HESI Insights - January 2021

HESI science is advancing the use of alternative methods! The recent US Food and Drug Administration (FDA) report on “Advancing New Alternative Methodologies at FDA” includes mention of several HESI programs:

• HESI Botanical Safety Consortium
• HESI Cardiac Safety Committee
• HESI Developmental and Reproductive Toxicology (DART) Committee
• HESI Genetic Toxicology Technical Committee (GTTC)

The report aims to highlight the progress the US FDA has made in integrating alternative approaches into FDA regulatory programs, and the inclusion of so many HESI programs further demonstrates the impact of HESI science on the global scientific community.

Click here to read the full report.

In 2019, the HESI Cardiac Safety Committee was awarded a multi-year U01 grant. This multi-year grant will support HESI in procuring and managing novel, in vitro experimental studies to develop targeted mechanistic data to inform drug safety assessment for key cardiac “failure modes”. The project includes a total of eight subgrants awarded for pilot studies with promising new technology platforms to assess specific cardiovascular liabilities. The last three of these subgrants were awarded recently to Dr. Gina Smith (Covance), Dr. Alex Savtchenko (Nanotools Bioscience), and Dr. Joe Wu (Stanford University).

Dr. Smith will use an in vitro microfluidic model of the human cardiovascular system that mimics blood vessels, with the goal to screen for inflammatory responses from drugs or chemicals. Dr. Savtchenko will use an optical pacing technology coupled with deep learning algorithms to explore cardiotoxicity in drug candidates. Dr. Wu aims to identify endothelial cell injury using a stem cell model and transcriptomic analyses.

For questions about this grant or the HESI Cardiac Safety Committee, please contact Jennifer Pierson (jpierson@hesiglobal.org).

Earlier this week, the HESI Board of Trustees met to review scientific programs, progress the strategic plan, and set goals for 2021. Throughout the course of two days, the HESI staff and Board reviewed the organizational status, achievements, and scientific portfolio, in addition to outlining ongoing plans to increase both global and academic outreach.

Over the next several months, the Board will continue work to progress both the academic and global outreach initiatives, as well as finalize the organization’s strategic plan and scientific foresight documents. For more information on these efforts, please contact HESI (hesi@hesiglobal.org).

In case you missed it, check out the recent Botanical Safety Consortium (BSC) December 2020 newsletter! The BSC was officially convened in November 2019 as the result of a Memorandum of Understanding (MOU) between the US Food and Drug Administration (FDA), the National Institute of Health’s National Institute of Environmental Health Sciences (NIEHS), and the non-profit Health and Environmental Sciences Institute (HESI). The BSC is a multi-partite, multi-stakeholder, international effort that brings together key scientific experts to enhance the botanical safety toolkit and bring clarity to botanical dietary ingredient assessments. It was formed to provide a sound scientific basis for integrating existing botanical safety and toxicity information with the latest toxicological tools.

Check out the full newsletter for more information on upcoming BSC events, how to get involved, technical working group updates, and more.

The HESI eSTAR Committee has co-organized a webinar with the American Association of Pharmaceutical Scientists (AAPS) titled “Journey of Biomarkers: From Discovery to Qualification.” This 11 February 2021 webinar is free and open to the public, so please feel free to share the link! Webinar details can be found below or on the AAPS website.

• Webinar Title: Journey of Biomarkers: From Discovery to Qualification
• Presenter: Dr. Alison Harrill (National Institute of Environmental Health Sciences)
• Date: 11 February 2021
• Time: 12:30 PM to 2:00 PM EST
• Cost: Free and open to the public
• Registration: Register here

For more information, please contact Dr. Syril Pettit (spettit@hesiglobal.org).

Save the date! The 2021 HESI Annual Meeting will be held virtually on 9–10 June 2021. Don’t miss the chance to hear from health and environmental scientists from around the world.

Stay tuned for program and registration details.

For the January edition of Insights, I want to highlight the topics discussed at the HESI Board of Trustees meeting earlier this week on 11–12 January. The HESI finances are sound and will allow us to continue our work as well as to support the initiatives discussed below. Significant progress was made on two Board strategic initiatives despite COVID-19. The global outreach initiative, led by Martin van den Berg, summarized our efforts to build global networks which will lay the foundation for future collaborations. The academic outreach initiative, led by Charlene McQueen, summarized our efforts to enhance academic participation and will include an award to recognize academic leadership. To guide HESI’s future plans, the science foresight initiative will be used to guide and prioritize strategic tactics and our scientific committees. A large portion of the meeting focused on progress made by HESI scientific committees and ways to strengthen the interaction between the Board and the committees. Lastly, we discussed our plans for the June meeting, which will likely be held virtually to allow flexibility for those who want to attend.

Let me end by acknowledging that everyone is weary of the pandemic, but I urge you to remain vigilant as the second wave of COVID-19 continues. Please wear masks, practice social distancing, and wash your hands while we wait to be vaccinated. Science is winning, so please keep your resolve!

Again, thank you for your contributions to advancing HESI’s mission during this challenging time. Best regards,

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