HESI Insights - February 2024

The OASIS Consortium, a working group within HESI’s Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee, received $1.2 million from the Massachusetts Life Sciences Center Bytes to Bytes Awards. These funds, supplemented with $2.5 from industry, will support laboratory work at the Broad Institute of Harvard and MIT to investigate Cell Painting, transcriptomics, and proteomics for decision making in toxicology. These funds also support two postdoc positions at the Broad Institute. This 3-year project will explore approximately 1600 compounds across 3 cell types, organoids, and microphysiological systems.

Read the full press release here.

The HESI Cell Therapy TRAcking, Circulation, & Safety (CT-TRACS) Committee is proud to be a partner in the CRACK-IT T-ALERT challenge, which aims to replace animal studies and improve the safety assessment of cell therapies. The Phase 2 winner, a team led by Professor Toni Cathomen at the University of Freiburg (Germany), has been awarded £1M of funding to develop an approach to evaluate the tumorigenicity of human engineered T-cell therapies.

CT-TRACS are pleased to partner with NC3Rs, the challenge sponsors and the University of Freiburg and leverage our network of experts and participating organizations to support the development of their approach. Additional information about the challenge award winner can be found here.

HESI is honored to collaborate with Dr. Robyn Tanguay from Oregon State University. Dr. Tanguay serves as Vice Chair of HESI’s multi-sector public/private Emerging Issues Committee. A full profile by the NIEHS on Dr. Tanguay’s research and how zebrafish can reveal important insights into environmental exposures and the ways they affect biology can be found here.

This Commentary by Health and Environmental Sciences Institute Director, Dr. Syril Pettit, asserts that the challenges of realizing the systems-level changes needed to catalyze the broad-scale adoption and use of New Approach Methodologies (NAMs) may be less unique than perceived to date, and points to specific opportunities to learn from decades of experience (both positive and negative) from the Quality Improvement (QI) movement in the public health and healthcare arenas. Read the full article at the link below.

A (not) new Rx: Quality Improvement for NAM. Syril D. Pettit (February 2024). Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2023.105558

The Health and Environmental Sciences Institute Developmental and Reproductive Toxicology (HESI-DART) Committee held a hybrid in-person and virtual workshop in Washington, DC, in 2022. The workshop was entitled, “Interpretation of DART in Regulatory Contexts and Frameworks.” There were 154 participants (37 in person and 117 virtual) across 9 countries. The purpose of the workshop was to capture key consensus approaches used to assess DART risks associated with chemical product exposure when a nonclinical finding is identified.

Read the full workshop report at the link below.

HESI workshop summary: Interpretation of developmental and reproductive toxicity endpoints and the impact on data interpretation of adverse. Green et. al. (February 2024). Birth Defects Research. http://doi.org/10.1002/bdr2.2311

The HESI Immuno-Safety Technical (ITC) Committee welcomes Dr. Cara Buchanan from Wellcome Leap, who will present an overview of the immune-competent engineered human models supported by Project Hope.

Speaker Bio: As the HOPE Program Lead at Wellcome Leap, Dr. Buchanan manages a multidisciplinary program that aims to deliver scientific breakthroughs in human health by leveraging engineered human models that recreate tissue function, vascularization and immune competency. Prior to Leap, Dr. Buchanan worked in a start-up where she developed synthetic hydrogel materials for patient-derived organoids in various applications, in close collaboration with academic institutions and biotech partners. Dr. Buchanan trained as a postdoctoral fellow in lymphatic biology at the EPFL in Lausanne, Switzerland and earned her PhD in biomedical engineering from Virginia Tech in Blacksburg, Virginia, USA.

About Wellcome Leap: Wellcome Leap is a wholly owned subsidiary of the Wellcome Trust. Leap builds and executes bold, unconventional programs, funded at scale. Programs that aim to deliver breakthroughs in human health over 5 – 10 years. Such programs require multi-disciplinary, multi-ecosystem teams from universities, companies, and non-profit labs, actively led & orchestrated by a Program Director who adjusts, iterates, and directs teams working together so as to solve problems they cannot solve alone.

No registration required. Meeting link can be found on the event page here.

HESI’s Environmental Epidemiology Committee is hosting a webinar series to illustrate the critical role epidemiology can play in the field of quantitative risk assessment. The purpose of these presentations is to provide insight on how to best realize the full potential of human studies in risk assessment and regulatory decision making, and to feature ongoing efforts in this space.

