HESI Insights - April 2023

Get ready to dive into the world of data and public health! In honor of National Public Health Week, HESI and the NSTA are thrilled to introduce Health DataWell! These free, online instructional materials are offered as a resource to help high-school science students (grades 9-12) advance the skills and knowledge needed to become analysts and practitioners of data-driven and equity-focused public and environmental health science. The lessons will also help students to understand the varied roles of citizens and health scientists in protecting and promoting the health and wellness of their communities. The first three lesson plans are available for free now and additional plans are in preparation for release later in 2023.

Explore the Free Lessons Here

The HESI NeuTox Committee publication, Can We Panelize Seizure? (Roberts et al., 2021), was recently cited in an FDA/CDER perspective paper focused on new approach methodologies (NAMS) (Avila et al., 2023). Avila et al., (2023) discuss how context of use, validation and/or qualification would help integrate NAMs into nonclinical regulatory testing. Authors called out the HESI Roberts et al., (2021) paper as an example where context of use could provide a path to bringing in vitro and in silico methods as part of an overall seizure risk assessment. Roberts et al., discuss the use of several NAMs to predict seizure risk and provide this information earlier in the drug development process. The HESI NeuTox Committee is currently finalizing a data analysis on the use of microelectrode arrays (MEA) to predict seizure – one of the NAMs cited in the paper. Learn more about HESI NeuTox by visiting our website or contact Jennifer Pierson (jpierson@hesiglobal.org).

The HESI Cardiac Safety Committee is pleased to announce the winners of the 2023 Early Career Seminar Award Series. This award is given to postdoctoral or early career researchers working in cardiovascular safety science or a related field and offers an opportunity to share their research, network and learn from experts in the toxicology and safety pharmacology fields. Save the dates for their upcoming seminars!

2023 Award Winners and Seminars
• Loukia Yiangou, Leiden University Medical Center (April 28th @10am EDT)
• Louise Hesketh, King’s College London (May 19th @10am EDT)
• Catherine Garrison, BMS (TBD)

Please join HESI in welcoming our newest Scientific Program Manager, Dr. Christine Crute. Chrissy Crute is a human health toxicologist with expertise in reproductive toxicology and global maternal and child health. Dr. Crute received her PhD from Duke University in Environmental Health and Toxicology, where she studied the effects of exposure to environmental contaminants during pregnancy. Her research expertise spans novel stem cell models to rabbit pregnancy models, and she is practiced in science communication and outreach. She also holds a B.S. degree from George Mason University in Environmental Science and Biology. Prior to joining HESI, Dr. Crute was a Science Corps Fellow in Morocco.

Welcome Chrissy!

The incidence of spontaneous arrhythmias in telemetered beagle dogs, Göttingen Minipigs and Cynomolgus non-human primates: A HESI consortium retrospective analysis (Boulay et al., 2023) was recently accepted for publication in the Journal of Pharmacological and Toxicological Methods, https://doi.org/10.1016/j.vascn.2023.107266.

Members of the Cardiac Safety Committee pooled retrospective data to explore the incidence of spontaneous arrhythmias and effect of telemetry implants in species typically used in safety pharmacology studies. Understanding this background level of spontaneous arrhythmias is important for interpretation of results when evaluating drugs in a safety study. Additionally, authors compared findings from non-implanted telemetered animals and found no significant differences in the implanted animals.

Learn more about the HESI Cardiac Safety Committee or contact Jennifer Pierson (jpierson@hesiglobal.org) for more information.

International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies (Watanabe et al., 2023), was recently published in Regenerative Medicine, https://doi.org/10.2217/rme-2022-0207.

HESI’s Cell Therapy-TRAcking, Circulation & Safety Technical Committee completed an international, multisite study to evaluate the sensitivity and reproducibility of the highly efficient culture (HEC) assay, an in vitro assay to detect residual undifferentiated human pluripotent stem cells (hPSCs) in cell therapy products. The results indicate that the HEC assay is highly sensitive and robust and can be generally applicable for tumorigenicity evaluation of hPSC-derived cell therapy products.

A number of HESI Committees attended the Society of Toxicology Meeting in Nashville, TN last month. Two of which made their “premiere” in the SOT community, presenting a talk or a session at the conference: congrats to the CT-TRACS and Targeted Protein Degrader Safety committees! Below are some of the highlights.

Dr. Lucilia Mouriès discussed Opportunities and Challenges of Targeted Protein Degradation Therapeutics with SOT TV, introducing the session presented in the main program. Watch the full interview here and learn more about HESI’s Targeted Protein Degrader Safety Committee here.

