Developing science
for a safer, more
sustainable world.

We are excited to announce that HESI is a partner on the NC3Rs CRACK-IT Challenge “Wings of Change” initiative, which is focused on advancing acute and chronic avian non-animal models (NAMs). This collaboration aims to develop innovative and ethically responsible methods for assessing toxicity in avian species, reducing the reliance on animal testing, and enhancing the scientific rigor of avian safety assessments.

A launch webinar for the “Wings of Change” initiative will be held on Tuesday 17 September 2024. Register here.

We invite researchers, innovators, and industry leaders to join us in solving this challenge and driving positive change in the field of toxicology.

For more details, visit NC3Rs CRACK-IT Challenge.

BE PART OF A NEW HESI PROGRAM ON ADC SAFETY ASSESSMENT!

• Antibody-drug conjugates (ADCs) have the potential to advance patient benefit by providing targeted delivery of therapeutics for both oncology and non-oncology indications.
• Advances in this space will require more robust methods to identify translationally appropriate nonclinical methods for safety assessment of ADCs.
• This newly launching program will leverage HESI’s expertise in academic, government and industry collaboration and study design/execution to define opportunities and guide the selection of new translational methods for the nonclinical safety evaluation of ADCs.

Learn more

The Nitrosamines research activities exist under the umbrella of the HESI Genetic Toxicology Technical Committee (GTTC) Mechanism-based Genotoxicity Risk Assessment (MGRA) working group as a “case study” to demonstrate the usefulness of innovative, mechanism-based testing approaches.

This subteam has three goals: (1) to develop a protocol for an optimized Ames assay to predict the carcinogenicity of nitrosamines; (2) identify and verify in vitro assays with metabolically competent cells to support nitrosamines risk identification, and (3) develop a possible in vivo follow-up strategy to verify Ames data within the frame of ICH M7.

View the Nitrosamines webpage here.

HESI and NSTA are thrilled to introduce Health DataWell! These free, online instructional materials are offered as a resource to help high-school science students (grades 9-12) advance the skills and knowledge needed to become analysts and practitioners of data-driven and equity-focused public and environmental health science.

The lessons will also help students to understand the varied roles of citizens and health scientists in protecting and promoting the health and wellness of their communities. The first three lesson plans are available for free now and additional plans are in preparation for release later in 2023.

Explore the Free Lessons

The Health and Environmental Sciences Institute (HESI) is excited about the recent news on the passing of the FDA Modernization Act 2.0 which will allow for the use of methods other than animal testing to establish a drug’s safety and effectiveness. These methods have the potential to both reduce animal use and lower the cost of developing life-saving medicines. The U.S. Food and Drug Administration (FDA) has acknowledged HESI’s role in this important endeavor and we are honored to be recognized for taking part in the 3Rs (Replacement, Reduction and Refinement) of animals in research by the FDA and many other leading safety standard organizations (e.g. OECD, EPA, JRC, etc.).

On 30 June 22, the Organisation for Economic Cooperation and Development (OECD) published Test #470: Mammalian Erythrocyte Pig-a Gene Mutation Assay, a Test Guideline (TG) that describes an in vivo gene mutation assay that can be combined with other genetic and general toxicology tests to promote the efficient use of animal resources. This TG is the culmination of fruitful discussions over more than a decade among HESI Genetic Toxicology Technical Committee (GTTC) Pig‐a Workgroup members who contributed directly to the Pig-a Assay Detailed Review Paper, the Pig-a Assay Retrospective Validation Report, the draft OECD TG, the OECD Expert Working Group, as wells as the recent GTTC best practices Review Paper.

The HESI eSTAR committee is proud to announce that it was awarded a $250,000 USD grant (U01) as part of the USFDA’s Biomarker Qualification Program in June 2022. This funding will be partnered with Committee resources to support a four-site ring trial generating additional data on the TGx-DDI (TGx = toxicogenomics; DDI = DNA damage inducing) biomarker. The TgX-DDI biomarker is currently under review by the FDA as part of the FDA Biomarker Qualification program. Pending the results of this final study, the marker is anticipated to gain FDA approval for optional use as added weight of evidence in the assessment of genotoxicity. The marker has the potential to improve upon the low specificity of in vitro chromosome damage assays used in current testing and to aid drug development by providing mechanistic insights into transcriptional changes occurring in genes involved in key DNA damage pathways.

The continued waves of the COVID-19 pandemic have repeatedly strained public health systems’ capacity to provide efficient and actionable SARS-CoV-2 testing. To help address this challenge, the Propagate Network – a collaboration of public health and research laboratories from Brazil, Chile, France, Malawi, Nigeria, Trinidad and Tobago and the U.S., was convened by the nonprofit Health and Environmental Sciences Institute.  Via the Propagate Network, the participants tested the reproducibility of a more rapid and lower resource methodology (“direct-PCR”) for detection of the SARS-CoV-2 virus in patients.  The results of this study, published in PLOS ONE, demonstrated that the method is highly reproducible and thus a feasible option for more efficient COVID-19 screening around the world.

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In honor of its 50th anniversary, Critical Reviews in Toxicology published a special editorial that lists two RISK21 Committee publications among the journal’s top 25 most read papers. Click here to read the editorial.

“A 21st Century Roadmap for Human Health Risk Assessment”
(Pastoor et al. 2014;44 Suppl 3:1–5)

“Risk Assessment in the 21st Century: Roadmap and Matrix”
(Embry et al. 2014;44 Suppl 3:6–16)

The Botanical Safety Consortium (BSC) was officially convened in November 2019 as the result of a Memorandum of Understanding (MOU) between the US Food and Drug Administration (FDA), the National Institute of Health’s National Institute of Environmental Health Sciences (NIEHS), and HESI, and through a federal funding award to HESI from those agencies. The mission of the BSC is to provide a forum for global scientists from government, academia, consumer health groups, industry, and non-profit organizations to work collaboratively to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate safety in botanical dietary supplements.
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In 2019, the HESI Cardiac Safety Committee was awarded a U01 grant from the US Food and Drug Administration (FDA) on the “Evaluation of Integrated Human-Relevant Approaches to Identify Drug-Induced Cardiovascular Liabilities.” This grant supports HESI’s role in awarding and managing novel, in vitro experimental studies to develop targeted mechanistic data to inform drug safety assessment for key cardiac “failure modes.” HESI Cardiac Safety Committee members have identified six main failure modes, or CV liabilities contributing to drug attrition.
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In June 2020, HESI launched a novel collaboration with clinical and research colleagues around the world to advance more efficient and accessible SARS-CoV-2 testing methods. The PROPAGATE Network, a voluntary global network of lab scientists in these countries, will assess the reproducibility and utility of an extraction-less PCR testing method developed by participating scientists at the University of Washington and University of Vermont. This method has the potential to be used as a screening test that requires fewer experimental resources, lower costs, and less time than traditional PCR analysis.
Learn more.