HESI Global Insights October 2025

In a continued effort to foster global collaboration in regulatory science, on September 29, 2025, HESI’s leadership staff from the Center for Patient and Consumer Safety and the Center for Translational Sciences met with local representatives from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) at their newly opened Washington, DC, office. The meeting served as a valuable opportunity to deepen ties, share ongoing initiatives, and explore future engagement opportunities.

During the in-person meeting, both HESI and PMDA presented their respective programs. HESI highlighted its long-standing history of successful collaboration with PMDA and other Japanese stakeholders, including the active participation of PMDA scientists in several HESI programs. The discussion also emphasized HESI’s commitment to public-private partnerships and the potential for joint initiatives.

The agenda included updates on HESI’s work in New Approach Methodologies (NAMs), cellular and regenerative medicine, and other areas of common interest, such as the ICH S7A initiative. Notably, the meeting confirmed the addition of a new PMDA participant to HESI’s Cell and Gene Therapies Safety (CGT-TRACS) Committee, Dr. Fumito MIKASHIMA, Principal Reviewer.

This meeting marks an exciting step forward in strengthening international regulatory partnerships and continuing to expand the reach of HESI’s mission!

At the 2025 Gesellschaft für Umwelt- und Mutationsforschung (GUM) Meeting, Dr. Stefan Pfuhler (Procter & Gamble) was honored with the 2025 GUM Award in recognition of his exceptional contributions to mutation and cancer research. In his role at P&G, Dr. Pfuhler leads the company’s genotoxicity expert team and oversees its comprehensive genotoxicity research program. Beyond his professional leadership, he is deeply engaged in the broader scientific community, serving as a current member of the HESI Board of Trustees, a former co-chair of the Genetic Toxicology Technical Committee (GTTC), and an active participant and leader in multiple GTTC and Botanical Safety Consortium working groups.

HESI Global extends its warmest congratulations to Dr. Pfuhler for this well-deserved recognition and his continued dedication to advancing the field of genetic toxicology!

HESI Global’s Environmental Epidemiology Committee, in collaboration with the Special Interest Group of the International Society of Environmental Epidemiology on Quantitative Bias Analysis, is excited to launch a new webinar series on Quantitative Bias Analysis (QBA), an essential tool for addressing bias in epidemiologic studies and improve risk assessment and decision making.

The first webinar in the series will feature Dr. Tim Lash (Rollins School of Public Health, Emory University), on October 28 at 11:00 AM Eastern Time. Through his presentation titled “Quantitative bias analysis: The good, the bad and the ugly”, Dr. Lash will introduce the fundamentals of various QBA methods, their utility, shortcomings, and how they are sometimes used (intentionally or unintentionally) against their best purposes.

If you are interested in learning about QBA, whether you are entirely new to the topic or looking to strengthen your foundation, this series will be of great value, and this first session is the perfect place to start.

Register on the event page here.

We look forward to your participation in this exciting new series!

HESI Global is pleased to share the latest publication from the Omics for Assessing Signatures for Integrated Safety (OASIS) Consortium: Rouquié et al., 2025. The OASIS Consortium: Integrating Multi-Omics Technologies to Transform Chemical Safety Assessment. Toxicological Sciences. https://doi.org/10.1093/toxsci/kfaf128

This open-access paper outlines how in vitro methods paired with multi-omics technologies—such as transcriptomics, proteomics, and Cell Painting—can be integrated to create more predictive, human-relevant methods for chemical risk assessment.

Addressing a Critical Challenge:
Traditional animal models often fail to reflect human biological responses. The OASIS Consortium, led in part by HESI Global and its Emerging Systems Toxicology (eSTAR) Committee, tackles this challenge by combining innovative in vitro tools. The goal? Gain confidence in in vitro methods paired with omics to understand their predictivity, for screening, prioritization, and potentially decision-making. This could lead to more human relevant toxicity data, fewer animal tests, and faster decision making.
Using the liver as a data-rich endpoint for toxicity and a dataset of over 1,500 compounds, OASIS is generating a large dataset that will help understand the use of different omics tools in vitro benchmarked to existing animal and human data. This work directly supports HESI’s mission to develop science-based solutions for safer, more sustainable health and environmental practices.

Why It Matters:
• Enhances human relevance in toxicity testing
• Supports adoption of New Approach Methodologies (NAMs)
• Provides tools for regulatory science across sectors
• Advances the global 3Rs (Replace, Reduce, Refine animal use)

This publication marks a major milestone in advancing translational toxicology and sets the stage for future regulatory innovations.
🔗 Learn more about the consortium: oasisconsortium.org

At EUROTOX 2025, HESI’s Global CITE (Combining Interdisciplinary and Translational Expertise) Lecture drew a full and highly engaged audience for Dr. Steven Levine’s visionary presentation, “From Data Silos to Virtual Humans: Guardrails for a New Era in Safety Prediction.”

