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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FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop

February 11, 2020

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

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				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. 

  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
    3. 

  3. What additional tools/methods are currently being developed that could address gaps
    4. 

  4. Global regulatory considerations across various immunomodulatory modalities
    5. 



 


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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            [post_content] => 
				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

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Committee Publications

Filter

Nonclinical Safety Assessment of Engineered T Cell Therapies

Regulatory Toxicology and Pharmacology, 2021

Lebrec H, Maier CC, Maki K, Ponce R, Shenton J, & Green S

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 ...

Read more

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

Cytokine, 2020

Vessillier S, Fort M, O'Donnell L, Hinton H, Nadwodny K, ...

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 ...

Read more

Cross-Company Evaluation of the Human Lymphocyte Activation Assay

Journal of Immunotoxicology, 2020

Collinge M, Schneider P, Li D, Parish S, Dumont C, Freebern W, ...

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 ...

Read more

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