HESI Insights - December 2022

Did you know that HESI has 5 active grants or government funded programs in 2022? As a US-designated nonprofit 501(c)(3) organization, HESI is eligible to apply for and receive funding from a variety of sources to support scientific programs. These current funds are supporting large-scale, multi-site laboratory studies, staff time and scientific programming and many grant-funded programs are also expanded with in-kind work from our committee members. As we are all aware, scientific endeavors are becoming increasingly complex and require more time, effort and resources. HESI’s ability to bring both private and public sector scientists together to collaborate and share resources is one key to success. Interested in learning more about HESI’s grant funded programs? Contact Jennifer Pierson (jpierson@heisglobal.org).

HESI THRIVE has a received a 25k contribution from Bristol Meyer Squibb’s Grants and Giving Department to support a THRIVE seed grant award in the 2022-2023 cycle. If you and your organization would like to learn more about you can contribute to this initiative, visit the HESI THRIVE page on the HESI website.

The ITC Translational Safety Fc effector Function Project team is seeking case studies that illustrate nonclinical safety testing approaches on Fc-modified molecules. Key modification of interest include:

1. Fc silencing
2. Fc Enhancement
3. Half-life extension
4. Fcγ Blockade

The most informative case studies will be included in a White Paper that intends to review the impact f Fc modifications for enhanced or reduced FcgR-mediated effector function (FcgR and FcRn binding, complement activation and associated activities (ADCC, ADCP, CDC, immune cell agonism, extended half-life etc) on the translational pharmacology, pharmacokinetics, toxicology, immmunogenicity and developability of Fc-containing molecules.

If you have a case study to contribute to this effort or if you are interested in learning more, please contact the project lead, Frank Brennan (Frank.brennan@novartis.com) or HESI program manager Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org)

The Health and Environmental Sciences Institute (HESI) DART Technical Committee is attempting to understand how and when dystocia is identified and reported in laboratory rodents and to identify how these calls may differ between organizations. As such, we are gathering qualitative data from various laboratories and animal facilities that conduct or support DART studies to understand laboratory practices and standard operating procedures (SOPs). Information gathered via this forum will be used to inform a best practices manuscript which will serve as a useful industry-wide tool to standardize the identification of dystocia and improve animal welfare practices.

On behalf of the committee, we would like to invite you to participate in this electronic survey by answering questions about your laboratory’s practices regarding identifying and reporting dystocia in the rodent. Should you be interested, we would also be happy to schedule a 1-hour teleconference to conduct the survey in an interview style format. (* Please note, the electronic survey contains a set of reference responses to assist you in understanding the expected responses).

We appreciate your assistance and value your contributions to this effort. Please note that all survey responses will be blinded from member company representatives and access to original submissions will be restricted to the HESI scientific program managers assigned to this project.

Questions regarding the aims of the project or the survey should be directed to the either of the project co-chairs: Rashin Ghaffari (Rashin.Ghaffari@corteva.com) or Pragati Coder (Pragati.Coder@crl.com).

If you are willing to participate, please complete the survey by Monday, February 6th, 2023, or submit a request for an interview style survey.

Sincerely,

Shermaine Mitchell-Ryan PhD,  HESI Scientific Program Manager (smitchell-ryan@hesiglobal.org) &
Connie Chen, PhD, MPH, HESI Senior Scientific Program Manager (cchen@hesiglobal.org)

On behalf of the HESI DART Dystocia Working Group. Please don’t hesitate to contact us should you have any questions.

The HESI DART – Dystocia Working Group

Pragati Coder (Charles River Laboratories)*
Rashin Ghaffari (Corteva Agriscience) *
Catherine Jaussely (Bayer)
Christopher Bowman (Pfizer)
Curtis Grace (Merck)
Edward Dere (Genentech)
Isabelle Leconte (Charles River Laboratories)
Jason Manton (Exponent)
Narinder Barraclough (LabCorp)
Nicola Powles-Glover (AstraZeneca)
Sheila Wason (Bayer)
Sonya Sobrian (Howard university)
Warren Foster (McMaster University)

*Denotes WG co-leads

The GTTC has published a new paper on the tissue sampling design recommended in the revised OECD Test Guideline 488 for the transgenic rodent (TGR) gene mutation assay for use in studying mutations. Results indicate that the recommended study design (28-day sampling period following 28-day exposure) is suitable for germ cells in both slowly and rapidly proliferating tissues and recommend this study design as the preferred TGR assay design.

