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CT-TRACS & Cell and Gene Therapy Joint Workshop: “Safety assessment of cell therapy products: current advances and challenges”

London, UK
2/14/2018
Cell and Gene Therapy Catapult

Workshop Agenda

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Dr. Carla Herberts, Medicines Evaluation Board, Netherlands

Regulatory Perspective (I)

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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

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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.