April 4, 2018 – April 5, 2018
Munich , Germany
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 ...
March 22, 2018 – March 23, 2018
Potsdam, Germany
Applied genetic toxicology is undergoing a major paradigm shift towards changing the strategies employed for assessment of chemically-induced genomic damage, evaluation methods of the mechanisms by which that damage translates into adverse effects, and the quantitative methods used to interpret dose-response data. This ...
February 14, 2018
London, United Kingdom
HESI's Cell Therapy--TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to present the first workshop of the new Cell and Gene Therapy Catapult seminar series.
January 1, 2018
RISK21 Committee, 2018-2021
A list of RISK21 events from 2018-2021 can be found here: https://risk21.org/trainings-and-events/
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[post_title] => T-Cell Biology and Application to Immunopharmacology and Immunotoxicology Course
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Mirjam Luitjen, RIVM
Kerry Dearfield, Former USDA
Veronique Thybaud, Sanofi & Nicholas Ball, DOW
Roland Frötschl, BfArM, Germany
Stefan Pfuhler, Procter & Gamble
Azeddine Elhajouji, Novartis
Paul White, Health Canada
George Johnson, Swansea University
Background and Objectives
Applied genetic toxicology is undergoing a major paradigm shift towards changing the strategies employed for assessment of chemically-induced genomic damage, evaluation methods of the mechanisms by which that damage translates into adverse effects, and the quantitative methods used to interpret dose-response data. This shift entails a movement away from simple dichotomous evaluations of genotoxicity (i.e., yes/no), that only supports identification of potential carcinogens, and towards a greater understanding of the diversity of adverse outcomes related to genomic damage, of the multitude of mechanisms (or modes of action) underscoring genomic damage, and the ability to determine point of departure metrics for human health risk assessment and regulatory decision making. Moreover, advanced technologies to investigate genotoxic mechanisms and to analyze dose-response functions are being developed and incorporated into assessments of genomic damage.
This workshop was organized by the HESI Genetic Toxicology Technical Committee (GTTC). The HESI GTTC brings together an international cohort of genetic toxicologists from industry, academia, and government to address issues related to all aspects of genetic toxicity assessment. These aspects include the development and validation of assessment approaches, technologies and strategies for mode-of-action determination, and approaches for data interpretation. The GTTC is comprised of experts in the fields of genetic and general toxicology, risk assessment, and computational biology. The workshop will examine a new generation of testing strategy for assessment of genomic damage, new approaches and technologies for mode-of-action determination and interpretation, and recent developments in quantitative interpretation of genetic toxicity dose-response data.
[post_title] => Applied Genetic Toxicity for Regulatory Decision Making: The Road Ahead
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[Download File]
Regulatory Perspective (I)
[Download Presentation]
Regulatory Perspective (II)
[Download Presentation]
Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods
[Download Presentation]
In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products
[Download Presentation]
In vivo tumorigenicity testing for pluripotent stem cell-derived products
[Download Presentation]
iPSC genomic instability and impact on product safety
[Download Presentation]
Industry perspective
[Download Presentation]
Academic/Translational Perspective
[Download Presentation]
HESI’s Cell Therapy–TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to have presented the first workshop of the new Cell and Gene Therapy Catapult seminar series.
Topics and Learning Objectives:
1. Future needs in patient safety of cell-based therapies. Identify challenges and opportunities to enhance the accuracy and efficiency of safety assessment of cell therapy products. Perspectives from a broad range of stakeholders from design to implementation settings.
2. Evolving safety tools and applied safety techniques. Learn about in vivo cell tracking approaches and their role in supporting clinical translation, as well as methods for evaluating the potential tumorigenicity risk of cell-based therapeutic products.
3. Role of collaboration in cell therapy development and use. Explore international opportunities to bridge stakeholders and improve our ability to develop and implement effective standards.
[post_title] => CT-TRACS & Cell and Gene Therapy Joint Workshop: "Safety Assessment of Cell Therapy Products: Current Advances and Challenges"
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[post_title] => RISK21 Past Events
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