BRINGING CLINICAL TRIALS TO LIFE

TheClinical InvEstigation and ReguL²atory Sciences (CELLS) team has been an integral part of connecting discoveries from Gates Center members, and products manufactured at the Gates Biomanufacturing Facility, to patients at the UCHealth University of Colorado Hospital and Children’s Hospital Colorado. This team of clinical trial and regulatory experts was previously housed in the Office of the Vice Chancellor for Research (oVCR), and was formed in 2020 to serve as a hub for CU Anschutz-sponsored investigational new drug (IND) applications and break down barriers that exist in the complicated regulatory landscape of cell and gene therapy. They successfully developed, submitted, and cleared two INDs and collaborated with campus and hospital partners to operationalize four separate clinical investigations under those INDs. Twenty patients were treated by the end of 2022.

SAME TEAM. NEW NAME. BIGGER GOALS.

The CELLS team, formerly known as the Cell Therapy Operations Program (CTOP), moved from the oVCR into the Gates Institute, where they will build on their previous successes bringing to life Phase I cellular therapy clinical trials. They will continue to develop, operationalize, and oversee clinical trial protocols, while expanding their scope of services to include regulatory support much earlier in the product lifecycle. The team is small but mighty. Cheri Adams, MSHS, RN, RAC, has been instrumental in developing a critical patient safety oversight program and establishing a positive rela- tionship and reputation with FDA project managers. Andrew Roth, PhD, collaborates with site principal investigators and staff to develop robust clinical trial protocols, databases, and obtain the necessary local regulatory approvals. Chanel Mansfield, MPH, CCRP, leads the team administratively, while Michael Verneris, MD, provides medical and scientific oversight.

As the team looks toward a bright future with the Gates Institute, they will continue to foster partnerships including, but not limited to the Hematology Clinical Trials Unit, the Blood and Marrow Transplant team at Children’s Colorado, the Clinical Research Support Team (CReST), and the newly formed IND/IDE office within the oVCR. After all, no one does their best work alone.