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.

Recent News

HESI CT-TRACS is proud to be a partner in NC3Rs 2022 CRACK-IT challengeT-ALERT: Animal-free tumourigenicity assessment of CAR-T and other genetically modified T cells”. CRACK-IT challenges provides UK and EU-based academics and SMEs with the opportunity to apply to develop new 3Rs tools, technologies or approaches and engage with new partners. The T-ALERT Challenge aims to develop an in vitro assay that can reliably evaluate tumourigenicity of human-engineered T cell therapies with the potential to be applied to multiple immune cell types.

As a partner, HESI and the CT-TRACS committee will help to create productive relationship between the challenge awardees and organisations that have expertise, data, or other resources that could support successful Challenge dissemination of the resulting technology. The HESI CT-TRACS Tumorigenicity Working Group  will leverage its successful track record of multi-laboratory evaluation of relevant methods and assays in support of tumorigenicity evaluation of cell therapy products in support of the challenge winners.

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

Society of Toxicology Meeting 2023

Nashville, TN, USA

A number of HESI committees will have presentations and posters at the Society of Toxicology Meeting in Nashville, TN.

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American College of Toxicology Annual Meeting

Denver, Colorado, USA

Don’t miss the overview of CT-TRACS’ Advanced Sequencing project as well at a talk by the GTTC on the HESI Nitrosamine Subgroup at the upcoming American College of Toxicology Annual Meeting.

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CT-TRACS at Advanced Therapies 2022 Congress

London, United Kingdom

HESI's Cell Therapy – TRAcking, Circulation & Safety (CT-TRACS) Committee will present preliminary results of their pilot project “New approaches for identification of potential off-target mutations associated with CRISPR genome editing in cell therapies” at the Advanced Therapies 2022 Congress, London, UK, as ...

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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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CT-TRACS Committee and NIH/NHLBI PACT Program Joint Webinar

Webinar, hosted by the National Heart, Lung, and Blood Institute (NHLBI) PACT Program

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Tracking Cells In Vivo and Following Biodistribtion" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program. Cell therapies show great ...

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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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What are your cells doing? Where do they go?

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program.

 

Details:

  • Date: Thursday, 3 September 2020
  • Time: 12:00 PM - 1:00 PM EST
  • Registration: Click here to register.
CT-TRACS Web Seminar Image v2

 

Speakers:

  • Bill Shingleton, PhD, Alliances Manager at Cytiva
  • Brooke Helfer, PhD, Director of Research and Development at Celsense, Inc.
  • David Morrow, PhD, MBA, ATMP and Vaccine Scientific Program Manager at EATRIS

Cell therapies show great therapeutic promise in the fields of regenerative medicine and immunotherapy. To realize their full clinical potential, there is a need for greater understanding of their mode of action, how they migrate after administration to deliver their therapeutic benefits, their persistence at sites of action, and whether their properties, localization, or distribution may cause safety issues. Currently, there are several existing and many emerging tools available to develop pharmacokinetic data on these cell-derived therapies to improve our understanding of the mechanism of action and demonstrate on-target delivery, but adoption by clinical investigators has been limited.

In this web seminar, the CT-TRACS Committee speakers will provide an overview of technologies currently available for use in patients, how these are relevant to evaluate safety and efficacy aspects of cellular therapies, and the importance of collaboration to address challenges and needs facing the translation of cell therapies into the clinic​.

The CT-TRACS Committee provides a neutral platform for cell therapy developers, researchers, regulators, imaging specialists, and other stakeholders to interact, discuss current challenges, and identify best practices to improve confidence in the safety and efficacy of these therapies.

 

Webinar Objectives:

  • To learn about available and emerging noninvasive cell tracking modalities and their value in assessing cell fate and safety in vivo
  • To bring awareness on how the application of existing cell tracking technologies, methods, and best practices can benefit the clinical translation of cell therapies
  • To emphasize the need for dialogue with the international community and discuss opportunities to address the challenges facing the translation of cell therapies into the clinic
  • To understand the importance of therapy developers communicating practical challenges and needs to aid the development of enabling technologies and tools addressing those needs

 

Additional details can be found via the webinar e-flyer here. For more information, please contact the CT-TRACS Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.

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Committee Publications

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 ...

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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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