HESI Insights - June 2024

We are pleased to announce the results of the 2024 HESI Board of Trustees vote! The below slate has been unanimously elected via electronic ballot and was approved at the June 5th virtual board meeting. Thank you to everyone who participated in the voting process and a big congratulations to our new and returning Trustees!

Current list of the full Board of Trustees is available here.

HESI Board of Trustees 2024 Newly Elected Members (*designates re-nominees):

Public Sector
• Tara Barton-Maclaren, Health Canada
• Roger Chammas, Universidade de São Paulo*
• Roland Froetschl, BfArM Germany
• Yasunari Kanda, National Institute of Health Sciences, Japan
• José Manautou, University of Connecticut*
• Rose Omari, Ghana Science and Technology Policy Research Institute*
• Marc Pallardy, Université Paris-Saclay*

Private Sector
• Patricia Escobar, Merck & Co., Inc*
• Mick Fellows, AstraZeneca
• Sarah Hughes, Shell Health – Americas*
• Robert Landsiedel, BASF
• Gladys Ouedraogo, L’Oréal
• Stefan Pfuhler, Procter & Gamble Company*

A special THANK YOU to our members who rotated of the Board! Your contributions have been invaluable!

The HESI Committee to Transform the Evaluation of Agrochemicals is pleased to announce the TEA Global Challenge, a competition designed to solicit CREATIVE and CUTTING-EDGE solutions to the modernization of the risk assessment paradigm for crop protection products.

The Objectives of the TEA Global Challenge are to:

1. Showcase the feasibility of a new approach for agrochemical safety assessment,
2. Encourage knowledge sharing,
3. Foster collaboration across disciplines, and sectors.

Anyone is welcome to submit a proposal to solve the problem posed by the TEA Committee. Competitors are encouraged to work in teams, preferable multidisciplinary, although this will not be a selection criterion. Register your team now!

Finalists will be invited to present their case study at the HESI TEA Symposium, in Washington, DC (2025 date TBD), where they will have the opportunity to meet professionals from academia, government and industry with expertise in the field of agrochemicals.

$2000 in travel funds to be used towards a relevant scientific conference (e.g., World Congress on Alternatives and Animal Use in the Life Sciences, SOT) will be awarded to the winners, chosen by the TEA Symposium attendees.

Winners will also be provided support to publish their work if they so desire (pre-publication review by Committee members, contribution to open access fees)

For more information, please, visit the TEA Global Challenge website.

An informational webinar will also be held on June 18 from 10 to 11 am ET. Register HERE to join the webinar.

Shout Out to CT-TRACS!

We are thrilled to announce that the Cell Therapy – Tracking, Circulation, & Safety (CT-TRACS) Committee has reached an incredible milestone: their Tumorigenicity Position Paper (Sato et al., 2019) has now been cited 100 times! This significant achievement highlights the impact and relevance of their work in the scientific community.

Notably, this influential paper was also cited by Nobel Prize winner Shinya Yamanaka, renowned for his groundbreaking development of induced pluripotent stem cells (iPSCs).

Read the full paper here.

Congratulations to the CT-TRACS team for this outstanding accomplishment!

We are thrilled to announce the publication of a groundbreaking white paper by the HESI Immuno-Safety Technical Committee, now available in Clinical Pharmacology & Therapeutics. This pivotal work delves into the integrative approach to first-in-human dose selection of immunomodulators, shedding light on the critical challenges and strategies involved in determining the appropriate dosage in clinical trials.

Congratulations to all the authors for their exceptional contributions!

A special shout-out to Mineo Matsumoto and Joseph Ryan Polli for their years of dedication and persistence in bringing this publication to life. Your hard work and commitment have been instrumental in advancing our understanding in this crucial area of clinical pharmacology.

Check out the full paper here: Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC). Matsumoto and Polli et. al., June 2024. Clinical Pharmacology & Therapeutics. https://doi.org/10.1002/cpt.3316

Last month we reported on the HESI presentations delivered at the May 13th FDA CDER Pharmacology Toxicology Symposium organized by the Education Subcommittee, focused on “Error-Corrected Next Generation Sequencing Strategies for Direct Assessment of Mutagenesis and Early Identification of Cancer Risk.” The education webinar which attracted over 160 attendees from various FDA centers is now available for viewing here.

The HESI Immuno-Safety Technical Committee (ITC) organized an extended joint session at BioSafe at Merck Research Laboratories in San Francisco. The session was chaired by Marie-Soleil Piche (Charles River Laboratories) and Wendy Freebern (J&J Innovative Medicines). Thanks to all who contributed and presented for a successful event!

