HESI Insights - December 2023

This year’s Annual Report has a new interactive format! Within you will find summaries of each program’s accomplishments over the past year, their goals for 2024 and selected HESI highlights. Click here to read the full report.

HESI staff spent a rewarding and joyful afternoon helping N Street Village prepare for its weekly clothes “shopping” event by organizing and sorting donated items. N Street Village provides critical housing services and support for DC women in need. Kudos to Dr. Raegan O’Lone for making all of the arrangements!

The eSTAR Annual Meeting held on November 8th and 9th saw an impressive turnout of over 220 participants. This successful two-day event showcased notable projects, featuring the utilization of error-corrected sequencing as a biomarker for tumorigenicity, the application of Cell Painting for toxicity testing, and the exploration of genomic biomarkers for informed decision-making in chemical assessment.

On November 8th, an in-person dinner brought together committee members from NIEHS, EPA, and Syngenta. Dr. Brian Chorley concluded his three-year term as co-chair for the project, and the team celebrated his contributions and leadership.

HESI’s EcoRisk committee made a notable presence at the SETAC North America meeting held in Louisville, KY. Drew Hetrick, an undergraduate student at Middle Tennessee University, and Matt Schultz, commencing his Ph.D. at the University of Saskatchewan, showcased their research projects:

• Comparing Water Quality Criteria from Around the World: Phthalates, Organophosphates, Carbamates, and Pyrethroids – Drew Hetrick
• Prospective Optimization, Evaluation, and Application of In Vitro Methods to Study Biotransformation of Organic Chemicals in Birds – Matt Schultz

Additionally, Connie Mitchell gave a talk on the current status and future needs of endocrine assays.

• Evaluation of regulatory in vivo endocrine assays in fish and amphibians: current status and future needs

Julie Krzykwa conducted a demonstration on the EnviroTox Database

• The EnviroTox Platform: Update & Applications

Furthermore, a poster titled “Integrated Approach for Testing and Assessment (IATA) for Bioaccumulation” was presented. This poster detailed an IATA recently submitted to the OECD.

On November 16-17, 2023, the Standards Coordinating Body (SCB) for Regenerative Medicine, in collaboration with the US FDA and the United States Pharmacopeia (USP), organized a workshop dedicated to the identification and standardization of methods for assessing 1) Gene Therapy Product Activity and Comparability, and 2) the Evaluation of T-Cell Therapies.

The HESI CT-TRACS committee contributed to the later, sharing perspectives on preclinical safety needs for modified T-cell therapies. This contribution was delivered from a multi-stakeholder perspective, with particular emphasis on their ongoing experimental project aimed at improving the “IL-2 independent growth assay”. This assay, with the proper controls, could be an important in vitro assay to de-risk CAR-T and other engineered T-cell products for the potential risk of transformation.

The project leaders, Dr. Yixiang (Sean) Xu and Dr. Hui Ling (participating remotely), presented the project and a general overview of the committee. Both speakers, along with HESI staff, Drs. Connie Chen and Lucilia Mouriès, participated in the hands-on prioritization exercise sessions.

The HESI UVCB Committee hosted a webinar presented by Dr. Antony Williams of the US Environmental Protection Agency titled “Applying Cheminformatics to Develop a Structure Searchable Database of Analytical Methods” on November 30th.

View abstract, speaker bio and webinar recording here.

On December 1st, Dr. Leon Stankowski of Charles River Laboratories delivered a presentation titled “Ongoing Efforts to Optimize the Ames Assay by the HESI-GTTC Mechanism-based Genotoxicity Risk Assessment (MGRA) Nitrosamines Subgroup” at the Uventia 3rd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond.

For further details, interested parties are encouraged to explore the newly established Nitrosamines Research webpage here, or reach out to Ms. Raechel Puglisi or Dr. Connie Chen for additional information.

The European Medicines Agency (EMA) Non-Clinical Working Party (NCWP) and the 3Rs Working Party (3RsWP) convened an interested parties meeting on the use of non-human primates (NHPs) in drug development on December 7th in Amsterdam, Netherlands. This meeting aimed to provide insights for an upcoming EMA reflection paper discussing alternatives to the use of NHPs.

During the meeting, Dr. Christopher Bowman from Pfizer presented a comprehensive update on the progress of the HESI DART NHP working group. In attendance virtually were Drs. Shermaine-Mitchell Ryan and Connie Chen. For those seeking more information about this working group, please feel free to reach out to either manager for further details.

The Health and Environmental Sciences Institute (HESI) seeks your suggestions for priority emerging scientific issues (human or environmental health) that should be addressed through a focused, multi-sector, collaborative program. Proposals will be reviewed in early 2024 and one or more may be selected to form a new scientific program within HESI.

This is NOT a grant program and no direct financial awards to external parties will be made. However, selected programs may receive funding in the form of HESI support for scientific program design, coordination, and staffing. We are seeking topics that focus on the applied human and/or environmental health sciences and that require scientific perspectives and expertise from academia, government, industry, NGOs, clinicians, and/or other research sectors.

Looking for somewhere to start? Learn more about HESI’s existing scientific activities on our committees page and in the 2022 Annual Report. These resources may help guide you when considering your idea, however, HESI welcomes all new proposals whether they are captured in these lists or not.

The deadline to submit proposals for consideration is 15 January 2024.

Click here to learn more about the Emerging Issues process and complete the proposal form!

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

HESI THRIVE is a seed grant program that is innovating translational research and improving quality of life after cancer. By providing researchers with both seed funding and access to critical networks, THRIVE enhances the visibility of the patient need, the value of the research, and the reasons that larger funding entities might elect to incorporate these research streams into future funding priorities.

THRIVE provides seed grants for clinical and translational research and technology-based solutions that enhance our ability to predict when and how adverse effects may occur in patients who have received cancer treatment. The THRIVE grant program is designed to provide seed funding to investigators for the testing of initial hypotheses and collecting of preliminary data to help secure long-term funding by the National Institutes of Health (NIH) and/or other major institutions. For details on eligibility, funding, the application process, and key deadlines, please click here.

THRIVE will accept letters of intent from 13 November 2023 until 8 April 2024.

For more information, contact research@hesithrive.org.

From all of us at HESI we want to thank you for your time, expertise, commitment, and support during 2023. The hundreds of scientists – who we are proud to call colleagues and friends – at HESI are truly special.

Wishing everyone a joyous, peaceful, and healthy New Year.

With kind regards,

Syril Pettit, DrPH, MEM
HESI Executive Director