HESI Insights - August 2023

HESI GTTC is proud to report that AOP 296 “Oxidative DNA damage leading to chromosomal aberrations and mutations” is now available on the OECD i-Library! The companion paper (Cho et al., 2022) to this AOP was published last year and given the Editor’s Choice article for the issue. This is the first of a series of genotoxicity AOPs to be published from the committee.

HESI and the NSTA have released a new Health DataWell lesson to help high school students advance skills and knowledge needed to become analysts and practitioners of data-driven and equity-focused public and environmental health science. In the Daily Do, “How does where you live effect your risk of heat-related death?”, students evaluate information and consider the limitations of data to investigate why cities have higher heat-wave death rates than suburban areas in the United States.

Explore the free lesson HERE.

The Protein Allergens, Toxins and Bioinformatics (PATB) Committee is seeking partners to help launch a new project to advance methods for the assessment of gluten-like peptide sequences that could trigger Celiac disease (CD). The proposed pilot study will test the potential of microbial derived peptides to mimic gluten peptides using organoid models.

The project will have relevance for those involved in the evaluation of genetically modified crops, novel foods, or proteins (e.g., for food ingredients) produced via precision fermentation or microbial production systems as well as those with an interest in NAMs for food safety and clinicians/researchers involved in the study of Celiac Disease pathology and immunology.

By involving in vitro NAMs and patient derived materials to generate CD-organoids, this study is anticipated to generate both biological and methodological advancements. We are seeking additional financial support and expertise to ensure that the design and impact of the study is optimized. Your involvement will be enhanced by significant contributions in-kind by a clinical collaborator from Harvard University with expertise in developing these in vitro organoid systems! Peptides will be generated this fall and bench work to launch in early 2024. For more background information, continue reading here.

As with all HESI projects, the success and impact of this initiative will depend on engaging thought leaders and international stakeholders, from government regulators to clinicians, to crop protection, food biotechnology, and biomedical industry experts, academics, and representatives from other relevant organizations.

Interested in finding out more?

Please contact Dr. Lucilia Mouriès at lmouries@hesiglobal.org

Two HESI programs will be featured throughout the meeting:

Transforming the Evaluation of Agrochemicals (TEA) Committee
August 30th – Session S402: Unlocking a New NAM-based Paradigm: Transforming the Evaluation of Agrochemicals.
Agrochemical Evaluation for the 21st Century: Achieving the Vision, presentation by Raechel Puglisi (HESI)

Cardiac Safety Committee
August 30th 14:00-16:00 – Track 6, Session S454: Predictive Toxicology: Data, Development, Delivery, and Application
#739 Chronic drug-induced cardiotoxicity assessment using in vitro human iPSC-cardiomyocytes and human heart slices: a multi-platform study conducted by the HESI Stem Cell Working Group, presentation by Dr. Jessica Palmer (Stemina Biomarker Discovery)

View meeting webpage here.

Dr. Douglas Wolf presents Risk Assessment in the 21st Century (RISK21) at ACTRA’s 15th Annual Scientific Meeting & Continuing Education Day in Perth, Australia. The course will be held on August 29th.

Full details can be viewed here.

Several HESI programs will be featured throughout the meeting:

• The HESI Botanical Safety Consortium Genotoxicity Technical Working Group will have a poster presentation entitled “A Strategy for Developing a Robust Framework of Genotoxicity Assays for Safety Assessment of Botanicals”
• Dr. Alexandra Long (Health Canada) will give an oral poster “In Vitro-In Vivo Extrapolation (IVIVE) of Genetic Toxicity New Approach Methodology (NAM) Data: A HESI-GTTC Case Study” during Platform 1: Modern in vitro genetox screening and data modeling, 10th September 2023, 9:45am – 11:45am.
• The GTTC’s ecNGS working group reconstruction experiment will be highlighted during Symposium 14: Ongoing validations of TGR tech transfer and bridging studies from TGR to ecNGS on Wednesday, 13 September 2023, 1:15 – 3:15pm.
• The HESI CT-TRACS committee will be featured in a full day session on “Evaluating genotoxic potential of genome editing for therapeutic use” on Tuesday Sept. 12th, with a presentation entitled “Induce-Seq followed by Duplex-Seq for identification and confirmation of CRISPR-Cas9 off-targets- A HESI CT-TRACS supported project”.

