Cell and Gene Therapy Trial Management (CGTM)

The CICET Cell and Gene Therapy Trial Management Team (CGTM), led by Vladimir Bermudez, PhD, MBA, PMP, provides dedicated clinical trial management for cell and gene therapy studies at Columbia University Irving Medical Center. The team supports the operational, clinical, regulatory, and financial activities required to advance cell and gene therapy clinical studies across indications safely, efficiently, and in alignment with institutional and regulatory expectations. Through this integrated clinical trial management infrastructure, CGTM supports a growing portfolio of studies across indications, phases, sponsor types, and therapeutic areas.

Cell and gene therapy trials require a high level of coordination because each study depends on multiple interdependent activities, including protocol development, study feasibility, clinical start-up, patient care, manufacturing timelines, safety oversight, regulatory submissions, monitoring, reporting, and closeout. CGTM serves as a central point of alignment for physician-scientists, investigators, sponsors, clinical teams, the CICET Translational Lab, the CICET GMP team, external manufacturing partners, and institutional stakeholders, helping ensure that first-in-human, investigator-initiated, and industry-sponsored trials are operationally feasible, consistently conducted, and centered on patient safety.

Through this integrated approach, CGTM strengthens Columbia’s ability to translate innovative cell and gene therapies into clinical studies across oncology, immune-mediated disease, rare disease, and other areas where engineered cellular and genetic therapies may offer new treatment options.

For questions or to discuss planned clinical trials, please contact CellAndGeneTherapy@lists.cumc.columbia.edu.