HESI Insights - February 2022

The HESI Cardiac Safety Committee is excited to announce the winners for the committee’s new Early Career Seminar Award Series. This award offers an opportunity for postdocs and early career scientists to share their research, learn from, and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies, and pharmaceutical companies. Awardees receive a $500 USD award and are invited to present their research on a public webinar with Cardiac Safety Committee members and other invited guests.

Three awardees were selected for this inaugural Seminar Series:

• Dr. Julia Hotek, Merck
• Dr. Arvin Soepriatna, Brown University
• Dr. Shagun Krishna, NTP-NIEHS

The first 2022 seminar was presented by Julia Hotek on February 11th. The title of her talk was “Understanding hemodynamic changes: Use of signal processing tools to advance preclinical blood pressure analysis“.

Watch our Events Page for upcoming seminars.

Don’t miss this great interview by Christine Crute with HESI Associate Director and Duke Alumni Dr. Michelle Embry! Michelle talks about her early years as a Duke graduate student and her path to becoming Associate Director at HESI.

Read the full interview HERE.

The COMPARE Database is a transparent resource for the identification of protein sequences that are known allergens. The sixth iteration of the database, COMPARE 2022, was released on 26 January 2022 and contains 2463 protein sequences. Check out the COMPARE Database updates at comparedatabase.org! For more information, please visit the website or email compare@hesiglobal.org.

Please join us in welcoming our newest staff member, Saddef Haq! Saddef received her BS in Biochemistry from Rutgers University and her PhD in Toxicology from University of Maryland, Baltimore. Her thesis work investigated the biochemistry of toxin production in harmful algal species. Prior to joining HESI she was an ORISE Fellow at BARDA where she supported early and late stage antibiotic development projects, as well as research modeling the effects of antimicrobial resistance after public health emergencies. In addition to her management work at BARDA, she brings applied lab experience in several molecular biological techniques and proteomic analyses for biomedical and environmental toxicology applications as well as data analysis and modeling experience. Dr. Haq will be supporting the eSTAR and PBPK Committees. Welcome Saddef!

The OneEU2022 YouTube video competition runs from February 1 – 28th. The top 3 videos have the possibility to present their project at the European Food Safety Authority EFSA ONE conference in June. HESI’s Associate Director, Michelle Embry, was part of a project funded by CEFIC-LRI, under the umbrella of the Animal Alternatives in ERA Committee, that focused on creating a Bayesian approach to predict acute fish toxicity. This project has been focused on moving the fish embryo test (FET) into regulatory use and application. PLEASE watch and like this video created by Adam Lillicrap at the Norwegian Institute for Water Research (NIVA) to vote!

Watch Video

Congratulations to Board member, Dr. Carole Yauk! Her paper, “High-Throughput Transcriptomic Analysis of Human Primary Hepatocycte Spheroids Exposed to Per- and Polyfluoroalkyl Substances as a Platform for Relative Potency Characterization” received this year’s Toxicological Sciences Paper of the year award!

HESI would like to welcome the newest members joining our +300 partner organizations.

5Metis

• Committee(s) to be determined

Gilead Sciences, Inc.

• Genetic Toxicology Technical Committee (GTTC)
• Immuno-Safety Technical Committee (ITC)

Inotiv

• Developmental and Reproductive Toxicology Committee (DART)
• Genetic Toxicology Technical Committee (GTTC)

Sonoma Biotherapeutics, Inc.

• Cell Therapy – TRAcking, Circulation & Safety Committee (CT-TRACS)
• Immuno-Safety Technical Committee (ITC)

Wave Life Sciences

• Translational Biomarkers of Neurotoxicity Committee (NeuTox)

HESI is comprised of public and private partnerships. Read more about our multi-sector operating model, learn about joining HESI from the public or private sector, or contact us at hesi@hesiglobal.org.

CALL FOR APPLICATIONS: The HESI Immuno-safety Technical Committee (ITC) is excited to announce a new Immuno-Safety Mentorship Program for graduate students working in immunology, toxicology, pathology, or a related field. This program will allow meaningful interactions between trainees and mentors to provide insight on various career pathways and discuss how to streamline the mentees’ long-term goals. The first cohort will be from May – July 2022 with 4-5 one-on-one mentor meetings.

More information, including the application to apply, can be found on the ITC website HERE.

Deadline to apply is 4 April 2022.

