This book chapter was published in Immunotoxicology and Immunopharmacology (R. W. Luebke, R. V. House, and I. Kimber, Ed.), 3rd ed., pp. 347-61. CRC Press, Boca Raton, FL.
Development of a Framework for Developmental Immunotoxicity Testing
2007
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:
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).
If you have any questions about the HESI ITC or this program, please contact Dr. Shermaine Mitchell-Ryan
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.
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.
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.
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.
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/
Université Paris-Saclay
Amgen, Inc.
GlaxoSmithKline
No results.
2007
This book chapter was published in Immunotoxicology and Immunopharmacology (R. W. Luebke, R. V. House, and I. Kimber, Ed.), 3rd ed., pp. 347-61. CRC Press, Boca Raton, FL.
Perspectives in Experimental and Clinical Immunotoxicology, 2007
The primary T-cell dependent antibody response (TDAR) to antigens is widely used as a functional test in immunotoxicology.
Journal of Immunotoxicology, 2007
EPA guidelines provide a choice in evaluating humoral immune system function in rats and mice immunized with sheep red blood cells (sRBC): an antibody-forming cell (AFC) assay or a sRBC-specific serum IgM enzyme-linked immunosorbent assay (ELISA).
International Journal of Toxicology, 2008
The evolution of the subdiscipline of developmental immunotoxicology (DIT) as it exists today has been shaped by significant regulatory pressures as well as key scientific advances.
Journal of Immunotoxicology, 2010
Non-human primates (NHP), particularly macaques, are commonly used in studies conducted to assess toxicity of new pharmaceutical entities.
Journal of Immunotoxicology, 2010
Non-human primates (NHP) are used to best understand and address pharmacology and toxicology obligations for human patients with highest and/or unmet need.
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
740 15th Street NW, Suite 600
Washington, DC 20005
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