HESI Insights - May 2024

Tracking the Fate of Cell Therapy Products In Vivo

A HESI Stakeholder Survey

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HESI’s Cell Therapy – TRAcking, Circulation, & Safety committee Biodistribution working group is launching an initiative to identify current approaches, gaps, and needs in monitoring/evaluating the fate and activity of cells after their administration in vivo, to assess the safety of cell-based therapies. As a result, we are reaching out to the broader scientific community, in Advanced Therapies, Regenerative Medicine and/or Imaging fields, to gather your valuable feedback.

Please help us gather important stakeholder input in this innovative and critical area by completing this short survey by 31 May 2024. Completion time is estimated at 10 min.

The outcome will be published in the peer-review literature to benefit the broader community.

Take the Survey HERE

COMprehensive Protein Allergen REsource

An update on the current status of the COMPARE database

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The COMprehensive Protein Allergen REsource (COMPARE) is a public database comprised of protein sequences of known allergens. The project Steering Team has put together a wonderful resource on the current status of the database. Click here to dive into what COMPARE is, who uses it and why. Understand the benefits of this multi-sector collaboration, how it is used for allergenicity assessment, and the continuous improvements it has undergone.


Within-laboratory reproducibility of Ames test results: Are repeat tests necessary?

Environmental and Molecular Mutagenesis

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A cross-sector group of experts from the Health and Environmental Sciences Institutes (HESI)’s Botanical Safety Consortium (BSC) and Genetic Toxicology Technical Committee (GTTC) analyzed data from the National Toxicology Program (NTP) Ames test database to evaluate the need for repeat testing when assessing the mutagenic and carcinogenic potential of chemical compounds.

Key Findings:

  • High reproducibility for initial positive and negative responses from the National Toxicology Program (NTP) Ames test database for 3000 test articles.
  • Repeating tests for initial positive and negative responses may be unnecessary in most cases.
  • Lower reproducibility for initial equivocal responses suggests a need for repeat testing.
  • Factors affecting reproducibility could include potency of the initial response, solubility of test substances, and laboratory experience.


  • Supports the OECD Test Guideline of not needing to repeat clear negatives and positives
  • Findings could inform revisions in testing guidelines.
  • Findings could apply to single chemicals or mixtures such as botanicals

These results can provide context for determining the optimal design of recommended test protocols for use in screening both individual chemicals and complex mixtures, including botanicals.

Within-laboratory reproducibility of Ames test results: Are repeat tests necessary? Zeiger et al., April 2024. Environmental and Molecular Mutagenesis. https://doi.org/10.1002/em.22597

Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis

Toxicological Sciences

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This review from the HESI Immuno-Safety Committee focuses on allergic reactions induced by systemically administered low-molecular weight drugs with an emphasis on drug- and patient-specific factors that could influence the development of drug-induced hypersensitivity reactions (DHRs). Strategies for predicting and diagnosing DHRs, including potential tools based on the current state of the science, are discussed.

Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis. Pallardy et al. April 2024. Toxicological Sciences. https://doi.org/10.1093/toxsci/kfae046

Prediction of physicochemical and pharmacokinetic properties of botanical constituents by computational models

Journal of Applied Toxicology

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A newly published study from the Botanical Safety Consortium used computational models to predict the physiochemical and pharmacokinetic properties of botanical constituents. This study investigated 103 major compounds from 13 botanicals (e.g., ashwagandha, kratom, and yohimbe), providing insights into their absorption, bioavailability, and safety profiles. The in-silico predictions could help guide future safety studies and the selection of appropriate concentrations for in vitro testing. This research represents a significant advancement in understanding how these computational tools commonly used for pharmaceuticals and other single chemicals, can be used for botanicals, contributing to expanding the toolkit of in silico and in vitro tools to understand the safety profile of botanicals. Stay connected (https://botanicalsafetyconsortium.org/current-members/) for more updates on this exciting research in botanical science!

