HESI Insights - June 2021

In response to the ongoing COVID-19 pandemic, HESI successfully held its second virtual Annual Meeting earlier this month. Nearly 150 attendees tuned in as speakers discussed the impact of the COVID-19 pandemic on the future of safety assessment as well as new scientific programming at HESI. The Annual Meeting included featured presentations by Dr. Larry Updyke (Pfizer, Inc.), Dr. Frederic Béen (KWR Water Research Institute, The Netherlands), Dr. Simon Funnell (Public Health England/World Health Organization), and Dr. Meytal Avgil Tsadok (Deloitte Israel/Israeli Ministry of Health) moderated by Dr. Donna Rivera (US FDA Oncology Center of Excellence). We thank those of you who were able to join us for the 2021 HESI Annual Meeting to support science for a safer, more sustainable world.

If you were unable to attend the 2021 HESI Annual Meeting and would like to learn more about scientific programming at HESI, click here.

The HESI Bioaccumulation Committee is coordinating an ongoing webinar series related to the advancement of toxicokinetics and bioaccumulation science to aid ecological and human health risk assessment. The purpose of these webinars is to share ongoing developments in the field, highlighting research, application, and needs from various stakeholders. We welcome suggestions for additional webinar topics and/or speakers within this series. Submit recommendations here.

Join the Bioaccumulation Committee for the next webinar within the series on 24 June 2021 from 9 AM to 10:30 AM EST. The webinar, titled “New QSARs for Key Toxicokinetic Parameters in Mammals,” will include a demo of new software for predicting in vitro biotransformation rates in mammals including new QSARs validated following OECD guidance for applications in regulatory decision-making. Register for the webinar here.

The Bioaccumulation Committee has developed a survey to solicit feedback on program activities. The purpose of this survey is to identify key areas of focus for the committee to evaluate and potentially address. We would greatly appreciate your input – please access the survey here. For more information, contact Michelle Embry (membry@hesiglobal.org) or Sandrine Deglin (sdeglin@hesiglobal.org).

Version 2.0 of the Bioaccumulation Assessment Tool (BAT) is now available! The BAT facilitates the systematic and transparent integration of information in a consistent framework to inform bioaccumulation assessment decision-making. The BAT is a user-friendly, spreadsheet-based tool to guide the collection, generation, evaluation, and integration of various lines of evidence for aquatic and air-breathing (mammalian) organisms. BAT Version 2.0 is now freely and publicly available for download at the ARC Arnot Research and Consulting website.

Apply now for the inaugural HESI Innovation Prize – an unrestricted cash prize of $80,000 USD. In 2021, the HESI Innovation Prize will recognize a public sector scientist(s) who has helped to reduce disproportionate health burdens in underserved populations and/or to promote greater health equity via their work or efforts in one or more of the following areas that are central to HESI’s core operations: (1) safe and effective medicines, (2) food safety and security, (3) chemical and consumer product safety, and/or (4) environmental quality and sustainability. The Prize will recognize impact achieved via research, training/education, and/or programmatic approaches.

HESI will be accepting applications until 30 June 2021. Awardees will be notified of their selection by August 2021 and must be willing to give a presentation about their work to the HESI membership.

For more information, please click here or email hesiprize@hesiglobal.org.

The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to announce the launch of a new project focused on advanced sequencing technologies for the identification of off-target mutations associated with genome editing. The first phase of this project utilizes novel, unbiased NGS technology (INDUCE-seq) to identify CRISPR off-target DNA strand breaks and follow-up with additional analysis to confirm the nature of the break. A multi-sector expert group is finalizing the gene editing protocol, which will be executed by two sites (Novartis and AstraZeneca) as a preliminary proof-of-concept. The committee welcomes additional participation in this first phase, as well as in the second phase of the project, where the mutations detected will be confirmed by additional analyses (e.g., Duplex Sequencing and functional assays). For more information, see the call for participants posted on the CT-TRACS Committee webpage.

Dr. Mick Fellows (AstraZeneca) provided an overview of the project at the recent 2021 HESI Annual Meeting. If you are interested in learning more or participating, please contact Lucilia Mouriès (lmouries@hesiglobal.org) or Connie Chen (cchen@hesiglobal.org).