The Genetic Toxicology Technical Committee (GTTC) is proud to announce the launch of a new professional development award, geared towards graduate students or postdoctoral fellows in the fields of genetic toxicology and genomics. Awardees will receive up to $1000 USD  to be applied towards scientific conferences, workshops or courses that will build core competencies and transferrable skills and/or share your research. Awardees will also be welcomed to attend GTTC’s Annual Meeting in May 2022 to learn about emerging projects and science at HESI and to network with experts in the gene toxicology field.

Deadline for submission is April 1, 2022.

For more information or to apply, please see the website.

Guest Editors Dr. Ksenia Blinova (FDA) and Ms. Jennifer Pierson (HESI) are seeking publications for a JoVE Methods Collection on Human In Vitro Assays for Cardiac Contractility and Electrophysiology Measurements. This Methods Collection is a unique opportunity to publish a peer-reviewed video detailing the techniques involved in the submitted method. Learn more and submit your abstract here.

The ORISE fellowship is a unique education and training opportunity for students and recent graduates. US FDA is seeking an ORISE fellow with a PhD in a related science field for research focused on human cardiac ion channels and electrophysiology. The selected applicant will work closely with FDA scientists to gain insight into translational research approaches and drug safety assessments and have an opportunity to learn laboratory techniques for whole cell patch clamp methods. Learn more about ORISE here. Learn more and apply for the FDA Patch Clamp Study ORISE Fellowship here.

HESI THRIVE Letters of Intent deadline has been extended to April 11th, 2022. Submissions are open to international applicants.

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. THRIVE also supports the development of approaches to avoid or lessen these effects.

THRIVE is interested in research that will advance our:
• Fundamental understanding of cancer drug or therapy-related toxicity
• Ability to identify and translate critical biomarkers of toxicity
• Models (in vitro, in vivo, in silico) of pediatric or adult drug exposure that predict early or impending toxicities
• Understanding the role of protective co-therapies or modified exposure protocols on the onset of therapy-induced damage; and
• Identification of novel protective therapies or dosing strategies.

KEY DATES
• April 11th, 2022: Letters of Intent are due
• May 23rd, 2022: Invitations to submit full proposal
• June 20th, 2022: Full proposals due
• July 29th, 2022: Awards selection and notification
• August 5th, 2022: Award period initiates

Read about our 2021 THRIVE Winners

More information can be found at https://hesithrive.org/

HESI’s Executive Director Syril Pettit, DrPH will be speaking at the STEM Career Exploration Seminar on February 17th at 11am EST. Hosted by the Career Mobility Committee – University of Vermont.

The seminar is an opportunity for students and professionals to learn about careers outside of academia and pose questions on how to leverage a STEM degree and maximize success.

Click for Meeting Details

See Meeting Flyer

The Botanical Safety Consortium is hosting an open webinar on Tuesday 22 February 11 am -12 pm ET as part of the Stakeholder Council Webinar Series.

Webinar Title: Chemical Safety of Phytomedicines – Perspectives for in vitro testing strategies?

Speaker: Dr. Dieter Schrenk, Senior Professor of Food Chemistry & Toxicology, University of Kaiserslautern

Abstract: Plants used for the preparation of phytomedicines or food supplements may contain natural constituents causing a safety concern. Furthermore, contamination of such plants with various types of weeds may result in the occurrence of unwanted constituents. Safety concerns typically arise from hazard considerations indicating genotoxic or carcinogenic properties of certain constituents in various test models. In addition, indications for system and/or organ toxicity may result form in vitro or animal experiments.

In modern safety assessment New and Alternative Methods (NAMs) are widely used in order to restrict animal experiments to a minimum. NAMs include all types of in silico and in vitro methods giving preference to those not requiring animal organs. Typically, such methods comprise in vitro genotoxicity testing, toxicity testing in tissue-specific cell culture, in vitro absorption and metabolism studies etc. Furthermore, in vitro searches for structural alerts including read-across of related structures are applied. In addition to hazard identification, combined cell culture-based toxicokinetic and toxicodynamic testing strategies may allow modeling of effective target concentrations of a chemical and/or its metabolite(s) upon a defined (human) exposure.

Since natural plant constituents often occur as large numbers of derivatives (congeners), establishing relative toxic potency factors is required for a science-based risk assessment. For this purpose, NAMs provide an excellent tool even allowing structure-related predictions of potency. Examples will be demonstrated for the family of pyrrolizidine alkaloids, for phototoxic furanocoumarins and for the diverse group of alkenylbenzenes.

