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HESI Cardiac Safety FDA Workshop

Silver Spring, USA

Save the date! HESI-FDA Public Workshop on Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities

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Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune Related Safety Assessments

South San Francisco, California, USA, 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.

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				Thyroid Workshop_Logo1 (003)
	

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

  1. 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,
  2. 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,
  3. Discuss and come to consensus on recommendations on how to improve data interpretation/understanding of thyroid changes and their relationship to adverse outcomes
dreamstime_s_127655942

WORKSHOP AGENDA

Click here to download the draft workshop agenda.

REGISTRATION DETAILS

Click here to register for the Thyroid Hormone Assessment Workshop. Questions? Contact Connie Chen (cchen@hesiglobal.org) for more information.

HOTEL INFORMATION

Washington Plaza Hotel
10 Thomas Circle NW
Washington, DC 20005

Room rate: $279 per night
Deadline to book room: Friday, April 5, 2019
Click here to reserve your room within the room block or call 1-800-424-1140 and reference the HESI DART Committee Spring Meeting.

Nearby Hotels
Click here for a map to nearby hotels to the office. An additional negotiated rate for 2019 is available at the Hamilton Hotel. Click on the icon within the map for additional information.

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Related Events

2019 Safety Pharmacology Society (SPS) Annual Meeting
Centre de Convencions Internacional de Barcelona
Barcelona, Spain
September 23–26, 2019

For more information regarding the agenda and to register for the meeting, please visit the website.