Prediction of physicochemical and pharmacokinetic properties of botanical constituents by computational models. Liu et al., April 2024. Journal of Applied Toxicology. https://doi.org/10.1002/jat.4617

Collaborative science in action: A 20 year perspective from the Health and Environmental Sciences Institute (HESI) cardiac safety committee

Journal of Pharmacological and Toxicological Methods

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The Health and Environmental Sciences Institute (HESI) Cardiac Safety Technical Committee (CSTC) has made significant strides in improving cardiovascular (CV) safety in drug development.  Here are the top 5 takeaways from their collaborative efforts:

  1. Collaborative Science: The CSTC brings together experts from academia, regulatory authorities, and the private sector to address CV safety challenges through research, studies, workshops, and symposia.
  2. Detection and Prediction: The CSTC utilizes innovative models to detect potential cardiac failure modes and improve study design, enhancing the translational predictability of nonclinical evaluations.
  3. Published Impact: The CSTC has published 38 peer-reviewed manuscripts, showcasing their contributions to the field of CV safety and advancing the development of safer medicines.
  4. Addressing Adverse Effects: By reducing unanticipated adverse drug effects, the CSTC aims to minimize attrition in drug development and withdrawal of marketed drugs, benefiting both patients and pharmaceutical companies.
  5. Future Opportunities: The CSTC’s work extends beyond drug development, providing insights into the impact of environmental or chemical exposures on cardiovascular function.

Read the full publication here: https://doi.org/10.1016/j.vascn.2024.107511


Immuno-Technical Committee Career Webinar

26 March 2024 – Recording Available!


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The Immuno-Safety Technical Committee’s Science Outreach project team presented a webinar highlighting careers in immune safety science. The panelists shared personal anecdotes and insights to help the next generation of immune safety scientists navigate their way to fulfilling careers. The panel was made up of ITC committee members Marie Fortin (Rutgers), Rashade Haynes (BMS), Danice Wilkins (CRL), and Shaji Theodore (US FDA).

See the webinar recording posted on the HESI YouTube Channel.

Donor Specific Toxicity of Copanlisib Identified Using Immune-Humanized Mice

22 April 2023 – Immuno-Safety Technical Committee Webinar


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The HESI Immuno-Safety Technical Committee’s humanized mouse project hosted Kristina Howard (FDA), who presented key findings from her SOT 2024 poster entitled “Donor specific toxicity of copanlisib identified using immune-humanized mice”. Copanlisib, an FDA-approved drug for lymphoma and breast cancer therapies, is being studied for its potential combined use with checkpoint inhibitors in immune-humanized mice. Initial studies revealed minimal toxicity in most cases, but significant immune responses in one donor highlight individual variations in drug effects.

HESI Developmental and Reproductive Toxicology Spring Business Meeting

24 – 25 April 2024

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🌱 Spring Blossoms at the HESI Developmental and Reproductive Toxicology Committee 🌸

Amidst the bloom of the season, the HESI Developmental and Reproductive Toxicology (DART) Committee convened virtually for their Spring meeting, spanning two productive half-days. Over 80 DART experts gathered online, fostering vibrant discussions on ongoing initiatives and outreach efforts.

Excitingly, the committee unveiled the inauguration of two novel scoping groups. The first group is dedicated to exploring new modalities and the intricacies of germline transition, while the second delves into the critical realm of EFD (Embryo-fetal Development) concordance. These scoping groups promise to enrich our understanding and advance research in these vital areas.

We extend a warm invitation to committee members and all interested parties to engage with these new ventures, as well as our existing activities. Those eager to contribute or participate are encouraged to connect with us by reaching out to Connie or Shermaine.

Let’s cultivate progress together! 🌿

Emerging spatial genomics and in situ sequencing technologies for carcinogenesis assessment

26 April 2024 – HESI eSTAR Webinar – Recording Available!

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The HESI eSTAR Committee hosted a webinar by Dr. Jesse Salk, discussing an emerging spatial genomics and in situ sequencing technology, with emphasis on its application for carcinogenesis assessment. The webinar recording is available on the event page here.

The Annual Meeting of the American Association of Immunologists (AAI)

3 – 7 May 2024

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The HESI Immuno-Safety Technical Committee hosted an exhibitor booth at AAI Chicago to invite academics and their trainees to join relevant ITC projects. ITC members Rashade Haynes (BMS) and Nikki Marshall (GSK) led Chat & Chew sessions to spread the word about ITC’s impact and their experience working with HESI.