Read the full article here:
Impact of sampling time on the detection of mutations in rapidly proliferating tissues using transgenic rodent gene mutation models: A review. Douglas GR, Beevers C, Gollapudi B, Keig-Shevlin Z, Kirkland D, O’Brien JM, van Benthem J, Yauk CL, Young RR, Marchetti F. Environmental and Molecular Mutagenesis (October 2022). https://doi.org/10.1002/em.22514

Learn more about the HESI Genetic Toxicology Technical Committee

The HESI Botanical Safety Consortium hosted a webinar by Dr. Jeremy Billson (InoCardia) entitled “An In-Silico Method to Predict Cardiotoxicity in Botanical Substances”. This work is a pilot project, using a predictive model for cardiovascular liabilities with botanical constituents. Dr. Billson discussed the model, preliminary results, and next steps for the project.

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

Click to view the Event Page and Register!

HESI Annual Meeting: New Approach Methodologies for Safety Assessment – from Aspiration to Implementation
A joint HESI and UK National Center for the 3Rs Event

Join us for 2 days of thought-provoking and challenging discussions. What will it take to move NAMs sufficiently into practice to meaningfully modulate the current safety assessment paradigms for drugs, chemicals, foods, and consumer products? This interactive meeting will engage participants in discussion with NAMs developers, risk assessors, sponsors, mission-driven organizations, and other stakeholders. HESI and NC3Rs led efforts to advance NAMs will be highlighted. Registration and detailed agenda to be released in February 2022.

The HESI ITC seeks graduate students working in immuno-safety or immunotoxicology fields for a new HESI ITC Professional Development Award. This award offers an opportunity to attend scientific conferences, workshops, or courses, etc. to build core competencies and transferrable skills, and/or share your research. Awardees will also be welcomed to attend ITC’s Business meetings to learn about the emerging projects and science at HESI and to network with experts in the immuno-safety field.

• Award: Selected candidates will receive up to $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 – please described in the application form). Proof of attendance 30 days after such event is required to be submitted to ITC committee.
• Qualifications and Requirements: Eligible candidates must be currently enrolled in a graduate program (MS or PhD candidates) in immunology, toxicology, pathology, or related field (cell biology, biochemistry, or similar).
• Application: To apply, please send along the following: 1) completed application form, 2) CV or bioksketch, and 3) one reference letter from your mentor to itc@hesiglobal.org
• Deadline for submission: Friday, January 6th, 2023. However, applications will be reviewed on a rolling basis for approval.

If you have any questions about the HESI ITC or this award, please contact Dr. E’Lissa Flores or Dr. Shermaine Mitchell-Ryan.

Download Application Form HERE

HESI THRIVE is a seed grant program that is innovating translational research and improving quality of life after cancer. By providing researchers with both seed funding and access to critical networks, THRIVE enhances the visibility of the patient need, the value of the research, and the reasons that larger funding entities might elect to incorporate these research streams into future funding priorities.

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. The THRIVE grant program is designed to provide seed funding to investigators for the testing of initial hypotheses and collecting of preliminary data to help secure long-term funding by the National Institutes of Health (NIH) and/or other major institutions. This year, we have expanded this opportunity to accept international applications, broadening our reach and heightening the visibility of this important research area. For details on eligibility, funding, the application process, and key deadlines, please click here.

THRIVE will accept letters of intent starting 18 October 2022, and the letters of intent deadline is 10 January 2023. For more information, contact research@hesithrive.org.

HESI is seeking your suggestions for new scientific projects (human or environmental health) for consideration as an emerging issue in 2023. Proposals will be reviewed in early 2023, and one or more may be selected to form a new scientific collaborative program within HESI. Although this is not a grant, the selected program will receive support from HESI for scientific program design, coordination, and staffing.

