HESI Insights - October 2019

HESI’s partnership base spans many thousands of miles from Washington, DC – 6,700 miles in fact! From 16-21 September 2019, HESI’s Executive Director, Dr. Syril Pettit, participated in lectures, outreach meetings, and scientific workshops in and around Tokyo, Japan. These visits provided an opportunity to exchange ideas and information on HESI’s diverse scientific portfolio as well as to learn about scientific priorities from HESI’s Japan-based stakeholder organizations. For example, in a visit to the Japan PMDA, Dr. Pettit met with regulatory scientists to discuss the ways in which HESI’s technical research is actively informing global safety approaches via organizations like the International Council for Harmonization (ICH), to learn about scientific challenges faced by the PMDA, and to better understand the many ways PMDA scientists are currently involved with HESI. Dr. Pettit (along with the former Commissioner of the U.S. FDA and the former Director of the PMDA) also lectured to more than 100 attendees of a conference on public-private collaboration and innovation at the University of Tokyo School of Medical Sciences. Special thanks are extended to HESI Trustee and University of Tokyo faculty member, Dr. Yuko Sekino, who accompanied Dr. Pettit at many of her outreach visits. According to Dr. Pettit, “Of the many visits I have made to Japan, this one stood out in one very important way – the active involvement of Japanese academic, government, and industry scientists in a range of HESI programs has grown to impressive new levels. It was incredibly rewarding and exciting to see so many of our colleagues proudly describe their active collaborations via HESI’s scientific committees.”

On 2 October 2019, the HESI Environmental Epidemiology Committee organized a very productive focus group at the Gulf Coast Consortia in Houston, Texas. This meeting engaged local government regulators (Texas Commission on Environmental Quality), academic researchers (Baylor College of Medicine, University of Texas School of Public Health, University of Texas Health Science Center), and industry scientists (Shell) in a dialogue on the use of epidemiology and exposure assessment in risk assessment and decision making. Via this kind of highly interactive workshop (two others were organized in 2018 in Washington, DC and Research Triangle Park, NC), we aim to identify a path forward to foster the realization of the full potential of epidemiology studies in risk assessment. A similar meeting will be organized at the CDC in Atlanta, Georgia, on 6 December 2019. For more information, please contact Sandrine Deglin (sdeglin@hesiglobal.org).

The HESI Immuno-safety Technical Committee (ITC), in collaboration with the U.S. FDA CBER, hosted a two-day workshop on the “Safety Assessment of Engineered T Cell Therapies” in September. This workshop engaged with over 700 participating scientists and 34 speakers across three continents. A proceedings is currently being developed along with discussions on potential areas HESI could contribute to this field.

The HESI CT-TRACS Committee will be represented at the upcoming “1st RESTORE Advanced Therapies Science Meeting” on 25‐26 November 2019 in Berlin, Germany, with committee member Beata Surmacz-Cordle (Cell and Gene Therapy Catapult, UK) presenting a poster on the committee’s new initiative “International Multi-Site Study – In Vitro Methods to Assess the Tumorigenicity of Human Cell-Based Therapeutic Products”. The CT-TRACS Committee also had poster in partnership with Cell and Gene Therapy Catapult at the Safety of Stem Cell-Derived Therapies: Trends and Future Technologies Meeting on 7-8 October 2019 in Edinburgh, UK. CT-TRACS opened a public call for participants in June 2019 to launch the initiative, through which the committee received expression of interest from over 10 organizations. RESTORE is a program funded by the European Union’s Horizon 2020 research and innovation program, with the unifying goal of helping the implementation newly developed Advanced Therapies in clinical routine to improve patients’ outcomes.

A three-day technical workshop was held at HESI offices in Washington, DC on 1-3 October 2019. The meeting was attended by 32 experts and focused on the state of the science and future research and regulatory needs for bioaccumulation assessment using fish models from eight different countries. This workshop follows the adoption of two OECD Test Guidelines (319A & 319B) in 2018 focused on estimation of intrinsic clearance using in vitro test systems in rainbow trout. Session topics included the current use of the in vitro methods and in vitro–in vivo extrapolation methods, improvements and refinements to the in vitro–in vivo extrapolation approaches, “second generation” in vitro methods and extrapolation approaches, and regulatory use and uptake. Output from the workshop will include a state of the science summary paper as well as several focused follow-up manuscripts detailing short, medium, and long-term needs related to research and coordination in this space. For more information on this work or the ongoing efforts of the HESI Bioaccumulation Committee, please contact Michelle Embry (membry@hesiglobal.org).