A 2022 publication by the HESI PBPK Committee was selected as one of the SOT RASS Top 10 Best Papers Demonstrating an Application of Risk Assessment. Read the full paper here:  Predicting nonlinear relationships between external and internal concentrations with physiologically based pharmacokinetic modeling. Hoer D, Barton HA, Paini A, Bartels M, Ingle B, Domoradzki J, Fisher J, Embry M, Villanueva P, Miller D, Nguyen J, Zhang Q, Edwards SW, Tan YM. Toxicol Appl Pharmacol. 2022 Apr 1;440:115922. doi: 10.1016/j.taap.2022.115922. Epub 2022 Feb 15. PMID: 35176293.

HESI Chair of Board, Dr. Ruth Roberts, was presented with the 2022 Mildred S. Christian Career Achievement Award from the Academy of Toxicological Sciences (ATS) at SOT2023. This award is conferred upon an ATS Fellow who has clearly demonstrated a lasting impact on toxicological sciences. Congratulations Ruth!

The HESI Botanical Safety Consortium will host a session at the 21st International Conference on the Science of Botanicals (ICSB).

ICSB Session 7a: Botanical Safety Assessment: Updates from the BSC
Chair: Dan Marsman, Proctor & Gamble
Location: OCC Auditorium
Date:25 April 2023 at 1 pm-2:15 pm CT

Session Details:
1:00-1:25 Connie Mitchell, Health and Environmental Sciences Institute (HESI) – The Botanical Safety Consortium: An Introduction and Recent Updates
1:25-1:50 Holly Johnson, AHPA – Analytical Tools to Support Botanical Safety
1:50-2:15 Amy Roe, Proctor & Gamble – New Approach Methodologies for Screening for Hepatotoxicity for Botanicals as Complex Mixtures

The Cardiac Safety Steering Team is proud to present the first webinar series featuring the 2023 Early Career Seminar Series Awardees. This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment.

Loukia Yiangou will present on April 28th at 10am EDT. See the Event Page here for abstract, bio and registration details.

The Protein Allergens, Toxins and Bioinformatics committee will present a poster and will have an exhibitor booth at the 16th ISBR Symposium (ISBR2023) taking place in St Louis, Missouri from 30 April to 4 May 2023. The poster entitled “Role of International Multi-Stakeholder Collaborative Platforms in Supporting Development of Safe Foods: Examples from the HESI PATB committee” will feature several output examples from the past 20+ years of PATB’s activities and how those contribute to solving complex challenges in novel foods/feed safety via collaboration and innovation. Spread the word and come visit HESI booth!

Save the Date! The GTTC will hold their Annual Meeting from May 7-9th, 2023.
More details to come closer to the meeting date.
Learn more about the HESI Genetic Toxicology Technical Committee

The HESI Developmental and Reproductive Toxicology Technical Committee will be hosting its annual spring business meeting in Washington DC at the HESI Offices. Those who cannot attend in person are welcome to join online. This is an internal committee meeting.

To view the agenda and register see the event page HERE.

The Cardiac Safety Steering Team is proud to present the second webinar series featuring the 2023 Early Career Seminar Series Awardees. This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment.

Louise Hesketh will present on May 19th at 10am EDT. See the Event Page here for abstract, bio and registration details.

Dr. Mick Fellows, co-chair of the CT-TRACS Committee was invited to speak about the developments of the committee project on advanced sequencing methods for detection of off-target edits in genome editing, a project that received support from HESI EIC via its “Foresight Proposal” award. The presentation will be featured as part of the ISCT 2023 Annual Meeting “Translational Pathway Program” in a session entitled “Progress and Challenges with Gene Editing”.

The Health and Environmental Sciences Institute (HESI) and NC3Rs are jointly hosting a meeting to bring fresh perspectives to the topic of new approach methodologies (NAMs) for safety assessment.

Through engaged discussion among experts, we will tackle core questions relating to the practical application of NAMs across different sectors and contexts of use.

You will hear about the reality of NAMs from experts with a deep understanding of their practical use for chemical risk assessment. You will learn about the barriers and incentives to a future NAMs-based safety evaluation paradigm, and potential actionable steps to implement change while ensuring that key safety questions are addressed. You can also expect to be part of the conversation – to challenge and be challenged by our panelists, and we encourage you to share your perspective with our panelists, and other attendees. Real-time meeting polls will help track potential shifts in perspective during the two-day meeting.

Join us if you are a research scientist or policy maker actively involved in navigating the often complex intersection between innovation, health protection, implementation and the 3Rs.

The meeting is free to attend, but registration is essential.

Meeting registration will be handled by our partners at NC3Rs. To view the agenda and register click here.

