HESI Insights - September 2024

From August 14-18, the USA Wildwater National Team journeyed to Sabero, Spain, for the 2024 Wildwater Canoeing World Championships. Sandrine Deglin, a Senior Program Manager at HESI and a member of the National Team since 2020, represented the USA in both the Senior (open category) and Masters (>35) Women’s Kayak events. Competing fiercely, Sandrine secured the gold medal in the Masters category, showcasing her skill and dedication on the global stage.

HESI is incredibly proud of Sandrine’s outstanding achievement and her commitment to excellence both in her professional role and in her athletic endeavors.

The HESI Protein Allergens, Toxins & Bioinformatics Committee is hosting a Protein Safety Assessment workshop in Porto, Portugal in one month! This workshop, on October 21-22, aims to bring together research scientists from academia, industry and government institutions to review current scientific advances and address particular challenges related to the safety evaluation of proteins in GM products and novel foods/feed.

The workshop is free and open to the public. Full details, including registration link, can be found on the event webpage here.

The HESI Cardiac Safety Committee seeks Postdoctoral or Early Career researchers working in cardiovascular safety science or a related field for the 2025 Early Career Seminar Award Series. This award offers an opportunity to share your research, learn from and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies and pharmaceutical companies.

Award: Selected candidates will receive a $500.00 USD award and be invited to present their research on a public webinar with HESI Cardiac Safety Committee scientists and other invited guests. Webinar dates will be scheduled with the awardees in Q1 2025.

Qualifications and Requirements: Eligible candidates must have a PhD or equivalent degree in biology or related field (cell biology, biochemistry, pathology, biomechanical engineering, or similar); have current post-doc position/appointment or consider themselves an early career scientist (~1-5 years post-academic training) and may not have previously received an award under this program. Open to both domestic and international applicants.

Deadline for submission: November 15, 2024.

Apply on the website here: https://hesiglobal.org/cardiac-safety/#earlycareeraward

2024 has been an exceptional year for the HESI Immunotoxicology Technical Committee (ITC), marked by an update in leadership, scientific publications, collaborative projects, and exciting events. Let’s take a look at some of the most significant moments from this whirlwind year.

New Leadership and Strategic Planning:
This year saw the election of a new ITC leadership team. Nominations for private sector chair and workgroup (WG) leadership wrapped up in June, and the results were announced in August, setting the stage for a dynamic team to lead the ITC’s future initiatives. A half-day leadership training and strategy meeting is scheduled for mid-October to further align committee goals and plan next steps.

Breakthrough Scientific Publications:

• Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis. Pallardy et al., April 2024. Toxicological Sciences.
• 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.

Stay tuned for soon-to-be published manuscripts on our webpage:

• Assessing the impact and risk of immunomodulatory compounds on pregnancy
• Impact of Antibody Fc Engineering on Translational Pharmacology and Safety: Insights from industry case studies
• Current Approaches to Evaluating Natural Killer Cell Function in Non-Clinical Immune-Safety Assessments (working title)
• Cross-Institutional Collation of In Vivo Cytokine Data from Control Cynomolgus Monkeys (working title)

Upcoming Events & Workshops:

• 16 October 2024, 12:00 – 1:00pm ET. SOT’s Biotechnology Specialty Section has invited the First in Human Dose project to present a webinar on their recent publication, “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).” Registration required: Click here to receive Zoom Link
• 17 October 2024, Washington, DC. Immunogenicity Bioassay Summit. HESI/AAPS: “Towards Harmonization of in vitro T Cell Assays to Predict Immunogenicity of Biologics.” Presented by Dr. Laurent Malherbe (Lilly).
• 12 – 13 November 2024. NIH/HESI Regulatory Workshop on T Cell Therapies. Co-organized with HESI’s CT-TRACS committee. This workshop promises to drive important discussions on the challenges and opportunities in T cell therapies.
• 18 November 2024, Nashville, TN. American College of Toxicology (ACT) Annual Meeting: “Immunogenicity Risk Assessment: Are Preclinical Methods Informative?” Presenters/Session Chairs: Drs Kirstina Howard (FDA) and Laurent Malherbe (Lilly).

