HESI Insights - June 2023

HESI and the NC3Rs recently joined forces to host a groundbreaking scientific conference in the vibrant city of London. The two-day meeting, aptly named “Not Just Another NAMs Meeting,” brought together 150 esteemed experts from around the world to delve into the practical application of new approach methodologies (NAMs) across various sectors and contexts.

Dr. Syril Pettit, HESI Executive Director, kicked off the meeting with her insightful opening remarks emphasizing the significance of the event in advancing the field of NAMs and addressing core questions surrounding their practical implementation.

The meeting featured five panel discussions, where experts from academia, industry, regulatory agencies, and advocacy groups engaged in dynamic conversations. These discussions explored topics such as the validation and acceptance of NAMs, the translation of in vitro and in silico data, and the integration of NAMs into decision-making processes across different industries.

To enhance audience engagement, pre- and post-session polls were conducted, allowing attendees to express their opinions and gauge the impact of the discussions. The interactive nature of the polls created an inclusive environment for knowledge exchange and active participation.

Beyond the enriching scientific sessions, the conference provided a platform for networking and collaboration. A reception held at the Sky Garden, overlooking the Thames, offered attendees a breathtaking setting to connect with experts, build collaborations, and forge lasting relationships. This informal atmosphere facilitated conversations on emerging trends, best practices, and potential partnerships.

The “Not Just Another NAMs Meeting” succeeded in fostering collaboration, knowledge exchange, and the exploration of practical solutions. Experts and attendees came together to share insights, exchange ideas, and shape the future of NAMs in scientific research and testing.

By leveraging the power of collaboration, the conference created a dynamic and inclusive platform for advancing the field of NAMs. The discussions and polls allowed participants to collectively address challenges, identify opportunities, and lay the groundwork for the widespread implementation of NAMs.

The joint collaboration between HESI and the NC3Rs in hosting this remarkable event exemplifies their commitment to advancing innovative science and promoting the use of alternative methodologies. The “Not Just Another NAMs Meeting” served as a catalyst for meaningful conversations, connections, and collaborations, driving the field of NAMs forward and fostering a more ethical, scientifically advanced, and animal-friendly approach to research and testing.

We are pleased to announce the results of the 2023 HESI Board of Trustees and Emerging Issues Committee vote! The below slate has been unanimously elected via electronic ballot and was approved at the June 6th Board meeting in London. Thank you to everyone who participated in the voting process and a big congratulations to our new and returning Trustees and EIC members!

Current list of the Board of Trustees is available here.
Current list the Emerging Issues Committee is available here.

HESI Board of Trustees 2023 Nominees:

• Warren Casey, National Institute of Environmental Health Sciences*
• Dorit Donoviel, Center for Space Medicine, Baylor College of Medicine
• Eliana Munarriz, University of Buenos Aires*Justin Teeguarden, PhD, Pacific Northwest National Laboratory
• Carole Yauk, University of Ottawa*
• Karissa Adkins, Sanofi*
• Jessica LaRocca, Corteva Agriscience
• Elise Madison Lewis, Charles River Laboratories

HESI Emerging Issues Committee 2023 Nominees:

• Ronald Hines, Yale University School of Public Health*
• Yasunari Kanda, National Institute of Health Sciences, Japan*
• Athena Keene, Afton Chemical Corporation
• Heike Laue, Givaudan Schweiz AG
• Norbert Tavares, Chan Zuckerberg Initiative

*Designates re-nominees

Our sincere thanks, on behalf of the entire HESI Board and organization, to Trustees Dr. Charlene McQueen and Dr. Jerry Lee who rotated off the Board at the close of the meeting.

Dr. McQueen served from 2008-2023 and is a former Board Secretary, Chair of the HESI Communications Committee, and Executive Committee member. Her many years of dedicated service and support to HESI have been invaluable.

Dr. Lee served from 2015-2023 as a Trustee and an inaugural THRIVE Advisory Board member and THRIVE program advocate. His efforts to build connections with the US White House Cancer Moonshot have had a lasting positive impact on HESI.

HESI would also like to thank Drs. Kathleen Shelton and Jon Cook for their service as they both retired from their professional organizations as well as HESI in the past year.

We are very pleased to announce TWO NEW ADDITIONS to the HESI STAFF!

Dr. Julie Krzykwa holds a PhD in Biology from Texas Christian University under the guidance of long-time HESI collaborator and advocate, Dr. Marlo Jeffries. Dr. Krzykwa’s dissertation research on fish embryo acute toxicity test (OECD 236) was awarded a SETAC/Procter & Gamble Fellowship for Doctoral Research in Environmental Science and received a STARS and Ida M. Green Fellowship awards from TCU. She also brings post-graduate experience as a contractor to the USEPA working on aquatic toxicity testing methods and as Study Director (ecotox) for Smithers contract laboratory. Dr. Krzykwa will work on the Next Generation EcoRisk Project, UVCB Committee, and the Botanical Safety Consortium.