The HESI ITC seeks graduate students working in immunology, toxicology, pathology, or related field for a second cycle of their new HESI ITC Mentorship Program. This program will allow meaningful interactions between trainees and mentors to give insight on various career pathways and discuss how to streamline the mentees’ long-term goals. The second cohort will tentatively be from May – June 2023 with 4-5 one-on-one mentor meetings. As well as an opportunity to network with past mentees and expert immuno-safety committee members at our ITC annual meeting (25-26 April 2023).

• Qualifications and Requirements: Eligible candidates must be currently enrolled in a graduate program (MS or PhD candidates) in immunology, toxicology, pathology or related field (cell biology, biochemistry, biomedical engineering, or similar). And must have completed at least one year in their program.
• Application: To apply, please send along the following: 1) completed application form, 2) CV or Biosketch, and 3) one reference letter from advisor or similar mentor to itc@hesiglobal.org
• Submission Deadline: April 21, 2023

*All documents must be merged into a single pdf with your first and last name in file title.
* Your mentor letter can be sent separately if they desire.

If you have any questions about the HESI ITC or this program, please contact Dr. Shermaine Mitchell-Ryan

Apply on the ITC webpage here

This award offers an opportunity to attend scientific conferences, workshops, or courses, etc. to build core competencies and transferrable skills, and/or share your research. Awardees will also be welcomed to attend GTTC’s Annual Meeting to learn about the emerging projects and science at HESI and to network with experts in the genetic toxicology field.

Award: Selected candidates will receive $1500.00 USD to support attendance at relevant scientific conferences, workshops, training courses, or another related opportunity (e.g., laboratory visit for specialized training or another venture) that contributes to professional development as described in the application form. To receive the funds, proof of attendance (e.g., registration, etc.) must be submitted to HESI within 1 year of the event.

Qualifications and Requirements: Eligible candidates must be currently enrolled in a graduate program (MS or PhD candidates) in genetic toxicology, genomics, or related field (cell biology, biochemistry, or similar) OR hold a current postdoc position/appointment (no longer than 5-yrs “post-PhD”). Previous awardees are ineligible.

Application: Please send the following to gttc@hesiglobal.org; 1) completed application form 2) CV (max 3 pages), and 3) one reference letter from a mentor.

Submission window: 1 April – 30 April 2023.

Applications will be scored based on the following criteria: (1) Impact of Research, (2) Research Relevance to GTTC, (3) How the chosen activity will advance/impact your professional development and (4) Mentor Letter. Additional consideration will be given to applicants from low- and middle-income countries.

Apply on the website here.

The HESI DART committee invites graduate trainees working in DART or any closely related field to apply for the DART Professional Development Award. Part of a multi-faced trainee program, this award provides an opportunity to attend scientific conferences, workshops, training courses, or related opportunities to build core competencies and transferrable skills, and/or share your research. Awardees are invited to attend HESI DART Business meetings to learn about the emerging topics and existing scientific programs within HESI DART along with the opportunity to network with experts in the DART field.

Award: For 2023, two selected candidates will each receive a $2000.00 USD award to support attendance at relevant scientific conferences, workshops, training courses, or another related opportunity that contributes to professional development (e.g., laboratory visit for specialized training or another venture). The award must be used within 12 months of receipt. A required “Proof of attendance” is to be submitted no later than 30 days after the sponsored event.

Qualifications and Requirements: Eligible candidates must be currently enrolled in a graduate program (MS or PhD candidates) and involved in research related to developmental or reproductive toxicology, pathology, or a related field (e.g., cell biology, biochemistry) OR hold a current postdoc position/appointment (no longer than 5yrs) related to these research areas.

Application: To apply, please send to smitchell-ryan@hesiglobal.org: 1) completed application form, 2) CV or bio sketch, and 3) one reference letter from mentor.

Deadline for submission: 31 May 2023

Contact Dr. Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org) or Dr. Connie Chen (cchen@hesiglobal.org) if you have any questions about HESI DART or this award or to submit your application.

Apply on the website here.

After 34 years, HESI is well recognized as a global leader in the design, execution, and implementation of science via multi-sector consortia. We take great pride in this area of continuous achievement and impact. I also want to recognize one of our newest and most rapidly growing areas of impact – training and education. This month we launched the first installment of the Health DataWell curriculum. Health DataWell, a project near and dear to my heart, is HESI’s first high school curriculum development effort. This innovative program will foster a new generation of public and environmental health scientists by introducing them to complex data sets and their applications for health protection. In the past two years HESI has also seen the launch of our ImmunoSafety online training courses, in-person risk assessment training events in South America and Southeast Asia via our new Global Risk Assessment Training Center, and career development seminars, grants, and traineeships offered by many of HESI’s scientific committees, among others. Education is a powerful tool for both giving back and building forward – we at HESI are proud to do both.

With best regards,

Syril Pettit, DrPH, MEM, HESI Executive Director