HESI Workshop – Cardiac Safety and Drug Development

 7 – 8 May 2024

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The HESI Cardiac U01 Advisory Steering Team and Cardiac Safety Committee recently convened a two-day workshop held at US FDA White Oak to discuss novel methods for cardiac toxicity screening as well as advances in cardiac safety assessments. More than 50 people attended in person and over 200 joined virtually to hear presentations from recipients of the HESI Cardiac U01 grant, perspectives and case studies on cardiac NAM use, and Cardiac Safety Committee updates. Participants also had the opportunity to discuss validation and implementation of novel cardiac assays and opportunities for future collaboration. HESI plans to release a full workshop summary in the coming weeks. Learn more about HESI Cardiac Safety here or contact Jennifer Pierson (jpierson@hesiglobal.org).

HESI GTTC and eSTAR Members Shine at FDA’s CDER Pharmacology Toxicology Symposium

13 May 2024

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On May 13, 2024, several esteemed members from HESI’s Genetic Toxicology Technical Committee (GTTC) and Emerging Systems Toxicology for the Assessment of Risk Committee (eSTAR) delivered insightful presentations at the FDA’s CDER Pharmacology Toxicology Symposium. This event, organized by the Education Subcommittee, focused on “Error-Corrected Next Generation Sequencing Strategies for Direct Assessment of Mutagenesis and Early Identification of Cancer Risk.”

Originally presented at the 2024 Society of Toxicology Annual Meeting, this session was co-chaired by Connie Chen (HESI) and Stephanie Smith-Roe (DTT/NIEHS). The impressive lineup of speakers included Sheroy Minocherhomji (Lilly), Jesse Salk (University of Washington), Anthony Lynch (GSK), Francesco Marchetti (Health Canada), Carole Yauk (University of Ottawa), and Arun Pandiri (DTT/NIEHS).

The education webinar attracted over 160 attendees from various FDA centers, reflecting the high level of interest and engagement in these cutting-edge topics.


HESI Immuno-Safety Technical Committee & BioSafe Meeting

20 – 22 May 2024

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The HESI Immuno-Safety Technical Committee will host a joint session with BioSafe in San Francisco, CA, to be followed by the ITC Annual Science Meeting. In addition to discussion of current projects, a Shark Tank pitch will be hosted to generate new ideas for committee projecst. Please reach out to Sheramine Mitchell-Ryan (smitchell-ryan@hesiglobal.org) or Chrissy Crute (ccrute@hesiglobal.org) if you have ideas for the pitch session or would like to attend.

Machine-Learning Aided Multi-Scale Modelling Framework for Toxicological Endpoint Predictions in the Dog

29 May 2024

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This project overview webinar will be given by Drs. Stephan Schaller and Mark Davies from ESQlabs GmbH. The project is funded via the NC3Rs CRACK IT Mega Challenge: Virtual Second Species, which seeks to exploit advances in computational approaches and machine learning to develop a “Virtual Dog” to ultimately replace their use for chronic toxicity studies. The webinar is co-sponsored by HESI and NC3Rs.

The webinar is free but registration is required. Click here to register.

International Congress of the European Society of Toxicology In Vitro (ESTIV)

3 – 6 June 2024, Prague, Czech Republic

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Society for Birth Defects Research and Prevention Annual Meeting

22-26 June 2024

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The 64th BDRP Annual Meeting will be held in Pittsburgh, PA from June 22-26. Current Co-Chair, Dr. Christopher Bowman, will also be receiving the Patricia Rodier Mid-Career Award for Research and Mentoring and giving his presentation on Sunday, June 23. The DART committee will have a featured symposium, “DART Strategies for Oligonucleotides” on Wednesday June 26. Both HESI staff members, Connie and Shermaine, will be attending in-person are looking forward to connecting!

International Congress On Natural Products Research (ICNPR)

13 – 17 July 2024, Krakow, Poland

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International Congress On Natural Products Research (ICNPR), Krakow, Poland 13-17 July 2024

The Botanical Safety Consortium is holding a training course as part of the meeting on Saturday 13 July entitled “Cultivating Safety: Toxicology 101 of Botanicals and Natural Products.

