The HESI Global GTTC Education and Science Outreach Committee is pleased to announce the recipients of the 2025 Professional Development Travel Awards and Training Awards.
The Professional Development Travel Award supports individuals in attending scientific conferences or workshops to advance their professional growth. The Training Award provides funding for travel to participate in targeted training opportunities—such as specialized courses or cross-laboratory experiences—designed to enhance core competencies and transferable skills.
As part of this recognition, awardees will also be invited to attend GTTC’s 2026 Annual Meeting, where they will have the opportunity to engage with emerging scientific initiatives at HESI Global and connect with experts from industry, academia, and government in the field of genetic toxicology.
Congratulations to all of the well-deserving recipients! We wish them continued success in their scientific endeavors.
Learn more about the Genetic Toxicology Technical Committee here.
The Botanical Safety Consortium is seeking experts in
These experts will support the Neurotoxicity Working Group in reviewing a dataset to evaluate whether these existing tools are suitable for assessing botanicals as complex mixtures.
We are asking experts to attend 1-2 virtual meetings (each model will meet separately) this fall to
Note, experts do not need to be a part of the Botanical Safety Consortium and are only asked to participate in 1-2 meetings and potential follow-up. Follow-up can include co-author in a peer-review manuscript and acknowledgement in presentations and publications.
Please write to Connie Mitchell (cmitchell@hesiglobal.org) by September 12 if you’d like to be involved or have questions.
The HESI Global Immuno-Safety Technical Committee (ITC) is deeply honored to highlight Dr. Mineo Matsumoto, whose distinguished service, scientific expertise, and unwavering dedication have enriched our work for many years. Dr. Matsumoto’s contributions reflect not only his exceptional professional knowledge but also his commitment to fostering mutual understanding and collaboration across cultures and disciplines. His presence within the ITC is both a privilege and an inspiration, and we extend our sincere respect and gratitude for his enduring partnership.
Fostering International Collaboration
Dr. Matsumoto has been a vital bridge between HESI and Japan’s PMDA, bringing invaluable regulatory insight and encouraging open scientific dialogue. His leadership has been pivotal in establishing a lasting relationship with Kitasato University, whose faculty and students have actively participated in numerous ITC events. This connection has strengthened the committee’s global network, creating opportunities for knowledge exchange and collaborative progress in immuno-safety.
Leadership in First-in-Human Dose Selection for Immunomodulators
Together with Ryan Polli (Novartis), Dr. Matsumoto co-led the ITC’s First-in-Human (FIH) Dose Workstream, which recently produced the landmark publication, “Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC)” in Clinical Pharmacology & Therapeutics.
This important work addresses the complexities of selecting safe and effective starting doses for immunomodulators, a diverse class of drugs with varied mechanisms of action and safety considerations.
The outcome was a revised decision tree that builds on IQ MABEL Working Group guidance, that incorporates mechanism of action, risk–benefit balance, and real-world considerations, offering a more nuanced and patient-centered approach to FIH dose selection.
Extending the Impact Through Education
In partnership with the Society of Toxicology’s Biotechnology Specialty Section, Dr. Matsumoto co-organized a highly attended webinar to share these findings with the broader scientific community. The workstream has also submitted a companion commentary to expand on these recommendations with additional examples, charts, and detailed analysis.
Commitment in Action
Dr. Matsumoto’s steadfast dedication to the committee is evident not only in his leadership but also in his consistent presence. He regularly joins 12:00 noon EST meetings from Japan, often late in the evening his time. His willingness to engage fully, despite significant time zone challenges, speaks to his remarkable commitment and respect for the collaborative mission of the ITC.
Dr. Matsumoto’s service reflects the very mission of the HESI Immuno-Safety Technical Committee: To advance the science and practice of immunosafety through collaborative, cross-border partnerships that strengthens the field while protecting human health worldwide. His leadership transforms the “ITC” acronym into a living example of purposeful action:
I – Inspires Trust and Collaboration: Brings together scientists, regulators, and academic partners across the globe to address critical challenges in immuno-safety.
T – Translates Science into Solutions: Leads research initiatives that convert complex data into practical, science-based guidance for safer drug development.
