HESI Global Insights July 2025

We are excited to share the newly released report from the HESI Global workshop, “Building a Roadmap for AI-Enabled Human and Environmental Health Protection,” held on June 4-5, 2025, in Washington, DC. This strategic workshop brought together over 150 leaders from academia, government, industry, and nonprofits across 10+ countries, united by the mission of advancing the safe and responsible use of artificial intelligence (AI) for human and environmental health protection.

The workshop emphasized a One Health approach, recognizing the interconnectedness of people, animals, and ecosystems, and explored how AI can help address critical global health and environmental challenges. A key innovation of the meeting was the use of a custom generative AI model (“Workshop GPT”) to help synthesize real-time input from participants and identify five Guiding Pillars essential for responsible AI integration:

• Connected Data
• Trust and Validation
• Real-World Use Cases
• Capacity Building
• Responsible Design

These Guiding Pillars define a strategic path for leveraging AI to protect biological, ecological, and regulatory systems worldwide. The final report integrates AI-generated insights with expert review to provide a practical, action-oriented framework for the field.

In addition to the report, we are pleased to offer:

• An AI-generated podcast episode exploring the workshop highlights and key takeaways.
• Speaker slide decks to further expand your understanding of the presentations and discussions.

All resources are available now at: https://hesiglobal.org/hesi-conference-series-2025-ai-health-protection/

We invite you to explore these materials and join us in shaping a future where AI serves as a powerful tool for safeguarding global health and environmental sustainability.

Thank you for your continued support of HESI Global’s mission to collaboratively develop science for a safer, more sustainable world.

Sincerely,
The HESI Global Team

Congratulations to the Cardiac Safety 2025 Early Career Seminar Series Awardees!

This award offers postdoctoral or early career researchers working in cardiovascular safety science an opportunity to share their research, learn from and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies and pharmaceutical companies.

Selected candidates receive a $500.00 USD award and are invited to present their research via a public webinar with HESI Global Cardiac Safety Committee scientists and other invited guests. Webinar dates are listed below.

2025 Awardees

• Dr. Carlos Serna, US FDA, September 26th, 2025 at 10:00 am EDT
• Dr. Katherine Fetterman, AbbVie, October 3rd, 2025 at 10:00 am EDT
• Dr. Leto Luana Riebel, Oxford University, October 24th, 2025 at 10:00 am EDT

We’re proud to share that HESI Global provided foundational support for the recently published study, “Results from an EFPIA, JPMA, PhRMA industry survey on reopening and revamping the ICH S7A guidance on safety and secondary pharmacology” (Journal of Pharmacological and Toxicological Methods).

This global survey highlights a strong industry consensus on the need to update the ICH S7A guideline, originally established in 2000. Key areas identified for revision include:

• Updates to the core safety pharmacology battery
• Clarification of adversity definitions
• Integration of modality-agnostic principles
• Enhanced guidance on secondary pharmacology
• Broader frameworks for integrated risk assessment

part of a specific HESI Global Cardiac Safety Committee effort, we are honored that our support contributed to this important work. The Cardiac Safety Committee is continuing discussions on how we can continue to support a potential update to these important guidelines. Contact Jennifer Pierson to learn more.

The survey findings will contribute to the body of evidence used to guide the creation of a concept paper to advance formal ICH revisions, representing a key step toward more modern, globally harmonized safety pharmacology practices.

🔗 Read the full article: https://doi.org/10.1016/j.vascn.2025.107763

HESI Global and the Society of Environmental Toxicology and Chemistry Latin America (SETAC LATAM) have signed a Memorandum of Understanding (MOU) that will help promote collaboration in environmental sciences across the Americas. This partnership will foster scientific exchange and capacity-building efforts, including workshops and training programs. The MOU reflects both organizations’ shared commitment to advancing science-based solutions for a healthier, more sustainable future.

HESI Global formalized a partnership with European Medicines Agency (EMA) by joining their Stakeholder Database. The EMA stakeholders’ database is a tool for the EMA to communicate with its stakeholders in a targeted, effective and systematic manner. The database itself is searchable by area of interest (e.g., therapeutic area) and is a useful tool for EMA members of staff when looking to contact a stakeholder.