Dr. Claire O’Brien holds a PhD in Pharmacology and Toxicology from the University of California, Davis, and an MPH in Environmental Health from San Diego State University. She comes to HESI with experience a Regulatory Specialist at a biotech company where she helped to develop a regulatory strategy for bringing innovative infant nutrition products to market. She also has experience in safety assessment and toxicology of dietary supplements, educational outreach on environmental health topics within a community setting, and as a lead clinical trials coordinator for a major research study. Dr. O’Brien will work on the Cardiac Safety Committee, PBPK Committee, and the PATB Committee. She will start with HESI at the end of June.

Welcome Claire and Julie!

The GTTC hosted a pre-workshop “Quantitative Interpretation of Genetic Toxicology Dose-Response Data for Risk Assessment and Regulatory Decision Making: State of the Science, Applications and Persistent Challenges” on 15 May that was attended by over 130 delegates from around the world. Dr. Connie Chen presented opening remarks to kick off the workshop. The scientific meeting also featured speakers and work from the committee. The program is available here.

The Cardiac Safety Steering Team presented the second webinar series featuring the 2023 Early Career Seminar Series Awardees on May 19th. Dr. Louise Hesketh presented “Utilising the prodrug concept and translational ex vivo animal models to assess and improve the therapeutic index of antiarrhythmic drugs.” This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment. A video recording can be viewed here.

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 was featured as part of the ISCT 2023 Annual Meeting “Translational Pathway Program” in a session entitled “Progress and Challenges with Gene Editing”.

Transforming the Evaluation of Agrochemicals (TEA): Opportunities towards the integration of established science into a Modern Approach to Testing and Evaluation (MATE)

The TEA Committee hosted their TEA MATE workshop on June 9th in London, UK. The purpose of the workshop was to identify and integrate relevant new science to enhance and advance the TEA project in the context of broader community engagement.

The meeting objectives were to educate a broad community of stakeholders about the work of the TEA committee and associated opportunities for potential collaborations (including across HESI committees) and identify the needs to be fulfilled to address the TEA mission of revamping the existing safety evaluation paradigm for crop protection products.

The workshop led to the identification of potential case studies illustrating the areas of the TEA project that are already operational. Additionally, the meeting expanded the community of parties interested in collaborating on this project while also enhancing cross HESI committee interactions and collaboration among stakeholders.

HESI DART science advisor Dr. Steven van Cruchten (Antwerp University) is a featured speaker in the “Applications of New Approach Methods in Developmental and Reproductive Toxicology Symposium” scheduled for 28 June 2023. His talk “How to Gain Confidence for Using NAMs in the Regulatory Arena of DART Testing” will highlight committee work. For anyone wanting to learn more about DART committee activities, contact Drs. Connie Chen and Shermaine Mitchell-Ryan who will both be in attendance!

Please join us for an upcoming webinar, organized by the HESI Next Generation Ecological Risk Assessment Committee. Dr. Jochen Zubrod of Zubrod Environmental Data Science will present ongoing research related to machine learning & species sensitivity. Register on the event page here.

The HESI DART committee is organizing a Fall workshop which will focus on applications of DART principles to fit attributes of antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs) and other oligonucleotide therapeutics and highlight gaps and challenges associated with determining the most appropriate strategies to account for potential risk to a varied patient population and spectrum of disease conditions. Considerations unique to oligonucleotide therapeutics for DART evaluations that will be discussed include mechanism of action/target engagement, dosing schedule, toxicokinetics and biodistribution, and species or model selection and validation. Speakers will represent institutions actively working in oligonucleotide therapeutic development and will deliver case study examples to illustrate various DART considerations. However, most of this workshop will be reserved for discussion rather than presentation. Reviewing existing DART strategies and initiating discussion on how to address gaps and challenges will help advance the field toward a fit for purpose and robust characterization of DART risk for this class of compounds. Registration will open later this summer. For more information, please visit the event page (here) or contact Connie Chen.

HESI sets itself apart from many other nonprofit organizations through its distinctive approach to collaborative science. This approach enables us to fulfill our mission and implement practical and meaningful changes by incorporating input and consensus from a multi-sector, international perspective.

With our knowledge of the ever-evolving landscape, new technologies, and budgetary pressures, the HESI board challenged us in 2016 to diversify our resources to fund our vital work. In that same year, HESI received its first grant, funding a novel research project. Since then, we received more than $5 million USD in grant funds in support of six different HESI Scientific Committees. These funds have not only expanded our reach and deepened our impact but also further enhanced the existing investments made by HESI Committees.

While we celebrate these accomplishments, we recognize that there is still more work to be done. As I approach my first year as the HESI Associate Director for Program Development & Resourcing, I am continually thinking about strategies to ensure the organization’s continued growth and success. I invite all of you to consider potential new partnerships with HESI that would benefit our mission.

With best regards,

Jennifer Pierson, MPH
HESI Associate Director for Program Development & Resourcing