This course will offer a deep dive into the world of botanicals, bridging the gap between their traditional uses and modern applications in supplements, medicines, and cosmetics. Participants will explore routes of botanical exposure, interactions with drugs, dose-response nuances, acute and chronic toxicity, and a range of potential health endpoints. With hands-on exercises, discussion of cutting-edge toxicity assessment tools, and interactive case studies—including challenges like product adulteration and new botanical discoveries—the course will provide a comprehensive look into the complexities of botanical safety, making it essential for researchers, practitioners, and thrill seekers.

Register at www.icnpr2024.org

Speakers and training course developers include BSC members Amy Roe (P&G), Holly Johnson (AHPA), Stefan Gafner (American Botanical Council), Olaf Kelber (Bayer), Richard van Breemen (Oregan State University), Cynthia Rider (NIEHS), Connie Mitchell (HESI), Michelle Embry (HESI), and Julie Krzykwa (HESI).

Meeting flyer available here.


International Collaboration on Cosmetics Safety Annual Meeting

3 October 2024

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Michelle Embry, Ph.D., Deputy Director, Health and Environmental Sciences Institute (HESI), will be a featured plenary speaker at the ICCS 2024 Annual Meeting taking place in Washington, DC. Dr. Embry will discuss her work towards “one health assessment” with bioaccumulation as a learning which sits at the intersection of human and environmental health. Michelle will discuss the commonalities and differences between human and environmental health and how that has highlighted the advances and needs in next generation risk assessments (NGRA) and new approach methodologies (NAMs). Included also in her talk is the importance of problem formulation and the context regarding existing NGRA/NAMs with an emphasis on exposure and fate.

NeuTox Mini Session at Society for Neuroscience Annual Meeting

8 October 2024

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We are excited to announce the upcoming Translational Biomarkers of Neurotoxicity (NeuTox) Mini Session at this year’s Society for Neuroscience Annual Meeting in Chicago! Join us for an enlightening session titled “Seizure and Epilepsy: New Opportunities for Detection and Treatment,” featuring esteemed speaker and HESI Board member Ruth A. Roberts.

Botanical Safety Consortium Summit 2024

10 – 11 October 2024, Hybrid, Durahm NC, USA

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The Botanical Safety Consortium (BSC) will hold it’s first in-person meeting (with virtual option) at NIEHS in Durham, NC in October 2024. The in-person meeting is limited to members, with preference for steering committee and working group members. The virtual option will be open to all.

The hybrid portion will include updates from the working group on the new approach methodologies (NAMs) tested for their suitability for botanicals. The in-person portions will include hands-on breakout groups and discussions to understand the current tool-kit, identify gaps, and identify future research priorities. Virtual connection information will be provided at a later date, expect an email with the connection information in the coming weeks for those who register.

Register on the event page here.



2024 GTTC Professional Development Awards

Apply by 31 May 2024

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The Health and Environmental Science Institute’s Genetic Toxicology Technical Committee (HESI GTTC) Education and Science Outreach Committee is pleased announce the 2024 awards that will provide opportunities for trainees to attend scientific conferences, workshops, or courses, etc., to build core competencies and transferrable skills, and/or share your research. Awardees will be invited to GTTC’s 2025 Annual Meeting to learn about the emerging projects and science at HESI and to network with experts in the gene toxicology field.

GTTC is pleased to announce TWO awards for 2024:

  • Professional Development Travel Award – Provides $1,500 USD for travel to attend scientific conference or workshops.
  • Professional Development Training Award (new!) – Provides $4,000 USD for travel specific to training courses, cross-lab trainings, etc. to build core competencies and transferrable skills.

Learn more and download the application here.

2024 DART Professional Development Awards

Apply by 31 May 2024

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HESI Developmental and Reproductive Toxicology Technical Committee (DART) is pleased to be able to continue its professional development award in 2024. Two awardees (MS, PhD, Post Doc) will receive $2000 USD towards attending professional meetings or trainings that occurs within the 12-month post application period. The application period is open from April 1 – May 31. Please see the HESI DART website for the 2023 awardees and more information on how to apply.

HESI is Hiring a Scientific Program Manager!

Apply today!

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Looking for an exciting career in human or environmental toxicology, drug safety, biomedical innovation, regulatory science, epidemiology, exposure-science, and risk assessment — outside of the lab?

Want a great place to grow your career via collaboration with thought-leaders from government, industry, academia, clinic, and NGOs?