The advantages of being part of the EMA stakeholder database include:

• Being able to be identified by the EMA in relation to any issue under discussion by the EMA and for which interaction with the stakeholder is needed/sought after.
• Information and potential invitations for participation in EMA conferences, workshops and other relevant to your organisation;
• Targeted dissemination of key communications (by area of interest) relevant to your organisation;
• Timely information on EMA consultations in line with the stakeholder’s area(s) of interest.

HESI Global, EMA and 3Rs Working Party look forward to working collaboratively in our ambitions for advancement of the 3Rs (Replacing, Reducing, Refining) and efforts towards global harmonisation on 3Rs-related topics.

The HESI Global Committee on Transforming the Evaluation of Agrochemicals (TEA Committee) will host a one-day Symposium on the Challenges of Pesticide Evaluation in Latin America on August 26 in Lima, Peru. This event will bring together regulators from across the region, along with stakeholders from industry and academia, to explore the scientific and regulatory challenges associated with the safety assessment of plant protection products in Latin America.

Participants will discuss region-specific hurdles and opportunities for improving agrochemical risk assessment, with a focus on how the TEA Committee’s framework can be adapted to support local needs. The symposium also presents a valuable opportunity for capacity building in the region, supported by HESI’s Global Risk Assessment Training Center (GRATC).

This event is being held in conjunction with the SETAC Latin America conference, and the coordination of both meetings has significantly increased interest and participation. SETAC LATAM’s logistical support has been instrumental in the planning of the symposium, and the back-to-back scheduling has encouraged cross-attendance, enriching both events.

For questions about the symposium or if you are interested in attending, please contact Sandrine Deglin at sdeglin@hesiglobal.org

The HESI Global Immuno-Safety Technical Committee is thrilled to announce an upcoming presentation by Dr. Rebecca Pompano, Associate Professor of Chemistry and Biomedical Engineering at the University of Virginia, on July 30th at 10am EST. As part of the New Approach Methodologies in Immuno-Safety webinar series, Dr. Pompano will present on microfluidic models and systems approaches to predict immunity.

Dr. Pompano’s research bridges immunology, bioengineering, and analytical science to answer complex biological questions about how immune responses are organized within lymphoid organs. Her lab develops innovative microfluidic and tissue culture techniques, enabling new insights into immune function and dynamics. Through her leadership in the Center for Immunology and Vaccine-related Modeling and Simulation (CIVMS), she is advancing the field of systems immunology and supporting the development of predictive models for vaccine safety and efficacy.

This is a must-attend talk for those interested in next-generation tools to model immune responses, evaluate vaccine safety, and improve nonclinical-to-clinical translation in immunotoxicology.

We are pleased to announce the previously postponed workshop will proceed this Fall. Please join us 30 September – 1 October for a 2-day workshop, “NAMs in DevTox Testing: Moving the Needle Forward” (in-person and online). This highly interactive and discussion-based workshop will include sector-specific panel discussions with experts from pharmaceuticals, agrochemical and industrial chemicals and consumer products, regulatory scientists and academicians. The workshop will have focused discussion session focused on key areas where a multi-partite effort can move the needle on increased confidence and use of DevTox NAMs in regulatory science. In-person registrations will be limited and will close on 1 September. To register, please visit the event page.

Registration is open for the HESI Global Botanical Safety Consortium 2025 Annual Meeting, a two-day virtual event advancing the science of botanical safety assessment.

Day 1 is open to all and will feature updates from working groups on topics like genotoxicity, cardiotoxicity, and dermal safety. This session will be recorded and shared online.

Day 2 will host breakout discussions for BSC Working Group and Steering Committee members to align on next steps and priorities.

The BSC unites cross-sector experts to improve tools for evaluating botanical dietary ingredient safety—helping fulfill HESI Global’s mission to create science-based solutions for global health.

Register here.

