HESI Insights February 2025

The HESI Board of Trustees convened on January 23–24, 2025, at the HESI offices in Washington, DC, for an insightful and dynamic in-person session. The meeting was a testament to HESI’s ongoing commitment to scientific advancement, strategic growth, and impactful programming.

Celebrating Success and Strategic Planning

The meeting opened with warm welcomes, including the introduction of new trustees: Dr. Gladys Ouedraogo, Dr. Roland Froetschl, Dr. Tara Barton-Maclaren, and Dr. Robert Landsiedel, along with Dr. Yasu Kanda in absentia. HESI’s Executive Director, Syril Pettit, and Deputy Director, Michelle Embry, led discussions reflecting on the past year’s achievements and charting the course for 2025 and beyond.

Key highlights included a robust review of HESI’s financial health and operational strategies. Treasurer Dr. Jose Manautou presented the Finance Committee Report, underscoring HESI’s strong financial standing, diversification of revenue streams, and strategic investment in scientific programs. The Board approved the 2025 budget, ensuring continued support for critical initiatives while maintaining fiscal responsibility.

Expanding Programmatic Impact

A major focus of the meeting was HESI’s flagship initiatives—Thrive, Health DataWell, and the Global Risk Assessment Training Center (GRATC). Updates on these programs demonstrated their growing influence:

• THRIVE continues to catalyze cutting-edge research on mitigating adverse effects of cancer therapies. New funding of $200,000 was approved to expand its reach.
• Health DataWell is set to enter its second phase, featuring an innovative teacher ambassador program designed to enhance science education and public health literacy among students.
• GRATC has successfully expanded risk assessment training in Latin America, Africa, and Asia, with new workshops and educational partnerships planned for 2025.

The Board expressed strong enthusiasm for these programs, recognizing their role in advancing HESI’s mission to provide science-based solutions for public and environmental health challenges.

Evolving Governance and Strategic Vision

The Board also took significant steps toward enhancing HESI’s governance structure. A pivotal decision was made to sunset the Emerging Issues Committee (EIC) and transition its functions to the Board of Trustees. This move streamlines decision-making while maintaining an open call for new scientific topics.

In an interactive session, Board members envisioned HESI’s trajectory over the next five to seven years. Through brainstorming activities, they identified four key areas for future growth:

1. Strategic Prioritization for Sustainable Growth
2. Advancing HESI’s International Impact
3. Building Future Leaders in Science
4. Strategic Growth Through New Scientific Programs and Funding Opportunities

Actionable strategies were developed to drive progress in these areas, ensuring HESI remains at the forefront of scientific impact.

Looking Ahead

The meeting wrapped up with a preview of HESI’s upcoming June 2025 Scientific Conference, themed A Roadmap for AI-Enabled Human and Environmental Health Protection. The Board discussed their role in outreach and engagement for the event, which promises to be a landmark gathering of experts in the field.

The Board’s collective energy, expertise, and dedication were evident throughout the meeting. As HESI embarks on another year of scientific excellence and strategic growth, the organization is poised to amplify its impact globally.

Stay tuned for more updates as we continue advancing science for a healthier world!

Join the Health and Environmental Sciences Institute (HESI) for a dynamic two-day conference on AI and machine learning‘s impact on drug, chemical, and food safety. Dive into cutting-edge insights, explore challenges, and shape the future of human and environmental health protection.

What to Expect:

Real-World Applications: Case studies from molecular toxicity modeling to global ecosystem analysis.
Critical Conversations: Discussions on ethical, legal, and technical challenges in AI adoption.
Collaborative Insights: Engaging panels and interactive polling to shape the future of AI in safety science.
Poster Session: A platform to showcase cutting-edge research and exchange ideas with experts across disciplines.
Strategic Roadmap: A final session synthesizing key takeaways into actionable next steps for AI-driven innovation for human and environmental health protection.

Who Should Attend?

• Scientists & Researchers
• Industry Experts & Innovators
• Regulators & Policymakers
• AI & Data Science Professionals

Be part of the conversation shaping the responsible and effective use of AI in human and environmental health protection.

Full details and registration link available here: https://hesiglobal.org/hesiannualmeetings/

The COMprehensive Protein Allergen REsource (COMPARE) has been updated for 2025, marking its ninth iteration as a leading publicly available resource for allergen identification. COMPARE continues to provide researchers, regulators, and industry professionals with transparent, peer-reviewed data on known allergenic protein sequences.
Key updates in COMPARE 2025:

• 88 new protein sequences added, bringing the database total to 2,836
• Enhanced user-friendly data download format for improved accessibility

This year’s update was guided by our esteemed COMPARE peer review panel, composed of leading academic and clinical allergy experts. The panel rigorously evaluated publicly available scientific evidence to ensure that only well-substantiated allergen sequences were included.

