HESI Insights - July 2023

Congratulations to the 2023 Developmental and Reproductive Toxicology (DART) Committee Professional Development Award recipients! Each recipient received a $2000.00 USD award to support attendance at relevant scientific conferences, workshops, training courses, or another related opportunity that contributes to professional development. Read more about the awardees here.

Mackenzie Connell, PhD Student
University of Florida, Florida, USA
Public and Environmental Health
Area of focus: Environmental stressors that affect organisms during critical reproductive windows

Madeline Vera-Colón, PhD Candidate
UC Irvine, California, USA
Environmental Health Sciences
Area of focus: The effect of environmental toxins on osteogenic differentiation

Congratulations to the Spring 2023 GTTC Professional Development Award recipients. Each recipient will receive a $1000 USD award to support attendance at relevant scientific conferences, workshops, training courses or other related opportunities that contributes to their professional development. They will also receive an invitation to attend the 2024 GTTC Annual Meeting, where they will be able to further learn about how to engage in committee activities and expand their professional network through interactions with committee members.

• Tony Okeke, Drexel University
• Ammer Khawam, McGill University
• Natalia Bertolez, University of Coruna
• Sarah Park, Oak Ridge, US EPA
• Victoria Bastos, Maastricht University
• Alper Alcarez, NIEHS
• Idoia Meaza Izusi, University of Louisville

See past winners on the GTTC webpage here.

Our wonderful (and growing) staff are a huge part of what sets HESI apart. I hope you will join us in recognizing every single staff member for their expertise, skill, leadership, creativity, and grit in pushing HESI ever forward!

We are excited to report that amongst all this excellence, we also have two promotions to announce this year. Special congratulations to:

Connie Mitchell, MS – Promoted to role of Senior Scientific Program Manager. Connie has done a fantastic job in her scientific and strategic co-leadership of the complex eSTAR, Botanical Safety, and EcoRisk committees. She serves as an author, speaker, advocate, and strategist for her programs and is a big asset to the organization. Congrats to Connie for this well-deserved recognition of her skills!

Raechel Puglisi, MPH – Promoted to role of Scientific Program Manager. Raechel started with HESI as a grad student intern, finished her graduate work, moved on to be a Program Associate and is now fully fledged! Raechel has supported multiple programs in her time with HESI, but more recently has skillfully stepped into significant managerial roles with our Genetox and Ototox programs. Congrats to Raechel for making this big step forward and we are thrilled to work with her in this new capacity.

In response to the increase use of novel anti-viral drugs for COVID, experts from our Botanical Safety Consortium have put out a review article that presents data on regionally relevant herbal medicine use that have the potential for herbal medicine interaction (HDI). This work highlights potential areas for future experimental studies and data collection, identifies herbal medicines for inclusion in future listings of regionally diverse potential HDIs, and underscores areas for low- and middle-income countries (LMIC)-focused provider-patient communication. This overview is presented to support governments and health protection entities as they prepare for an increase of availability and use of PaxlovidTM. Read the full paper at the link below.

Potential pharmacokinetic interactions with concurrent use of herbal medicines and a ritonavir-boosted COVID-19 protease inhibitor in low and middle-income countries. Dallas J. Smith, Huichang Bi, Josias Hamman, Xiaochao Ma, Constance Mitchell, Kumbukani Nyirenda, Tsitsi Monera-Penduka, Hellen Oketch-Rabah, Mary F. Paine, Syril Pettit, Wihan Pheiffer, Richard B. Van Breemen and Michelle Embry. Frontiers in Pharmacology. https://doi.org/10.3389/fphar.2023.1210579

On June 13-14, Dr. Ali Hamade (Oregon Health Authority) attended the Annual Meeting of the Society of Epidemiological Research in Portland Oregon, and presented a poster titled “Improving the integration of epidemiological data into human health risk assessment: What risk assessors told us they need”, summarizing the results of the Risk Assessors Survey designed and deployed by the Environmental Epidemiology Committee.

Dr. Michelle Embry served as teaching faculty in a training course on Environmental Toxicology in Ulaanbaatar, Mongolia, organized by the Ministry of Environment and Tourism, Mongolia with collaboration and support from the Chulabhorn Research Institute, Thailand. The Course Director was Professor Dr. Her Royal Highness Princess Chulabhorn Mahidol, President of the Chulabhorn Research Institute, Bangkok, Thailand. The course was attended by 46 participants representing the Mongolia Ministries of Environment and Tourism, Foreign Affairs, and Health; Representatives from the 21 Mongolian provinces; National Center for Public Health of Mongolia; Central Laboratory of Environment and Meteorology; Institute of Chemistry and Chemical Technology, Mongolian Academy of Sciences; Mongolian University of Life Sciences; and the National Reference Laboratory for Food Safety.