C – Cultivates Global Progress: Fosters partnerships and knowledge-sharing that strengthen regulatory science and improve patient outcomes worldwide.
We sincerely thank Dr. Mineo Matsumoto for his exceptional service, his leadership in advancing immuno-safety science, and the generosity of spirit he brings to every interaction. We are privileged to have him as a valued colleague, partner, and member of the ITC family.
We are proud to share that the HESI Global Genetic Toxicology Technical Committee’s Nitrosamines Research Program has been recognized in the European Medicines Agency’s (EMA) 2025 report: “Nitrosamine Impurities in Human Medicines – The Response of the European Medicines Regulatory Network.”
The report, published on July 8, 2025, provides a comprehensive overview of the EU regulatory response to nitrosamine impurities in pharmaceuticals. On page 12, the EMA acknowledges the valuable contributions of the HESI GTTC Mechanism-Based Genotoxicity Risk Assessment (MGRA) working group in advancing safety science related to nitrosamines.
This mention reflects HESI Global’s growing impact in shaping science-based regulatory decisions through multi-sector collaboration. Research led by the GTTC MGRA group has informed new approaches for assessing the carcinogenic potential of nitrosamines, including the development of structure-based risk categorization methods and improved in vitro testing strategies.
We thank our global collaborators for their ongoing contributions to this important work, which supports HESI Global’s mission to advance health and environmental safety through collaborative science.
Read the full EMA report here.
We’re proud to share that Dr. Julie Krzykwa, HESI Global Scientific Program Manager, has been named Co-Chair of the Animal Alternatives Interest Group at the Society of Environmental Toxicology and Chemistry (SETAC). She will serve alongside Dr. Maria Blanco-Rubio in this leadership role for the next two years.
This group plays a vital role in advancing the development and application of New Approach Methodologies (NAMs) within environmental sciences—aligning closely with HESI Global’s mission to promote innovative, science-based strategies for health and environmental safety.
We extend our sincere thanks to outgoing chairs, Adam Lillicrap and Theresa Norberg-King, for their outstanding leadership in bringing animal alternatives and NAMs to the forefront of SETAC’s scientific programming.
Under Julie’s co-leadership, the group will continue to foster dialogue, collaboration, and progress on alternative approaches to animal testing. We look forward to supporting this important work and encourage the community to get involved by sharing ideas and discussion topics with the group.
Congratulations, Julie!
Eco-NAMs Webinar Series Starts on 10 September 2025; State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach
The Eco-NAMs Webinar Series aims to offer the most informative and up-to-date science on new approach methodologies (NAMs) for ecotoxicity assessments. Each webinar will consist of presentations by experts followed by a discussion. The webinar series will provide an open forum for scientists from academia, industry, non-government organisations, regulatory authorities, and other interested parties, including the general public, to learn about and discuss various ecotoxicity NAMs topics.
The first webinar in the Eco-NAMs series on the use of NAMs in regulatory ecotoxicology will cover NAMs in bioaccumulation assessment. The webinar will be held on 10 September 2025 at 8:00 AM EDT. Registration details and more information are available here.
The webinar will feature presentations by Dr Pippa Curtis-Jackson, Senior Specialist at the Chemical Assessment Unit, United Kingdom Environment Agency (UK EA), and Dr Michelle Embry, Deputy Director of the Health and Environmental Sciences Institute (HESI).
Dr Curtis-Jackson will discuss the regulatory and industry acceptance of NAMs in bioaccumulation assessment. This presentation aims to provide a short history of Persistent, Bioaccumulative and Toxic (PBT) assessment, highlight the benefits and drawbacks of current practice, i.e., NAMs that are available but not routinely used, and spotlight evidence reviews commissioned by the UK EA.
Dr Embry will present an Integrated Approach to Testing and Assessment (IATA) for bioaccumulation to aid evaluators in the collection, generation, evaluation, and integration of multiple lines of evidence for clear and transparent decision making in bioaccumulation assessment for aquatic and terrestrial environments. Three illustrative case studies representing data-poor and data-rich chemicals will be discussed.
