This two-day hybrid workshop, co-sponsored by the National Institutes of Health (NIH) and the Health and Environmental Sciences Institute (HESI Global) will bring together experts from government, academia, industry, and other stakeholders to discuss in vivo tracking and biodistribution for cell and gene therapies (CGTs). Participating NIH Institutes and Centers include the National Heart, Lung, and Blood Institute (NHLBI); National Cancer Institute (NCI); National Center for Advancing Translational Sciences (NCATS); National Institute of Neurological Disorders and Stroke (NINDS); and National Institute of Biomedical Imaging and Bioengineering (NIBIB).

The workshop will consider both preclinical and clinical applications, with a focus on how approaches used in these settings can better inform one another. Discussions will cover current methods for assessing the localization, persistence, and fate of CGTs, their strengths and limitations, and key gaps that can make translation from preclinical studies to clinical use challenging.

The meeting will also explore emerging technologies, regulatory considerations, and practical challenges associated with implementing tracking and biodistribution approaches across different therapeutic areas and clinical settings. Through presentations, panel discussions, and breakout sessions, participants will identify research needs and opportunities for collaboration to improve how biodistribution information is generated, interpreted, and applied throughout CGT development.

Workshop Objectives

1. Assess the current state of knowledge for in vivo tracking and biodistribution in organ-specific and disease-specific applications
2. Identify knowledge gaps related to quantifying cells at intended engraftment sites and remote tissues
3. Detail the continuum from preclinical to clinical applications
4. Examine challenges related to accessibility and implementation across multiple sites

Register Here: https://luma.com/r34hzmbl.