While in San Francisco, the ITC held its Annual Spring Meeting at Sonoma Bio (with global virtual attendees present). During this time, all four committee workgroups presented project updates, and members gave “Shark-Tank”-style pitches for new project ideas. Committee members are currently voting on their favorite pitches, and the top pitches will be scoped as future projects for the committee. Stay tuned for an announcement of these new projects – we would love to have new members join us in these exciting new endeavors!

HESI has teamed up with the US National Science Teaching Association to develop Health DataWell, storyline units to help high school students understand the varied roles of citizens and health scientists in protecting and promoting the health and wellness of their communities.

A free webinar was hosted by the NSTA on June 4 which focused on introducing participants to the Using Data to Understand and Improve Health Outcomes unit, designed to empower upper grade school students to wrestle with complex environmental health data, social determinants of health, & to foster a culture of health protection within their communities.

For more information on Health DataWell please contact Syril Pettit.

The 43rd Annual STP Symposium will be held in Baltimore, Maryland. HESI Immuno-Safety Technical Committee (ITC) members, Dr. Tracey Papenfuss and Dr. Daniel Weinstock, are co-chairing a Continuing Education course titled “Immunotoxicology from a Pathological Perspective” on Sunday, June 16th, from 8:00 AM to 12:00 PM EST.

The course will feature the following topics presented by current ITC members:

• The Changing Landscape of Immune System Evaluation: From Immunotoxicology and How to Navigate in the Brave New Work of Immunotherapies
  Tracey L. Papenfuss, DVM, MS, PhD, DACVP, StageBio
• Relevant Tox Species and Translational Aspects Relating to Immune System
  Ashwini Phadnis Moghe, MS, PhD, DABT, Takeda
• Spontaneous and Immunotoxic Pathology Findings in the Hematolymphoid System
  Lauren E. Himmel, DVM, PhD, DACVP, AbbVie
• WOE (Weight of Evidence), Holistic Interpretation, Regulatory Guidances: Practical Approaches for Various Therapeutics
  Ana Goyos, PhD, The Janssen Pharmaceutical Companies of Johnson & Johnson

The 64th BDRP Annual Meeting will be held in Pittsburgh, PA from June 22-26. Current Co-Chair, Dr. Christopher Bowman, will also be receiving the Patricia Rodier Mid-Career Award for Research and Mentoring and giving his presentation on Sunday, June 23. The DART committee will have a featured symposium, “DART Strategies for Oligonucleotides” on Wednesday June 26. Both HESI staff members, Connie and Shermaine, will be attending in-person are looking forward to connecting!

International Congress On Natural Products Research (ICNPR), Krakow, Poland 13-17 July 2024

The Botanical Safety Consortium is holding a training course as part of the meeting on Saturday 13 July entitled “Cultivating Safety: Toxicology 101 of Botanicals and Natural Products.”

This course will offer a deep dive into the world of botanicals, bridging the gap between their traditional uses and modern applications in supplements, medicines, and cosmetics. Participants will explore routes of botanical exposure, interactions with drugs, dose-response nuances, acute and chronic toxicity, and a range of potential health endpoints. With hands-on exercises, discussion of cutting-edge toxicity assessment tools, and interactive case studies—including challenges like product adulteration and new botanical discoveries—the course will provide a comprehensive look into the complexities of botanical safety, making it essential for researchers, practitioners, and thrill seekers.

Register at www.icnpr2024.org

Speakers and training course developers include BSC members Amy Roe (P&G), Holly Johnson (AHPA), Stefan Gafner (American Botanical Council), Olaf Kelber (Bayer), Richard van Breemen (Oregan State University), Cynthia Rider (NIEHS), Connie Mitchell (HESI), Michelle Embry (HESI), and Julie Krzykwa (HESI).

Meeting flyer available here.

Science from the HESI Genetic Toxicology (GTTC) and Emerging Systems Toxicology for the Assessment of Risk (eSTAR) committees will be well represented at the 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS) in Palm Springs, California.

A full line-up of HESI science will be included in the July Insights, but in the interim you can reach out to Connie Chen or Raechel Puglisi if you have any questions!

Saturday September 7

• Workshop 1 “Sequencing the Future: Understanding Error-Corrected Sequencing” is organized by Connie Chen & Meagan Myers. Shaofei Zhang (Pfizer) will be presenting work from GTTC and Alberto del Rio (GentiBio) will be presenting work for CT-TRACS.

Sunday September 8

• Symposium 2: Towards the development of a global genotoxocity AOP network will feature several GTTC speakers and activities – Wen Sun (Pfizer) will present on Topoisomerase II and Dan Roberts (Toxys) will present on Tubulin and Kinase inhibitors.
• Poster Session 1: TBD

Monday September 9

• Poster Session 2: TBD

Tuesday, September 10

• Symposium 9: Under the Spotlight: High-Profile Chemicals will feature an overview of the HESI GTTC Nitrosamine program presented by Tetyana Cheairs (NYMC)
• Platform 3: Sequencing the Genome and Beyond will include a presentation by Shaofei Zhang (Pfizer) on the GTTC reconstruction project and James Alcaraz (U Ottawa) on cancer driver gene mutations for the eSTAR committee.