Seeking an opportunity to apply your skills in leadership and program management while applying science to real world challenges?

The Health and Environmental Sciences Institute (HESI), a global nonprofit scientific organization, seeks a Scientific Program Manager to help lead collaborative scientific programs in the biomedical and environmental health fields. Successful candidates will have a passion for fostering creative and rigorous scientific collaborations that pool expertise, resources, and technical input from a diverse base of stakeholders. HESI Scientific Managers are responsible for developing, managing, and providing scientific input to large international scientific teams that generate science to protect public health and the environment. HESI offers the opportunity to work with internationally recognized scientists from government, academia, NGOs, clinic, and industry. This responsible position requires leadership skills and the ability to work as part of a team to help realize HESI’s mission of achieving science for a safer, more sustainable world.

This position works in Washington, DC, and reports to the HESI Executive Director.


Provides scientific, strategic, management, and administrative support to collaborative scientific committees involving academic, government, nonprofit, and private sector scientists;

Works with committee members to design and execute novel scientific research programs, publications, workshops, and trainings;

Prepares and monitors committee budgets, assists with communications (technical and non-technical), supports membership development, facilitates workshops and meetings, and contributes to overall HESI strategy and outreach.


• A Master’s or Ph.D. in a scientific field such as toxicology, pharmacology, genetics, immunology, epidemiology, genetics, molecular biology, cell biology, pathology, chemistry, environmental health, or related life sciences and a minimum of 3 years of experience in project management, drug or chemical safety evaluation, scientific consulting, and/or regulatory affairs.
• Strong facilitation skills and the ability to work with groups meeting virtually or in person.
• Advanced written and verbal communication skills, outstanding management and organizational ability.
• At least 5 years of experience in project or program coordination.
• Leadership experience and presentation skills.
• Technical/scientific writing.


Expertise in any/all of the following areas preferred:

• Regulatory Science
• Exposure Science
• Drug Safety Assessment
• Chemical Safety Assessment
• Computational Toxicology


At HESI, it is our mission to collaboratively identify and help to resolve global health and environmental challenges through the engagement of scientists from academia, government, industry, clinical practice, research institutes and NGOs. We achieve that in a variety of ways:

Create a collaborative environment where scientists from academia, government, industry, and NGOs come together to find solutions that improve health and environmental safety.

Encourage the development of meaningful studies that ask the right questions, structure the right framework, and develop solutions that inform decision-making by both private- and public-sector scientists.

Create a knowledge base that can be easily transferred from the laboratory or journal page to real life.

Individuals interested in applying for this position should send their RESUME with COVER LETTER to Career@hesiglobal.org.

Principals only, please. Unsolicited resumes from third-party agencies will not be considered. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Learn more about us at www.hesiglobal.org.


Anthony Holmes, PhD, President of HESI Assembly

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It’s plain to see from this month’s ‘Insights’, that conference season is still in full swing! As I come towards the end of my tenure as HESI President and having been a member of the Board of Trustees for the last 8 years you’d think I wouldn’t be surprised any more by quite how much this relatively small organisation has to communicate. But just looking through this edition of the newsletter, I’m left blown away once more. It’s such a powerful indication of the breadth, quality and impact of HESI science, and how highly regarded the organisation is across scientific communities, that it’s staff and committee members are invited with such regularity to share the outputs of their work on a global scale. There are so many opportunities to engage in HESI science in the coming months, so make sure you’re part of the conversation.

On a personal note, I’m delighted to see the long history of collaboration between HESI and my own organisation, the NC3Rs, continue as we co-host a webinar to showcase the fascinating cross-sector collaboration that is delivering the ‘Virtual Second Species’ CRACK IT Challenge. There’s so much global interest in both advancing opportunities to reduce the use of dogs in research and the application of in silico modelling approaches that it’s great to be able to move the conversation forward across both our networks.

If all of the great content in this month’s ‘Insights’ has you wishing you could be part of such a forward thinking, dynamic and collaborative organisation…and who wouldn’t? Well, the good news is you can! Be sure to check out the Scientific Program Manager role currently open for applications to be part of the HESI team.

Kind regards,

Anthony Holmes, PhD, President of HESI Assembly

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Fax: +1-202-659-3859

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