We are pleased to announce a new publication from HESI Global’s Committee on Transforming the Evaluation of Agrochemicals (TEA): “Transforming the Evaluation of Agrochemicals: A Conceptual Model” in Regulatory Toxicology and Pharmacology.

As global demand for safe and sustainable food production intensifies, traditional agrochemical safety assessments, often heavily reliant on animal testing, are struggling to keep pace with scientific advancements. The TEA Committee tackled this challenge head-on by creating a conceptual model designed to modernize agrochemical evaluation.

What’s New: The TEA model introduces a fit-for-purpose, exposure-driven, and science-inclusive framework, layered with principles of adaptability, transparency, data-sharing, and trust-building. It shifts the paradigm from a hazard-first to an exposure-first approach, leveraging New Approach Methodologies (NAMs) to support humane, efficient, and scientifically robust risk assessments.

Why It Matters: This model addresses both global and local regulatory needs, reducing unnecessary animal testing while maintaining rigorous safety standards. It empowers regulators to make timely, science-driven decisions that protect human and environmental health, advancing HESI Global’s mission to resolve pressing global challenges.

Read the full article here:

Transforming the Evaluation of Agrochemicals: A Conceptual Model. Yadvinder et al., 2025. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2025.105889

From idea to impact.
What began as a spark during a HESI Global Immuno-Safety Technical Committee (ITC) business meeting evolved into a dedicated Immunotoxicology session at the BioSafe Spring 2024 meeting—and today, we’re proud to share the result: a timely new publication in mAbs, authored by experts in HESI’s Immuno-Safety Technical Committee.

• This paper addresses the translational evaluation of Fc-modified antibodies, offering practical, science-driven recommendations to guide safety assessment in alignment with evolving regulatory expectations.
• It’s a comprehensive and forward-thinking piece of work—one that reflects the scientific foresight of the ITC in anticipating emerging challenges in immuno-safety science.
• Key findings will be shared at the 5th Annual Fc-Mediated Function Summit, but this is just the beginning. The ITC is committed to widely sharing the insights from this effort to inform best practices across the field.

Read the full article at the link below:
Impact of antibody Fc engineering on translational pharmacology, and safety: insights from industry case studies. Brennan et al., 2025. mAbs. https://doi.org/10.1080/19420862.2025.2505092

We are pleased to announce a new peer-reviewed publication from the HESI Global Nitrosamines Research Program: “Evaluating the Lifetime Cumulative Dose as a Basis for Carcinogenic Potency of Nitrosamines – A Key Tenet Underpinning Less-Than-Lifetime Approaches for Establishing Acceptable Intake Limits,” published in Regulatory Toxicology and Pharmacology.

The Issue
Nitrosamines (NAs) are a class of compounds that have garnered significant concern in recent years due to their presence as impurities in pharmaceutical products and their classification as potent carcinogens. While regulatory agencies have set conservative intake limits based on lifetime exposure to mitigate cancer risk, a gap remains in how to appropriately assess risk for drug products intended for short-term or intermittent use.

Why It Matters
Applying a one-size-fits-all risk threshold may unnecessarily limit the availability of certain life-saving medications, particularly when the exposure is temporary. The current default assumption does not consider whether the total cumulative exposure, not just daily dose, drives carcinogenic potency.

The Problem
Existing regulatory guidance lacks clarity on whether less-than-lifetime (LTL) exposure scenarios should warrant adjusted Acceptable Intake (AI) limits for NAs, despite the scientific foundation laid by ICH M7(R2) for other mutagenic impurities. This ambiguity has impeded harmonized global decision-making and risk assessments, particularly for LTL-use medicines.

The Solution
Led by a multi-sector team including HESI Global experts, this review of the literature analyzed rodent carcinogenicity data across eight NAs and one comparator compound, aflatoxin B1. The findings demonstrated that carcinogenic potency correlates strongly with lifetime cumulative dose, not just dose rate or duration, validating the scientific foundation for applying LTL exposure adjustments to nitrosamines.

