Welcome to November Insights. Inside this edition: EnviroTox Database, Bioaccumulation Assessment Tool, and more!
November Insights
Database and Tools Available to Support Ecological Threshold of Toxicological Concern (ecoTTC) Approach
The HESI Animal Alternatives in Environmental Risk Assessment Committee is happy to announce the availability of the EnviroTox Database and analysis tools, freely available at www.envirotoxdatabase.org. The database and tools were developed via a global, collaborative partnership with government, academia, and industry, managed by HESI. The official launch of the site occurred at a special SETAC reception on 6 Novemeber 2018 in Sacramento, CA, with approximately 80 people in attendance.

The site includes a database of approximately 91,000 curated aquatic toxicity records with a user-friendly database filtering interface. This interface allows various search filters to be applied to create subsets of target data that can then be evaluated using the available tools. A predicted no-effect concentration (PNEC) calculator can be applied to these data to derive an ecoTTC distribution, or the dataset can be evaluated directly via the chemical toxicity distribution (CTD) tool. A full description of the database and analysis tools is included in the accompanying user’s guide on the website.

A manuscript detailing the database will be submitted for publication before the end of the year, and several others are in development. The committee is actively looking for ideas and partners to test the approach and help with case studies. Contact Michelle Embry ( membry@hesiglobal.org) for information on this project.
Bioaccumulation Assessment Tool Version 1.0 Now Available!
HESI is proud to have been a partner on the Bioaccumulation Assessment Tool (BAT) Version 1.0 , which is now publicly available. The BAT was developed by ARC Arnot Research and Consulting with the involvement of stakeholder representatives from academia, government, and industry and was funded by a Cefic-LRI grant.

The BAT provides a consistent and transparent quantitative weight-of-evidence approach to aid bioaccumulation assessment decision-making. It guides the user through data collection, generation, evaluation, and integration for various lines of evidence. 

Of particular interest to recent HESI work, in vitro biotransformation data, such as that generated from the recently adopted rainbow trout OECD Test Guidelines ( 319A and 319B ) can be entered into the tool and evaluated, providing an easy way for users to integrate these data into their evaluations. 

The BAT can be downloaded for free after completing a registration form and obtaining a password. If you have questions or require additional information about the BAT, please contact Jon Arnot ( jon@arnotresearch.com ). 
Translational Science Symposium in Tokyo
Professor Yuko Sekino (University of Tokyo) presented at the Science on Facilitating Advancement of Innovation and Regulation ( S-FAIR ) symposium on “Advancement of Innovation and Regulation in Translational Medicine on 12 October 2018 in Tokyo, where she emphasized the critical role that HESI has been playing to advance translational science. In her presentation on “The Organizational Function Needed in Japan to Facilitate Cross-Sectional Activities,” Professor Sekino introduced her experiences with HESI to realize the global standardization of the new testing system to evaluate cardiac safety pharmaceuticals using human induced pluripotent stem cell−derived cardiomyocytes (hiPSC-CMs). Her talk was well received by the audience, including both regulators and researchers, and prompted active discussions.
PATB Committee Workshop in Denmark
On 17–18 October 2018, approximately 30 scientists gathered in Copenhagen, Denmark, for the HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee’s workshop on “Bioinformatics Approaches to Assess Safety of Novel Proteins in Relation to Food Hypersensitivity . Through presentations and panel discussions, participants were exposed to bioinformatics and novel approaches used for the identification of potential food allergens.
The proceedings and discussions from this workshop will be captured in a publication, and further information about the workshop can be found here
HESI at SETAC North America

Sandrine Deglin gave a poster corner presentation on the HESI UVCB Committee’s substance mapping initiative at the SETAC North America meeting in Sacramento, CA, on 8 November 2018. A companion poster that provided an overview of the committee was presented by Daniel Salvito (RIFM) in the same session. The committee is holding a small workshop on 10 - 11 December 2018 in Washington, DC entitled “From Mapping to Identification: Paving the Way to UVCB Risk Assessment” to advance the work presented in the SETAC mapping poster and develop a path forward for the committee. For more information on this project, contact Sandrine Deglin ( sdeglin@hesiglobal.org ).
THRIVE Letters of Intent Deadline Extended  

HESI THRIVE , a partner in the 2018 Biden Cancer Initiative , 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 and/or other major institutions. For details on eligibility, funding, the application process, and key deadlines, please click here .

The letters of intent deadline has been extended to 30 November 2018. If you have submitted a letter of intent and not received a confirmation email, please resubmit to ensure we have received your application. For more information, contact research@hesithrive.org.
Upcoming Events

Save the Date!

Cardiotoxicity Workshop at FDA

Save the date for the upcoming FDA- and HESI-sponsored workshop on “Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities.” This event will be held in the FDA Great Room at the White Oak campus in Silver Spring, MD, on 29 March 2019 . Invited speakers will highlight cardiac safety liabilities, including arrhythmias, contractile dysfunction, myocardial injury, and more and how we might use hiPSC-CMs to detect and reduce these liabilities. More details and registration are coming soon. Please direct any questions to Jennifer Pierson ( jpierson@hesiglobal.org ). 
Thyroid Hormone Assessment Workshop
The HESI Developmental and Reproductive Toxicology (DART) Technical Committee and the European Teratology Society (ETS) will hold a 2-day workshop on 9−10 May 2019 in Washington, DC, to address the state of the science of thyroid hormone assessment testing in young rodents in regulatory settings and improving data interpretation of thyroid changes and their relationship to adverse outcomes. Results of the HESI-ETS historical control survey/database will also be presented. Registration will open in early 2019. Space will be limited, so mark your calendars now! For more information, please contact Connie Chen ( cchen@hesiglobal.org ). 
From the Leadership
As we approach the end of the 2018—which is simply hard to believe—it’s time to reflect on the events and accomplishments of the year. For HESI, year number 29 was a busy and productive one. The committee meetings, workshops, publications, and presentations are simply too many to list here, but participation in the Biden Cancer Summit (see the October 2018 Insights ) is a major highlight of the year. Additionally, as we look ahead to 2019, HESI will no longer be part of the International Life Sciences Institute (ILSI), a decision that has been communicated to our membership throughout the year. As November is the time we stop to consider what we are thankful for (at least in the United States), I want to say a very big “thank you” to our technical committees who have worked tirelessly to continue to develop the broad scientific portfolio that HESI has advanced in human and environmental safety sciences. Participation in the Biden Cancer Summit is an acknowledgement that our programs are having impact in our technical disciplines and in the general community. I also want to acknowledge our members whose support has enabled the development and growth of the scientific contributions of HESI since our inception. Finally, our staff under the leadership of Syril Pettit is highly engaged in our work, and their commitment to our programs has enabled HESI to sustain high-quality science and expand our visibility around the world.
Lois Lehman-McKeeman
HESI Chair
Health and Environmental Sciences Institute (HESI)
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