HESI Insights - August 2019


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Professor Robert Barouki (Paris Descartes University) will present the 2019 HESI CITE Lecture, “Toxicology in the Era of the Exposome,” at EUROTOX on 10 September 2019 from 1:30 to 2:30 p.m. The HESI Combining Interdisciplinary and Translational Expertise (CITE) initiative is an ongoing outreach series that promotes discussion and progress on opportunities for, and challenges in, the application of interdisciplinary, multidisciplinary, and translational sciences to improve human and environmental health outcomes. Professor Barouki’s research focus is on the study of the dioxin receptor (AhR) in the fields of health and the environment. His clinical focus is on the identification of new metabolic biomarkers for rare diseases. Click here for the full EUROTOX program.

Microbiome Committee in Nature Reviews Drug Discovery

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The HESI Microbiome Committee was referenced in Nature Reviews Drug Discovery (2018;17:383–384) for their work to address the state of the science and data gaps in gut microbiome research. The full article, titled “When Drugs Unintentionally Affect Gut Bugs,” is available here. Materials from the subsequent Microbiome Committee workshop are also available here.

Call for Participants:
CT-TRACS Multi-Site Study

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The HESI CT-TRACS Committee is seeking participants in an international multi-site study to test in vitro methodologies for tumorigenicity assessment of cell therapy products (CTPs). The call was announced on 30 June 2019, as part of the Pluripotent Stem Cells Manufacturing Experts Panel Meeting in Los Angeles, California.

  • Open Date: 30 June 2019
  • Application Deadline: 30 August 2019
  • Project Start Date: 27 September 2019
    • In-person kick-off meeting at HESI facilities in Washington, DC
  • Title: “Predictive Methods to Assess the Tumorigenicity of Human Cell-Based Therapeutic Products In Vitro: A Multi-Site Replication Study”
  • Preliminary Materials From the MEASURE Study: Click here for preliminary materials, including presentations from Dr. Keiji Yamamoto (Takeda/FIRM, Japan), Dr. Yoji Sato (NIHS, Japan), and Dr. Takatoshi Koujitani (Sumitomo Dainippon Pharma, Japan).
  • Benefits for Participants:
    • Knowledge and know-how: Access preliminary data and protocols from the MEASURE studies; learn from a multi-disciplinary team of experts.
    • Data access: Access new data generated at all sites through this international study.
    • Leadership: Contribute to the study design with your expertise; help guide the evolution to a more data-driven characterization framework, rather than theoretical; and help lead the development of new standardized approaches for CTPs safety evaluation.
    • Authorship: Take part in publication opportunities and fostering open scientific interaction in the public domain.
    • Working group activities: This is an opportunity to benefit from other CT-TRACS working groups’ activities at no extra cost.

Click here to learn more about the study or to express interest. Please contact Lucilia Mouriès (lmouries@hesiglobal.org) with any questions.

FDA/CBER-HESI Workshop on the Safety Assessment of Engineered
T Cell Therapies

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The Immuno-safety Technical Committee (ITC) will hold a workshop in partnership with FDA/CBER in Silver Spring, Maryland, on 24–25 September 2019. The goal of this workshop is to discuss the preclinical and translational safety assessment of engineered T cell therapies. The workshop will focus on six topics, followed by an in-depth discussion:

  • Designing engineered T cells for optimal activity and safety
  • Target expression and associated liability assessment
  • In vivo models informing safety and activity
  • Safety of viral and non-viral gene delivery systems—utility, risk of genomic injury
  • Linking preclinical development with the clinical experience
  • Regulatory considerations

For more information and to register, please visit the website or contact Stan Parish (sparish@hesiglobal.org).

Interested in the Science of Fish Biotransformation in Bioaccumulation?

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Are you interested in hearing about new science to evaluate the bioaccumulation of organic chemicals? Would you like to learn how fish biotransformation can be integrated into bioaccumulation assessment? Do you want to hear about the new OECD in vitro biotransformation fish methods? Would you like to have training and experience using the Bioaccumulation Assessment Tool (BAT)? Plan to attend the HESI Bioaccumulation Committee Fish Biotransformation in Bioaccumulation Outreach Session on 4 October 2019 in Washington, DC. Registration is free! Contact Michelle Embry (membry@hesiglobal.org) for more details.

From the Leadership

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In the Northern Hemisphere where I live, summer can be a time of hot, sultry, and uncomfortable days. This year is no exception, with unusually high temperatures being recorded in the U.S. and Europe. For some, summer is a time for relaxing and holidays, but not so for HESI. There are several upcoming events of note. Michelle Embry, HESI Associate Director, will be presenting “Bridging the Gap with RISK 21: Risk Assessment in the 21st Century” at the Cellular and Molecular Mechanisms of Toxicity Gordon Research Conference on 14 August 2019. The HESI CITE initiative is sponsoring a lecture at EUROTOX on 10 September 2019; Professor Robert Barouki of Paris Descartes University will be presenting “Toxicology in the Era of the Exposome.” The FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T Cell Therapies will be held 24-25 September 2019 in Silver Spring, Maryland. Information on the workshop can be found here. I hope you have the opportunity to attend one of these events and hear for yourself what HESI is doing to create science-based solutions for a healthier world.

Charlene McQueen, PhD
HESI President

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