Shermaine Mitchell-Ryan had the distinct honor of introducing Dr. Levine, whose talk exemplified the kind of forward-thinking, interdisciplinary science that defines HESI’s mission. His discussion of virtual twin technology (digital human models that integrate data across biological scales) demonstrated how collaborative innovation can improve safety prediction, enhance regulatory confidence, and accelerate the path from discovery to application.

Dr. Levine’s Living Heart Project, uniting academia, industry, and regulators, embodies the same collaborative framework that drives HESI’s work. The enthusiastic response from EUROTOX participants underscored HESI’s leadership and growing global visibility as a trusted convener translating complex, data-driven science into real-world solutions for human and environmental health.

Momentum and imagination were on full display in Athens as HESI Global’s OASIS Consortium took the spotlight at EUROTOX 2025 with the session, “Fundamentals and Evolving Uses of Cell Painting in Toxicology Studies.” Chaired by Dr. David Rouquié (Bayer) and Dr. Chrissy Crute (HESI Global), the session brought together a distinguished panel of speakers to explore the power of high-content imaging for predictive toxicology and chemical risk assessment.

Thanks to insightful presentations from Drs. Philip Marx-Stoelting (BfR), Jessica Ewald (EMBL-EBI), Jo Nyffeler (Helmholtz Centre for Environmental Research), and Claire Pecoraro-Mercier (Bayer), attendees were treated to an engaging deep dive into how morphological profiling is evolving to capture early biological responses, detect mechanisms of action, and enhance decision-making for safety science.
The session sparked lively discussion on how Cell Painting data can be leveraged across public, private, and regulatory sectors—especially when integrated with transcriptomics, metabolomics, and machine learning. Participants highlighted the need for continued standardization and open data sharing to accelerate global adoption.

The energy and collaboration in the room reflected the growing momentum behind image-based NAMs and the leadership role of the OASIS Consortium in advancing these efforts. This session stood as a clear milestone in the field—evidence that phenotypic profiling is not only maturing scientifically but becoming a central tool in the future of regulatory toxicology.

Curiosity was contagious in Athens this September as HESI Immuno-Safety (ITC) took the spotlight at EUROTOX 2025 with the symposium “New Approach Methodologies (NAMs) in Immunotoxicology: From in vitro to Risk Assessment.” Chaired by Dr. Marc Pallardy (Université Paris-Saclay) and Dr. Emanuela Corsini (Università degli Studi di Milano), and featuring Dr. Hervé Lebrec (Sonoma Biotherapeutics) and Dr. Andreas Natsch (Givaudan), the session sparked wide interest and discussion among international attendees. As co-chairs of HESI’s ITC, Pallardy and Lebrec brought to the session the same spirit of collaboration and innovation that defines HESI’s leadership in global immunotoxicology.

Speakers traced the evolution of NAMs from classical in vitro assays to advanced, pathway-based, and computational models that enable human-relevant risk assessment. Dr. Corsini illustrated how Adverse Outcome Pathway frameworks and key characteristics of immunotoxicants are transforming how chemical exposures such as PFAS are evaluated. Dr. Natsch highlighted progress in applying NAMs to skin sensitization and environmental immunotoxicology, linking human and ecological safety. Dr. Lebrec then demonstrated how these same approaches are advancing the immunosafety assessment of biologics and cell-based therapies using predictive in silico and in vitro tools.

The session reflected the collaborative, cross-sector spirit at the heart of HESI’s ITC, which continues to advance multiple workstreams focused on refining animal-model selection, expanding computational and weight-of-evidence frameworks, and mapping the rapidly evolving landscape of complex in vitro systems for immune safety assessment. Together, these efforts are reinforcing HESI’s role as a global convener driving innovation, 3Rs implementation, and regulatory confidence in next-generation immune-safety science.

From the international stage in Manchester, UK to the NAMs for DevTox Workshop and Fall Business Meeting in Washington, D.C., Developmental and Reproductive Toxicology (DART) Committee members demonstrated over the month of September how creativity, scientific rigor, and collaboration can together redefine what’s possible in developmental and reproductive toxicology.

Reimagining Possibilities at ETS Manchester
At the European Teratology Society (ETS) 2025 meeting in Manchester, UK, DART committee leaders reimagined what developmental and reproductive toxicology can look like in an era of automation, AI, and mechanistic insight:

• During Symposium 3, chaired by Christopher Bowman (Pfizer, HESI DART Co-Chair), speakers demonstrated how next-generation tools are transforming the field. Steven Van Cruchten (University of Antwerp, HESI DART Co-Chair) emphasized the importance of context of use over universal validation. James Bailey (CRL EDI) introduced automated, AI-assisted follicle imaging to improve speed and reproducibility. Matthew Burbank (L’Oréal, France; HESI DART Committee member) connected NAMs to Adverse Outcome Pathways (AOPs) for greater mechanistic clarity, and Max Langham (TIO Companies) unveiled advanced 3D imaging to capture subtle phenotypes previously unseen. The session reflected a shift toward more predictive, transparent, and human-relevant science; blending technology and collaboration to shape the next generation of safety assessment tools.