Education and Outreach Success: The ITC’s Education & Outreach workgroup organized a career symposium in March, providing students and trainees with valuable insights on building careers in immunotoxicology. Panelists from ITC member institutions, including BMS, Rutgers, and the FDA, shared their experiences, helping the next generation of scientists navigate the immune safety field.

Check out the full list of recent ITC events on the ITC webpage here.

Project Update: HESI/AAPS Immunogenicity Collaboration: The ITC and AAPS have made significant strides in their collaboration to standardize in-vitro immunogenicity assays. With Stage I of the UK grant completed, the project is now poised to expand further. Upcoming Outreach from this effort will be presented at the American College of Toxicology (ACT) Annual Meeting (November 2024, Nashville, TN): Session: “Immunogenicity Risk Assessment: Are Preclinical Methods Informative?” chaired by Drs. Kristina Howard (FDA) and Laurent Malherbe (Lilly), focusing on the predictive value of preclinical methods for immunogenicity.

New Scoping Projects: The ITC is excited to begin scoping three new projects!

• New Alternative Methods: Exploring cutting-edge methodologies for more effective safety assessments.
• Translational Immune Safety: Emphasizing the relevance of non-human primate (NHP) studies for better predictive outcomes.
• Best Practices for Cytokine Release: Addressing the regulatory challenges in cytokine release risk assessment.

If you are interested in learning more about these projects or joining the scoping teams, please reach out to ITC managers Shermaine Mitchell-Ryan and Christine Crute.

Dr. Jesse Salk (consultant) and Connie Mitchell (HESI) presented on the use of Error-Corrected Sequencing for measuring clonal expansion as part of the ICCVAM NAMs for Carcinogenicity Forum. The session was well-attended, with over 100 participants online over two days. This work is part of the HESI Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee.

HESI’s COMPARE Database Program was invited to lecture at the University of Buenos Aires School of Agriculture as part of a Certificate on Risk Analysis for the Agrifood Sector. The course, titled “Information Sources and Databases for Risk Assessment,” took place August 23, 2024. During the session, students were introduced to the allergen database (https://comparedatabase.org/) and guided through a practical example of using COMPARE and its associated bioinformatics tool, COMPASS, to assess the allergenicity risk of a protein sequence.

For more information, please contact Liisa Koski or Lucilia Mouriès

HESI’s GTTC, eSTAR, CT-TRACS and BSC science were featured throughout the 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS) in Palm Springs. A review of committees’ activities is available on the event page here.

The Botanical Safety Consortium (BSC) leadership was invited to the FDA’s 2024 Foods Program Regulatory Science Conference. Over two days, scientists discussed new advancements aimed at improving food safety. Connie Mitchell (HESI), Julie Krzykwa (HESI), and Amy Roe (P&G) represented the BSC, by sharing results from the Cardiotoxicity and Hepatotoxicity working groups, and how these findings can be applied to other mixtures such as foods.

The HESI Cardiac Safety Committee will be presenting several posters at SPS2025 in San Diego, CA. Please see the full list on the event page, and if you are attending, stop by and say hello!

The HESI Genetic Toxicology Technical Committee (GTTC) is proud to be a co-sponsor of the 52nd EEMGS and 15th ICAW Meeting from September 23 – 27 in Rovinj, Croatia. GTTC will kick off the meeting with a pre-workshop “Where the Rubber Hits the Road: Transitioning Genotoxicity Testing from Academia 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 its first in-person meeting (with a 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 sessions 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 details in the coming weeks for those who register.

Register on the event page: Botanical Safety Consortium Summit 2024

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 welcome back 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 present an update on the collaborative HESI/AAPS effort to develop 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!

The UVCBs and Multi-Constituent Substances (MCS) Committee and the Next Generation Ecological Risk Assessment Committee will be attending SETAC North America in Fort Worth, Texas. Full details on their sessions, talks, and posters can be viewed on the HESI event page. Reach out to connect with us if you are attending!

The HESI Developmental and Reproductive Toxicology (DART) Committee will hold their Fall meeting virtually over two half-days. During the meeting, the committee will hear updates on its various working groups and consider the adoption of new ones. For more information, contact Connie or Shermaine.