The course was designed to provide participants with a background on environmental toxicology and risk assessment and was taught by eight teaching faculty, including Professor Martin van den Berg (HESI Board of Trustees) and Professor Herman Autrup (former HESI Board of Trustees). Dr. Embry gave 5 lectures on ecological risk assessment, with a focus on exposure, bioavailability, and ecotoxicity for both organic chemicals and metal, with an ecological risk case example to provide participants with a real-world illustration of how one might integrate the various principles.

HESI DART science advisor Dr. Steven van Cruchten (Antwerp University) was a featured speaker in the “Applications of New Approach Methods in Developmental and Reproductive Toxicology Symposium” on 28 June 2023. His talk “How to Gain Confidence for Using NAMs in the Regulatory Arena of DART Testing” highlighted committee work. For anyone wanting to learn more about DART committee activities, contact Drs. Connie Chen and Shermaine Mitchell-Ryan.

HESI CT-TRACS committee members, Prof. Simon Reed and Dr. Felix Dobbs, and HESI Senior Scientific Program Manager, Lucilia Mouries, attended the CASSS Cell & Gene Therapy Symposium in Bethesda, Maryland.  The Cell and Gene Therapy Products Symposium enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products. HESI CT-TRACS committee was invited to present their work on the evaluation of new emerging NGS methodologies for the detection of off-target mutations after genome editing of cell therapy products. Prof. Simon Reed (Cardiff University) presented preliminary results from this collaborative project. Dr. Felix Dobbs (Broken String), and HESI Senior Scientific Program Manager, Dr. Lucilia Mouriès, were also in attendance.

The HESI Next Generation Ecological Risk Assessment Committee hosted a webinar by Dr. Jochen Zubrod of Zubrod Environmental Data Science who presented ongoing research related to machine learning & species sensitivity. A webinar recording is available here.

Dr. Michelle Embry served as teaching faculty in a training course on Environmental Toxicology and Health at the Chulabhorn Research Institute, Thailand. The course was attended by 37 international participants from 18 countries (Bhutan, Brunei, Cambodia, Egypt, Eritrea, India, Indonesia, Kenya, Laos, Malaysia, Maldives, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, Thailand, and Vietnam). Twelve Chulabhorn Graduate Institute Students also participated in the course from various departments (Environmental Health and Environmental Toxicology).

The course was designed to provide participants with a background on environmental toxicology and risk assessment and was taught by seven teaching faculty, including Professor Martin van den Berg (HESI Board of Trustees) and Professor Herman Autrup (former HESI Board of Trustees). Dr. Embry gave four lectures on ecological risk assessment and led a journal club discussion.

A HESI Botanical Safety Consortium workshop on Current Topics in Botanical Safety will be held Saturday, 22 July from 1:30 – 4:30pm at the 2023 American Society of Pharmacognosy Annual Meeting in Rockville, Maryland. Workshop details can be found here.

Dr. Sandrine Deglin will highlight the work of the Environmental Epidemiology Committee in a presentation titled “Application of Environmental Epidemiology in Risk Assessment and Decision-Making: Past and Ongoing HESI Projects”. This presentation will be part of a session proposed by HESI’s Environmental Epidemiology Committee co-chair, Mr. David Miller, and titled “Epidemiology: A Growing Field in Agrochemistry and Agrochemical Regulation.” (Session information: 2pm – 6pm, Room 3022, West Bldg. [Moscone Center])

View the meeting website here.

Several HESI programs will be featured throughout the meeting:

• The HESI Botanical Safety Consortium Genotoxicity Technical Working Group will have a poster presentation entitled “A Strategy for Developing a Robust Framework of Genotoxicity Assays for Safety Assessment of Botanicals”
• Dr. Alexandra Long (Health Canada) will give an oral poster “In Vitro-In Vivo Extrapolation (IVIVE) of Genetic Toxicity New Approach Methodology (NAM) Data: A HESI-GTTC Case Study” during Platform 1: Modern in vitro genetox screening and data modeling, 10th September 2023, 9:45am – 11:45am.
• The GTTC’s ecNGS working group reconstruction experiment will be highlighted during Symposium 14: Ongoing validations of TGR tech transfer and bridging studies from TGR to ecNGS on Wednesday, 13 September 2023, 1:15 – 3:15pm.
• The HESI CT-TRACS committee will be featured in a full day session on “Evaluating genotoxic potential of genome editing for therapeutic use” on Tuesday Sept. 12th, with a presentation entitled “Induce-Seq followed by Duplex-Seq for identification and confirmation of CRISPR-Cas9 off-targets- A HESI CT-TRACS supported project”.

