Several HESI programs will be featured throughout the meeting.
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 is proud to be a partner in NC3Rs 2022 CRACK-IT challenge “T-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.
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.
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.
Several HESI programs will be featured throughout the meeting.
Dr. Mick Fellows, co-chair of the CT-TRACS Committee was invited to speak about the developments of the committee project on advanced sequencing methods for detection of off-target edits in genome editing, a project that received support from HESI EIC via its “Foresight Proposal” award.
A number of HESI committees will have presentations and posters at the Society of Toxicology Meeting in Nashville, TN.
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.
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 ...
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 ...
Workshop Program Outline (subject to change)
Wednesday, 21 October 2020
Thursday, 22 October 2020
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HESI’s Cell Therapy-TRAcking, Circulation & Safety Technical Committee completed an international, multisite study to evaluate the sensitivity and reproducibility of the highly efficient culture (HEC) assay, an in vitro assay to detect residual undifferentiated human pluripotent stem cells (hPSCs) in cell therapy ...
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 ...
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 ...