In the time of virtual meetings and social distancing, there are still opportunities to engage with peers outside of the conference room to foster group spirit. Dr. Lucilia Mouriès, HESI Senior Scientific Program Manager, participated in the International Society for Cell & Gene Therapy (ISCT) 2021 Annual Meeting Virtual 5K Run last month, and was recently selected as the winner of the 5K Run’s “most creative tweet” for embracing the ISCT spirit. As winner, Lucilia will receive a complimentary 2022 ISCT e-membership as well as ISCT 2022 5K run registration. Check out Lucilia’s winning tweet here or on ISCT’s “Kudoboard” here!

The HESI Genetic Toxicology Technical Committee (GTTC) recently held its annual meeting on 1-3 June 2021. Despite being a virtual event, over 100 participants joined throughout the 3-day meeting. If you are interested in learning more about committee activities or joining the GTTC, please contact Connie Chen (cchen@hesiglobal.org), Carolina Morell-Pérez (cmperez@hesiglobal.org), or E’Lissa Flores (eflores@hesiglobal.org) for more information.

The HESI CT-TRACS Committee will be represented at the Next Generation CAR & T-Cell Therapies Conference on 22 June 2021 from 10:30 AM to 10:50 AM PST with an oral presentation titled “Creating a Feedback Loop Between Clinical Trials and Translational Science for Product Improvement.” Two CT-TRACS Committee members, Prof. Gilbert Fruhwirth (King’s College London) and Dr. Mya Thu (VisiCELL Medical), will present perspectives from the committee and will take part in a live Q&A with other speakers from the session. For more information, see the conference website or contact Lucilia Mouriès (lmouries@heisglobal.org) and Connie Chen (cchen@hesiglobal.org).

The Botanical Safety Consortium (BSC) is hosting its annual meeting on 24 June 2021 from 11 AM to 3 PM EST. Talks will include updates on the consortium’s progress and future plans, as well as keynote talks on botanical safety evaluation research. The meeting is free and open to all. Learn more about the BSC annual meeting agenda and speakers here and register here.

The HESI Developmental and Reproductive Toxicology (DART) Committee will have a featured symposium titled “Nonclinical Considerations for Inclusion of Pregnant and Lactating Women” on 29 June 2021 from 1 PM to 3 PM EST at the Society for Birth Defects Research and Prevention (BDRP)’s 2021 Virtual Annual Meeting. For more information, see the BDRP website or contact Connie Chen (cchen@hesiglobal.org) and Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org).

One of HESI’s core strengths is in its convening power – the ability to draw together scientists from around the globe representing various sectors to help resolve global health and environmental challenges. HESI’s scientific portfolio reflects this strength, with 16 scientific committees and two HESI-led consortia (you can read all about them on the HESI website!) comprising over 1,000 participants. I wanted to take some time in this edition of Insights to highlight two relatively new HESI initiatives that have taken convening to a new level. In addition to the traditional multi-sector stakeholder involvement that underpins all HESI programs, these projects have created connections between existing programs, working to leverage committee expertise and knowledge to connect the dots and amplify their specific project goals.

The Botanical Safety Consortium (BSC) was initiated in March 2020 with the aim of evaluating the suitability of in silico and in vitro approaches to assess the safety of botanical dietary supplements. The broad scope of the BSC, which covers various toxicity endpoints, has led to fruitful collaborations and information sharing with the DART, GTTC, Cardiac Safety, and PBPK Committees, while additional partnerships are anticipated to evolve as the BSC laboratory work gets underway.

The Transforming the Evaluation of Agrochemicals (TEA) Committee began work in 2021 and has a wonderful “project landscape” map on the HESI website – check it out! Although the project is focused on the development of fit-for-purpose safety evaluation strategies for agrochemicals, the challenges and opportunities in the map could be applied to the majority of the programs in HESI’s portfolio. Recognizing these connections, the project was specifically designed as an integrative program within HESI and elsewhere, and as a result, has cited the need and opportunity to collaborate and amplify the work-products of nine different programs (and counting) within the HESI portfolio.

It is wonderful to see new initiatives taking shape that are using the amazing expertise that our committee members, project participants, and staff provide, and continuing to develop these integrative, inter-connected programs.

For more information about either of these programs, please contact me (membry@hesiglobal.org), Sandrine Deglin (sdeglin@hesiglobal.org – TEA Committee), or Connie Mitchell (cmitchell@hesiglobal.org – BSC).

Michelle Embry, PhD
HESI Associate Director, Environmental Science