Please, join us for our next webinar, presented by Dr. Charles Haas (Drexel University). Q&A session to follow.

Click HERE to Register

Abstract: Use of epidemiologic information to set recreational water criteria for microorganisms.

Exposure of people to infectious microorganisms occurs in a variety of venues and by different activities. Venues include saline, brackish and fresh natural waters, pools, spray parks, etc. Exposure may occur via inadvertent ingestion during contact (primary or secondary) recreation, impact of water on skin, and inhalation (with or without aspiration) from spray activities. There are a diversity of pathogens that may be of concern, although historically the focus has been on gastroenteric pathogens. US EPA has developed recreational criteria, with a focus on primary contact, from several epidemiological studies done since the 1970’s. This talk will review the underlying epidemiological studies used (in which microbiological indicator organisms were employed to assess water quality), and outline the data gaps that pure reliiance on epidemiological evidence has. The complementary approach of developing criteria using a quantitative microbial risk assessment (QMRA) approach will be discussed, and compared (with respect to both advantages and limitations) to the epidemiological approach, and some paths forward to fuse the two types of evidence indicated.

Speaker Bio: Charles N. Haas is the L.D. Betz Professor of Environmental Engineering, at Drexel University, where he has been since 1991. He received his BS (Biology) and MS (Environmental Engineering) from the Illinois Institute of Technology and his PhD in Environmental Engineering from the University of Illinois at Urbana-Champaign. He has served on the faculties of Rensselaer Polytechnic Institute and the Illinois Institute of Technology prior to joining Drexel. He co-directed the USEPA/DHS University Cooperative Center of Excellence Center for Advancing Microbial Risk Assessment (CAMRA). He is a distinguished fellow of the International Water Association, and a fellow of the American Academy for the Advancement of Science, the Society for Risk Analysis, the American Society of Civil Engineers the American Academy of Microbiology and the Association of Environmental Engineering and Science Professors. He is a Board Certified Environmental Engineering Member by eminence of the American Academy of Environmental Engineers. He has received the Dr. John Leal Award and the AP Black Award of the American Water Works Association and the Clarke Water Prize. In 2021, he was elected to the National Academy of Engineering. Over his career, Professor Haas has specialized in the assessment of risk from and control of human exposure to pathogenic microorganisms, and in particular the treatment of water and wastewater to minimize microbial risk to human health. Professor Haas has served on numerous panels of the National Academies of Sciences, Engineering and Medicine. He is a past member of the Water Science and Technology Board of the National Academies, and the US EPA Board of Scientific Counselors.

The HESI COMPrehensive Allergen REsource (COMPARE, http://db.comparedatabase.org/) Steering Team will meet to plan for the upcoming COMPARE 2024 review cycle.

For inquires contact Lucilia Mouriès or Liisa Koski.

A number of HESI Committees will present at the Society Of Toxicology 2024 Annual Meeting.

We would love to connect with you! Click the link below to view complete details on where you can find us!

HESI at SOT 2024: https://connect.hesiglobal.org/gNb8am

Please save the date for our second webinar in the Cardiac Safety Early Career Seminar Series on March 22nd at 11:00 am ET where Dr. Victoria Au Yueng of AstraZeneca will present Computational approaches to investigate and identify mechanisms of structural cardiotoxicity.

Bio: Dr. Victoria Au Yeung has a BSc in Biology, an MRes in Biomedical Research from Imperial College London, and a MRes/PhD in Metabolic and Cardiovascular Disease in the University of Cambridge. Dr. Au Yeung is currently a postdoctoral research fellow at AstraZeneca, where she is applying bioinformatic and machine learning approaches to multi-omics data to study mechanisms of structural cardiotoxicity.

For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org

Please join us for our final webinar in the Cardiac Safety Early Career Seminar Series on April 5th at 11:00 am ET where Dr. Alexandra Schaffert will present: Redefining Cardiotoxicity Assessment of Environmental Chemicals using Adverse Outcome Pathways.

Bio: Dr. Alexandra Schaffert is a postdoctoral researcher at the Medical University Innsbruck in Austria. She has a background in systems toxicology and her career has been focused on advancing human-relevant in vitro experimentation and reducing reliance on animal testing. Her current work under the EU H2020 Project “ALTERNATIVE” intersects regulatory science and cutting-edge toxicological research. Her efforts include investigating cardiotoxic mechanisms of environmental contaminants and developing an Adverse Outcome Pathway network for cardiotoxicity, aiming to establish an integrated approach to testing and assessment for cardiotoxicity.