Learn more about the HESI Emerging Issues Process on our website or download the proposal form here. The deadline to submit proposals is 12 January 2023. Don’t miss out!

The 2022-2023 HESI Innovation Prize will recognize public sector scientists who have helped to reduce disproportionate health burdens in underserved populations and/or to promote greater health equity. Both Mid-career ($75,000 USD) and Lifetime Achievement ($25,000 USD) awards will be offered.

Interested in applying? Click here!

Applicants must submit a short letter (maximum 5 pages) that includes examples of the impact of the nominee’s work in creating novel, cross-disciplinary collaborations in relation the year’s thematic focus. Applications must also include a CV (5-10 pages maximum) for the nominee, as well as 1-2 letters of support.

Nominations are being accepted until 31 January 2023

The Health and Environmental Sciences Institute (HESI) & Safety Pharmacology Society (SPS) present a new, on-demand training opportunity: A closer look at the new ICH E14/S7b Q&A’s and Training Materials. The target audience includes all sponsors (small and large; other stakeholders in pharma), safety pharmacologists and toxicologists participating in the delivery of the nonclinical data, clinicians, and regulators.

This training is being provided complimentary for SPS and HESI members, and offered to nonmembers for $49.00 USD until 31 December 2022.

Click to link to training course

Contact Jennifer Pierson at jpierson@hesiglobal.org for details.

Register now for the Immuno-Safety Technical Committee’s “Introduction to Immuno-safety Science” on-demand training course module.

This module features a collection of 16 lightening talks (~10-20mins) designed to introduce you to key concepts and tools that are essential to mastering fundamental knowledge within this discipline. All together this course will provide a comprehensive overview of the field in “bite size” digestible pieces suitable for professionals who need refresher or quick snapshot of the immuno-safety landscape to ground them in human risk and safety assessment as it pertains to agents that may modify the immune system. Register now and begin taking the course today at https://elearning.hesiglobal.org/ . Tiered pricing is available for graduate and post-doctoral trainees. Groups of 5 or more are eligible for a 20% discount, please contact Dr. Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org) for more information regarding the group discount rate.

As 2022 draws to a close and we head towards the holiday season it’s a perfect time to reflect on what has been another busy and productive year for HESI. There have been many highlights to look back on:

• The initiation of the HESI Global Risk Assessment Training Center (GRATC) to increase access and availability of foundational chemical risk assessment and training resources in low and middle-income and resource limited regions.
• The establishment of two new committees focused on Next Generation Ecological Risk Assessment and Targeted Protein Degrader Safety.
• A welcome return to an in person annual meeting where we awarded our first Innovation Prize to Professor Kenneth Olden, an exceptional scientist who has helped to advance health equity and who shares HESI’s commitment to creating a safer, more sustainable world through innovative collaborations.

There are many more of course, but you can read about these on the HESI website or in the HESI 2022 Annual Report which will be out in January.

There is also much to look forward to in 2023. We have evolved our Innovation Prize in recognition of the breadth of experience prevalent in the applications received in the first round, to include two awards, a mid-career award and a lifetime achievement award. We are accepting applications until the end of January so if you haven’t done so already, get your skates on (he says looking out of the window and seeing the ice currently covering the UK) and start compiling your nominations. There is also still time to submit project proposals to our Emerging Issues Committee to bring HESI’s expertise to bear on your human and environmental health research challenges. But what I am looking forward to most of all for 2023 is the annual meeting which this year takes place in London, UK and I’m delighted to say will be co-hosted by the NC3Rs. This will be such a great opportunity to connect with European colleagues on moving forward the application of NAMs into practice and we very much hope you will join us.

Finally, I want to take this opportunity to say “thank you” to all the staff at HESI, my fellow Board of Trustee members and all of you for your support and hard work over the last 12 months. I wish you all the best for a happy holiday season and I look forward to working with you all again in 2023.

With best regards,

Anthony Holmes, PhD, HESI President of Assembly