The Eco-NAMs webinar series will be held quarterly. Links to past webinars will be available at https://www.thepsci.eu/eco-nams-webinars/. The webinar series is co-organised by the European Medicines Agency (EMA), HESI, the National Institute for Environmental Studies (NIES, Japan), PETA Science Consortium International e.V., the US Environmental Protection Agency (EPA), and the US Food and Drug Administration (FDA).
Disclaimer: The views expressed in this webinar series are those of the presenters and do not necessarily represent the official views or policies of the US government, the EMA, or the NIES. The US FDA, US EPA, EMA, and NIES involvement in this webinar series does not imply official endorsement of, or responsibility for, the opinions, ideas, data, products, or services presented.
For nearly a decade, the COMprehensive Protein Allergen REsource (COMPARE) has been a trusted, freely accessible, and peer-reviewed tool supporting global regulatory assessments, academic research, and public transparency in allergenicity evaluation. This unique database has been made possible through the generous contributions of a small group of funders — and now, we’re seeking broader community support to keep it open and growing.
To ensure COMPARE remains free, up-to-date, and responsive to user needs, we are inviting new partners to join our growing community of supporters. Your contribution, whether large or small, plays a critical role in sustaining and enhancing this one-of-a-kind resource. Every dollar helps us maintain open access, implement user-requested improvements, and continue delivering high-quality, peer-reviewed data to the global research and regulatory community.
To learn more or discuss how you can get involved, contact us at compare@hesiglobal.org.
Thank you for being part of the COMPARE community — your support helps ensure this globally relied-upon resource remains transparent, current, and impactful.
Nature Scientific Reports
HESI Global, in partnership with the U.S. Food and Drug Administration (FDA) through the FDA’s Broad Agency Announcement (BAA) program, has published a new peer-reviewed study evaluating manual patch clamp hERG data generated using harmonized protocols and regulatory best practices.
The manuscript, titled “Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices” by Alvarez Baron et al., is now available open access in Nature Scientific Reports (2025).
🔗 Read the full article
The hERG potassium channel is a critical tool in cardiac safety assessments, as inhibition of this channel is associated with the potential for drug-induced arrhythmias. This study presents results from a multi-site comparison of manual patch clamp data and evaluates the application of ICH S7B Q&A 2.1 recommendations. The findings offer important insights into the reproducibility, performance, and variability of this assay across laboratories and platforms.
Importantly, all hERG data used in this publication are publicly available via the Open Science Framework:
📂 https://osf.io/a6k5t/
This effort aligns with HESI Global’s mission to collaboratively generate science that informs safer, more effective public health decisions. It also supports broader regulatory confidence in in vitro cardiac safety assessments by improving transparency and access to standardized datasets.
Learn more about the HESI Global Cardiac Safety Committee here.
Anal. Bioanal. Chem.
Ensuring the safety and authenticity of botanical supplements starts with understanding what’s inside. In a new case study on ashwagandha, the HESI Global Botanical Safety Consortium showcases a multi-detector analytical platform designed to do just that.
This innovative approach combines *UHPLC, PDA, CAD, and HRMS to:
✔️Identify and semi-quantify over 60 constituents
✔️Support material authentication and detect variability
✔️Enable in silico and in vitro safety evaluations
By generating detailed chemical fingerprints, this method helps advance consistent, science-based assessments of complex botanical products—contributing to both consumer confidence and product innovation.
Read the publication:
Sica, V.P., Mitchell, C.A., Krzykwa, J. et al. A multi-detector analytical approach for characterizing complex botanical extracts: a case study on ashwagandha. Anal Bioanal Chem (2025). https://doi.org/10.1007/s00216-025-06006-8
Learn more about the Botanical Safety Consortium: botanicalsafetyconsortium.org
* Ultra-high-performance liquid chromatography (UHPLC) coupled with photodiode array (PDA) detection, charged aerosol detection (CAD), and high-resolution mass spectrometry (HRMS)
Environmental and Molecular Mutagenesis
The HESI Global Genetic Toxicology Technical Committee (GTTC) has published a critical new review in Environmental and Molecular Mutagenesis titled “Critical Evaluation of Methods for the Identification of Aneugens.” This publication provides much-needed clarity on using NAMs to evaluate aneugenic potential, helping to advance safer chemicals, medicines, and regulatory practices.