As a trusted resource in allergenicity assessment and novel protein safety, COMPARE plays a vital role in advancing scientific knowledge and supporting safe innovation in food and biotechnology. Whether used for regulatory applications, risk assessment, or research, COMPARE continues to provide valuable insights for the global scientific community.

Explore COMPARE 2025 today: https://comparedatabase.org/

For more information about COMPARE and its role in allergen research, contact Lucilia Mouriès or Liisa Koski.

The blog post below, written by Robyn Tanguay (Oregon State University) and Sandrine Deglin (HESI), was originally posted on Toxchange here.

Toxicology plays a critical role in protecting human and environmental health, yet the field faces systemic obstacles that may hinder its progress. While scientific advancements continue, structural inefficiencies in research funding, regulatory science, interdisciplinary collaboration, and public engagement could be limiting its full potential. Addressing these challenges is essential to ensuring that toxicology research aligns with real-world human and ecological health needs.
To assess whether toxicology is effectively serving its intended purpose, several fundamental questions must be considered. For example, one could ask:

• Are researchers asking the most relevant questions to address pressing toxicological concerns?
• Do current funding structures, publication practices, and institutional systems support research that leads to meaningful health and environmental protection?
• Are existing regulatory frameworks keeping pace with scientific advancements?
• How well is toxicology integrating interdisciplinary expertise?
• Are toxicologists effectively communicating the impact of their research to policymakers and the public?

These questions underscore the need for a critical assessment of how the research ecosystem supports—or potentially inhibits—progress in toxicology.

Upcoming Panel Discussion
The 2025 Society of Toxicology meeting in Orlando, FL, will feature an interactive session titled “Facing Inconvenient Truths: How the Current Toxicology Research Ecosystem Limits Its Potential for Public and Environmental Health Protection.” Co-chaired by Robyn Tanguay (Oregon State University) and Sandrine Deglin (HESI), this panel will bring together experts from various sectors, including academia, government, industry, and early-career researchers.

Session Objectives:
• Foster open dialogue among toxicologists from different sectors.
• Critically evaluate the limitations within the toxicology research ecosystem.
• Identify actionable strategies to enhance the impact of toxicology on human and environmental health.

Call to Action
We invite all attendees to engage in this crucial conversation. By recognizing the obstacles our field encounters and collaboratively developing solutions, we can enhance toxicology’s influence and guide its evolution to more effectively tackle current health and environmental challenges.” Bring your:

• Open mind
• Constructive comments
• Innovative ideas

We look forward to seeing you and hearing your valuable insights in Orlando!

Are you a postdoctoral or early career researcher working in cardiovascular safety science or a related field? The HESI Cardiac Safety Committee invites you to apply for the Early Career Seminar Award Series!

Award Details:

• $500 USD award
• Opportunity to present your research in a public webinar with leading experts from academia, regulatory agencies, and the pharmaceutical industry
• Network & gain insights from top scientists in toxicology and safety pharmacology

Eligibility:

• PhD or equivalent in biology or related fields (cell biology, biochemistry, pathology, biomechanical engineering, etc.)
• Currently in a postdoc position or early career stage (~1-5 years post-academic training)
• Open to both domestic & international applicants
• Must not have previously received this award

Deadline to Apply: April 25, 2025

For details on how to apply visit: https://hesiglobal.org/cardiac-safety/#earlycareeraward

Don’t miss this opportunity to showcase your work and connect with the HESI Cardiac Safety Committee! Know someone who should apply? Send them the weblink above!

HESI is proud to announce the launch of the Nancy Doerrer Elevate Award, a new annual recognition celebrating individuals who exemplify collaborative and catalytic leadership within the HESI community.

Named in honor of Nancy Doerrer, HESI’s former Associate Director and a long-standing champion of HESI’s mission, this award acknowledges those who go above and beyond in engaging, strengthening, and advancing HESI’s programs and initiatives. Recipients of this distinguished award are individuals whose dedication and uplifting presence significantly enhance the HESI community.

We invite you to learn more about this exciting new opportunity and how you can nominate a deserving colleague. Visit https://hesiglobal.org/nancy-doerrer-elevate-award/ for details.

For questions, contact HESI at Elevate@hesiglobal.org

Let’s celebrate those who elevate HESI’s impact!

