Watch the webinar recording here.
The HESI ITC Science Outreach Group aims to increase awareness about careers in the immuno-safety and immuno-pharmacology fields, with a target audience of graduate ...
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
September 16, 2021
Career webinar, hosted by the HESI ITC Education & Outreach Workgroup
Watch the webinar recording here.
The HESI ITC Science Outreach Group aims to increase awareness about careers in the immuno-safety and immuno-pharmacology fields, with a target audience of graduate ...
May 6, 2021 – May 7, 2021
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.
February 19, 2021 – May 21, 2021
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 ...
April 22, 2020 – April 23, 2020
Tres Cantos, Spain
THIS EVENT HAS BEEN POSTPONED IN RESPONSE TO COVID-19. PLEASE STAY TUNED FOR AN UPDATED DATE, TIME, AND OTHER MEETING DETAILS. 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 ...
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 ...
September 24, 2019 – September 25, 2019
Silver Spring, Maryland, USA
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.
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.
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Non-human primates may be the only relevant species for pharmacology or toxicology studies of certain biologics, due to lack of activity in other species.
Regulatory Toxicology and Pharmacology, 2014
As experience is gained with toxicology testing and as new assays and technologies are developed, it is critical for stakeholders to discuss opportunities to advance our overall testing strategies.
Regulatory Toxicology and Pharmacology, 2014
The T-cell-dependent antibody response (TDAR) assay is a measure of immune function that is dependent upon the effectiveness of multiple immune processes, including antigen uptake and presentation, T cell help, B cell activation, and antibody production.
Regulatory Toxicology and Pharmocology, 2015
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 ...
Regulatory Toxicology and Pharmacology, 2016
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 ...
Cytokine, 2016
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, ...
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
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