View the meeting website here.

The HESI Global Risk Assessment Training Center (GRATC) will be attending SETAC Latin America’s 15th Biennial Meeting in Montevideo, Uruguay. Michelle Embry (HESI) will give a presentation on Ecological NAMs and Eliana Munarriz (University of Buenos Aires) will provide an overview of RISK21.

• The HESI Botanical Safety Consortium DART Technical Working Group will present a poster.
• The HESI DART Extended One- Generation Reproduction Toxicity Study (EOGRTS) will have a Symposium that will cover (1) Critical aspects for designing and conducting EOGRTS under REACH (2) ECHA’s Review of EOGRTS for EU REACH and their impact, including Case Study examples (3) International Positions, Perspectives and Challenges in Utilizing the EOGRTS in Regulatory Decisions for Industrial and Agrochemicals and (4) EOGRTS and the Endocrine Relevant Outcomes for Neurodevelopmental Effects.

View meeting website here.

The HESI UVCBs and Multi-Constituent Substances Committee would like to invite you to attend an engaging two-day workshop in Reykjavik, Iceland to explore the complexities of UVCBs for testing and risk assessment. This workshop will bring together scientist from government, academia and industry to help develop solutions for assessing these substances. Access the agenda and register here.

Members of the public sector are encouraged to contact Sandrine Deglin (sdeglin@hesiglobal.org) or Julie Krzykwa (jkrzykwa@hesiglobal.org) to discuss potential travel funding opportunities

The HESI Botanical Safety Consortium Cardiotoxicty Technical Working Group will present a poster at the 2023 Safety Pharmacology Society Annual Meeting in Brussels, Belgium. View details here.

The HESI Botanical Safety Consortium 2023 Annual Meeting will be held virtually on Thursday, September 28, 2023 from 8:00 – 4:00 (US Eastern). The meeting is free and open to all. View the agenda and register now on the BSC webpage here!

The HESI DART committee is organizing a Fall workshop which will focus on applications of DART principles to fit attributes of antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs) and other oligonucleotide therapeutics and highlight gaps and challenges associated with determining the most appropriate strategies to account for potential risk to a varied patient population and spectrum of disease conditions. Considerations unique to oligonucleotide therapeutics for DART evaluations that will be discussed include mechanism of action/target engagement, dosing schedule, toxicokinetics and biodistribution, and species or model selection and validation. Speakers will represent institutions actively working in oligonucleotide therapeutic development and will deliver case study examples to illustrate various DART considerations. However, most of this workshop will be reserved for discussion rather than presentation. Reviewing existing DART strategies and initiating discussion on how to address gaps and challenges will help advance the field toward a fit for purpose and robust characterization of DART risk for this class of compounds. Registration will open later this summer. For more information, please visit the event page (here) or contact Connie Chen.

HESI’s Global Risk Assessment Training Center (GRATC) was initiated at the end of 2021 with the aim of increasing access to and availability of foundational chemical risk assessment capacity building, training, and resources, particularly in low and middle-income and resource-limited regions. I have been working very closely with three HESI Board of Trustee Members – Drs. Eliana Munarriz, Martin van den Berg, and Rose Omari – to identify opportunities and create partnerships to help realize this mission and build an impactful program. There has been a lot of activity in the short 18 months that this program has existed, many of which have been highlighted in past issues of Insights and will be up on a new GRATC website in September (stay tuned!).

I just returned from a two-week trip that took me to Ulaanbaatar, Mongolia, where I was honored to join an esteemed group of faculty teaching an Environmental Risk Assessment course with the Chulabhorn Research Institute. I valued the opportunity to learn about a new area of the world – their culture, climate, ecosystems, economy, and environmental challenges – and to explore areas of common interest. As GRATC continues to grow and mature, I look forward to reaching additional audiences and areas of the world, identifying spaces where HESI’s great work can have an even broader impact.

Kind regards,

Michelle Embry, PhD
HESI Deputy Director