HESI is honored to recognize the exceptional contributions of Professor Richard van Breemen from Oregon State University for his pivotal role in advancing the objectives of the Botanical Safety Consortium. Throughout his illustrious career, Professor van Breemen has been a source of knowledge and innovation in the field of natural products and botanical safety.

Professor van Breemen’s research has spanned the discovery and development of natural products as chemoprevention agents, integrating mass spectrometry into drug discovery, metabolism, and pharmacokinetics to enhance our understanding of drug interactions and the safety of botanical dietary supplements. His work has significantly contributed to the Consortium’s efforts, particularly through his detailed chemical analyses of kratom, milk thistle, and kava, as well as his lab’s work in identifying cytotoxic metabolites across 16 botanicals.

Beyond his research, Professor van Breemen has demonstrated a lifelong commitment to education and mentoring within the scientific community. He has been instrumental in educating future generations of scientists, as evidenced by his support of a foundational Toxicology 101 course that BSC leadership created. This course debuted last year at the International Congress on Natural Products Research in Krakow, Poland. It educated participants on the complex interactions within botanical drug safety, showcasing his profound knowledge and dedication to advancing botanical safety.

Professor van Breemen’s distinguished career, marked by numerous accolades, including the Varro E. Tyler Prize and the Harvey W. Wiley Award, underscores his profound impact on the field of pharmacognosy and botanical safety. His leadership roles, such as his involvement with the USP Dietary Supplements Admission Evaluation and Labeling Expert Committee and his directorship at the UIC/NIH Center for Botanical Dietary Supplements Research, have fostered significant advancements in the field.
HESI extends its deepest gratitude to Professor van Breemen for his unwavering commitment and outstanding contributions to the field of botanical safety.

Please join us in welcoming Dr. Cissy Li to the HESI staff as Scientific Program Manager.

Cissy Li holds a PhD in Molecular and Translational Toxicology from the Johns Hopkins Bloomberg School of Public Health, along with a Certificate in Risk Sciences and Public Policy.

Dr. Li brings eight years of experience at the U.S. Food and Drug Administration (FDA), where she worked in both the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Tobacco Products (CTP). At CFSAN, she spent two years conducting safety and risk assessments of chemical contaminants in food, including updating the fish consumption advice. She then spent six years at CTP, where she played a key role in product review, research, and regulatory science. Her work included leading large interdisciplinary teams and research projects focused on the toxicity of tobacco products and analyzing public health risks and benefits to inform regulatory decisions. Notably, she co-founded the Risk and Decision Analysis Branch at CTP, contributing to the advancement of regulatory science.

Dr. Li will be working on the Antibody-Drug Conjugate, Targeted Protein Degraders, and BIOME programs.

Her email is cli@hesiglobal.org

We are thrilled to have her on the team and know you will enjoy working with her!

The Health and Environmental Sciences Institute’s (HESI) Next Generation Ecological Risk Assessment Committee is proud to announce the release of new publication: “Control Performance of Amphibian Metamorphosis Assays with Xenopus laevis.”

This study addresses variability challenges in the Amphibian Metamorphosis Assay (AMA), a widely used assay to detect the endocrine-disrupting effects of chemicals on the thyroid system. By analyzing data from 52 studies across seven laboratories, the paper highlights how variability in controls affects the assay’s reliability and provides actionable solutions to improve its consistency and interpretability.

Why It Matters:
• Protecting Ecosystems and Public Health: The AMA helps identify chemicals that disrupt thyroid function, helping safeguard wildlife and human health from harmful environmental exposures.
• Regulatory Impact: Enhanced assay performance strengthens confidence in regulatory decision-making and enables harmonized global standards for chemical safety assessments.

Key Highlights:
• Identification of variability drivers in biological endpoints such as growth and development.
• The utility of historical control data (HCD) for contextualizing results and optimizing study designs.
• Proposed refinements to OECD and US EPA guidelines to ensure reliability while minimizing animal use.
• Insights into how New Approach Methodologies (NAMs) can complement or replace the AMA.

Potential Benefits:
• Resolving these issues will result in more reliable scientific outcomes, efficient regulatory processes, and potential reduced animal use.

Read the full article at the link below:
Control Performance of Amphibian Metamorphosis Assays with Xenopus laevis. Wheeler et al., 2025. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2025.105773

The HESI Botanical Safety Consortium’s Genotoxicity Working Group has developed a proposed screening strategy to identify the genotoxic potential of botanicals. Botanical products are complex mixtures that are difficult to test in traditional toxicology mammalian models due to their inherent variability. Genotoxicity is important to measure carcinogenesis, and for other types of damage, like to germ-line cells.

