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.

Call for Participants (March 2021): International Collaborative Study for the Identification of Off-Target Mutations Associated with Genome Editing

The CT-TRACS Committee is seeking additional partners (academic/research institutions, government agencies, non-profit institutions, private sector companies, or CROs) for an international collaborative project focused on advancing the application of sequencing technologies for identification and evaluation of off-target mutations that may be associated with genome editing via CRISPR Cas9. This initiative aims to advance the implementation of novel cell and gene therapies by improving the science underlying their safety evaluation. For full details on study objectives, rationale, roles for project partners, and instructions on how to express interest, please read the call for participants description document here.

Working Groups

  • Point of Administration-Biodistribution (PoA/BD) Working Group (Cell Tracking)

    This working group aims to identify current approaches, gaps, and needs in monitoring/evaluating the fate and activity of cells after their administration in vivo, to assess the safety of cell-based therapies.

  • Tumorigenicity Working Group

    This working group aims to address concerns regarding the potential for tumorigenicity of PSC-derived products by assessing and/or developing methodologies and approaches that could support tumorigenicity evaluation.

HESI Staff

Leadership Team

  • Tineke van den Hoorn, PhD

    Medicines Evaluation Board, The Netherlands

  • Mick Fellows, PhD

    AstraZeneca

Committee Events

Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee Regulatory Perspectives Webinar

Zoom webinar, co-organized by EATRIS and the HESI CT-TRACS Committee

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar on September 28, 2021 featuring three speakers who will share regulatory perspectives from both sides of the Atlantic. This activity is party of the CT-TRACS Committee's efforts to continue filling the knowledge gap about ...

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Next Generation CAR & T-Cell Therapies Conference

Virtual conference, hosted by Informa Connect

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee will be represented at the Next Generation CAR & T-Cell Therapies Conference on June 22, 2021 from 10:30am-10:50am PST in a presentation titled "Creating a Feedback Loop Between Clinical Trials and Translational Science for Product ...

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The HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is hosting a virtual workshop focusing on the state of the science for a wide array of protein toxins classes, MOAs, structures, activity, and general biology. Additionally, the workshop will cover the bioinformatics analysis of protein toxins and how to leverage computational biology for protein toxins identification/characterization, with in silico approaches.

The Protein Toxins Workshop will serve the dual purpose of learning from the experts in the field about the state of the science as well as assessing the translation of knowledge to practical applications, e.g., into weight-of-evidence approaches for the safety assessment of biotechnology products. The workshop aims to gain insight into how feasible/useful (or not) a protein toxin database could be in risk assessment/product development. This meeting will serve as an informational platform about HESI and will demonstrate the advances in protein toxins research, presented by international experts, and will help inform the development of novel approaches for the identification and classification of potential toxicity risk in novel proteins.

Details

  • Date: Wednesday, 21 October 2020 - Thursday, 22 October 2020
  • Time: 9:00 AM - 12:00 PM EST
  • Registration: Details coming soon
PATC_resize

Workshop Program Outline (subject to change)

Wednesday, 21 October 2020

  • 9:00 AM - Opening Remarks (Dr. Laura Privalle, BASF Corporation)
    • From protein toxins to biotechnology products
    • Setting the stage; considerations for publication of meeting report
  • 9:30 AM - Brief Codex Discussion
    • Allergenicity assessment vs. toxins/toxicity assessment
  • 10:00 AM - Terrestrial Toxins
  • 11:30 AM - Marine Toxins

 

Thursday, 22 October 2020

  • 9:00 AM - Bacterial Toxins
  • 10:30 AM - Bioinformatics & Computational Biology in Protein Toxins Research

 

For more information, please contact the PATB Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.

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The HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is hosting a virtual workshop focusing on the state of the science for a wide array of protein toxins classes, MOAs, structures, activity, and general biology. Additionally, the workshop will cover the bioinformatics analysis of protein toxins and how to leverage computational biology for protein toxins identification/characterization, with in silico approaches.

The Protein Toxins Workshop will serve the dual purpose of learning from the experts in the field about the state of the science as well as assessing the translation of knowledge to practical applications, e.g., into weight-of-evidence approaches for the safety assessment of biotechnology products. The workshop aims to gain insight into how feasible/useful (or not) a protein toxin database could be in risk assessment/product development. This meeting will serve as an informational platform about HESI and will demonstrate the advances in protein toxins research, presented by international experts, and will help inform the development of novel approaches for the identification and classification of potential toxicity risk in novel proteins.

Details

  • Date: Wednesday, 21 October 2020 - Thursday, 22 October 2020
  • Time: 9:00 AM - 12:00 PM EST
  • Registration: Details coming soon
PATC_resize

Workshop Program Outline (subject to change)

Wednesday, 21 October 2020

  • 9:00 AM - Opening Remarks (Dr. Laura Privalle, BASF Corporation)
    • From protein toxins to biotechnology products
    • Setting the stage; considerations for publication of meeting report
  • 9:30 AM - Brief Codex Discussion
    • Allergenicity assessment vs. toxins/toxicity assessment
  • 10:00 AM - Terrestrial Toxins
  • 11:30 AM - Marine Toxins

 

Thursday, 22 October 2020

  • 9:00 AM - Bacterial Toxins
  • 10:30 AM - Bioinformatics & Computational Biology in Protein Toxins Research

 

For more information, please contact the PATB Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.

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Committee Publications

Options for Imaging Cellular Therapeutics In Vivo: A Multi-Stakeholder Perspective

Cell-based therapies have been making great advances toward clinical reality. Despite the increase in trial activity, few therapies have successfully navigated late-phase clinical trials and received market authorization. One possible explanation for this is that additional tools and technologies to enable their ...

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Tumorigenicity Assessment of Cell Therapy Products: The Need for Global Consensus and Points to Consider

Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated cells or transformed cells. Here, we critically review currently available ...

Read more

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