HESI Insights - May 2023

HESI and the FDA will host a workshop to engage invited stakeholders and key opinion leaders with expertise in the assessment of nitrosamines (NA), including Nitrosamine Drug Substance-related Impurities (NDSRI) detection and evaluation in order to achieve the following:

• Provide a high-level synthesis of key areas/objectives of current research on NA detection and evaluation;
• Identify short-term (1-2 years) research needs that can address data gaps required to improve nitrosamine (NA) risk assessments;
• Identify mid-term (3-5 years) and long-term (5+ years) research needs to improve nitrosamine (NA) risk assessments;
• Discuss potential opportunities and forums to realize the identified research gaps (e.g., FDA-initiated Public Private Partnership , existing or new consortial efforts, grants, private sector research efforts, etc.)
• Develop a NA-research roadmap in support of an uninterrupted drug supply that is also protective of public health.

Note: In-depth technical discussions of data sets or methodologies are out of scope for this workshop. Similarly, regulatory policy discussions are also out of scope.

The Webcast is open all interested participants. Online viewers may submit comments via the chat feature. A moderator in the meeting room will review these comments and may introduce them into active discussion when/if feasible. Direct/live participation in the workshop is not available – the in-person event is by invitation only and is at capacity.

All of the meeting sessions (with exception of the breakout group meetings) will be broadcast live for viewing online via GoToWebinar. Online viewers may submit comments via the chat feature. A moderator in the meeting room will review these comments and may introduce them into active discussion when/if feasible.

To View the Agenda and Register for the Webcast: Click here for the Event Page

For questions, please contact hesi@hesiglobal.org

Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] to the nonprofit Health and Environmental Sciences Institute totaling $347,618 (U01FD006676-03S2). Approximately 80% of the workshop expenses ($39,000) are covered by U01FD006676-03S2. The remaining 20% of the workshop expenses ($10,000) are contributed by the nonprofit Health and Environmental Sciences Institute’s Genetic Toxicology Technical Committee (HESI GTTC). The HESI GTTC budget includes direct funding from multiple industry partners (www.hesiglobal.org) to support a range of genetic toxicology related research projects as well as substantial in-kind support from the GTTC’s academic, government, NGO, and industry partners.

The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The HESI DART Committee hosted its Spring Career Symposium on 12 April 2023. The symposium featured DART experts from various sectors and featured a keynote address, career panel and a networking session. You can view the symposium recording here.

The HESI Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee hosted a webinar by Dr. Jurek Kozyra of Nanovery, titled “Nucleic Acid Nanorobotics: A Novel Approach to MicroRNA Quantification” on April 18th. View the full webinar recording here.

The HESI Botanical Safety Consortium hosted a session titled “Botanical Safety Assessment: Updates from the BSC” at the 21st International Conference on the Science of Botanicals (ICSB).

From left to right:

• Session Chair: Dan Marsman, Proctor & Gamble
• Holly Johnson, AHPA – Analytical Tools to Support Botanical Safety
• Amy Roe, Proctor & Gamble – New Approach Methodologies for Screening for Hepatotoxicity for Botanicals as Complex Mixtures

The Cardiac Safety Steering Team presented the first webinar in the 2023 Early Career Seminar Series on April 18th. Dr. Loukia Yiangou, Leiden University Medical Center, presented a talk titled “Human pluripotent stem cell models and their use in cardiac disease modeling, cardiotoxicity and drug screening”. The full recording can be viewed here.

This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment.

The next seminar will be by Dr. Louise Hesketh, King’s College London on May 19th.

The Protein Allergens, Toxins and Bioinformatics committee presented a poster at the 16th ISBR Symposium (ISBR2023) 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”, presented by PATB co-chair Andre Silvanovich (Bayer CropScience), featured 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.

The HESI GTTC held their Annual Meeting from May 7-9th, 2023. We were pleased to have 50 in-person attendees and an equal number of virtual attendees engaged throughout the meeting discussing the current progress and output of its working groups, potential projects and meaningful ways of engaging and developing the next generation of genetic toxicologists. Although the meeting agenda was very full, committee members found ways to relax as well (see photo).

Meeting materials will be made available to all members in the next week.

The HESI Developmental and Reproductive Toxicology Technical Committee hosted its annual spring business meeting in Washington DC at the HESI offices on 11 May 2023. Meeting details can be viewed on the event page HERE and meeting materials will be made available to committee members in the coming weeks.

The GTTC is pleased to be hosting 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. Dr. Connie Chen will be presenting opening remarks to kick off the workshop. The Scientific meeting will also feature speakers and work from the committee. The program is available 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.

Meeting registration is now closed. To view the agenda click 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.

As I come up to the start of my second year as Chair of the Board of Trustees, it is a good time to reflect on all the exciting things we have planned in the coming months. Forefront in our minds is our upcoming annual meeting to be held in London June 7-8th 2023. We are delighted to be hosting this jointly with the NC3Rs, an outstanding organisation that has worked for many years to find alternatives to the use of animals in research. The meeting is entitled ‘Not just another NAMs meeting’ since we will be focused on tangible steps towards our goal of the use of NAMs in decision making (see meeting details here). I recently spent time at several data science/AI meetings (AR-BIC and MCBIOS) where the main theme was how these new approaches can be used in regulatory science – a very interesting and challenging topic but an area where great progress is being made.

I am also delighted to see that the next HESI Cardiac Safety Early Career Seminar will be given (or has just been by the time you read this!) by Dr. Louise Hesketh from Kings College London. Dr. Hesketh has done outstanding work on improving the therapeutic index of antiarrhythmic drugs – do connect in and listen to her on May 19th!

Meanwhile, I look forward to seeing you in London at the annual meeting to catch up with friends and colleagues and make new ones!

With best regards,

Ruth Roberts, PhD, FRSB, FRCPath, HESI Chair of Board