Key takeaways from this publication include:

1. New Approach Methodologies (NAMs): Exploration of NAMs that are being proposed (in vitro and in silico models) to screen for genotoxicity effectively.
2. Broad Botanical Testing: Testing a variety of botanicals through case studies, with established assays for evaluating genotoxicity.
3. Development of a Safety Toolkit: Creation of a toolkit to assist researchers in screening botanicals, informing further studies, and potentially reducing animal testing.

This publication is valuable for toxicologists, regulatory bodies, and botanical product researchers interested in advancing safety assessment frameworks for botanical supplements.

Read the full article at link below:
A proposed screening strategy for evaluating the genotoxicity potential of botanicals and botanical extracts. Witt et al., 2025. Food and Chemical Toxicology. https://doi.org/10.1016/j.fct.2025.115277

On February 11, 2025, the HESI Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee chaired an engaging session titled “Omics to Facilitate More Accurate Translation from Non-Clinical Models to Human Health” at the 2025 Toxicology Forum Winter Meeting.

Co-chaired by Deidre Dalmas (Pharma Expert) and John Rooney (Syngenta), the session explored cutting-edge advancements in omics technologies and their critical role in improving the translation of non-clinical model data to human health applications. Session Highlights included:

Speaker Presentations:
• John Rooney (Syngenta)
• Jessica Ewald (Broad Institute)
• Brian Chorley (US EPA)
• Chris Corton (US EPA)

Expert Panel Discussion among all session speakers including Deidre Dalmas (Pharma Expert) and Brian Berridge (Formerly NIEHS)

This session was a key part of the broader meeting agenda, which focused on innovative approaches and collaborative efforts in toxicology and human health assessment. The discussions reinforced the importance of omics-based methodologies in modern risk assessment and regulatory decision-making.

The HESI THRIVE 2025 Seed Grant Program is accepting Letters of Intent until April 7, 2025. This grant of up to $50,000 USD supports innovative research aimed at predicting, preventing, and reducing adverse effects from cancer therapy. To learn more about this unique funding opportunity, visit the webpage at https://hesithrive.org/.

The Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee is excited to announce an expansion of its focus to include gene therapies as part of its ongoing commitment to advancing safety science in emerging advanced therapies. This addition reflects the growing importance of understanding and addressing safety concerns specific to these cutting-edge gene delivery systems, which are being increasingly utilized in clinical applications. By leveraging our existing expertise and global network, we aim to foster the development of best practices, innovative tools, and collaborative projects to support the safe translation of gene therapies to the clinic. Two new project proposals are on track to launch as new working groups in 2025: “Methods for Integration Site Analysis and Data Interpretation” and “Assessing Risk of Germline Transmission in AAV Gene Therapy Products” (the latter, in collaboration with HESI DART committee).

The committee is welcoming new partners with expertise in gene therapies development and their nonclinical safety assessment, with interest in advancing the field of safety science. Through our collaborative, pre-competitive forum, we aim to build a robust network of contributors. Reach out to committee managers Lucilia Mouriès and Connie Chen to express your interest and learn more.

The Carpenter–Singh laboratory at the Broad Institute of Harvard and MIT is seeking a postdoctoral researcher to lead efforts in analyzing a first-of-its-kind toxicology dataset.

As leaders of the HESI OASIS Consortium, which brings together 40 pharmaceutical/agrochemical companies, government agencies, academic labs and non-profit organizations, the group aims to develop novel approaches for predicting liver toxicity to reduce reliance on animal testing and increase the accuracy of safety assessment. The dataset includes high-dimensional readouts including Cell Painting, transcriptomics, and proteomics.

See the full posting here.

What does HESI stand for?

HESI is 35 years old and since its inception, has and continues to represent an unwavering commitment to science across disciplines, sectors, and geographies. We have weathered various storms – mergers, acquisitions, downsizing, economic upturns and downturns, travel restrictions, political administration changes, and even a global pandemic.

However, recent sweeping actions and proposals represent a storm bigger than many have seen before and requires not only a recommitment to our core mission, but also considerable introspection.

HESI is dedicated to inclusivity, equality, and diversity in ALL aspects. This applies to our staff, our board members, our committee members, and the broad community of people around the globe who we reach with our programs, presentations, and materials. It applies to the work that we do to advance health and health science practices for ALL populations.

We have challenging times ahead. True strength will lie in ensuring that every voice is heard, every person is valued, and we remember what HESI stands for.

“A world that respects and values differences is a world that is richer in humanity and wisdom.” – Desmond Tutu

Warm regards,

Michelle Embry, PhD
HESI Deputy Director