View the meeting website here.

The HESI DART NAMs working group will lead a session on the “Current use of NAMS/Alternatives in DART Testing” on Monday, September 11th from 16h00 – 18h00. Full details are on the meeting website here.

The HESI Global Risk Assessment Training Center (GRATC) will be attending SETAC Latin America’s 15th Biennial Meeting in Montevideo, Uruguay. Michelle Embry (HESI) will give a presentation on Ecological NAMs and Eliana Munarriz (University of Buenos Aires) will provide an overview of RISK21.

• The HESI Botanical Safety Consortium DART Technical Working Group will present a poster.
• The HESI DART Extended One-Generation Reproduction Toxicity Study (EOGRTS) will have a Symposium that will cover (1) Critical aspects for designing and conducting EOGRTS under REACH (2) ECHA’s Review of EOGRTS for EU REACH and their impact, including Case Study examples (3) International Positions, Perspectives and Challenges in Utilizing the EOGRTS in Regulatory Decisions for Industrial and Agrochemicals and (4) EOGRTS and the Endocrine Relevant Outcomes for Neurodevelopmental Effects.

View meeting website here.

The HESI UVCBs and Multi-Constituent Substances Committee would like to invite you to attend an engaging two-day workshop in Reykjavik, Iceland to explore the complexities of UVCBs for testing and risk assessment. This workshop will bring together scientist from government, academia and industry to help develop solutions for assessing these substances. Access the agenda and register here.

Members of the public sector are encouraged to contact Sandrine Deglin (sdeglin@hesiglobal.org) or Julie Krzykwa (jkrzykwa@hesiglobal.org) to discuss potential travel funding opportunities

The HESI Botanical Safety Consortium Cardiotoxicty Technical Working Group will present a poster at the 2023 Safety Pharmacology Society Annual Meeting in Brussels, Belgium. View details here.

The topic will be introduced by the Translational Immune Safety WG leads: Ana Goyos and Jean Sathish
This will be followed by short statements from our clinician scientist and a roundtable discussion.

View the list of guest speakers and register here.

The HESI Botanical Safety Consortium 2023 Annual Meeting will be held virtually on Thursday, September 28, 2023 from 8:00 – 4:00 (US Eastern). The meeting is free and open to all. View the agenda and register now on the BSC webpage here!

The HESI DART committee is organizing a Fall workshop which will focus on applications of DART principles to fit attributes of antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs) and other oligonucleotide therapeutics and highlight gaps and challenges associated with determining the most appropriate strategies to account for potential risk to a varied patient population and spectrum of disease conditions. Considerations unique to oligonucleotide therapeutics for DART evaluations that will be discussed include mechanism of action/target engagement, dosing schedule, toxicokinetics and biodistribution, and species or model selection and validation. Speakers will represent institutions actively working in oligonucleotide therapeutic development and will deliver case study examples to illustrate various DART considerations. However, most of this workshop will be reserved for discussion rather than presentation. Reviewing existing DART strategies and initiating discussion on how to address gaps and challenges will help advance the field toward a fit for purpose and robust characterization of DART risk for this class of compounds.

Registration is now open!

For more information, please visit the event page (here) or contact Connie Chen.

Although we are approaching the end of the calendar year, September (‘back to school’ in the USA) has always felt like a starting line to me. This feeling certainly rings true when it comes to HESI activity! We will launch into the fall with a flurry of activity at events in Australia, Iceland, Slovenia, Brazil, and more. We are fully staffed with a team of outstanding scientist-leaders and excited to engage with our new cohort of Board Trustees. Our Scientific Committees are actively rolling with new research studies, new partnerships, new grants, new publications, new trainings, and always new and more positive impacts on human and environmental health. Grab your backpacks, sharpen your pencils, and get ready for a busy fall!!!

With best regards,

Syril Pettit, DrPH, MEM, HESI Executive Director