HESI Insights - July 2021

HESI Scientific Program Manager, Connie Mitchell, gave a keynote lecture at the 11^th Congress of Toxicology in Developing Countries (CTDC11) last month. Her talk, titled “The Botanical Safety Consortium: A Public-Private Partnership to Enhance the Botanical Safety Toolkit,” included updates on the Botanical Safety Consortium (BSC)’s progress and future plans as well as current research on botanical toxicity testing.

To learn more about the BSC or to get involved, click here or contact Connie Mitchell (cmitchell@hesiglobal.org).

HESI announces a new Open Science Challenge: Innovation in Characterizing Drug Exposures During In Vitro Cardiovascular Safety Mechanistic Assay Systems. This challenge comes from the HESI Cardiac Safety Committee U01 Advisory Team. They are seeking ideas (theory or tested) to help understand the robustness and reproducibility of mechanistic in vitro assay systems. Idea submissions are due 23 July 2021. A later call for proposals will be issued to fund and test the winning idea(s). Learn more here or contact Jennifer Pierson (jpierson@hesiglobal.org).

The Society for Birth Defects Research and Prevention (BDRP)’s 2021 Annual Meeting recently concluded. Several sessions focused on pregnant and lactating women, including the HESI DART Committee’s featured symposium “Nonclinical Considerations for Inclusion of Pregnant and Lactating Women in Clinical Trials,” which was held on 29 June 2021. The recorded symposium is on-demand for the next 90 days, and the white paper that prompted the symposium is being finalized and should be published by the end of the year. If you have any questions, please contact Dr. Connie Chen (cchen@hesiglobal.org).

Earlier this year, the HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee received an expertise request to present at the Next Generation CAR & T-Cell Therapies Conference in June 2021.

On 22 June 2021, CT-TRACS Committee members Prof. Gilbert Fruhwirth (King’s College London) and Dr. Mya Thu (VisiCELL Medical) provided an oral presentation titled “Creating a Feedback Loop Between Clinical Trials and Translational Science for Product Improvement.” Prof. Fruhwirth and Dr. Thu presented insights based on the committee’s recent publication, “Options for Imaging Cellular Therapeutics In Vivo: A Multi-Stakeholder Perspective,” and took part in a live Q&A with other speakers from the session. Through the Q&A session, Prof. Fruhwirth and Dr. Thu explained how current experiences show that non-invasive in vivo cell tracking technologies and methods can provide unique opportunities to optimize the efficacy of cell-based therapies and aid in the assessment and management of eventual toxicities, offering this as a path toward creating a positive feedback loop mechanism between clinical trials and translational science for safety and general product improvements.

The slides and recording of the presentation will be available in the “Events” section of the CT-TRACS Committee page in the coming weeks. For more information, see the conference website or contact Dr. Lucilia Mouriès (lmouries@hesiglobal.org) or Dr. Connie Chen (cchen@hesiglobal.org).

HESI congratulates Dr. Carole Yauk for earning the University of Ottawa Canada Research Chair in Genomics and the Environment! Dr. Yauk’s research addresses an urgent need to modernize the toxicological risk assessment of environmental chemicals. She will develop and deploy genomics approaches that measure how toxic chemicals can alter the function of genes or damage genetic material. Her laboratory will work with regulatory and industry partners to determine the best use of this information to predict toxicological risks to humans and wildlife.

Read the full University of Ottawa announcement here.

Save the date! The HESI Immuno-Safety Technical Committee (ITC) Science Outreach Group is hosting an Immuno-Safety Career Webinar on 16 September 2021. The group aims to increase awareness about careers in the immuno-safety and immuno-pharmacology fields, with a target audience of graduate students, post-docs, and early career scientists. This webinar will allow meaningful Q&A interactions between the audience and speakers to give insights on their respective career pathways.

Stay tuned for additional program and registration details.

The HESI Immuno-Safety Technical Committee (ITC) will present its work at the EUROTOX Virtual Congress 2021 on 28 September 2021. Additionally, Dr. Syril Pettit, HESI Executive Director, will participate in the EUROTOX/Society of Toxicology (SOT) debate as the SOT debater on 28 September 2021.

Tuesday, 28 September 2021
1:00 PM – 2:00 PM BST
EUROTOX/SOT Debate

• SOT Debater: Dr. Syril Pettit, HESI

Tuesday, 28 September 2021
2:00PM – 4:00PM BST
Session 28 – Symposium
Preclinical Immune-Safety Evaluation of Immuno-Oncology Therapies

• HESI Immuno-Safety Technical Committee (ITC)
• Chair: Curtis Maier, GlaxoSmithKline

For the July edition of Insights, I want to highlight our June Board of Trustees meeting and our Annual Scientific Meeting, which were held virtually on 8 and 9 June 2021, respectively. The Board of Trustees reviewed the significant progress of the Academic and Global Outreach Initiatives. The Academic Outreach Strategy Team is providing financial support to committee initiatives, organizing outreach site visits to universities (albeit still virtual), and launching the HESI Innovation Prize, which will recognize a public-sector scientist whose research promotes health equity. The Global Outreach Strategy Team is supporting an electronic Distance Learning Training (eDLT) tool developed by WHO and the Thailand government, and is in exploratory conversations with WHO to advance other risk assessment initiatives. These efforts led the group to propose the formation of a HESI Risk Assessment Training Center, which was endorsed by the Board of Trustees. The Board also provided input on the Science Foresight document, which will provide strategic guidance for future programming, and welcomed new members to the Board of Trustees and Emerging Issues Committee.

Our usual two-day scientific meeting was reduced to one day because it was being held virtually. The morning session highlighted HESI’s impacts, described new initiatives for 2021, and reviewed the Science Foresight document. Three HESI projects were highlighted and included advance sequencing technologies (Dr. Mick Fellows, AstraZeneca), ototoxicity (Dr. Rick Neitzel, University of Michigan), and drug-related thrombosis (Dr. Marjory Brooks, Cornell University). If you are interested in participating in these projects, please reach out to the HESI staff. The afternoon session discussed how learning from the COVID-19 pandemic can affect the future of human and environmental health safety assessment. Dr. Donna Rivera (US FDA Oncology Center of Excellence) moderated the session, which included talks from Drs. Larry Updyke (Pfizer, Inc.), Frederic Béen (KWR Water Research Institute), Simon Funnel (Public Health England/WHO) and Meytal Avgil Tsadok (Deloitte Israel/Israeli Ministry of Health). It was an engaging session that highlighted how working across the academic, industry, and government sectors can accelerate drug development to protect public health.

Next January, the Board will meet in person at the HESI office in Washington, DC. A key goal will be to advance the plans outlined in the Science Foresight document. In addition, a virtual meeting between committee chairs and the Board of Trustees is planned. We are anxiously awaiting the resumption of routine face-to-face meetings!

Again, thank you for your contributions to advancing HESI’s mission. We have thrived during this difficult time because of your dedication and ingenuity!

Best regards,

Jon C. Cook, PhD, ABT, DABT
HESI President