A one-day outreach session was held at HESI offices in Washington, DC on 4 October 2019 aimed at communicating new science to evaluate bioaccumulation of organic chemicals, including the new OECD in vitro biotransformation fish methods and use of the Bioaccumulation Assessment Tool (BAT). The course provided details on the OECD test methods, recent advances of in silico predictions of biotransformation, and integration of various lines of evidence into the BAT via hands-on examples. The course was organized in partnership with ARC (Arnot Research and Consulting) and the HESI Bioaccumulation Committee. Instructors included Karla Johanning (KJ Scientific), Heike Laue (Givaudan), Kellie Fay (U.S. EPA), Jon Arnot (ARC), Alessandro Sangion (University of Toronto / University of Insubria), Liisa Toose (ARC), and Michelle Embry (HESI). For more information on this work or the ongoing efforts of the HESI Bioaccumulation Committee, please contact Michelle Embry (membry@hesiglobal.org).

HESI is supporting a special session on “Publicly Accessible Data Analytic Tools for Environmental Toxicology, Chemistry, and Risk Assessment” at the upcoming SETAC North America Annual Meeting in Toronto that will highlight publicly-available tools in an interactive and informative session. Twelve different tools will be highlighted in this new format, with five minute overview presentations followed by live demonstrations on large video monitors stationed around the room. This “Genius Bar” type of format will allow participants at the meeting to receive hands-on interactions with the tool developers. The session will be held on Monday, 4 November 2019 starting at 1:00 PM in room 713A and is co-chaired by Michelle Embry (HESI), Carlie LaLone (U.S. EPA), and Nil Basu (McGill University).

HESI science will be well-represented at SETAC North America this year! See below for details on where you can catch HESI work in action.

Monday, 4 November 2019

• SF011: EnviroTox Database: Overview and Applications (Presentation & interactive demonstration by Ryan Otter, MTSU, on behalf of the HESI Animal Alternatives in ERA Committee)
• MP309: Holistic Assessment of Trophic Level Sensitives: A Big Data WOE Case Study (Poster by Kristin Connors, Procter & Gamble, on behalf of the HESI Animal Alternatives in ERA Committee)
• MP311: The Risk Assessment in the 21^st Century (RISK21) Web-Tool (Poster by Michelle Embry, HESI, on behalf of the HESI RISK21 Committee)

Tuesday, 5 November 2019

• 204: UVCB Risk Assessment Framework: Substance Identity and Characterization Considerations (Presentation by Sandrine Deglin, HESI, on behalf of the HESI UVCB Committee)
• 313: Biotransformation for Bioaccumulation Assessment: From In Vitro Data to In Silico Models (Presentation by Alessandro Sangion, University of Toronto; Michelle Embry, co-author)
• TP 234: In Vitro Biotransformation in Fish and Mammals: Differences and Similarities (Poster by Alessandro Sangion, University of Toronto; Michelle Embry, co-author)
• TP238: The Bioaccumulation Assessment Tool (BAT): Case Studies for the Assessment of Bioaccumulation of Chemicals in Both Air-Breathing and Aquatic Organisms (Poster by Liisa Toose, ARC; Michelle Embry, co-author)

Wednesday, 6 November 2019

• 418: Quantifying Conservatism in ecoTTCs and Chemical Toxicity Distributions: Case Study of Chemicals with Regulatory Water Quality Values (Presentation by Adriana Bejarano, Shell, on behalf of the HESI Animal Alternatives in ERA Committee)

• works proactively to bring together multidisciplinary teams to solve difficult challenges in risk assessment;
• fosters the development of meaningful studies that identify and ask the right questions and develop solutions that help to inform decision making;
• helps to develop understanding and consensus among groups that don’t always work together.