomedicine (Nanopharmacology)

    A position paper on the immunotoxicity assessment of nanomedicines will be developed.

  • 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.

  • 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.

  • Safety Assessment of Engineered T-Cells Workshop

    The committee also plans to convene a two-day workshop on the safety assessment of engineered T-cells.

  • 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.

  • ITC Website Development

    An ITC-centric website where both scientists and the public can find information on the field of immuno-safety will be developed.

HESI Staff

Leadership Team

  • Marc Pallardy, PhD

    Université Paris-Sud

  • Hervé Lebrec, PhD

    Amgen, Inc.

  • Curtis Maier, PhD

    GlaxoSmithKline

Committee Events

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.

Read more

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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FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop

Silver Spring, Maryland, USA

The goal of this workshop is to convene 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 ...

Read more

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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 ) [3] => WP_Post Object ( [ID] => 22078 [post_author] => 14 [post_date] => 2020-01-02 13:06:03 [post_date_gmt] => 2020-01-02 18:06:03 [post_content] => FDA CDER Immunomodulators and Pregnancy Workshop

ABOUT THE EVENT

The goal of this workshop is to convene 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 a longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.

 

The  workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss:

  1. The current state of reproductive immunology
  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
  3. What additional tools/methods are currently being developed that could address gaps
  4. Global regulatory considerations across various immunomodulatory modalities

 

Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).

 

Registration: Up-to-date information and registration can be found here. Registration will close on February 5, 2020. Due to the format and structure of this workshop, attendance is restricted to in-person attendees only.

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The goal of this workshop is to discuss the preclinical and translational safety assessment of engineered T cell therapies. The workshop will focus on six topics, followed by an in-depth discussion:

  • Designing engineered T cells for optimal activity and safety
  • Target expression and associated liability assessment
  • In vivo models informing safety and activity
  • Safety of viral and non-viral gene delivery systems – utility, risk of genomic injury
  • Linking preclinical development with the clinical experience
  • Regulatory considerations

 

Agenda: Please find workshop agenda here.

Accommodations: Click here to find a list of nearby hotels. Please note that participants are responsible for their own transportation to and from the US FDA site.

Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).

Registration: Onsite registration is now closed. To attend the workshop virtually, please use the webinar link located below.

Webinar: Click here to join the webinar.

[post_title] => FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T-Cell Therapies [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => fda-cber-hesi-workshop-on-the-safety-assessment-of-engineered-t-cell-therapies [to_ping] => [pinged] => [post_modified] => 2020-10-28 15:00:39 [post_modified_gmt] => 2020-10-28 15:00:39 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21355 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [5] => WP_Post Object ( [ID] => 20922 [post_author] => 13 [post_date] => 2019-02-05 11:54:03 [post_date_gmt] => 2019-02-05 16:54:03 [post_content] => [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 [to_ping] => [pinged] => [post_modified] => 2020-10-28 15:01:04 [post_modified_gmt] => 2020-10-28 15:01:04 [post_content_filtered] => [post_parent] => 0 [guid] => http://hesiglobal.org/?post_type=event&p=20922 [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] => 23961 [post_author] => 14 [post_date] => 2021-03-31 18:13:24 [post_date_gmt] => 2021-03-31 18:13:24 [post_content] => [post_title] => HESI ITC Committee 2021 Spring Meeting [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => hesi-itc-committee-2021-spring-meeting [to_ping] => [pinged] => [post_modified] => 2021-03-31 18:23:41 [post_modified_gmt] => 2021-03-31 18:23:41 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=23961 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 16 [max_num_pages] => 3 [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

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

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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