The HESI Genetic Toxicology Technical Committee (GTTC) is proud to be a co-sponsor of the 52nd EEMGS and 15th ICAW Meeting meeting from September 23 – 27 in Rovinj, Croatia. GTTC will be kicking off the meeting with a pre-workshop “Where the Rubber Hits the Road: Transitioning Genotoxicity Testing from Academica to Regulatory Settings”, which will feature several GTTC members as speakers and will be co-chaired by GTTC manager, Connie Chen.

Michelle Embry, Ph.D., Deputy Director, Health and Environmental Sciences Institute (HESI), will be a featured plenary speaker at the ICCS 2024 Annual Meeting taking place in Washington, DC. Dr. Embry will discuss her work towards “one health assessment” with bioaccumulation as a learning which sits at the intersection of human and environmental health. Michelle will discuss the commonalities and differences between human and environmental health and how that has highlighted the advances and needs in next generation risk assessments (NGRA) and new approach methodologies (NAMs). Included also in her talk is the importance of problem formulation and the context regarding existing NGRA/NAMs with an emphasis on exposure and fate.

We are excited to announce the upcoming Translational Biomarkers of Neurotoxicity (NeuTox) Mini Session at this year’s Society for Neuroscience Annual Meeting in Chicago! Join us for an enlightening session titled “Seizure and Epilepsy: New Opportunities for Detection and Treatment,” featuring esteemed speaker and HESI Board member Ruth A. Roberts.

The Botanical Safety Consortium (BSC) will hold it’s first in-person meeting (with virtual option) at NIEHS in Durham, NC in October 2024. The in-person meeting is limited to members, with preference for steering committee and working group members. The virtual option will be open to all.

The hybrid portion will include updates from the working group on the new approach methodologies (NAMs) tested for their suitability for botanicals. The in-person portions will include hands-on breakout groups and discussions to understand the current tool-kit, identify gaps, and identify future research priorities. Virtual connection information will be provided at a later date, expect an email with the connection information in the coming weeks for those who register.

Register on the event page here.

We are excited to announce that the 16th Annual CHI Immunogenicity & Bioassay Summit will take place this fall in Washington, DC! This year, we are proud to have Chairs from the HESI Immuno-Safety Technical Committee’s Immunogenicity Pilot Study Project returning to share fresh insights from their ongoing research with our community.

Dr. Laurent Malherbe will be presenting an update on the collaborative HESI/AAPS effort aimed at developing a monoclonal antibody reference panel for preclinical immunogenicity risk assessment. Don’t miss this opportunity to stay informed and connect with leading experts in the field.

We look forward to seeing you there!

We are thrilled to announce that the 45th Annual American College of Toxicology Meeting will be held in Austin, Texas! Several HESI committees have organized workshops and symposia to showcase their ongoing efforts.

Immuno-Safety Technical Committee:
Symposium: “Immunogenicity Risk Assessment: Are Preclinical Models Informative?”
Date & Time: Monday, November 18th, 9:00 AM – 12:00 PM CT
Chairs: Drs. Laurent Malherbe and Kristina Howard

Developmental and Reproductive Toxicology Committee:
Symposium: “Informing Risk of Infertility and Adverse Pregnancy Outcomes: Are Nonhuman Primates Really Needed? (S11)”
Date & Time: Monday, November 18th, 2:00 PM – 5:00 PM CT
Chairs: Drs. Christopher Bowman and Peter J.K. van Meer

We look forward to seeing you in Austin for this exciting event!

We are pleased to announce that the application deadline for the Developmental and Reproductive Toxicology (DART) Professional Development Award has been extended to July 1st, 2024. Here’s your chance to take advantage of this opportunity to explore the world by promoting your science and gaining incredible new experiences. If you are a graduate student or postdoctoral fellow in Developmental and Reproductive Toxicology or a related field, don’t miss out on this fantastic opportunity to elevate your research and your professional journey. We encourage the HESI community to share this opportunity with talented and deserving trainees within your networks.

To apply visit the HESI DART website.

SCIENTIFIC PROGRAM MANAGER

Looking for an exciting career in human or environmental toxicology, drug safety, biomedical innovation, regulatory science, epidemiology, exposure-science, and risk assessment — outside of the lab?

Want a great place to grow your career via collaboration with thought-leaders from government, industry, academia, clinic, and NGOs?

