HESI Insights - September 2021

The HESI DART Committee DARTable Genome Workgroup recently received the first external government-supported grant from the Belgian Federal Public Service (FPS) Health, Food Chain Safety and Environment to develop a provisional AOP wiki on retinol dehydrogenase/retinaldehyde dehydrogenase (RDH/RALDH) and cardiovascular developmental defects. For more information on the project, please contact Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org).

The HESI Cardiac Safety Committee is excited to announce that applications are now being accepted for the committee’s new Postdoctoral Seminar Award Series. This award offers an opportunity for postdocs to share their research, learn from, and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies, and pharmaceutical companies. Selected candidates will receive a $500 USD award and will be invited to present their research on a public webinar with Cardiac Safety Committee scientists and other invited guests. Webinar dates will be scheduled with the awardees in Q1 2022.

The deadline to apply is 1 November 2021. Click here to learn more and click here to download the application form.

The Botanical Safety Consortium (BSC) recently hosted a Stakeholder Webinar on 24 August 2021. The webinar, titled “St. John’s Wort (Hypericum perforatum) Products: How Variable Is the Primary Material,” was presented by Dr. Michael Heinrich, University College London School of Pharmacy, and was attended by over 60 people.

Want to attend a future BSC webinar? Become a BSC Stakeholder here. Want to suggest a future topic related to botanical safety, botanical constituent analyses, or new approach methodologies for mixtures? Please email Connie Mitchell (cmitchell@hesiglobal.org) or Michelle Embry (membry@hesiglobal.org).

This year, HESI launched the inaugural HESI Innovation Prize to recognize an exceptional scientist who has helped to advance health equity and who shares HESI’s commitment to creating a safer, more sustainable world through innovative collaborations. Congratulations to the 2021 HESI Innovation Prize awardee, Dr. Kenneth Olden!

Dr. Olden most recently served as Director of the US Environmental Protection Agency (EPA) Center for Public Health and Environmental Assessment. He has had an immeasurable impact on the field of health equity and has a strong legacy of promoting excellence in environmental health research and chemical risk assessment.

Dr. Olden shared, “It is a great honor to be recognized by such a distinguished panel of experts and noble organization. While my name is associated with the award, the body of work for which the award is given could not have been achieved without the support of the outstanding and dedicated scientists who offered sage advice and were willing to engage lay members of affected communities as co-equals in creative ways. I am particularly pleased that HESI recognizes that the work to achieve environmental equity is still far from complete, and that they are willing to lend their prestige and financial resources to highlight and advance the field.”

Throughout his leadership roles at the National Institute of Environmental Health Sciences (NIEHS), National Toxicology Program (NTP), and US EPA, Dr. Olden is most pleased with the success in expanding the scope of environmental health research to include social determinants of health. This involved community outreach, education, and community-based participatory research.

Dr. Olden continues to provide intellectual and practical leadership to his ground-breaking collaboration with a research team he organized at the EPA, Duke University, and the University of North Carolina. The team is working to examine his hypothesis that one can use neighborhood-specific epigenetic signatures to quantify the cumulative effects of exposure to both chemical and non-chemical stressors over the life course.

HESI is proud to award the inaugural HESI Innovation Prize to Dr. Kenneth Olden. Congratulations, Dr. Olden! Learn more about the HESI Innovation Prize here.

On 18 August 2021, an online RISK21 Workshop was held at the National University of San Martín in Buenos Aires, Argentina. Dr. Eliana Munarriz (University of Buenos Aires, HESI Board of Trustees) conducted the workshop, which was held in Spanish, with the support of Drs. Michelle Embry and Sandrine Deglin. The attendees were students in a Toxicological Risk and Environmental Pollution Assessment Postgraduate Specialization and were from the government and private sectors. The 5-hour course covered the principles of the RISK21 approach, an introduction to the roadmap, and the visualization matrix and webtool. Hands-on case studies were used, and students debated the uses of the RISK21 webtool in risk management and communication.

To learn more about the HESI RISK21 Committee, please contact Michelle Embry (membry@hesiglobal.org) or Sandrine Deglin (sdeglin@hesiglobal.org).

Please join us for an upcoming webinar co-organized by HESI, Eawag, and AquaTox Solutions on 16 September 2021 from 9:00AM – 10:00AM EST. The RTgill-W1 cell line assay has recently been adopted by OECD, marking the first in vitro-based test guideline in ecotoxicology. This assay, set up to forecast acute fish toxicity, has been developed under the leadership of the team of Prof. Kristin Schirmer at Eawag, the Swiss Federal Institute of Aquatic Science and Technology, with the support of numerous collaborators around the globe. In this webinar, the assay will be introduced and its advantages and limitations as well as potential future applications and developments will be discussed.