The Issue
Chemicals that interfere with chromosome number, known as aneugens, can lead to severe health consequences, including developmental disorders and cancer. Regulatory frameworks across pharmaceutical, industrial, and consumer sectors require accurate evaluation of such genotoxic risks. However, distinguishing aneugenicity from other types of chromosome damage remains challenging.
Why it Matters
Accurately identifying how a chemical causes genetic damage (its mode of action) is critical for making informed human health risk assessments and designing appropriate follow-up studies. Without this, potentially harmful exposures may be mischaracterized, potentially delaying development or overlooking risks.
The Problem
Microscopy-based techniques like FISH or CREST staining have widely been used to identify chromosomal damage mechanisms, but are low-throughput, and limited in mechanistic insight. This makes them difficult to apply consistently across regulatory and industrial settings.
The Solution
To address these limitations, the HESI Global Genetic Toxicology Technical Committee conducted a comprehensive review and SWOT analysis of legacy methods (FISH and CREST) alongside emerging New Approach Methodologies (NAMs), including high-content imaging and flow cytometry. The team applied these tools to in vitro studies using well-characterized reference aneugens (colchicine, taxol, AMG900) and clastogens (mitomycin C, MMS).
The Benefit
This work illustrates how NAMs can improve the accuracy and efficiency of genetic toxicology assessments. This review provides a roadmap for integrating more advanced, tools into safety science, supporting HESI Global’s mission to create science-based solutions for a safer, more sustainable world.
Read the open-access article:
Critical Evaluation of Methods for the Identification of Aneugens. Sun et al., 2025. Environmental and Molecular Mutagenesis. https://doi.org/10.1002/em.70023
HESI Global was honored to contribute to Food Allergens Asia 2025, held June 25–27 in Bangkok, Thailand. During the Day 3 workshop on Food Allergen Predictive Management, the COMPARE Program was featured in a webinar titled “From Sequence to Safety: The Role of the COMPARE Database in Predicting Protein Allergenicity.”
The presentation introduced COMPARE (https://comparedatabase.org/), a publicly accessible, rigorously curated database of allergenic protein sequences that supports global IgE-mediated allergenicity assessments for GM foods and novel proteins. Aligned with Codex guidelines, COMPARE is designed to assist regulators, industry, and researchers in evaluating allergenic risk using high-quality, peer-reviewed data.
The session also showcased COMPASS, COMPARE’s integrated bioinformatics tool that enables homology and cross-reactivity searches to support early risk identification and regulatory dossier preparation. Used by agencies such as the FDA, USDA, and EFSA, COMPARE empowers transparent, science-based food safety evaluations that advance innovation while protecting allergic consumers.
Click the HESI Event Page link in the table below for full details on each event
HESI Global is excited to announce two open positions for Senior Scientific Program Manager roles, each with a unique focus area:
Why HESI Global?
Join a mission-driven nonprofit where science drives public good. At HESI Global, your work will advance safety science, protect public and environmental health, and promote sustainable decision-making. You’ll collaborate with world-renowned experts from academia, government, and industry, working at the forefront of scientific progress that matters.
Full job descriptions and application details can be found here: https://hesiglobal.org/careers/
If you’re ready to bring your expertise to a collaborative, high-impact scientific community, we encourage you to apply today!
Michelle Embry, PhD, HESI Global Deputy Director
SCIENCE. It is at the core of everything we do at HESI and has been for over 35 years. We are committed to serving as a neutral forum for stakeholders to discuss, advance, debate, and uphold the scientific method. To all those who work with us on our various programs, serve on our board, attend workshops and webinars, and share our output, THANK YOU. Thank you for supporting science and constructive dialogue through collaboration. To those reading this newsletter and want to become more involved, please reach out. To those who are interested in joining our scientific staff, we are hiring! Together, we can advance and protect science.
Kind regards,
Michelle Embry, PhD, HESI Global Deputy Director
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403
740 15th Street NW, Suite 600
Washington, DC 20005
Sign up for our monthly e-newsletter.
