Several HESI programs will be featured throughout the meeting.
Environmental Mutagenesis & Genomics Society 54th Annual Meeting
September 9, 2023 – September 13, 2023
Chicago, IL, USA
CGT-TRACS committee is an international network of experts from multiple sectors (public and private sector research scientists, regulators, cell therapy developers, clinicians, imaging experts, and enabling tool developers) who work collaboratively sharing knowledge, experience, and resources to secure the safety of cell and gene therapies.
To facilitate the translation of cell and gene therapies to the clinic by driving the development of tools, methods and knowledge required to evaluate their safety and fate.
The CGT-TRACS Committee is excited to announce an expansion of its focus to include gene therapies as part of its ongoing commitment to advancing safety science in emerging advanced therapies. This addition reflects the growing importance of understanding and addressing safety concerns specific to these cutting-edge gene delivery systems, which are being increasingly utilized in clinical applications. By leveraging our existing expertise and global network, we aim to foster the development of best practices, innovative tools, and collaborative projects to support the safe translation of gene therapies to the clinic.
A group of experts was convened in 2024 (from within existing participating organizations, as well as potential new future partners with a focus on gene therapy development) to identify key needs and gaps. Two new project proposals were developed and endorsed by the committee in 2024 and have been launched in Q1 of 2025:
The committee is welcoming new partners with expertise in gene therapies development and their nonclinical safety assessment, with interest in advancing the field of safety science. Through our collaborative, pre-competitive forum, we aim to build a robust network of contributors. Reach out to committee managers Lucilia Mouriès and Connie Chen to express your interest and learn more.
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.
Senior Advisor, Center for Patient and Consumer Safety (CPCS)
lmouries@hesiglobal.orgMedicines Evaluation Board, The Netherlands
AstraZeneca
September 9, 2023 – September 13, 2023
Chicago, IL, USA
Several HESI programs will be featured throughout the meeting.
June 1, 2023
Paris, France
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.
March 19, 2023 – March 23, 2023
Nashville, TN, USA
A number of HESI committees will have presentations and posters at the Society of Toxicology Meeting in Nashville, TN.
Cytotherapy, 2025
STEM CELLS Translational Medicine, 2024
This study addresses a critical safety concern in regenerative medicine—the presence of residual undifferentiated pluripotent stem cells (PSCs) in cell therapy products (CTPs), which poses a risk of tumor formation.
Regenerative Medicine, 2023
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 ...
Cytotherapy, 2021
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 ...
Cytotherapy, 2019
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 ...
The Cell and Gene Therapy – TRAcking, Circulation, & Safety (CGT-TRACS) Committee is part of the Center for Patient and Consumer Safety. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.
Other Committees in the Center for Patient and Consumer Safety:
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403
740 15th Street NW, Suite 600
Washington, DC 20005
Sign up for our monthly e-newsletter.