HESI Insights - April 2021

Congratulations to the HESI CT-TRACS Committee, whose 2019 article in Cytotherapy (“Tumorigenicity Assessment of Cell Therapy Products: The Need for Global Consensus and Points to Consider“) was cited for its recommendations in a 2020 article in Cell Stem Cell. Dr. Shinya Yamanaka is the lead author of the 2020 article titled “Pluripotent Stem Cell-Based Therapy – Promise and Challenges.” He received the Nobel Prize in Medicine in 2012 for his work in developing induced pluripotent stem cells. We are excited to see that the HESI CT-TRACS Committee’s growing contributions on cell therapy safety were incorporated and recognized by a Nobel Prize winner!

HESI recently launched its newest Emerging Issues program focused on ototoxicity: the Collaboration on Ototoxicity Risk Assessment (CORA). Drs. Rick Neitzel (University of Michigan) and Laura Maurer (ExxonMobil Biomedical Sciences, Inc.) will chair the group. CORA aims to understand the current state of hazard assessment and assess the current metrics against newer methods. The group will explore co-exposures to noise and suspected ototoxic substances and begin by identifying gaps in the current state of the science. CORA is actively recruiting new members; please contact Jennifer Pierson (jpierson@hesiglobal.org) and Raechel Puglisi (rpuglisi@hesiglobal.org) for more information or visit the webpage to learn more.

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 February 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” (presentation recording available here). In the coming months, the webinar series will provide insight on how to best realize the full potential of human studies in risk assessment and regulatory decision-making and will highlight ongoing efforts in this space.

The next webinar will be held on 27 April 2021 from 1 to 2 PM EST. Drs. Omobola Mudasiru (American Petroleum Institute), Dana Sargent (Bayer Crop Science), and Sandrine Deglin (HESI) will present ongoing efforts from their respective organizations to increase the impact of epidemiology in the field of risk assessment. This joint presentation will be followed by a Q&A session.

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

The CT-TRACS Committee is seeking additional partners (academic/research institutions, government agencies, nonprofit institutions, private sector companies, or CROs) for an international collaborative project focused on advancing the application of sequencing technologies for identification and evaluation of off-target mutations that may be associated with genome editing via CRISPR Cas9. This initiative aims to advance the implementation of novel cell and gene therapies by improving the science underlying their safety evaluation. For full details on study objectives, rationale, roles for project partners, and instructions on how to express interest, please read the call for participants description document here.

HESI is pleased to announce the launch of 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 from 1 April to 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.

Congratulations to the authors of “Recommendations for Improving Methods and Models for Aquatic Hazard Assessment of Ionizable Organic Chemicals.” This publication, led by Dr. Beate Escher (Helmholtz Centre for Environmental Research – UFZ) was recognized recently as one of Environmental Toxicology and Chemistry’s top 10 Exceptional Papers of 2020. The concepts for the publication were initiated at an “Experts Workshop on the Ecological Risk Assessment of Ionizable Organic Chemicals” that was co-sponsored by HESI, Environment and Climate Change Canada, CEFIC, and SETAC. Read the full publication here.

The paper will also be highlighted in the July 2021 issue of Environmental Toxicology and Chemistry.

Stanford’s Annual Drug Discovery Symposium will be held on 19–20 April 2021. This year, the symposium will be held virtually and registration is free! Hear from experts in the field on research, policy, and more. See the full agenda and register online here.

The National Centre for the 3Rs (NC3Rs) 10 Years of CRACK IT Webinar will be held on 20 April 2021 from 2 to 3 PM BST. This webinar forms part of the CRACK IT 10-year anniversary celebrations and will showcase an in silico platform developed to model the host response to chronic infection by Leishmania parasites, which is now delivering 3Rs benefits across other disease areas and in ecotoxicology testing. Learn more and register here.

The HESI Developmental and Reproductive Toxicology (DART) Committee, Immunosafety Technical Committee (ITC), Genetic Toxicology Technical Committee (GTTC), and Botanical Safety Consortium (BSC) will be hosting meetings in the coming months. While the DART, ITC, and GTTC Committee meetings are open to committee participants only, the BSC annual meeting is open for registration. Please see the information below to learn more about the upcoming committee meetings.

• DART Committee 2021 Spring Meeting (20–21 April 2021)
• ITC Committee 2021 Spring Meeting (6–7 May 2021)
• GTTC Committee 2021 Annual Meeting (1–3 June 2021)
• BSC 2021 Annual Meeting (24 June 2021)

Save the date! The HESI 2021 Annual Meeting will be held virtually on 9 June 2021. Don’t miss the chance to hear from health and environmental scientists from around the world.

Stay tuned for program and registration details.

For the April edition of Insights, I want to wish you a joyous Spring and convey my hope that you have been vaccinated or will soon be! While our June meeting will be virtual, the Board hopes to meet face-to-face in January 2022.

I want to highlight the topics of our June 2021 Annual Meeting. On 8 June, the Board of Trustees will meet to review the significant progress on two Board initiatives: academic and global outreach. We will also discuss the Science Foresight document, welcome the new members to the Board of Trustees and the Emerging Issues Committee, and vote on the Executive Committee. Our normal two-day scientific meeting has been reduced to one day, since it is being held virtually (hopefully for the last time!). On 9 June, our streamlined meeting includes a morning session highlighting HESI’s impacts, describing new initiatives for 2021, and reviewing the Science Foresight grid. The afternoon session will be a panel discussion by five scientists on how the COVID-19 pandemic will impact the future of safety assessment. Next year, the Board will meet in person in January and we have been discussing ways to improve engagement between Committee Chairs and the Board, with a virtual meeting being planned for the Chairs and the Board at the January meeting.

Again, thank you for your contributions to advancing HESI’s mission during this challenging time.

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