The XVII Brazilian Congress of Ecotoxicology (ECOTOX 2024) will take place in Belém, Pará, with the theme of “ECOTOX in the Amazon – Integrating Climate, Environment, and Society.” Michelle Embry, from HESI, will speak in a session on Next Generation Ecological Risk Assessment on 25 October, where she will highlight advances in the field and the ongoing work of the HESI Next Generation Ecological Risk Committee.

HESI’s Targeted Protein Degrader Safety Committee will attend the Targeted Protein Degradation Summit 2024 in Boston.

30 October, 10:00 AM, HESI Targeted Protein Degrader Safety Committee participation in a panel session: How Are Regulators & Industry Thinking About Degraders from a Safety Perspective in 2025?

31 October, 12:30 PM, Collaborative Approaches to Advancing Integrated Safety Assessment of Targeted Protein Degraders. This talk will describe the projects of the HESI Targeted Protein Degrader Safety Committee. Speaker: Raegan O’Lone, HESI.

HESI Senior Program Manager Connie Mitchell will be presenting at the U.S. Environmental Protection Agency NAMs Conference: State of Science on the Development and Use of NAMs for Chemical Safety Testing on 6 November 2024.

Her talk is titled “Collaborative Vision for Omics-Based Chemical Testing.”

More information about the meeting can be found on the EPA website here.

The HESI Emerging Systems Toxicology for Assessment of Risk (eSTAR) Committee will hold its 2024 Annual Meeting on 13 – 14 November 2024. The meeting is free, virtual, and open to all!

Agenda and meeting link will be added closer to the date.

The HESI Cell Therapy – Tracking, Circulation, & Safety (CT-TRACS) Committee will hold its annual meeting from 14-15 November at the HESI Offices, with an exciting opening keynote presentation by Dr. Bruce Levine (University of Pennsylvania). In addition to hearing updates from existing Work Groups, the committee will be considering new project proposals and discussing new collaborations. For more information, contact Lucilia or Connie.

Several HESI committees (DART, ITC, and Cardiac Safety) have organized a number of workshops and symposia to showcase their ongoing efforts at the 45th Annual American College of Toxicology Meeting in Austin, Texas. Please see the full list on the event page here.

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

HESI’s Committee on Transforming the Evaluation of Agrochemicals (TEA) invites you to participate in the TEA Global Challenge, a groundbreaking initiative focused on advancing ecological and human safety assessments of plant protection products using non-animal methods. This year’s challenge focuses on the safe use of a hypothetical grape fungicide (VineGuard).

Not familiar with agrochemicals? No problem! Anyone can participate!

Your mission is to propose creative solutions to evaluate the safety of VineGuard.

We offer great flexibility in how you can participate:

• You are free to choose the scope of the problem you want to solve.
• You can propose conceptual solutions (simply explain how you would proceed) or more specific solutions based on hypothetical datasets of your choice.
• You only need to explain your approach, using the provided reporting template.

Exciting Rewards:

• $2,000 USD in travel funds to attend a relevant scientific conference.
• Support from the HESI TEA committee to publish your work.

For detailed guidelines, visit TEA Global Challenge website.

Watch our recent webinar outlining the Challenge!

We are excited to announce that HESI is a partner in the NC3Rs CRACK-IT Challenge “Wings of Change” initiative, which focuses on advancing acute and chronic avian non-animal models (NAMs). This collaboration aims to develop innovative and ethically responsible methods for assessing toxicity in avian species, reducing the reliance on animal testing, and enhancing the scientific rigor of avian safety assessments.

We invite researchers, innovators, and industry leaders to join us in solving this challenge and driving positive change in the field of toxicology.

For more details, visit the NC3Rs CRACK-IT Challenge page.

DONOR RELATIONS and OPERATIONS MANAGER

Want to work for a nonprofit organization that creates science-based solutions for a safer, more sustainable world? Join HESI as a Donor Relations and Operations Manager, where you’ll manage key donor relationships, support institutional operations, accounting, and budgets as part of HESI’s effort to address global health and environmental challenges.

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

KEY RESPONSIBILITIES

Donor Management

• Manages key facets of donor stewardship including processing annual donor invoices, maintaining lists of key contacts in donor organizations, fulfilling payment-related donor information requests, and working with HESI leadership and management staff to address other donor-related reporting as assigned.
• Leads annual member outreach activities to donors through dissemination of customized HESI Sponsorship reports as prepared by the HESI Scientific Staff.
• Maintains member information in the Constant Contact database.
• Reports to Executive Director/Deputy Director on trends in donor composition.
• Assists the Associate Director for Program Development & Resourcing in tracking of grants and grant-related contracts.

