2019 HESI Annual Meeting
June 11, 2019 – June 12, 2019
Alexandria, Virginia, USA
Past Events
Past Events
HESI PATB Public Webinar – Emerging Opportunities and Innovations in Biotechnology and Food Safety Assessment
May 22, 2019
The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) Committee will be hosting a webinar to discuss emerging opportunities and innovations in the biotechnology and food safety assessment arenas. Learn more!
HESI DART Committee Thyroid Hormone Assessment Workshop
May 9, 2019 – May 10, 2019
Washington, DC, USA
Save the date! HESI DART Committee and European Teratology Society Workshop on Thyroid Hormone Assessment: Implications for Developmental and Reproductive Toxicology
Validation of New Approaches in Genetic Toxicology
May 8, 2019
Newark, Delaware, USA
Novel in vitro and in vivo assays have been developed to improve the reliability of tools employed for identification of genotoxic hazard. Several of the new assays can provide insight into mode-of-action (MoA). As emerging technologies generally used for evaluating human hazard and/or risk, these novel assays require rigorous evaluation and validation before use in a regulatory setting. Validating novel toxicology assaysis a continuing labor-intensive challenge. More specifically, many questions arise around choosing reference compounds, and comparing results against the current standard battery used for genotoxicity testing.
Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune Related Safety Assessments
April 9, 2019 – April 10, 2019
South San Francisco, California, USA
The field of immunotoxicology is a dynamic one in which changing public health concerns, novel biomedical research advances, and innovative technological developments constantly change the landscape and the way in which work is carried out and utilized. As this field requires combined expertise in both immunology and toxicology, the need for continued training and interdisciplinary interactions are critical for those who work within this field. This is essential both for those with an immunology background who seek to apply this expertise to drug development and safety, as well as those who wish to enhance their current drug safety expertise with a deeper understanding of immunology.
- Date: Wednesday, May 22, 2019
- Time: 11 AM - 12:30 PM EST
- Registration: Click here to register.
Speakers:
- Scott McClain, Regulatory Product Safety Scientist, Syngenta Crop Protection (USA), PATB Committee Co-Chair
- Lars Poulsen, Head of Research, Allergy Clinic, Copenhagen University Hospital at Gentofte (Denmark), Member of the COMPARE Database Peer-Review Expert Panel
Advances in agricultural and food biotechnology bring the opportunity to improve the way we grow food and feed crops. As part of the requirements to ensure food safety, it is vital to mitigate potential risks of introducing new allergens or unintended components in the food chain that could induce adverse reactions in humans.
The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee engages international collaborative teams of academics, clinicians, regulators, and industry scientists who conduct research, design and populate public database resources, and convene trainings on the use and evaluation of biotechnology products. The PATB oversees the creation, maintenance, and distribution of the Comprehensive Protein Allergen Resource (COMPARE) Database whose use in conjunction bioinformatic tools, offers an effective means for assessing allergenic potential of novel food proteins.
Webinar attendees will:
- Learn directly from experts in the committee about the nuts and bolts of food safety assessment of biotechnology products, the committee contributions to the field and new emerging issues
- Engage in an interactive discussion about emerging opportunities, challenges, and innovations in the biotechnology and food safety assessment arenas
Recent updates to OECD developmental/reproductive toxicology guidelines and other regulatory guidelines and guidance require the measurement of thyroid hormone levels in the blood of mammalian laboratory species during development. Preliminary analyses indicate that there is a wide variability across laboratories in the methods being used to measure thyroid hormones in young rodents, as well as in the success of obtaining reliable data. Even though publicly available regulatory guidelines and guidance address study design, they allow varied approaches to thyroid hormone measurement in rodents, and an optimal study design or logical approach to thyroid hormone testing in young rodents has not yet been established in a regulatory testing context. Validity, accuracy, sensitivity and reproducibility of the assays are issues of concern. It is not clear to what extent variability in the data can be attributed to methodological issues or to innate biological variability.
WORKSHOP AIMS
- Present the state-of-the-science on thyroid hormone assessments, specifically as it relates to preclinical methods and data collection, and identify gaps and knowledge as it relates to regulatory DART testing,
- Provide clarification and guidance regarding the collection (timing and methods), assessment (standardization and validation), and interpretation of thyroid hormone data (as it relates to adversity) for regulatory toxicology and risk assessment,
- Discuss and come to consensus on recommendations on how to improve data interpretation/understanding of thyroid changes and their relationship to adverse outcomes
WORKSHOP AGENDA
Click here to download the workshop agenda.
Session 1: Setting the Stage
The Thyroid Axis - Overview of Anatomy, Physiology, Regulation in Mammalian SystemsMary Gilbert, U.S. EPA (Download presentation) An AOP Network for Thyroid Hormone Disruption and Adverse Outcomes
Kevin Crofton, R3Fellows, LLC (Download presentation) Mild Thyroid Dysfunction During Pregnancy; Consequences for Pregnancy Outcome and Fetal Development
Robin Peeters, Erasmus University (Download presentation)
Session 2: Methodologies & Interpretation
Regulatory Requirements for Evaluation of Thyroid StatusSue Marty, Dow (Download presentation) Pathology Endpoints: Evaluation of Thyrotoxicants in Animal Studies
Brent Walling, Charles River (Download presentation) Overview of In Vitro Assays to Investigate Chemicals for Thyroid-Axis Disrupting Potential
Michael Hornung, U.S. EPA (Download presentation)
Session 3: Global Thyroid Activities
Overview of Ongoing Thyroid Activities in the European Union and United StatesManon Beekhuijzen, Charles River (Download presentation) HESI DART - ETS Thyroid Hormone Survey - Results & the Path Forward
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