For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org

The HESI Genetic Toxicology Technical Committee will be holding it’s 2024 Annual Meeting at the HESI Office from 14 – 16 April. The event will kick-off the morning of the 14th with a working group meeting of the Mechanism-based Genotoxicity Risk Assessment Nitrosamines Research Program. The Annual Meeting will officially commence after lunch on the 14th.

For registration and agenda information, please contact Connie Chen or Raechel Puglisi.

The Botanical Safety Consortium will be in attendance and presenting at the 22nd International Conference on the Science of Botanicals.

Speakers include Connie Mitchell (HESI), and committee members Cynthia Rider (NIEHS), Amy Roe (P&G), Bill Gurley (University of Mississippi), and Holly Johnson (AHPA).

The HESI Developmental and Reproductive Toxicology Committee will be meeting for two half-days virtually for their Spring meeting. Please contact Connie Chen or Shermaine Mitchell-Ryan for any questions or if you would like to attend.

The Next Generation Ecological Risk Committee will be presenting at SETAC Europe.

Session: Alternatives to Animal Testing for Ecotoxicity Assessments: Exploring Approaches and Avenues for the Future.
Connie Mitchell (HESI) is co-chairing along with HESI Board of Trustees member Adam Lilicrap (NIVA) and Eco-Risk Committee members, Teresea Norberg-King (retired from US EPA) and Kristin Schirmer (EAWAG).

The Transforming the Evaluation of Agrochemical (TEA) Committee will present at the 22nd International Congress of the European Society of Toxicology In Vitro (ESTIV) taking place 3-6 June 2024.

Details will be added to the event page here.

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.

HESI THRIVE is a seed grant program that is innovating translational research and improving quality of life after cancer. By providing researchers with both seed funding and access to critical networks, THRIVE enhances the visibility of the patient need, the value of the research, and the reasons that larger funding entities might elect to incorporate these research streams into future funding priorities.

THRIVE provides seed grants for clinical and translational research and technology-based solutions that enhance our ability to predict when and how adverse effects may occur in patients who have received cancer treatment. The THRIVE grant program is designed to provide seed funding to investigators for the testing of initial hypotheses and collecting of preliminary data to help secure long-term funding by the National Institutes of Health (NIH) and/or other major institutions. For details on eligibility, funding, the application process, and key deadlines, please click here.

THRIVE will accept letters of intent from 13 November 2023 until 8 April 2024.

For more information, contact research@hesithrive.org.

It’s a busy time of year for scientific meetings, and so much of what I am hearing about is focused on AI/machine learning and New Approach Methodologies (NAMs). Here at the 2024 Arkansas Bioinformatics Consortium (AR-BIC) meeting, I had the fascinating experience of being introduced before my talk by an Avatar of Dr. Weida Tong (FDA, NCTR) reading a script written by ChatGPT! Aside from the unconventional introduction, this fascinating meeting focused on real world use of AI, including ethics and trust. I presented some of the HESI NAMs work, including use of MEA to detect seizure. I also took the opportunity to share the HESI NAMs resources and our great collaborations with the NC3Rs.

We have a couple of excellent presentations coming up from our Cardiac Safety Early Career Seminar Series Awardees. First, Dr. Victoria Au Yueng (AstraZeneca) will address ‘Computational approaches to investigate and identify mechanisms of structural cardiotoxicity’ March 22nd and then Dr. Alexandra Schaffert will address ‘Redefining Cardiotoxicity Assessment of Environmental Chemicals using Adverse Outcome Pathways’ April 5th. We encourage all of you to sign up (cardiacsafety@hesiglobal.org) and listen to these excellent early career researchers.

Following the AR-BIC 2024, it will be time for SOT 2024, and we have many HESI committees presenting, as described in this edition of Insights. SOT is a great opportunity for us all to scan for new science and generate ideas for emerging issues and for new collaborations. Beyond SOT, we encourage all of you to take the HESI message on NAMs, collaborations and great new science into all your meetings, networks and events.

With best regards,

Ruth Roberts, PhD, FRSB, FRCPath, Chair of HESI Board