The Benefit
This study provides critical scientific justification for tailoring AI limits based on realistic exposure durations. Such an approach better aligns with modern principles of cancer risk assessment and supports regulatory flexibility without compromising public health.

This paper marks an important step forward in risk science and policy. Stay tuned for future publications that will further address remaining challenges in applying the LTL approach to nitrosamines.

Read the full paper here:
Evaluating the lifetime cumulative dose as a basis for carcinogenic potency of nitrosamines – a key tenet underpinning less-than-lifetime approaches for establishing acceptable intake limits. Felter et al. 2025. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2025.105903

Learn more about the HESI Global Nitrosamines Research Program

HESI Global’s Developmental and Reproductive Toxicology (DART) Committee had a major footprint at this year’s Birth Defects Research and Prevention Annual Meeting, advancing scientific dialogue across key sessions on embryofetal development (EFD) studies, non-human primate (NHP) alternatives, new approach methodologies (NAMs), and Virtual Control Groups (VCGs), as highlighted below:

ELMO goes to Denver: Drs. Shermaine Mitchell-Ryan and Connie Chen introduced the BDRP community to ELMO. ELMO served as the unofficial third chair for a rapid-fire platform session featuring emerging research from DART trainees and collaborators.

EFD Education Course: DART members led the “ABCs of EFDs” education course, covering study strategy, design, conduct, interpretation, and communication. Speakers included Rüdiger Cordts, Susan Laffan, Denita Williams, Bethany Hannas, and Tacey White. The session referenced findings from the recent HESI publication: Developmental and Reproductive Toxicity Testing Strategies for Oligonucleotides: A Workshop Proceedings (Hannas et al., 2025, Nucleic Acid Therapeutics).

Advancing NAMs: HESI DART members Nicola Powles-Glover (ExxonMobil) and Allen Kaczor (Merck and Co.) highlighted the use of PBPK models and in vitro/in silico tools to support regulatory uptake of NAMs in DART assessments—in advance of the upcoming HESI NAMs workshop on Sept 30–Oct 1, 2025 in Washington, DC and virtually (Register here).

VCG Debate: HESI DART Co-Chair Chris Bowman (Pfizer) represented BDRP in the ETS-BDRP Exchange Lecture on VCGs. Opponent Bernd Baier referenced the HESI DART publication: Interpretation of developmental and reproductive toxicity endpoints and the impact on data interpretation of adverse events (Green et al., 2024, Birth Defects Research).

Minimizing NHP Use in DART: The meeting closed with this standout symposium where HESI DART members presented retrospective analyses and strategies to reduce non-human primate use in DART. Speakers included HESI DART NHP working group members Angela Stermer (Merck & Co.), Puck Roos (CBG-MEB), Hsiao-Tzu Chien (CBG-MEB), and Chris Bowman, with findings from the cross-sector NHP working group. The session was chaired by Chris Bowman and Ronald Wange (Aclairo).

Trainee Mentorship & DEIA: HESI DART, Mid-Atlantic Reproductive Toxicology Association (MARTA) and the BDRP DEIA Committee co-sponsored an interactive trainee career event that offered networking and mentorship opportunities in a relaxed setting (DART Pictionary – what a riot!). HESI DART trainee Puck Roos was a Wilson Award finalist and NHP symposium speaker.

Bottom line: HESI DART’s science, leadership, and community-building were front and center at BDRP 2025.

The HESI Global Immuno-Safety Technical Committee (ITC) proudly brought together a dynamic lineup of keynote and invited speakers in 2025 to spotlight the latest scientific advances in immunogenicity and immune safety assessment. From cutting-edge in silico tools to high-dimensional immune profiling, our Spring Science Summit and webinar series featured insights from:

• Laurent Malherbe, Eli Lilly, on preclinical immunogenicity risk assessment,
• Sangeeta Kowli, Stanford University, on decoding immune dynamics in complex disease contexts,
• Prof. Morten Nielsen, Technical University of Denmark, on advanced computational pipelines for protein immunogenicity,
• Lars Siim Madsen, Ellegaard Göttingen Minipigs, on the use of mini pigs as an alternative animal model in immune safety assessments,
• Dr. Tomasz Kostrzewski, CN-BIO, representing the NAMs in Immuno-Safety Group, discussing animal-free model systems.

