HESI Insights - September 2019

CT-TRACS Committee in Berlin, Germany

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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”. 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.

Environmental Epidemiology Focus Group Meetings

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The HESI Environmental Epidemiology Committee has two upcoming focus group meetings planned for 2 October 2019 in Houston, Texas and 6 December 2019 in Atlanta, Georgia. Both meetings will engage local government regulators, academic researchers, and industry scientists in a dialogue on the use of epidemiology and exposure assessment. The goal of these meetings is to identify incentives and barriers to conducting epidemiology for risk assessment, and develop areas of consensus and paths forward toward fully utilizing and leveraging environmental epidemiology for public health decision making. For more information, please contact Sandrine Deglin (sdeglin@hesiglobal.org) or Connie Chen (cchen@hesiglobal.org).

Save the Date!
HESI 2020 Annual Meeting

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Save the date! The HESI 2020 Annual Meeting will be held 9-10 June 2020 in Amsterdam, Netherlands at Kimpton DeWitt Hotel in Amsterdam. Stay tuned for more information on the agenda, speakers, room blocks, and more.

Genetic Toxicology Technical Committee (GTTC) Workshop

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The HESI Genetic Toxicology Technical Committee (GTTC) will be holding a workshop titled “OECD Assessment of Miniaturized Ames Assays: Results and Recommendations” during the Environmental Mutagenesis and Genomics Society (EMGS) meeting on 19 September 2019 in Washington, DC. More information, including an agenda, can be found via the website here.

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 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.

RISK21 Committee Risk
Assessment Summit

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The HESI RISK21 Committee will be hosting a Risk Assessment Summit on 18-19 February 2020, in Washington, DC. This event will provide a platform to a broad group of stakeholders to discuss scientific, transparent, and efficient approaches to risk assessment, and to identify risk assessment challenges. It will also create an opportunity to share risk assessment case studies illustrating the key concepts and principles underpinning the RISK21 framework and its applications. For more information, please email Michelle Embry (membry@hesiglobal.org) or Sandrine Deglin (sdeglin@hesiglobal.org).

From the Leadership

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I am using my space this month to celebrate HESI’s international reach. Although we are based in the U.S. – our program participants hail from five continents. Over the next few months HESI staff and projects will be in Japan, Brazil, Cuba, Finland, Spain, Canada…and that is only what is on the books as of now! During the coming months, the HESI Board of Trustees will also undertake active plans to further expand our global engagement into those regions and countries where HESI has traditionally been less active (e.g., Africa, Southeast Asia, etc.) The quality of human and environmental health has never been more globally connected than it is now. HESI is committed to studying and serving these connection points to help realize improvements worldwide.

Syril D. Pettit, DrPH, MEM
HESI Executive Director

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