Info
Talk Summary:
In oncology, autoimmune disease, and regenerative medicine, non-invasive clinical imaging plays a critical role across diagnosis, treatment planning and delivery, response assessment, and longitudinal follow-up. As ex vivo and in vivo cell and gene therapies (CGT) emerge as promising treatment modalities, molecular imaging can provide additional insight into critical development questions, particularly at solid-organ disease sites: Where did the therapeutic cells go? Did they reach and penetrate the intended site? Are their localization and persistence associated with dose, safety, or treatment response?

Using examples from MRI/CEST, MPI, PET/SPECT, CT, ultrasound, and other emerging approaches – including applications in brain cancer – this talk will illustrate how quantitative imaging data can be connected to specific CGT development and clinical pharmacology questions. Seeing that cells are present is one step; understanding whether that information addresses a biodistribution and safety requirement, informs delivery or dosing strategy, identifies on- or off-target localization, or helps relate targeting to treatment response is what makes the data actionable for developers.

The discussion will then examine what is required to move an imaging probe or technology from technical feasibility toward practical use and adoption – including sensitivity and specificity, quantitative performance, impact on the cell product, workflow and accessibility, fit with existing clinical practice, integration into drug-development workflows, and regulatory considerations. Selected VisiCELL examples, together with published cell-tracking studies, will illustrate how the development question and intended use influence the data that need to be generated and the way an imaging probe or technology is ultimately designed and applied.

As cell and gene therapies become more complex and increasingly move toward in vivo engineering approaches, the need for actionable imaging will continue to grow. The talk will close with a broader question for the molecular imaging community: How do we move beyond demonstrating biological and imaging feasibility toward generating evidence that informs development and clinical decisions – and how can we work together toward clearer translational and regulatory pathways that enable promising non-invasive imaging technologies to better support CGT development and improve patient outcomes in clinical trials and clinical care?

Presenter Biography:
Mya S. Thu, MSc, MBA, is Co-Founder and CEO of VisiCELL Medical, where she leads the translation and commercialization of molecular imaging technologies for cell and gene therapy. She brings more than 20 years of experience spanning theranostic nanomaterials, stem and immune cell labeling, multimodality imaging, technology development, and biotechnology company building. Her earlier scientific work included research at City of Hope Medical Center and the National Institutes of Health, contributing to the development and translation of imaging approaches for tracking cells in vivo. Mya is a named inventor on VisiCELL’s international patent family covering its proprietary cell-tracking imaging-agent technology. She was first author of foundational in vivo cell-tracking research published in Nature Medicine. Today, she leads the development of VisiCELL’s “GPS for Cell Therapy” platform, integrating imaging agents, multimodality imaging, and quantitative analytics to understand therapeutic-cell biodistribution, trafficking, persistence, and response from translational research through clinical development. She has also contributed to two successful biotechnology startup exits, including an IPO and an acquisition, and leads VisiCELL’s corporate strategy, strategic partnerships, capital formation, and commercialization. Beyond VisiCELL, Mya serves as Industry Co-Chair of the Point of Administration/Biodistribution Workgroup within HESI’s CGT-TRACS initiative, helping advance the cell and gene therapy field through cross-sector scientific collaboration, education, surveys, publications, and primary research initiatives. She holds engineering degrees from the University of Southern California and an MBA from the Rady School of Management at UC San Diego.

Author
Mya S. Thu
VisiCELL Medical Inc.