Together, these speakers underscored ITC’s commitment to fostering innovation, promoting collaboration, and advancing regulatory science. Stay tuned for upcoming events and publications!

HESI Global, in partnership with the National Science Teaching Association (NSTA), has launched the 2025 Health DataWell (HDW) Ambassador Program – an initiative to support science educators and strengthen public and environmental health literacy in the classroom.

About Health DataWell

What is it?: Health DataWell (HDW) is a FREE curriculum co-developed by the non-profit HESI Global organization and the National Science Teaching Association (NSTA). HDW is designed to help students learn basics of data science as it is applied to public and environmental health outcomes in their communities and around the globe. The program also helps students to better understand the varied roles of citizens and careers in health sciences related to these efforts.

For Whom?: The instructional materials are designed for use in secondary science classrooms (~grades 9-12, although it could be appropriate for some university level courses as well).

What topics?: Topics incorporated in these lessons include: Data science, Public Health, Environmental Health, Health Outcomes and Populations, Exposure Science, Biology, Toxicology, Public Health, and Related Careers, and more! Lessons focus on topics like the differential impact of Air Pollution on Health Outcomes, etc.

What kind of content?: The materials are in English and are freely available online. The content aligns with widely used U.S. standards of learning, though it is not state-specific and can also be used in other countries as it aligns with core instructional focus areas in biology, chemistry, statistics, health sciences, environmental science, social science, and more. The lessons are written as curriculum to be led by a teacher in the classroom. They are not online lessons that can be executed independently by a student.

Can Anyone Use HDW?: YES! The materials are publicly available and free for anyone to access and use! Instructors do not need to be affiliated with the HDW Ambassador program to use them, and we encourage broad adoption and uptake! We also welcome feedback.

THE OPPORTUNITY! We are Seeking HDW Teacher Ambassadors!

The Health DataWell Ambassador Program is seeking 50 science teachers (from any country) to apply for a year-long professional learning and outreach opportunity to be conducted as part of their regular teaching duties.
This is a competitive program designed to elevate teacher skills and spread the reach of the HDW curriculum.

Applications will be accepted until August 15, 2025.

If you are selected to be an Ambassador you agree to:
1. Implement Health DataWell materials in your classroom;
2. Participate in live and asynchronous professional development trainings about the HDW curriculum as led by NSTA staff;
3. Share your experience with the HDW curriculum at the NSTA Spring 2026 National Conference in Anaheim, CA;
4. Complete at least one community outreach activity to share the HDW curriculum with others in your school, district, or network.
5. Participate in our program evaluation with your feedback.

If you are selected to be an Ambassador you will receive:
• Complimentary registration and travel stipend to offset in person attendance cost for the Spring 2026 NSTA National Conference (April 15-17, 2026, in Anaheim, California)
• A free one-year NSTA membership and access to a virtual educator cohort
• Customized planning and mentorship support from NSTA staff
• A certificate for 20 to 25 hours of professional learning

More details available here.

For many, July brings the promise of vacations, long weekends, and a change in the weather. Things are heating up behind the scenes at HESI Global as well since July is one of the most crucial months for looking ahead.

A dozen meetings, workshops, and scientific symposiums are planned for the next few months, all aimed at shaping what’s next. It’s also the month when plans start to solidify—not just for the coming weeks, but for the entire year ahead. We’re knee-deep in budgeting for 2026, aligning strategic priorities, and building the kinds of partnerships that make long-term goals possible. The groundwork we lay now ensures that when January rolls around, we’re not just reacting, we’re ready.

We hope everyone is enjoying their summer holidays and sunshine—but know there’s plenty happening behind the scenes to make the next season of work a successful one.

Kind regards,

Jennifer Pierson, MPH
HESI Global Associate Director for Program Development & Resourcing