HESI Insights - October 2023

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 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!

The HESI Cardiac Safety Committee seeks Postdoctoral or Early Career researchers working in cardiovascular safety science or a related field for the 2024 Early Career Seminar Award Series. This award offers an opportunity to share your research, learn from and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies and pharmaceutical companies.

Award: Selected candidates will receive a $500.00 USD award and be invited to present their research on a public webinar with HESI Cardiac Safety Committee scientists and other invited guests. Webinar dates will be scheduled with the awardees in Q1 2024.

Qualifications and Requirements: Eligible candidates must have a PhD or equivalent degree in biology or related field (cell biology, biochemistry, pathology, biomechanical engineering, or similar); have current post-doc position/appointment or consider themselves an early career scientist (~1-5 years post-academic training) and may not have previously received an award under this program. Open to both domestic and international applicants.

Application: To apply, please send 1 PDF document with the following: 1) completed application form, 2) CV, and 3) one reference letter: to Jennifer Pierson or Claire O’Brien at cardiacsafety@hesiglobal.org.

Deadline for submission: November 1, 2023.

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

HESI CT-TRACS reaching new audiences, making new connections!

On September 7-8, HESI’s CT-TRACS Senior Scientific Program Manager, Lucilia Mouriès, attended the World Molecular Imaging Congress and was invited to present the committee’s activities to the Imaging in Cell and Immune Therapies (ICIT) Interest Group. Both groups share common interests and complementary expertise, in particular with CT-TRACS’ Point of Administration/Biodistribution working group, which focuses on approaches and methodologies to monitor/evaluate the fate and activity of cells from cellular therapeutics, in vivo, after administration in the patient. We thank ICIT’s Chair, Dr. Gilbert Fruhwirth (left), and WMIS organizing committee member, Dr. Valdimir Ponomarev (right), for their invitation to meet the WMIS community and look forward to exploring potential synergies!

On September 18-19, 2023, HESI’s UVCBs and Multi-Constituent Substances Committee held a workshop in Reykjavik, Iceland to explore the complexities of UVCBs for testing and risk assessment. This interactive workshop brought together scientists from government, academia and industry to help develop solutions for assessing these substances. A regulatory panel, several technical presentations, and four breakout sessions based on case studies made for an engaging discussion about two main themes: 1) how to combine whole substance and representative constituents approaches when testing and assessing UVCBs and, 2) how to assess persistency and biodegradability of these substances. The committee is now working on a manuscript that will highlight some key takeaways from the meeting.

View meeting presentations and posters on the event page here.

Many thanks to all who attended the Botanical Safety Consortium Annual Meeting. We had an excellent day of updates on the experimental work being conducted, keynotes related to botanicals, and global outreach.

For those who were not able to attend, or want to re-watch the talks, the recordings can be found here, under the agenda, separated by speaker.

After 3 years without in person meetings, HESI’s CT-TRACS committee convened a good number of its members in person, and many more online, for its 2023 Annual Business Meeting, at the HESI Offices in Washington DC. Over two full days of programming, the committee took a deep dive into the various projects, addressing critical gaps and needs in the safety assessment of cell therapies, to help translate these life changing “living drugs” to patients. We were delighted to meet in person many new and longtime participants in the committee, from all parts of the USA, Europe and Japan!

The committee’s portfolio includes: a Cell Tracking Database; co-sponsorship with University of Newcastle of a PhD Student who’s research aims to improve understanding of cell fate using multi-visceral normothermic machine perfusion models; 4 experimental multi-site studies evaluating methods for tumorigenicity assessment or transformation risk from various types cell therapies (iPSC-derived; CAR-Ts; genome edited cells with CRISPR). At the meeting, the committee also adopted the undertaking of two new position papers and two stakeholders’ surveys. Contact Connie Chen or Lucilia Mouriès if you want to learn more and/or would like to contribute to these efforts!

Cardiac Safety Committee

• Heart Rate Corrected JTp and TpTe as Proarrhythmia Biomarkers in Safety Pharmacology Non-Human Primate Studies: Outcome from a HESI Consortium Prospective Study, presented by Brian Roche, CRL.

View meeting webpage here.

HESI’s eSTAR Committee will hold its 2023 Annual Meeting on November 8th. The meeting is free, virtual, and open to all. No registration required!

View the meeting details here.

HESI Next Generation Ecological Risk Assessment Committee presents 10:00am – Monday, November 13, 2023:

Session: 1.06.T
New Approach Methodologies, Enhanced Strategies and Best Practices for Identifying and Evaluating Endocrine System Adverse Effects
Title: Evaluation of regulatory in vivo endocrine assays in fish and amphibians: current status and future needs

View Meeting Website HERE

The HESI UVCB Committee will host 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” at 11am EST on November 30th. Registration is required.

View abstract, speaker bio and registration details here.

In lieu of a narrative this month, I thought I’d share a few ‘Did You Know’ items about HESI…so here we go!

Did you know…

• HESI staff are happy to brainstorm with you on how to translate your ‘issues’ and ideas into new program proposals?
• We love building HESI’s network and welcome you to contact us about setting up online discussions to build new or strengthen existing relationships?
• HESI gets ~30% of its annual revenue from government granting agencies and is skilled at grant submission and management?
• HESI has active programs and partners in North America, South America, Asia, Africa, and Europe?

To learn more about any of these – reach out to me. We want to hear from you!

With best regards,

Syril Pettit, DrPH, MEM, HESI Executive Director