HESI Insights - October 2021

The HESI Genetic Toxicology Technical Committee (GTTC) is launching several new projects and working groups, outlined below.

• Historical Control Distribution Working Group: This group will focus on identifying consistent approaches for compiling, maintaining, and monitoring historical control ranges agreed upon by consensus across testing laboratories, industry, and regulators. The results of this working group will feed into next year’s International Workshop on Genotoxicity Testing meeting.
• Mechanism-Based Genotoxicity Risk Assessment Working Group: This newly formed group will continue developing a new mechanism-based risk assessment paradigm for genotoxicity by building on the Clean Sheet approach and using genetox AOPs to develop case studies and launch a series of workshops.
• Quantitative Analysis GeneToxPi Project: The Quantitative Analysis Working Group has been exploring use of the ToxPi concept for interpretation of genotoxicity dose-response (DR) data, employing BMD analyses and the ToxPi methodology to generate a GeneToxPi score that facilitates hazard profiling and MOA determination. The group will develop and refine a foundation for application of the ToxPi concept to interpretation to complex, multi-endpoint genotoxicity DR data. The work will contribute to eventual establishment of the GeneToxPi approach for routine use of genotoxicity NAMs DR data for chemical prioritization and regulatory decision-making.

Please contact Connie Chen (cchen@hesiglobal.org) or E’Lissa Flores (eflores@hesiglobal.org) with any questions or if you want to get involved with any of these new projects!

Earlier this month, the first two sessions of a four-part online RISK21 training course were held with the Colombian Ministry of Health (Ministerio de Salud). Dr. Eliana Munarriz (University of Buenos Aires, HESI Board of Trustees) conducted the training course in Spanish, with the support of Drs. Lady Jhoana Dominguez Majin (Colombian Ministry of Health), Michelle Embry (HESI), and Sandrine Deglin (HESI). Over 30 employees of the Ministry of Health attended each session. The course covered risk assessment basics, the principles of the RISK21 approach, an introduction to the roadmap, as well as the RISK21 matrix and RAFT tool. After the first course, attendees were asked to independently work on case studies illustrating the needs for problem formulation and to present conceptual models built using the RAFT tool. Future sessions will engage participants via hands-on case studies relevant to the current needs of the ministry, such as the prioritization of contaminants in drinking water. They will also demonstrate how RISK21 could be the tool of choice in helping the ministry prioritize efforts and resources while making drinking water safer.

A recording of the first day of the workshop is available here. To learn more about the HESI RISK21 Committee, please contact Michelle Embry (membry@hesiglobal.org) or Sandrine Deglin (sdeglin@hesiglobal.org).

Dr. Syril Pettit, HESI Executive Director, was recently featured on the Caring Greatly podcast to discuss how advances in cancer treatment have increased survivorship but have also resulted in patients living long enough to experience the long-term side effects of both primary and adjuvant therapies. On the podcast, Dr. Pettit discusses supporting research and innovation that can bridge the interests and inputs of patients, life sciences firms, academic medicine, clinicians, and public health to reach a future of survivorship that supports all aspects of patients’ health and well-being.

Learn more about the Caring Greatly podcast and listen to Dr. Pettit’s episode here.

HESI Scientific Program Manager, Connie Mitchell, gave a platform presentation at the Society of Medicinal Plant and Natural Product Research (GA) 2021 Virtual Meeting last month. Her talk, titled “The Botanical Safety Consortium: A Public-Private Partnership to Enhance the Botanical Safety Toolkit,” included updates on the Botanical Safety Consortium (BSC)’s progress and future plans as well as current research on botanical toxicity testing.

To learn more about the BSC or to get involved, click here or contact Connie Mitchell (cmitchell@hesiglobal.org).

The HESI Cardiac Safety Committee is excited to announce that applications are now being accepted for the committee’s new Early Career 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 members 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.

Meet Gina Menna, the recipient of the 2021 DARTable Genome Quantitative AOP Internship.  This professional development award is one component of a newly developed and multi-faceted HESI Developmental and Reproductive Toxicology (DART) Committee initiative to train and mentor the next generation of DART scientists.

Gina is a PhD Candidate in Developmental Toxicology and Alternative Test Methods under the tutelage of DART Committee member, Dr. Aldert Piersma, at the National Institute for Public Health and the Environment (RIVM, The Netherlands). Her current research focus is on the Embryonic Stem Cell Test and selecting biomarkers to predict embryotoxicity within chemical classes.

Gina shares, “Protecting human health is better than curing the disease. I love to do this by keeping humans safe and understanding the biology is part of that. During my PhD in Developmental Toxicology and Alternative Test Methods, I have already learned a lot about the importance of the retinoic acid balance in cardiomyocyte development. I am very motivated in bringing this to the next level by generating an AOP on retinoic acid and cardiac development.”

If you are interested in learning more about the DARTable genome project, please contact Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org).

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. This year, we have expanded this opportunity to accept international applications, broadening our reach and heightening the visibility of this important research area. For details on eligibility, funding, the application process, and key deadlines, please click here.

THRIVE will accept letters of intent starting 18 October 2021, and the letters of intent deadline is 10 January 2022. For more information, contact research@hesithrive.org.

Every month, the HESI Environmental Epidemiology Committee is hosting webinars illustrating 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). In September, after a summer hiatus, Dr. Julie Goodman (Gradient) presented “A Case for Good Epidemiology Practice Guidelines for Regulatory Risk Assessment” (the presentation is available here).

The next webinar in the series will be held on 21 October 2021 from 1:00PM – 2:00PM EST. Dr. Scott Bartell (University of California, Irvine) will provide a presentation on “Understanding the Replication Crisis and Its Implications in Epidemiology.” The presentation will be followed by a Q&A session. For more information, read the presentation abstract and learn more about the speaker 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).

Dr. Syril Pettit, HESI Executive Director, will be participating in the American Association of Pharmaceutical Scientists (AAPS) 2021 PharmSci 360 session titled “Navigating Non-Traditional Scientific Careers: From Bench to Board Room.” The session will focus on the pathways of successful professionals who started as bench pharmaceutical scientists but navigated their careers using non-traditional pathways and utilized their skillsets to build effective careers. The hybrid meeting will be held both virtually and in Philadelphia, PA on 17-20 October 2021, and the “Navigating Non-Traditional Scientific Careers” session will be available for attendees on-demand.

Learn more and register here.

Raechel Puglisi, MPH, will be presenting on behalf of the HESI Collaboration on Ototoxicity Risk Assessment (CORA) to the American Petroleum Institute (API) on 16 November 2021. She will be presenting on the current state of the science regarding ototoxicity, CORA’s current program status, and will discuss future goals of the committee with the API membership and US Military.

To learn more about CORA, please contact Raechel Puglisi (rpuglisi@hesiglobal.org) or Jennifer Pierson (jpierson@hesiglobal.org).

Jon C. Cook, PhD, ABT, DABT
HESI President