Operational Management

• Works directly with HESI’s finance department and legal department to support HESI operations and the annual organizational financial audits and other compliance requirements.
• Supports the Executive Director in disseminating communications and requests to the HESI Board of Trustees and broad HESI membership. This includes engaging directly with members of HESI’s global Board of Trustees to communicate logistical and administrative needs, scheduling and providing logistical support for Board-related events and activities.
• Identifies opportunities to enhance and streamline internal systems to support the work of the organization.
• Manages organization-wide vendor contracts, payment, and financial transactions.
• In partnership with senior HESI staff, monitors organizational budget relative to Board expenditures and expenses for Bi-Annual Scientific Conference.
• Leads logistical support for events, meetings and conferences for HESI and its programs on an as needed basis. This may include coordinating banquet event orders (BEOs), and providing onsite logistical support, and assisting with booking guest travel for events.
• Adhere to strict deadlines for completion of all assigned work.
• Completes special projects and ad hoc tasks as needed to support the organization.
• Exercise a high degree of judgment and discretion while collaborating with leaders and staff throughout the organization.

Knowledge, Skills, Abilities and Experience

• Familiarity with nonprofit member and donor management a plus.
• Bachelor’s degree or equivalent experience required, with a minimum of 3+ years of work experience involving increasing responsibilities in a related field or discipline such as project management, donor relations, grant management, membership management, nonprofit administration, or similar.
• Proficiency with the Windows environment and MS Office suite, along with experience using databases like Constant Contact and PN3 (AR/AP) preferred.
• Ability to quickly learn and adapt to new software and technologies as needed.
• Proven track record of strategic and creative approaches to tasks.
• Demonstrated ability to lead and manage multiple, concurrent projects with strong organizational skills, setting priorities, and meeting tight deadlines in a dynamic environment.
• Flexible and adaptable to shifting priorities and new tasks, with a proactive approach to managing change.
• Self-motivated and able to work well with and through others, having a strong commitment to customer service.
• Strong attention to detail and superior verbal, writing, and proofreading skills.
• Ability to travel domestically or internationally.

Work Environment and Additional Tasks

• This role involves work performed in an office or similar environment and may involve extended periods of sitting, working at a computer, and supporting meeting logistics.
• Occasional physical tasks may include lifting and moving items up to 20+ pounds, such as boxes or meeting materials, and setting up or breaking down event logistics.
• Mobility in confined or restricted spaces may be required for brief periods, particularly when supporting meetings or event logistics, which may involve occasional movement or physical tasks.

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.

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.

Although it is not officially over until September 22nd in the Northern Hemisphere, it is quite apparent from the activity within HESI that summer vacation time is over! The number of presentations and meetings happening this fall are remarkable and HESI will be well-represented around the world, with nearly all of our programs sharing their work.

There is, as always, a lot to talk about, but I wanted to specifically highlight two activities that I think are particularly new and innovative:

• If you haven’t seen it yet, take a look at the TEA (Transformation Evaluation of Agrochemicals) Global Challenge, even if agrochemical risk assessment isn’t your area. What this program is working toward is a new model to solicit truly creative and cutting-edge ideas outside of our “normal” committee operations. The task is to develop an approach to register a new fungicide entirely based on non-animal data, and ideally, we will get submissions from numerous teams with diverse experience to compete for travel funding and prestige. Kudos to the TEA team and especially Sandrine and Raechel for taking the leap and putting this idea out there. I am excited to see the results and look forward to more such challenges in the future!
• HESI is also a partner in the recently announced NC3Rs CRACK-IT Challenge, “Wings of Change,” that is aimed at developing new approach methodologies (NAM) to assess acute and chronic avian toxicity. Seeing this level of interest and funding dedicated to bird alternatives is extremely exciting and HESI is proud to have helped push this concept forward. Stay tuned for updates!

I look forward to connecting with many of you at the upcoming meetings this fall!

Best regards,
Michelle Embry, PhD
HESI Deputy Director