• During the annual ETS-BDRP exchange lecture on Virtual Control Groups vs. Concurrent Controls, what began as a debate at BDRP reignited in Manchester with upgraded datasets, sharper arguments, and a captivated audience. Bernd Baier (Boehringer Ingelheim; “The Benchmark”) returned with refined statistics and critical analysis, while Christopher Bowman (Pfizer; “The Control Disruptor”) countered with five years of Bayesian modeling, real-world case studies, and a hybrid control approach that challenged long-held assumptions. Chris will bring his fancy footwork, expertise, and leadership to the newly formed HESI VCG Working Group by serving as Co-Chair.

The Development and Reproductive Toxicology (DART) Committee held a 1.5-day workshop on 30 September – 1 October on “NAMs in DevTox Testing: Moving the Needle Forward”. The workshop drew over 130 attendees in person and online (including 50 in person) from across North America, Europe, and Asia. Discussions focused on emerging scientific and regulatory themes shaping the integration of new approach methodologies in developmental toxicology. Participants emphasized building scientific confidence through fit-for-purpose application, leveraging case examples to inform practice, and strengthening the connection between mechanistic understanding and regulatory decision-making. Workshop co-chairs Allen Kaczor (Merck) and Steven Van Cruchten (University of Antwerp) and session moderators deftly guided perspectives and experiences from across regulatory/government, industry (pharmaceuticals, agrochemicals, petrochemicals, consumer products), contract research organizations, non-profits, consultants, and academics. Stay tuned for the workshop proceedings and a new phase of work within HESI DART!

This whirlwind of activities culminated in a return to the DART-side — the DART family came together on 2 October for the DART Fall Business Meeting. Established working groups provided highlights on progress, collaboration, and next steps for 2026, and new program ideas were discussed and turned into action. The global family was also treated to a Lunch & Learn session, where Dr. Shuo Xiao (Rutgers University) and Dr. Paul Brownbill (University of Manchester) showcased innovative ovary-on-a-chip and placental barrier models advancing translational science. The meeting reinforced the objective of bringing science and strategy into alignment; to ensure that creative ideas translate into tangible progress. It also reflected the enduring undercurrent that keeps the DART Committee thriving: a community that comes together to listen, learn, and uplift one another in the pursuit of better science.

The 2025 inaugural Innovate EcoSafety Summit in Reykjavík, Iceland, brought together international leaders, scientists, academia, and regulators to accelerate the use of NAMs in environmental safety assessment.

Co-sponsored by the Health and Environmental Sciences Institute (HESI Global), U.S. Environmental Protection Agency (EPA), UK National Centre for the 3Rs (NC3Rs), and International Collaboration for Cosmetic Safety (ICCS), the three-day meeting focused on the application and implementation of NAMs to reduce and replace acute fish testing and to advance the science for evaluating endocrine activity potential in fish and amphibians. Sessions featured a mix of scientific talks, poster presentations, and interactive group discussions, fostering cross-sector dialogue and collaboration.

Discussions focused on exchanging insights about achievements and obstacles, addressing scientific and regulatory challenges, and strengthening trust in the pursuit of a more protective, ethical, and sustainable safety framework.

A special thanks to the 2025 supporters: European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), European Partnership for Alternative Approaches to Animal Testing (EPAA), American Chemistry Council (ACC), and Research Institute for Fragrance Materials (RIFM) for their support and partnership in driving forward ecological safety science.

With Canadian Thanksgiving just behind us, I find myself reflecting with gratitude on the dedication of my colleagues in HESI Global and around the world who continue to push the boundaries of safety science. I recently participated in the eSTAR Committee’s three-day workshop on transcriptomic points of departure (tPODs), a remarkable showcase of scientific expertise and collaboration. The hard work and robust debates by this group of global leaders are helping define acceptable practices for advancing regulatory implementation of tPODs. The scientific committees truly are the engine of HESI, and the impact of their work, seen throughout this issue, is inspiring.

I also very much appreciate the humor and fun that HESI staff inject into activities that keep us coming back for more, such as the “DART side” feature. A bit of levity goes a long way in keeping our community connected, even when we are addressing the toughest challenges.

HESI’s Board of Trustees and staff are equally hard at work. Following our decision to sunset the Emerging Issues and Program Strategy and Stewardship Committees, board members have taken on new responsibilities to strengthen strategic oversight. We held an online board meeting on October 10, where we discussed the successes of the AI conference, global outreach efforts, and tools to help guide next steps. These conversations reaffirm how dynamic and forward-thinking HESI Global is.

As the year winds down, I am deeply thankful for how HESI Global continues to bring people together across disciplines, borders, and perspectives. Let’s keep building on this shared core value and continue moving safety science forward together.

Carole Yauk, PhD, FCAHS,
Chair, Board of Trustees, HESI Global