Meeting info: No registration required. Click here to join the meeting

Click for Meeting Flyer

One of the core objectives of the Immuno-Safety Technical Committee  (ITC) Method Development Working Group is to share optimized methodologies used for immune safety testing between companies and research organizations to assure appropriate preclinical data for public health safety. To ensure that the committee remains current on emerging methods and technologies in immune safety science the Working Group has organized a “ New Methods and Technologies Webinar Series”. In January, Dr. Adrian Roth gave a presentation entitled “Novel Human Cell Models in Drug Development-How 3D, Organoids, and Organ on Chip Models can improve and renew current paths- and our vision for the future” where he outlined how MPS may be applied in immune safety space. In March, the committee will welcome Dr. Phillipe Couttet, who will present on single-cell omics in immunology.

Date: 18 March 2022
Time: 9:00 – 10:00 AM EST / 14:00 – 15:00 CET

The EnviroTox Database and Tools: Overview and application

The EnviroTox database contains 80,912 aquatic toxicity effects records representing 1,641 species and 4,267 unique chemical identifiers and was specifically developed to provide a curated dataset to explore the concept of the ecological threshold of toxicological concern (ecoTTC). These data are associated with physical chemistry data and curated taxonomic information, including a process that assigns acute and chronic effects, and that identifies PNECs based on the available data. Several mode of action schemes are also included to facilitate development of a best approach for grouping compounds. This database has been made freely available via a web-based query system that integrates the various tools. This interface allows users to explore and upload data, derive threshold values based on specific criteria, and explore the use and application of ecoTTCs.

This presentation will provide an overview of the EnviroTox database and tools, with a live demonstration on how this valuable resource can be used. Please visit www.envirotoxdatabase.org to give it a try!

Click to REGISTER

The following HESI Scientific Committees will be presenting at the upcoming Society of Toxicology meeting, which will be held virtually and in person in San Diego, CA March 27-31, 2022:

Platform Sessions

PBPK Models

Optimizing the Design of Repeated-Dose Animal Studies to Inform Human Health Risk Assessment by Integrating Exposure, In vitro, and In Silico Data; Platform session; Speaker Dr. Michelle Embry 3/31/2022 8:30 – 11:15

Immuno-safety

HESI Scientific Program Manager, E’Lissa Flores, was invited by the Education Committee of the Immunotoxicology Specialty Section (ITSS) of the Society of Toxicology (SOT) to speak at their 8th Networking/Mentoring event for student and postdoctoral trainees. This event allows trainees to meet experts from the ITSS working in academia, government, industry, nonprofits, and contract research organizations.

Posters

Botanical Society Consortium (BSC)

Application of In Silico and In Vitro Approaches for Evaluating Developmental and Reproductive Toxicity in Botanical Products, 3/28/2022 2:30:00 PM to 3/28/2022 4:15:00 PM

A Strategy for Developing a Framework of Genotoxicity Assays for Safety Assessment of Botanicals 3/30/2022 2:30:00 PM to 3/30/2022 4:15:00 PM

In Silico Prediction of Botanical Constituents’ Metabolites 3/30/2022 2:30:00 PM to 3/30/2022 4:15:00 PM

Physiologically based pharmacokinetic (PBPK) simulations and modeling of botanical constituents – TBD

Emerging Systems Toxicology for the Assessment of Risk (eSTAR)

A Collaborative Initiative to Establish Molecular Biomarkers for Assessing Risk of Chemical Carcinogenesis to Reduce Reliance on Conventional Rodent Carcinogenicity Studies, 3/30/2022 10:45:00 AM to 3/30/2022 12:30:00 PM

Registration and meeting details can be viewed on the SOT website here.

Hard to believe, but the HESI Annual Meeting is only four months away! We are optimistic that we can safely gather in person in Washington DC on June 8-9, 2022 but plan to incorporate a virtual attendance option as well to expand participation. Please book it on your calendars now! Program planning is in full swing, but you can expect to hear about exciting HESI science in new technological arenas such as error-corrected sequencing, new capacity building efforts such as the Global Risk Assessment Training Center, growing impacts of the HESI THRIVE grant program, and the inaugural Innovation Prize Lecture from Dr. Kenneth Olden. More details to come…so stay tuned!

Syril D. Pettit, DrPH, MEM
HESI Executive Director