Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee

 

Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee

Mission Statement

 

To establish a platform where an international network of experts from multiple sectors (public and private sector research scientists, regulators, clinicians, health foundations, and technology developers) can collaborate sharing knowledge, experience and resources in the rapidly evolving field of cell therapy.

HESI CT-TRACS Survey: “Assessing the Needs for Cell-Based Therapies Translation”

CT-TRACS developed a survey to hear directly from the stakeholders with hands-on experience about the current gaps and needs encountered at the stage of safety evaluations of cellular therapies. The survey reflects the two areas of focus of this HESI Emerging Issues sub-committee: 1) tracking cells in vivo at the point of administration and short term biodistribution; and 2) methods of evaluation for tumorigenicity safety. The results of this survey will be included in future committee publications.

To complete the online survey, please click here.

Committee Contacts

HESI Staff

Lucilia Mouries, PhD
lmouries@hesiglobal.org

 

Leadership Team

William Shingleton, PhD
GE Healthcare

Carla Herberts, PhD
Medicines Evaluation Board

Members and Fact Sheet

Committee Events

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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)

[Download Presentation]

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

[Download Presentation]

Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan

In vivo tumorigenicity testing for pluripotent stem cell-derived products

[Download Presentation]

Professor Peter Andrews, University of Sheffield, UK

iPSC genomic instability and impact on product safety

[Download Presentation]

Dr. Bill Shingleton, GE Healthcare, UK

Industry perspective

[Download Presentation]

Professor Phil Blower, King's College London, UK

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.

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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)

[Download Presentation]

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

[Download Presentation]

Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan

In vivo tumorigenicity testing for pluripotent stem cell-derived products

[Download Presentation]

Professor Peter Andrews, University of Sheffield, UK

iPSC genomic instability and impact on product safety

[Download Presentation]

Dr. Bill Shingleton, GE Healthcare, UK

Industry perspective

[Download Presentation]

Professor Phil Blower, King's College London, UK

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.

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Society for Immunotherapy of Cancer (SITC) Meeting

Join the Society for Immunotherapy of Cancer (SITC) for the 32nd Annual Meeting & Pre-Conference Programs Nov. 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Md.

Brooke Helfer will be presenting a poster developed by the CT-TRACS committee for the "Emerging Models and Imaging" conference: Cell Therapy--TRAcking, Circulation, & Safety (CT-TRACS): The Health and Environmental Sciences Institute (HESI)'s New Collaborative Effort to Address the Challenges of Cell Therapies Translation. Brooke Helfer, Carla Herberts, Jan Willem van der Laan, Vladimir Ponomarev, William Shingleton, Keiji Yamamoto, Lucilia Pereira Mouries.

The poster sessions will occur in the poster hall on Friday, November 10 from 12:30-2:00 PM and 6:30-8:00 PM. The poster ID is P299.

 

Committee Publications

All Publications

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