Click here to register.

The HESI Immuno-Safety Technical Committee (ITC) Education & Outreach Workgroup is hosting a career webinar on 16 September 2021 from 11:00AM – 12:00PM EST to increase awareness about careers in the immuno-safety and immuno-pharmacology fields. The webinar has a target audience of graduate students, post-docs, and early career scientists, and will allow for meaningful Q&A interactions between the audience and speakers to give insight on their respective career pathways.

Registration is free – learn more and register.

The Botanical Safety Consortium (BSC), Genetic Toxicology Technical Committee (GTTC), and Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee will present their work at the Environmental Mutagenesis and Genomics Society (EMGS) 2021 Virtual Annual Meeting on 15-25 September 2021.

Wednesday, 15 September 2021
3:00PM EST
Genotoxicity Risk Assessment and Public Health SIG Meeting

• Genetic Toxicology Technical Committee (GTTC) and Botanical Safety Consortium (BSC)
• Presenters: Stephanie Smith-Roe, NIEHS/Division of the National Toxicology Program (NTP), and Stefan Pfuhler, Procter & Gamble
• Note: This meeting is open to the public and you can register using this link

Tuesday, 21 September 2021
11:40AM – 11:45AM EST
Poster Session Q&A – PS34
Optimal Design of In Vivo Studies Employed for Quantitative Assessment of Genotoxicity

• Genetic Toxicology Technical Committee (GTTC)
• Presenter: Alexandra Long, University of Toronto

Wednesday, 22 September 2021
10:35AM – 10:40AM EST
Poster Session Q&A – PS59
The Botanical Safety Consortium’s Strategy for Developing a Toolkit of Assays for Robust Genotoxicity Assessments of Botanicals

• Botanical Safety Consortium (BSC)
• Presenter: Kristine Witt, NIEHS/Division of the National Toxicology Program (NTP)

Friday, 24 September 2021
12:15PM – 1:45PM EST
Symposium 04
Interpretation of Genotoxicty Dose-Response Information in a Human Health Context

• Genetic Toxicology Technical Committee (GTTC)
• Presenter: Marc Beal, Health Canada, In Vitro to In Vivo Extrapolation Incorporating Toxicokinetics
• Presenter: Robert Heflich, US FDA National Center for Toxicological Research, Effect of Animal Life-Stage on Chemically-Induced Mutagenicity
• Presenter: Paul White, Health Canada, Quantitative Interpretation of In Vivo Mutagenicity Dose-Response Data: UFs for Calculation of Human Exposure Limits

Saturday, 25 September 2021
4:10PM – 4:30PM EST
Symposium 07
Development and Application of Genomic Approaches to Evaluate Human Cancer Risk

• Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee
• Presenter: Chris Corton, US Environmental Protection Agency (EPA), Towards Reduction and Replacement of the 2-Year Rodent Bioassay Using Genomic Approaches: Update from eSTAR and Impact on ICH S1

Earlier this year, the HESI Environmental Epidemiology Committee launched a webinar series to illustrate the critical role that epidemiology can play in the field of quantitative risk assessment. In March 2021, Prof. Harvey Checkoway (University of California San Diego) kicked off the series with a presentation titled “The Contributions of Environmental Epidemiologic Research to Causal Attribution and Risk Assessment” (the presentation recording is available here). This presentation was followed in April with a joint presentation by Drs. Omobola Mudasiru (American Petroleum Institute), Dana Sargent (Bayer Crop Science), and Sandrine Deglin (HESI), on the ongoing efforts from their respective organizations to increase the impact of epidemiology in the field of risk assessment (the presentation recording is available here).

The next webinar in the series will be held on 23 September 2021 from 1:00PM – 2:00PM EST. Dr. Julie Goodman (Gradient) will make “A Case for Good Epidemiology Practice Guidelines for Regulatory Risk Assessment.” The presentation will be followed by a Q&A session. For more information, read the presentation abstract and speaker bio here.

To register for this webinar, please click here. To learn more about the Environmental Epidemiology Committee or the webinar series, or to suggest speakers, please contact Sandrine Deglin (sdeglin@hesiglobal.org).

The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar on 28 September 2021 from 10:00AM – 12:00PM EST featuring three speakers who will share regulatory perspectives from both sides of the Atlantic.