Seeking an opportunity to apply your skills in leadership and program management while applying science to real world challenges?

The Health and Environmental Sciences Institute (HESI), a global nonprofit scientific organization, seeks a Scientific Program Manager to help lead collaborative scientific programs in the biomedical and environmental health fields. Successful candidates will have a passion for fostering creative and rigorous scientific collaborations that pool expertise, resources, and technical input from a diverse base of stakeholders. HESI Scientific Managers are responsible for developing, managing, and providing scientific input to large international scientific teams that generate science to protect public health and the environment. HESI offers the opportunity to work with internationally recognized scientists from government, academia, NGOs, clinic, and industry. This responsible position requires leadership skills and the ability to work as part of a team to help realize HESI’s mission of achieving science for a safer, more sustainable world.

This position works in Washington, DC, and reports to the HESI Executive Director.

KEY RESPONSIBILITIES

Provides scientific, strategic, management, and administrative support to collaborative scientific committees involving academic, government, nonprofit, and private sector scientists;

Works with committee members to design and execute novel scientific research programs, publications, workshops, and trainings;

Prepares and monitors committee budgets, assists with communications (technical and non-technical), supports membership development, facilitates workshops and meetings, and contributes to overall HESI strategy and outreach.

QUALIFICATIONS

• A Master’s or Ph.D. in a scientific field such as toxicology, pharmacology, genetics, immunology, epidemiology, genetics, molecular biology, cell biology, pathology, chemistry, environmental health, or related life sciences and a minimum of 3 years of experience in project management, drug or chemical safety evaluation, scientific consulting, and/or regulatory affairs.
• Strong facilitation skills and the ability to work with groups meeting virtually or in person.
• Advanced written and verbal communication skills, outstanding management and organizational ability.
• At least 5 years of experience in project or program coordination.
• Leadership experience and presentation skills.
• Technical/scientific writing.

EXPERIENCE

Expertise in any/all of the following areas preferred:

• Regulatory Science
• Exposure Science
• Drug Safety Assessment
• Chemical Safety Assessment
• Computational Toxicology
• ADME

ABOUT HESI

At HESI, it is our mission to collaboratively identify and help to resolve global health and environmental challenges through the engagement of scientists from academia, government, industry, clinical practice, research institutes and NGOs. We achieve that in a variety of ways:

Create a collaborative environment where scientists from academia, government, industry, and NGOs come together to find solutions that improve health and environmental safety.

Encourage the development of meaningful studies that ask the right questions, structure the right framework, and develop solutions that inform decision-making by both private- and public-sector scientists.

Create a knowledge base that can be easily transferred from the laboratory or journal page to real life.

Individuals interested in applying for this position should send their RESUME with COVER LETTER to Career@hesiglobal.org.

Principals only, please. Unsolicited resumes from third-party agencies will not be considered. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Learn more about us at www.hesiglobal.org.

Here comes the summer!

Looking for some thrilling beach reading as we head into summer? We hope this newsletter, filled with exciting updates and achievements from HESI, will be the perfect companion to your summer relaxation!

Before we break for some well-deserved R&R, the HESI Board met to celebrate success and embrace coming change. At our bi-annual meeting on June 6th, the Board reflected on the significant strides that HESI has made over the past six months in advancing human and ecological safety assessment and in nurturing the next generation of scientists. I’m always humbled to learn about the incredible progress being made within and outside the scientific committees and thrilled and proud to be a part of it. A loud ‘hip-hip hurrah’ to our committee members and to the HESI staff who are such stellar and effective leaders and managers.

At this time of year, we also experience a season of change in our leadership. We bid a fond farewell to our exiting board members. Their contributions have been invaluable, and they leave big shoes to fill. Very special thanks go to Anthony Holmes and Ruth Roberts—or as we affectionately call them, Ranthony. They have completed their terms as HESI Chair of the Assembly and Chair of the Board of Trustees, respectively. A highlight of their unique leadership for me was their hosting of one of HESI’s most successful annual meetings of all time – Not just another NAMs meeting – at the NC3Rs in London.

Gary Minsavage and I are excited to step into the roles of President and Chair. We’ll do our best to uphold the high standards set by our predecessors and look forward to continuing HESI’s tradition of excellence. We are delighted to introduce and work with a fresh cohort of board members from the public and private sectors. In particular, a warm welcome to Nina Hallmark, beginning her term as Vice-Chair of the Board, Warren Casey, who will be serving as Vice-President of the Assembly, and José Manautou, incoming treasurer. The commitment of all these volunteers to advancing HESI’s mission is inspiring, and we are grateful for their willingness to serve.

Wishing you all the best on your summer adventures!

Carole Yauk, PhD
Chair of HESI Board