Past Events

Past Events

ISCT 2018

Montreal, Canada

For the second consecutive year, the CT-TRACS Committee will participate in a 4-day annual meeting organized by the International Society for Cellular Therapy.

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T-cell Biology and Application to Immunopharmacology and Immunotoxicology Course

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 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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Applied Genetic Toxicity for Regulatory Decision Making: The Road Ahead

Potsdam, Germany , United States

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. 

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Workshop Agenda

Workshop Objectives

Mirjam Luitjen, RIVM

Path Forward for Genetic Toxicity Assessment

Kerry Dearfield, Former USDA

The New Strategy in Practice: Case Study Examples

Veronique Thybaud, Sanofi & Nicholas Ball, DOW

Incorporating Mode of Action into Genetic Toxicity Assessment

Roland Frötschl, BfArM, Germany

Novel Approaches and Technologies to Assess Genotoxic Modes of Action

Stefan Pfuhler, Procter & Gamble

Genetic Toxicity Mini-Adverse Outcome Pathways (mini-AOPs)

Azeddine Elhajouji, Novartis

Approaches for Analyses and Interpretation of Genetic Toxicity Dose-Response

Paul White, Health Canada

Quantitative Dose-Response Analyses for Risk Assessment and Regulatory Decision Making: Issues, Applications, and Challenges

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.

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Workshop Agenda

[Download File]

Dr. Carla Herberts, Medicines Evaluation Board, Netherlands

Regulatory Perspective (I)

[Download Presentation]

Dr. James McBlane, MHRA, UK

Regulatory Perspective (II)

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Dr. Keiji Yamamoto, Takeda/FIRM, Japan

Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods

[Download Presentation]

Dr. Yoji Sato, NIHS, Japan

In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products

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Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan

In vivo tumorigenicity testing for pluripotent stem cell-derived products

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Professor Peter Andrews, University of Sheffield, UK

iPSC genomic instability and impact on product safety

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Dr. Bill Shingleton, GE Healthcare, UK

Industry perspective

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Professor Phil Blower, King's College London, UK

Academic/Translational Perspective

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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.

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