HESI Insights - August 2020
Don't miss your chance to provide feedback on HESI's Emerging Issues proposal, "Building Novel Methods and Science for Ototoxicity Detection and Prevention." Surveys are due 1 September 2020.
This proposal was received as part of HESI’s 2019-2020 Emerging Issues annual call for proposals. The Emerging Issues Committee received a total of seven proposals this year, and after careful review, determined that this Ototoxicity project had the most potential as a new HESI program. The proposal was presented by Dr. Laura Maurer (ExxonMobil Biomedical Sciences, Inc.) at the virtual 2020 HESI Annual Meeting in early June. If HESI receives enough interest via the 2020 prioritization survey, the proposal will be initiated as a new project in late 2020 or early 2021.
For more information about the proposal, please view the slide set describing the proposed project and the written project proposal. All HESI members are encouraged to complete the prioritization survey by 1 September 2020. If applicable and feasible, please work with your colleagues to provide one vote per organization.
HESI has been actively involved in the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative since the first workshop held in 2013. While much of the novel data collection has concluded, the CiPA Steering Team, managed by HESI Senior Scientific Program Manager, Jennifer Pierson (firstname.lastname@example.org), continues to meet and monitor the progress with the ICH S7B/E14 Implementation Working Group. The most recent updates regarding the ICH Q&As are now available on the CiPA website here.
HESI’s Botanical Safety Consortium (BSC) recently formed a Cardiotoxicity Technical Working Group and a Neurotoxicity Technical Working Group. The consortium is working to integrate existing botanical safety and toxicity information with the latest toxicological tools. We plan to use in vitro and in silico tools to test botanical ingredients and compare them to existing safety data. Each group will meet monthly via teleconference.
The early goals of each group are to:
- Bring in scientific and technical experts
- Define the mission and objectives of the group
- Select botanical ingredients based on existing safety data
- Select suitable in vitro and in silico techniques to evaluate toxicity with respect to cardiotoxicity and neurotoxicity
If you or anyone in your network is interested in joining the BSC, please fill out this form. If you would like to be on either of the technical working groups, please indicate that you wish to be considered for the Stakeholder Council or a Technical Working Group, then select "Technical Working Group," and select either "Cardiotoxicity" or "Neurotoxicity" and submit your CV.
The National Academy of Sciences (NAS) workshop on 12-13 August 2020 titled “Translatable and Accessible Biomarkers of Effect: From Model Systems to Humans” is highlighting a significant number of HESI programs. The programs featured include the HESI eSTAR Committee’s TGx-DDI Biomarker and Carcinogenomics Project (Dr. Carole Yauk, University of Ottawa), the HESI eSTAR Committee’s miRNA Biomarker Project (Dr. Brian Chorley, U.S. EPA), and the work of the HESI Biomarkers of Neurotoxicity Committee (Dr. Syed Imam, U.S. FDA). Additionally, Dr. Syril Pettit, HESI Executive Director, was featured as panelist for a session titled “The Role of Emerging Methodologies and Technologies in Biomarker Discovery and Translation.”
The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on “Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients” in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program. The webinar will take place on 3 September 2020 from 12:00 PM to 1:00 PM EST.
The webinar has the following objectives:
- To learn about available and emerging noninvasive cell tracking modalities and their benefits in assessing cell fate and safety in vivo
- To bring awareness on how the application of existing cell tracking technologies, methods, and best practices can benefit the clinical translation of cell therapies
- To emphasize the need for dialogue with the international community and discuss opportunities to address the challenges facing the translation of cell therapies into the clinic
- To understand the importance of therapy developers communicating practical challenges and needs to aid the development of enabling technologies and tools addressing those needs
The HESI PBPK Committee is co-sponsoring a symposium on 30 September 2020 with the U.S. Environmental Protection Agency and National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICETAM) on "Opportunities and Challenges in Using the Kinetically Derived Maximum Dose Concept to Refine Risk Assessment." Presenters will describe the incorporation of pharmacokinetics into the design of in vivo toxicity testing studies and discuss how the kinetically derived maximum dose can be useful in dose selection and other aspects of study design. The half-day symposium is open to the public and will be recorded.
With the global and still increasing spread of the COVID-19 virus, HESI remains committed to its mission of improving human and environmental health. Daily activities for many of us are still ruled by limitations, and online meetings have now become an essential part of our daily lives. Within HESI, staff members were already accustomed to organizing activities remotely prior to the onset of COVID-19. This experience, in combination with a strong ongoing motivation and commitment, has allowed all programs to continue operations remotely. For this, a big thanks to the HESI staff is surely in order!
Nevertheless, several recent initiatives taken up by HESI are now more difficult to commence. This is especially true for the Board of Trustees initiative to build HESI’s global presence that was recently introduced. Due to the large-scale global impact of the COVID-19 virus, the initial progress of this project has been slowed. The major aim of the initiative is to expand HESI's activities to continents with emerging economies, including Africa and South America. Capacity building with respect to human and environmental chemical risk assessment, the sustainable and responsible use of biocides and pharmaceuticals, as well as the transfer of basic toxicological and environmental knowledge are considered the main objectives.
Although the development of such initiatives has been slowed as the primary COVID-19 response is focused on prevention and health care, HESI is still examining new ways to support the global health community in light of the pandemic. In June 2020, HESI launched the international PROPAGATE Network to enhance COVID-19 testing methods in low-resource settings. Additionally, the HESI Cardiac Safety Committee is working to share information and data related to cardiac liabilities and some potential COVID-19 therapies, as well as exploring ways to use some of the latest approaches to better understand and help inform cardiac risks. While we continue to examine ways HESI can contribute to the COVID-19 response efforts, we will also pursue our mission of improving human and environmental health.
Martin van den Berg, PhD, ERT