• Regulatory Considerations for Preclinical Development of Cell-Based Therapies, Learnings for the Future – Tineke van den Hoorn, PhD, Medicines Evaluation Board, The Netherlands
• Preclinical Considerations for Cellular Therapies, A CBER/FDA Perspective – Kate Dabirsiaghi, VMD, MS, MA, US Food and Drug Administration (FDA), CBER/OTAT
• Case Study, nTRACK Project – Utilizing Nanoparticles for Cell Tracking; Lessons Learned From the Regulatory Process in the EU – Marta Rayo Lunar, BSc Pharm, Asphalion, Spain

This activity is party of the CT-TRACS Committee’s efforts to continue filling the knowledge gap about methods that can assess the fate of therapeutic cells and/or can help the timely identification of eventual unexpected effects while highlighting the regulatory component of these endeavors.

This webinar is co-organized by the European Infrastructure for Translational Medicine (EATRIS) and the HESI CT-TRACS Committee and will be open to the public. Participants in the audience will have the opportunity to ask questions through the webinar platform. To learn more about this webinar and to register, please click here.

To learn more about the CT-TRACS Committee or to suggest topics for future webinars, please contact Lucilia Mouries (lmouries@hesiglobal.org).

The HESI Immuno-Safety Technical Committee (ITC) and Translational Biomarkers of Neurotoxicity (NeuTox) Committee will present their work at the EUROTOX Virtual Congress 2021 on 28-30 September 2021. Additionally, Dr. Syril Pettit, HESI Executive Director, will participate in the EUROTOX/SOT Debate as the SOT Debater on 28 September 2021 and Dr. Jason Cannon, Purdue University, will present a HESI CITE Lecture on 1 October 2021.

Tuesday, 28 September 2021
1:00PM – 2:00PM BST
EUROTOX/SOT Debate

• SOT Debater: Syril Pettit, HESI Executive Director

Tuesday, 28 September 2021
2:00PM – 4:00PM BST
Session 28 – Symposium
Preclinical Immune-Safety Evaluation of Immuno-Oncology Therapies

• HESI Immuno-Safety Technical Committee (ITC)
• Chair: Curtis Maier, GlaxoSmithKline
• Presenter: Hervé Lebrec, Amgen

Wednesday, 29 September 2021
2:00PM – 4:00PM BST
Session 14 – Symposium
New Approaches Using In Vitro Assays and 3D Models Can Improve Prediction of Immune Reactions to Xenobiotics

• HESI Immuno-Safety Technical Committee (ITC)
• Chair: Marc Pallardy, Université Paris-Saclay

Thursday, 30 September 2021
2:00PM – 4:00PM BST
Session 19 – Workshop
Can We Panelize Seizure?

• HESI Translational Biomarkers of Neurotoxicity (NeuTox) Committee
• Chairs: Ruth Roberts, ApconiX, and Jennifer Pierson, HESI

Friday, 1 October 2021
1:00PM – 2:00PM BST
HESI CITE Lecture
Linking Primary Mechanisms of Environmentally Induced Neurotoxicity to Human Neurological Disease Relevance

• Presenter: Jason Cannon, Purdue University

Metrics. Impacts. Outcomes. We all want to document the way in which our programs help to achieve HESI’s mission of science for a safer, more sustainable world. Within our Annual Report, for example, we capture the way in which specific programs move the needle on our core strategic impact areas. We also use the long-standing, albeit imperfect, metric of publications and citations (see here and here).

This past week, we hosted a virtual outreach event on “Translating Science Into Real-World Applications via Cross-Sector Collaborations” with our colleagues in the University of Ottawa and Carleton University’s Chemical and Environmental Toxicology joint program. The goal of the meeting was to introduce a new cadre of faculty and students to HESI’s programming and to discuss how and why to get involved with personal perspectives offered by active HESI volunteer members (both government and academic) about what participation in HESI has meant to them. They commended the value of the scientific programs to global human and environmental health – and that was great to hear. But what was incredibly striking, and personally touching, were comments about the profound ways participation in HESI programs impacted them individually. We heard phrases like “I couldn’t be more grateful for my involvement in HESI. It has had a huge positive impact on my career.” “HESI is an unparalleled networking opportunity.” “HESI has had beneficial impacts not only on my career, but has also provided positive benefits to my students through the opportunities it offers.” It was thrilling and invigorating to hear such affirmative comments and to receive such resounding endorsements from early, mid, and later career scientists who have chosen to volunteer their time as part of HESI programming. Thank you to all who participated in this session and who have been such great supporters of HESI. We couldn’t be prouder to have you as part of our HESI family and to know that your efforts have helped to develop your professional and personal growth as well.

If you would like to learn more about participating in or setting up this type of session at your academic or research institution, please contact us at cnobles@hesiglobal.org.

Syril D. Pettit, DrPH, MEM
HESI Executive Director